Bowel Management Devices

Number: 0522

Table Of Contents

Policy
Applicable CPT / HCPCS / ICD-10 Codes
Background
References

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Policy

Scope of Policy

This Clinical Policy Bulletin addresses bowel management devices.

1. Medical Necessity

   Aetna considers the following bowel management devices medically necessary:

   1. Manual pump enema systems (e.g., Peristeen Anal Irrigation System, Coloplast, Minneapolis, MN) for the management of chronic neurogenic bowel when initial management involving diet, bowel habit, laxatives or constipating mediations has failed
   2. Gravity-administered enema systems for the treatment of constipation, fecal incontinence, and bowel management protocols
   3. Use of a stent for bowel obstruction due to colorectal malignancy for palliation and as a bridge to surgery.

2. Experimental and Investigational

   Aetna considers the following experimental and investigational because their effectiveness has not been established:

   1. Ingestible vibrating capsule devices (e.g., Vibrant System) for the treatment of constipation;
   2. Manual pump enema systems for the treatment of idiopathic constipation and treatment of fecal incontinence;
   3. Pulsed irrigation and evacuation systems (e.g., Pulsed Irrigation Evacuation (PIE), P.I.E. Medical Inc., Buford, GA) for persons with chronic constipation. Note: Consistent with Medicare policy, pulsed irrigation evacuation systems are not covered because they are considered institutional equipment;
   4. Rectal inserts and related accessories.

3. Related Policies

   • CPB 0429 - Bathroom and Toilet Equipment and Supplies - for toilet seats, raised toilet seats, toilet seat lift mechanisms, bidets and bidet toilets
   • CPB 0533 - Urologic Supplies - for incontinence garments (e.g., briefs, diapers) and disposable underpads
   • CPB 0611 - Fecal Incontinence

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Table:

CPT Codes / HCPCS Codes / ICD-10 Codes

Code	Code Description
Other CPT codes related to the CPB:
99511	Home visit for fecal impaction management and enema administration
Gravity-administered enema systems:
HCPCS codes covered if selection criteria is met:
A4458	Enema bag with tubing, reusable
ICD-10 codes covered if selection criteria is met:
K59.00 - K59.09	Constipation
R15.0 - R15.9	Fecal incontinence
Manual pump enema system:
HCPCS codes covered if selection criteria is met:
A4453	Rectal catheter for use with the manual pump-operated enema system, replacement only
A4459	Manual pump-operating enema system, including balloon, catheter and all accessories, reusable, any type [covered for chronic neurogenic bowel when initial management involving diet, bowel habit, laxatives or constipating medications have failed] [not covered for idiopathic constipation and treatment of fecal incontinence]
HCPCS codes not covered for indications listed in the CPB:
E0350	Control unit for electronic bowel irrigation/evacuation system
E0352	Disposable pack (water reservoir bag, speculum, valving mechanism and collection bag/box) for use with the electronic bowel irrigation/evacuation system
ICD-10 codes covered if selection criteria is met:
K59.2	Neurogenic bowel [chronic]
ICD-10 codes not covered for indications listed in the CPB (not all inclusive):
K59.00 - K59.09	Constipation
R15.0 - R15.9	Fecal incontinence
Bowel management devices:
CPT codes covered if selection criteria is met:
Stent for bowel obstruction - no specific code
HCPCS codes covered if selection criteria is met:
Bowel management devices - no specific code
HCPCS codes not covered for indications listed in the CPB:
A9268	Programmer for transient, orally ingested capsule
A9269	Programable, transient, orally ingested capsule, for use with external programmer, per month
ICD-10 codes covered if selection criteria is met:
K56.600 - K56.699	Other and unspecified intestinal obstruction
ICD-10 codes not covered for indications listed in the CPB:
K59.00 – K59.09	Constipation

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Background

Generally accepted standard treatments for chronic constipation include: minimization of use of any medications known to cause constipation; correction of metabolic abnormalities (e.g., hypothyroidism) that may contribute to constipation; exercise; increased fluid intake; increase dietary fiber; and bulk (fiber) forming laxatives.  In addition, hyper-osmotic laxatives (e.g., lactulose, magnesium hydroxide, and sorbitol), enemas, and emollient laxatives (docusate sodium) are used in selected cases.

Pulsed Irrigation Evacuation (PIE)

A pulsed irrigation evacuation system is a colorectal irrigation system that consists of an irrigation fluid holding chamber, a rectal catheter with an inflatable balloon and an electric pump. Irrigation fluid is administered in a pulsatile manner to hydrate stool to a semi-liquid form and allow the liquefied stool to evacuate. 

Pulsed irrigation evacuation (PIE) (P.I.E. Medical Inc., Oakwood, GA) has been used for bowel management of chronic constipation patients without voluntary bowel control (e.g., paraplegics, quadriplegics, and spina bifida, etc.).  Pulsed irrigation evacuation has been described as an automated enema in which small pulses of warm tap water are delivered into the rectum, serving to rehydrate feces and promote peristalsis.  The system consists of a speculum, tubing, a disposable collection container, and an electrical unit that delivers positive and negative air pressure through the tubing.  The device was cleared by the Food and Drug Administration (FDA) based on a 510(k) application due to its substantial equivalence to pre-amendment devices.   Hence, the manufacturer was not required to present clinical efficacy data to the FDA.

The published evidence of efficacy of PIE in patients with conditions predisposing them to chronic constipation is limited to several uncontrolled case series.  Most of the published studies are from the experience of a single investigator.

However, the only comparative study of PIE compared the device to a standard per-oral colonic lavage in patients undergoing colonoscopy preparation.  The study found PIE equivalent to, but not superior to, standard per-oral lavage.

There are no comparative studies of PIE in patients with conditions predisposing them to fecal impaction.  Hence, the value of PIE in place of or in addition to a standard bowel regimen in these patients has not been demonstrated.  Reviews on chronic constipation by Lembo and Camilleri (2003) as well as by Talley (2004) did not include PIE as a tool for managing patients with this condition.

Guidelines from the Paralyzed Veterans of America (1998) concluded that "the research is insufficient to support recommendations" for PIE.  "Randomized controlled trials involving people with varying levels of SCI [spinal cord injury] should be conducted to determine the efficacy and safety of this treatment.  Such studies will provide data on risk of autonomic dysreflexia and indications of when and when not to use this technique".

The Peristeen Anal Irrigation System

A manual pump enema system describes a device used to empty the lower bowel and to prevent chronic constipation and fecal incontinence or simply as a method of bowel management. An enema system consists of an irrigation fluid holding chamber and a rectal catheter (with or without an inflatable balloon). Fluid is instilled either via a manual pump.

The Peristeen Anal irrigation (PAI; also known as rectal irrigation and trans-anal irrigation) is a method for bowel management; it is used to prevent chronic constipation and fecal incontinence. The PAI can be administered either on one’s own or with assistance. The PAI consists of a control unit with a pump, a water bag and a rectal catheter. The water bag is designed to stand on the floor and can easily be moved around. The rectal catheter is small, smooth, and discreet that facilitates easy insertion into the rectum. The soft balloon ensures that the rectal catheter is fixed inside the bowel so both hands are free during the irrigation.

In a multi-center study, Del Popolo et al (2008) evaluated the effects of the PAI on neurogenic bowel dysfunctions (NBD) and patient quality of life (QoL). A total of 36 patients with unsatisfactory treatment of NBD were enrolled from Spinal Units and Rehabilitation Centers in Italy. Treatment was for 3 weeks using a newly developed integrated system with an enema continence catheter for trans-anal irrigation (Peristeen, Coloplast A/S Kokkedal Denmark). Lesion level, ambulatory status and hand functionality were determined in all patients. Symptoms of NBD and QoL were evaluated before and after treatment, using a specific questionnaire. Statistical analysis was performed using McNemar Test and Sign Test. Of the 36 enrolled patients, 32 patients completed the study. At the end of the treatment, 28.6 % of patients reduced or eliminated their use of pharmaceuticals; 24 (75 %) patients became less dependent on their caregiver. There was a significant increase in patients' opinion of their intestinal functionality (p = 0.001), QoL score (p = 0.001) and their answers regarding their degree of satisfaction (p = 0.001). A successful outcome was recorded for 68 % of patients with fecal incontinence, and for 63 % of patients with constipation. The authors concluded that the PAI is a simple therapeutic method for managing NBD and improving QoL. It should be considered as the treatment of choice for NBD, playing a role in the neurogenic bowel analogous to that of intermittent clean catheterization in bladder treatment.

Christensen et al (2009) estimated the cost-effectiveness of trans-anal irrigation using a self-administered irrigation system when compared with conservative bowel management.  A randomized clinical trial was conducted at 5 spinal centers situated in Denmark, Germany, Italy, United Kingdom and Sweden.  Estimates of resources and unit costs were made for the German health care system.  Efficacy outcomes were drawn from a randomized controlled trial (RCT) conducted in 2003 to 2005.  Adult SCI patients with NBD were randomized to 10 weeks with either PAI or to conservative bowel management.  Costs were calculated based on results from the clinical trial and on 24 interviews conducted in Germany.  Unit costs were obtained from the Federal Statistical Office Germany and product list prices.  When comparing outcome measures at termination, trans-anal irrigation significantly reduced symptoms of NBD.  Product-related costs were higher for PAI; however, costs for a care-giver to help with bowel management and changes/washing due to leakage were lower.  For PAI, costs associated with urinary tract infections and patient time spent were reduced.  Thus, the total cost to society is lower when patients use PAI.  The results were shown to be robust in the sensitivity analysis.  The authors concluded that trans-anal irrigation using a self-administered system reduced symptoms of NBD and resulted in a lower total cost to society than conservative bowel management.

Neel (2010) prospectively evaluated the effectiveness and durability of combined intra-detrusor botulinum-A toxin and endoscopic treatment for vesicoureteral reflux with anal irrigation as a total endoscopic and anal irrigation management approach.  This minimally invasive protocol is used to manage myelomeningocele and non-compliant bladder in children who do not respond to standard conservative therapy and have urine and stool incontinence.  A total of 13 patients (10 females and 3 males with a mean +/- SD age of 5.3 +/- 2.5 years) with myelomeningocele and vesico-ureteral reflux (VUR) who did not respond to standard conservative treatment were prospectively included in this study.  All had at least 1 year of follow-up.  All patients received a cystoscopic intra-detrusor injection of 12 U/kg (maximum 300 U) botulinum-A toxin into an infection-free bladder.  Vesico-ureteral reflux in a total of 20 refluxing ureters, including bilateral VUR in 7 patients, showed no resolution on pre-treatment voiding cystourethrogram.  Thus, these investigators administered a submucosal Deflux injection.  Since most patients were still diaper-dependent due to stool incontinence, these researchers extended management to include complete bowel rehabilitation with the PAI to manage stool incontinence.  Mean maximum bladder capacity increased significantly from 75 +/- 35 to 150 +/- 45 ml after 1 month (p < 0.02), to 151 +/- 48 after 6 months (p < 0.002) and to 136 +/- 32 after 1 year (p < 000).  Maximum detrusor pressure decreased significantly from 58 +/- 14 to 36 +/- 9 cm H(2)O after 1 month (p < 0.001), to 39 +/- 9 after 6 months (p < 0.001) and to 38 +/- 6 after 1 year (p = 000).  Of 20 refluxing ureters, 95 % completely resolved, including 1 after the 2nd attempt; and 1 with grade-V VUR remained unchanged despite 2 attempts. Seven of 8 urinary incontinent patients (87.5 %) attained complete dryness between catheterizations and 1 partially improved. Ten of 13 patients achieved stool dryness with the PAI 1 to 2 times weekly; 3 patients who were stool continent on standard enemas did not require this irrigation system.  The authors concluded that this new total endoscopic and anal irrigation management approach is a comprehensive, minimally invasive, safe, simple, effective way to achieve most goals when treating these patients by protecting the upper tract, maintaining the bladder at safe pressure and providing a satisfactory social life with satisfactory urine and stool continence.

Rosen et al (2011) stated that trans-anal irrigation has been reported to be a cheap and effective treatment for the “anterior resection syndrome (ARS)”.  In a prospective study, these researchers evaluated the effect of trans-anal irrigation on the QoL of patients suffering from ARS.  A total of 14 patients (11 males; median age of 68 (45 to 80) years) were included in the study.  The median duration of ARS was 19 (9 to 48) months.  The median number of defecations was 8 (4 to 12)/day and 3 (2 to 5)/night.  All patients were trained to perform trans-anal irrigation using the PAI under the guidance of a stoma nurse.  Anal physiology was performed; QoL was estimated by the SF-36 and Rockwood (ASCRS) questionnaires and continence by the Cleveland Incontinence Score.  At the last follow-up, the median time of using trans-anal irrigation was 29 (15 to 46) months.  The median volume of water used for the irrigation was 900 (500 to 1,500) ml.  There was a significant decrease in the number of defecations during the day (baseline, 8 [4 to 12]; last follow-up, 1 [1 to 2]) and at night (baseline, 3 [2 to 5]; last follow-up, 0 [0 to 0]).  The Cleveland Incontinence Score fell from 17 [15 to 20] (baseline) to 5 [4 to 9] (last follow-up) and the mental component of the SF-36 and all domains of the Rockwood quality of life (QOL) instrument improved.  The authors concluded that trans-anal irrigation was an effective treatment of anterior resection syndrome and resulted in a marked improvement of the continence score and QoL.

Corbett et al (2014) reported their 5-year experience with the PAI to manage children with fecal incontinence secondary to myelomeningocele, Hirschsprung disease, and anorectal anomalies.  This study was a combination of a retrospective case note review and assessment using a validated QoL questionnaire to determine pre- and post-PAI bowel function and continence.  Functional outcomes and QoL scores before and during PAI use were compared using Wilcoxon matched pairs test (p < 0.05 significant).  A total of 24 children (median age of 6 years) were managed with the PAI to treat fecal incontinence; 3 did not tolerate the system.  Median QoL scores in 20 out of 21 patients using the PAI demonstrated significant improvement in bowel management and continence; 2 discontinued use due to failure to improve continence; 1 underwent the Malone antegrade continence enema (MACE) procedure and 1 returned to oral/rectal medications; 19 of 24 patients (79 %) continued using the PAI.  The authors concluded that the PAI is a safe, effective, non-operative alternative to MACE in children with fecal incontinence, if initial compliance can be achieved.

Alenezi et al (2014) evaluated the effectiveness of the PAI, as a stool cleansing mechanism, to gain stool continence in children who need reconstructive bladder surgery and have fecal incontinence.  These investigators prospectively evaluated children with neuropathic bladder and bowel dysfunction who were intended for reconstructive bladder surgery and the MACE procedure.  All patients were started on the PAI at least 3 months before surgery to assess their response.  Each patient's bowel function, frequency of using the system, satisfaction (and that of their parents) and diaper independency were evaluated before and after reconstructive surgery.  These investigators included 18 patients (11 females, 7 males) who were evaluated from April 2006 to the present.  The mean age of the group was 7.6 years (range of 4 to 15); 15 patients (83.3 %) showed complete dryness from stools.  Of the 15 patients, 8 (53.3 %) were able to be diaper-free, while 6 continued wearing diapers due to fear of soiling and 1 due to urinary incontinence.  Patients underwent reconstructive bladder surgery and continued to use the PAI with the same results post-operatively.  The authors concluded that these initial results suggested that the PAI is a successful conservative substitute for the MACE procedure in children who require reconstructive bladder surgery.

Pacilli et al (2014) examined the effectiveness of the PAI in a series of children with incontinence or constipation and overflow soiling.  Irrigations were performed with a volume of 10 to 20 ml/kg of water with schedules depending on patient response.  Data were reported as median (range).  A total of 23 patients were reviewed.  Median age at commencement of irrigations was 7 (2 to 15) years.  Median follow-up was 2 (0.7 to 3.4) years.  Diagnoses include the following: spina bifida (n = 11), anorectal anomaly (n = 6), Hirschsprung's (n = 1), and other complex anomalies (n = 5).  Sixteen (70 %) patients had associated anomalies; 12 (52 %) had constipation and overflow soiling, and 11 (48 %) had fecal incontinence; 20 (87 %) had associated urinary wetting.  Sixteen (70 %) children used alternate-day irrigations, 4 (17 %) used daily irrigations, and 3 (13 %) used every 3rd-day irrigations; 9 (39 %) patients were taking oral laxatives.  Sixteen (70 %) reported to be clean and 3 (13 %) reported a significant improvement with occasional soiling; 4 patients (17 %) did not tolerate the irrigations and underwent subsequent colostomy formation for intractable soiling.  The authors concluded that in their experience, the PAI is an effective method of managing patients with focal soiling in childhood.  The majority (83 %) of children achieved social fecal continence or a significant improvement with occasional soiling.  This was accompanied by high parental satisfaction.  They stated that the PAI is a valid alternative to invasive surgical procedures and should be considered the first-line of treatment for bowel management in children with soiling where simple pharmacological maneuvers failed to be effective.

Midrio et al (2016) presented the results of a multi-center study using the PAI in a group of pediatric patients with ano-rectal malformations (ARM) and congenital or acquired spinal cord lesions (SCL).  A total of 8 Italian pediatric surgery and spina bifida centers participated in the study.  The inclusion criteria were age between 6 to 17 years, weight above 20 kg, and unsatisfactory bowel management.  Patients with chronic inflammatory bowel disease, mental disability and surgery within the previous 3 months were excluded.  At the beginning of treatment (T0) and after 3 months (T1), the Bristol scale, a questionnaire assessing bowel function and 2 questionnaires on QoL for patients aged 6 to 11 years (CHQ pf50) and 12 to 17 years (SF36) were administered.  A total of 83 patients were enrolled, and 78 completed the study (41 ARM, 37 SCL).  At T1, constipation was reduced in ARM from 69 % to 25.6 % and in SCL from 92.7 % to 41.5 %, fecal incontinence in ARM from 50 % to 18.6 %, and in SCL from 39 % to 9.8 % and flatus incontinence in ARM from 20.9 % to 9.8 %, and in SCL from 31.7 % to 10 %. At T0, the Bristol Stool Scale types were 1 to 2 in 45 % of ARM and 77.5 % of SCL patients, whereas at T1 types 1 to 2 were recorded in only 2.5 % of SCL patients; QoL improved in both groups.  In the younger group, a significant improvement in QoL was recorded in ARM patients for 8 of 9 variables and in SCL patients for 7 of 9 variables.  The authors concluded that the findings of this study showed that the PAI resulted in a significant time reduction in colonic cleansing, increased independence from the care-giver, and improved QoL in pediatric patients with ARM and SCL.

The United Kingdom’s NHS assessment on “Transanal Irrigation/Rectal Irrigation Systems” (2015) states that “For fecal incontinence in adults, the NICE CG49 recommends rectal irrigation as one of a number of options following failure of initial management involving diet, bowel habit, toilet access, medication and coping strategies.  The NICE CG99 does not recommend transanal irrigation as an option for the management of idiopathic constipation in children, due to a lack of robust evidence for this indication”.

Trans-Anal Irrigation

In a prospective study, Juul and Christensen (2017) examined the effect of trans-anal irrigation (TAI) on bowel function and QOL in a cohort of Danish patients with FI or constipation.  Patients with FI or constipation of heterogeneous origin were treated by a specialist nurse at the Anal Physiology Clinic/Department of Surgery at Aarhus University Hospital, Aarhus, Denmark.  If satisfactory results were not obtained after conservative bowel management, patients were instructed in the use the TAI procedure and were consecutively recruited for this observational cohort study in the period from March 2010 to September 2013.  Patients completed questionnaires regarding bowel function, QOL and the TAI procedure at baseline and after 12 months.  A total of 507 were introduced to TAI; 83 % were women; the median age was 56 (range of 19 to 86) years.  At follow-up, 216 (43 %) patients still used TAI, 174 (34 %) reported that they had discontinued the treatment for various reasons, while no response was obtained from the remaining 117 (23 %) patients.  The main reason for not adhering to the treatment was an unsatisfactory outcome, which was reported by 86 (49.4 %) of those who discontinued the treatment.  Among patients still using the procedure at follow-up, a statistically significant improvement of bowel function scores (St. Marks/Wexner incontinence score, Wexner constipation score and obstructed defecation syndrome score) was detected: the Wexner incontinence score decreased from 12.4 at baseline to 10.2 at follow-up (p < 0.001); the St. Marks incontinence score decreased from 14.9 to 12.7 (p < 0.001); the Wexner constipation score decreased from 14.3 to 12.4 (p < 0.001); and the obstructed defecation syndrome score also dropped, from 15.1 to 11.8 (p < 0.001).  Furthermore, the influence of bowel dysfunction on daily activities and QOL diminished significantly, while the general satisfaction with bowel function increased significantly (p < 0.001 in all 3 measures).  The authors concluded that bowel function and QOL improved in the group of patients adhering to TAI after 12 months.  However, more than 1/3 of the patients discontinued the treatment within the 1st year with TAI.  Thus, further studies are needed to identify factors predicting success and failure with this treatment and to improve supervision during initiation and follow-up.

In a retrospective study, Gimenez Aleixandre and colleagues (2019) reported their findings with TAI for the treatment of FI and fecal constipation without response to other therapies.  A Rintala questionnaire was performed comparing pre- and post-treatment findings.  A total of 25 patients were included with a median age of 13 (range of 6 to 44) years; 19 patients had spinal pathology (76 %), 4 colorectal surgery (16 %) and 2 functional constipation (8 %).  They presented FI in 20 % of cases, 12 % of fecal constipation and 68 % both conditions.  Following a mean follow-up of 1.5 years (1 month to 4 years), 52 % of the patients abandoned the treatment.  The mean Rintala score was 6.8 ± 4 before treatment, and 11.42 ± 2.75 after treatment (p = 0.001).  The main complications throughout the treatment were pain (68 %) and balloon leaks (28 %).  The patients declared as cause of treatment cessation: reduced mobility (15 %), fear or mis-information (32 %) and pain (76 %).  All patients with reduced mobility (n = 3) left treatment, versus 45 % (n = 12) of the patients that had full mobility (odds ratio [OR] 8.3; 95 % confidence intervals [CI]: 0.3 to 38, p = 0.17).  Complementary treatments such as laxatives, enemas or digital extraction were abandoned in 55 % of the patients.  The authors concluded that TAI appeared to improve QOL in patients with fecal constipation and FI refractory to other treatments.  The abandonment rate was higher than expected, so these researchers believed it is necessary to create a support group to improve follow-ups.  This was a small (n = 25), retrospective study; its findings need to be validated by well-designed studies.

Other Bowel Management Devices

Rectal inserts are prosthetic devices constructed of rubber, latex, silicone or other similar material and act as a barrier to the passage of fecal matter through the rectum.

A gravity administered enema system is a reusable enema bag with tubing used to empty the lower bowel and to prevent chronic constipation and fecal incontinence or simply as a method of bowel management.  An enema system consists of an irrigation fluid holding chamber and a rectal catheter (with or without an inflatable balloon). Fluid is instilled via gravity. 

A bed pan is a shallow vessel placed under a bedridden patient to collect feces and urine.

Stents for the Management of Bowel Obstruction Due to Colorectal Malignancy

Suzuki and associates (2019) noted that emergency surgical resection is a standard treatment for right-sided malignant colonic obstruction (RMCO); however, the procedure is associated with high rates of mortality and morbidity.  Although a bridge to surgery can be created to obviate the need for emergency surgery, its effects on long-term outcomes and the most practical management strategies for right-sided malignant colonic obstruction remain unclear.  These investigators determine the appropriate management approach for RMCO.  A total of 40 patients with RMCO who underwent curative resection from January 2007 to April 2017 were included in the study.  These researchers compared the peri-operative and long-term outcomes of patients who received bridges to surgery established using decompression tubes and those created using self-expandable metallic stents (SEMS).  The primary outcome was the overall survival (OS) duration; secondary end-points were the disease-free survival (DFS) duration and the pre-operative and post-operative morbidity rates.  Analysis was performed on an intention-to-treat (ITT) basis.  There were 21 patients in the decompression tube group and 19 in the SEMS group.  There were no significant differences in the peri-operative morbidity rates between the 2 groups.  The OS rate was significantly higher in the decompression tube group than in the SEMS group (5-year OS rate; decompression tube 79.5 %, SEMS 32 %, p = 0.043).  Multi-variate analysis revealed that the bridge to surgery using a decompression tube was significantly associated with the OS (hazard ratio [HR], 17.41; p = 0.004).  The 3-year DFS rate was significantly higher in the decompression tube group than in the SEMS group (68.9 % versus 45.9 %; log-rank test, p = 0.032).  A propensity score-adjusted analysis also demonstrated that the prognosis was significantly better in the decompression tube group than in the SEMS group.  The authors concluded that the bridge to surgery using trans-nasal and trans-anal decompression tubes for RMCO was safe and may improve long-term outcomes.

The authors stated that this study had several drawbacks.  First, as it involved a single center, the findings required external validation.  Second, relatively few patients (n = 19 I the SEMS group) were analyzed; this was unavoidable due to the low incidence of RMCO.  Third, the treatments applied for malignant colonic obstruction differ among Asian countries, European nations, and the United States.  In Japan, long trans-nasal and trans-anal tubes are routinely used for bowel obstruction.  However, in Europe and the United States, long tubes are not routinely used for bowel obstruction, based on the results of an older trial, and trans-anal decompression tubes are not available.  In addition, the pre-operative quality of life of RMCO patients who were treated with a decompression tube was obviously worse than that of those treated with SEMS.  The fecal odor from the tube and the presence of the tube itself made patients feel extremely uncomfortable.  Nevertheless, as recent studies have demonstrated the satisfactory performance of trans-nasal and trans-anal decompression tubes, their efficacy for the management of RMCO should be evaluated in a multi-center RCT.  In addition, as the decompression tubes could make patients uncomfortable, a study including QOL measures is desirable.

Mashar and co-workers (2019) stated that large bowel obstruction is the presenting feature in 24 % of colorectal carcinoma.  Malignant obstruction was conventionally treated by surgical diversion and stoma formation, associated with higher morbidity and mortality as compared to elective treatment.  Insertion of SEMS can be used as a bridge to surgery for subsequent 1-stage resection as well as for palliative purposes in patients with irresectable tumors.  In a systematic review and meta-analysis, these researchers compared outcomes of uncovered stent and covered stent in management of large bowel obstruction secondary to colorectal malignancy.  These researchers performed a search of electronic databases identifying studies comparing outcomes of uncovered and covered stents in management of large bowel obstruction secondary to colorectal malignancy.  The Cochrane risk-of-bias tool and the Newcastle-Ottawa scale were used to assess the included studies.  Random or fixed effects modelling were applied as appropriate to calculate pooled outcome data.; 1 RCT and 9 observational studies, enrolling 753 patients, were identified.  Uncovered stent was associated with lower risks of complications (relative risk [RR] 0.57; 95 % CI: 0.44 to 0.74, p < 0.0001), tumor over-growth (RR 0.29; 95 % CI: 0.09 to 0.93, p = 0.04), and stent migration (RR 0.29; 95 % CI: 0.17 to 0.48, p < 0.00001); longer duration of patency (mean differences [MD] 18.47; 95 % CI: 10.46 to 26.48, p < 0.00001); lower need for stent re-insertion (RR 0.38; 95 % CI: 0.17 to 0.86, p = 0.02); and higher risk of tumor ingrowth (RR 4.53; 95 % CI: 1.92 to 10.69, p = 0.0008).  Rates of technical success (RR 1.02; 95 % CI: 0.99 to 1.04, p = 0.21), clinical success (RR 1.03; 95 % CI: 0.98 to 1.08, p = 0.32), perforation (RR 0.01; 95 % CI: - 0.03 to 0.02, p = 0.65), bleeding (RD 0.00; 95 % CI: - 0.03 to 0.03, p = 0.98), stool impaction (RR 0.56; 95 % CI: 0.12 to 2.04, p = 0.38) and stent obstruction (RR 2.23; 95 % CI: 0.94 to 5.34, p = 0.97) were similar.   The authors concluded that these findings suggested that uncovered stents were superior as indicated by fewer complications, lower rates of stent migration, longer duration of patency and a reduced need for stent re-insertion. Moreover, these researchers stated that the best available evidence was mainly derived from non-randomized studies; there is a need for more RCTs.

The authors stated that this study had several drawbacks.  These investigators identified only 10 eligible studies of which 9 were non-randomized, observational studies that were inevitably subject to selection bias.  Thus, data did not provide robust basis for conclusions.  Data from the included studies were not adequate to perform subgroup analysis based on the purpose for stenting (pre-operative decompression versus palliative) or type of covered stent in terms of being fully or partially covered.  Less than 10 studies were eligible for this review, preventing formal assessment of publication bias as planned in the protocol; therefore, reporting bias could not be excluded in this study.

Xu and colleagues (2020) stated that the surgical management of acute malignant left-sided bowel obstruction is associated with high morbidity and mortality.  Recently, trans-anal drainage tubes (DTs) and MS used as a "bridge to surgery" have become widely used decompression methods compared with emergency surgery.  In a systematic review and meta-analysis, these researchers examined the safety and efficacy of DTs and MSs for the decompression of acute left-sided malignant colorectal obstruction.  All studies were acquired from PubMed, Medline, Embase, CNKI and the Cochrane Library.  Data were extracted by 2 of the co-authors independently and were analyzed with RevMan5.3; MDs, ORs and 95 % CIs were calculated.  The Cochrane Collaboration's risk of bias tool and the Newcastle-Ottawa scale were used to assess the risk of bias.  A total of 11 studies, which included 3 RCTs and 8 observational studies, were evaluated.  The methodological quality of the trials ranged from low to moderate.  The pooled results of the technical success rate showed that the difference was not statistically significant between the 2 devises.  The differences in clinical success rate, operative time and complications were statistically significant between MSs and DTs, and MS were associated with a better clinical success rate, increased operative time and fewer complications.  Sensitivity analysis proved the stability of the pooled results, and the publication bias was low.  The authors concluded that MS insertion for acute left-sided malignant bowel obstruction was safe and effective with a better technical success rate and with fewer complications than decompression using a DT, and MS insertion could avoid stoma formation.  Moreover, MS insertion appeared to be a useful treatment strategy for malignant colonic obstruction even if the lesion is located in the right colon.  Moreover, these researchers stated that more large-sample, multi-center, high-quality RCTs with long-term follow-up are needed to verify the outcomes of this meta-analysis.

The authors stated that this study had several drawbacks.  First, the small sample size might have affected the significant differences observed between the 2 devises.  Second, MS insertion is currently considered to be a safe and effective alternative modality for decompression, especially in Western countries.  DT insertion is only used in limited areas, including Asia.  This regional difference may add to the clinical heterogeneity.  Third, the proper indications for each procedure (MS and DTs) are not exactly the same.  MS insertion can be performed relatively easily not only for left-sided low bowel obstruction but also for right-sided low bowel obstruction.  These researchers only included the left-sided low bowel obstruction patients to decrease the clinical bias.  Fourth, the included studies were mostly observational studies and not RCTs, and they largely relied on retrospectively collected data, resulting in a high risk of selection.

Cao and colleagues (2021) stated that bridge to elective surgery (BTS) using self-expanding metal stents (SEMSs) is a common alternative to emergency surgery (ES) for the treatment of acute malignant left-sided colonic obstruction (AMLCO); however, studies regarding the long-term impact of BTS are limited and have reported unclear findings.  In an observational, multi-center study performed at 3 hospitals from April 2012 to December 2019, these researchers used propensity score matching (PSM) to minimize selection bias stenting in comparing BTS with ES for acute malignant left-sided colonic obstruction.  The primary endpoint was OS; and the secondary endpoints included surgical approaches, primary resection types, total stent-related adverse effects (AEs), surgical AEs, length of hospital stay (LOS), 30-day mortality and tumor recurrence.  A total of 49 patients in both the BTS and ES groups were matched.  Patients in the BTS group more often underwent laparoscopic resection (31 (63.3 %) versus 8 (16.3%), p < 0.001), were less likely to have a primary stoma (13 (26.5 %) versus 26 (53.1 %), p = 0.007) and more often had perineural invasion (25 (51.0 %) versus 13 (26.5 %), p = 0.013).  The median OS was significantly lower in patients with stent insertion (41 versus 65 months, p = 0.041).  The 3-year OS (53.0 versus 77.2 %, p = 0.039) and 5-year OS (30.6 versus 55.0 %, p = 0.025) were significantly less favorable in the BTS group.  In multi-variate Cox regression analysis, stenting (HR = 2.309 (1.052 to 5.066), p = 0.037), surgical AEs (HR = 1.394 (1.053 to 1.845), p = 0.020) and pTNM stage (HR = 1.706 (1.116 to 2.607), p = 0.014) were positively correlated with OS in matched patients.  The authors concluded that SEMS as "a BTS" were associated with more perineural invasion, a higher recurrence rate and worse OS in patients with acute malignant left-sided colonic obstruction compared with ES.

Ingestible Vibrating Capsule Devices 

The Vibrant System (Vibrant Gastro Inc.) is an ingestible vibrating capsule device that received U.S. FDA marketing approval in August 2022 as a Class II de novo device indicated for the treatment of adults with chronic idiopathic constipation (CIC) who have not experienced relief of bowel symptoms despite using laxative therapies at the recommended dosage for at least one month. 

The Vibrant System is comprised of a reusable base unit (Pod) and single-use, non-pharmacological, orally ingested, programmable capsules that vibrate intraluminally to induce bowel movements. 

The Vibrant Pod is pre-programmed via the Pod and can be monitored and altered by the physician to deliver patient-specific treatment. The Pod is used to activate and calibrate (sync) the naïve capsule via an electromagnetic signal. Once the capsule is activated with the encoded time span and vibration intensity sessions, it is taken orally. After ingestion, the capsule sends out pulsed micro-vibrations to stimulate the colon locally, inducing peristalsis to help the colon contract mechanically, synchronizing with the circadian rhythm of colonic contractile activity thereby increasing complete spontaneous bowel movements. The capsule is expelled from the body during bowel movements.

FDA marketing authorization is based on the efficacy and safety results from a randomized, double-blind, multi-centered, placebo-controlled, phase 3 clinical trial that evaluated treatment with the Vibrant System in 312 adults with chronic constipation by Rome III criteria. Rao and colleagues (2023) randomized patients to receive either a vibrating or placebo capsule, once daily, 5 days a week for 8 weeks. The primary efficacy end points were an increase of 1 or more complete spontaneous bowel movements per week (CSBM1 responder) or 2 or more CSBMs per week (CSBM2) from baseline during at least 6 of the 8 weeks. Safety analyses were also performed. The investigators found that a greater percentage of patients receiving the vibrating capsule achieved both primary efficacy end points compared with placebo (39.3% vs 22.1%, P = .001 for CSBM1; 22.7% vs 11.4% P = .008 for CSBM2). In addition, the investigators found significantly greater improvements for the secondary end points of straining, stool consistency, and quality-of-life measures compared with placebo. Adverse events were mild, gastrointestinal in nature, and were found similar between groups, except that a mild vibrating sensation was reported by 11% of patients in the vibrating capsule group; however, none withdrew from the trial. The investigators concluded that in patients with chronic constipation, the vibrating capsule was found to be superior to placebo in improving bowel symptoms and quality of life. Although the investigators note that the vibrating capsule was found to be safe and well tolerated, the safety and efficacy beyond 8 weeks is unknown.

The capsules are intended to be orally ingested up to 5 times per week, as directed by a physician. Per the package insert, the capsule should be taken shortly before going to sleep on 5 out of 7 days of the week according to the following schedule: 3 days on, 1 day off, 2 days on, 1 day off. Use for more than 8 weeks has not been evaluated.

The Vibrant capsules are contraindicated for any of the following:

• History of complicated/obstructive diverticular disease
• History of intestinal or colonic obstruction or suspected intestinal obstruction
• Clinical evidence of current and significant gastroparesis
• History of significant gastrointestinal (GI) disorder, including any form of inflammatory bowel disease or GI malignancy (celiac disease is accepted if the subject has been treated and is in remission), and/or anal fissures and fistulas
• History of Zenker's diverticulum, dysphagia, esophageal stricture, eosinophilic esophagitis or achalasia
• Women who are pregnant or lactating.

Warnings and precautions include the following (not an all-inclusive list):

• The Vibrant capsule is magnetic resonance (MR) unsafe
• After ingesting the capsule, and until it is excreted, person should not be near any source of powerful electromagnetic fields such as one created near an MRI device
• The capsule should be kept away from implants such as pacemakers, defibrillators, nerve stimulators, and other devices that could be affected by proximity to a direct current magnetic field
• Patients with pelvic floor dyssynergia may have impaired muscular ability to evacuate stool; therefore, patient should be monitored for any signs of adverse response and to ensure ability to pass the capsule
• Use of the capsule has not been studied in persons who chronically use non-steroidal anti-inflammatory drugs (NSAIDs; defined as taking full dose more than 3 times per week for at least 6 months).

Saeed and colleagues (2023) conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) to evaluate the efficacy and safety of vibrating capsules (VC) for functional constipation. The authors acknowledged that ingested VC had been introduced in published literature as an eligible option for treatment of chronic constipation. In their search of electronic databases (i.e., CENTRAL, PubMed, EMBASE, Scopus, and WOS), the authors found literature published through February 27, 2023. They used RevMan to perform their meta-analysis. The results were reported as risk ratios (RRs), mean differences (MDs), and 95% confidence intervals (CIs). The study protocol was registered in PROSPERO with ID: (CRD42023409422). The authors state that three RCTs with a total of 601 patients were included in their analysis for which they found "no difference between the VC and placebo in responder rate (RR: 1.37 with 95% CI [0.82, 2.28], p = .22), CSBM change from baseline (MD: 0.21 with 95% CI [-0.26, 0.69], p = .38), SBM [spontaneous bowel movement] change from baseline (MD: 0.14 with 95% CI [-0.22, 0.49], p = .46), and the incidence of any adverse event (RR: 1.45 with a 95% CI of [0.79, 2.63], p = .23). However, VC was associated with increased vibration sensation (RR: 17.23, 95% CI [3.29, 90.20], p = .0008)". The authors concluded that "VC was not effective to improve bowel movement in patients with functional constipation with no difference in response rate." However, the authors note that the evidence is still uncertain, as they found 3 small RCTs that yielded heterogeneous findings, mainly due to the different vibration protocols. Although their findings do suggest that VC is safe and well-tolerated, "more large-scale RCTs are needed to confirm the efficacy and safety of VC in patients with functional constipation, determining the most effective dose, frequency, and duration of treatment".

An UpToDate review on "Management of chronic constipation in adults" (Wald, 2023) does not mention the use of ingestible vibrating capsule devices as a treatment option.

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References