Effect of Simethicone on Postoperative Ileus in Patients Undergoing Colorectal Surgery

Study Overview
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Brief Summary
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Post-operative ileus is a common complication following abdominal surgery. It results in abdominal distension, nausea and vomiting as well as abdominal pain. Furthermore, this results in prolonged hospital stay and occasionally readmission following abdominal surgery.The etiology of post-operative ileus is multifactorial and studies evaluating potential treatment options are abundant, though few reliable interventions exist. This study proposal describes a double-blinded randomized controlled trial investigating the effect of simethicone on post-operative ileus in patients undergoing colorectal surgery.

Detailed Description
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Simethicone is an orally administered anti-foaming agent comprised of polydimethylsiloxane and hydrated silica gel. Its leads to the coalescence of gas bubbles in the intestinal tract, facilitating its emission. To date, there are no contemporary studies evaluating the efficacy of simethicone on POI in patients undergoing colorectal surgery. The proposed study is a pilot double-blinded randomized controlled trial of simethicone versus placebo in patients undergoing colorectal surgery. Starting on postoperative day one, patients in the experimental arm of the study will receive, in a blinded fashion, 160mg of simethicone orally four times a day for the first five postoperative days. Patients assigned to the control arm will receive a placebo agent orally with the same frequency and duration. All consenting patients over the age of 18 undergoing elective, abdominal colorectal surgery involving bowel resection with or without re-anastomosis at either the Juravinski Hospital and Cancer Center or St. Joseph's Hospital in Hamilton, Ontario will be enrolled. This will include patients undergoing both open and laparoscopic surgery. Patients will be prospectively evaluated by a trained research assistant on a daily basis while in hospital. Passage of flatus, bowel movements, and postoperative pain will be evaluated at those visits. A two-week, and 30-day phone call to patients discharged from hospital will be done to assess for outcomes after discharge. Follow-up will end after the 30th postoperative day.

Official Title
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A Randomized Controlled Trial of the Effect of Simethicone on Postoperative Ileus in Patients Undergoing Colorectal Surgery: A Pilot Study

Conditions
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Postoperative Ileus, Ileus

Intervention / Treatment
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* Drug: Simethicone
* Drug: Oral Suspending Vehicle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All consenting patients over the age of 18 undergoing elective, abdominal colorectal surgery involving bowel resection with or without re-anastomosis (both open and laparoscopic surgeries) at either the Juravinski Hospital and Cancer Center or St. Joseph's Hospital in Hamilton Exclusion Criteria: Patients undergoing emergency surgery Documented allergy to simethicone Unable to provide informed consent (non-English speaking patients and those with cognitive impairment) Patients not having an abdominal operation (ie. perineal procedure)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Simethicone, OVOL<br>Patients in the intervention arm will receive, in a blinded fashion, 160mg of simethicone orally four times a day for the first five postoperative days. Patients will be evaluated by a trained research assistant on a daily basis while in hospital. Passage of flatus, bowel movements, and postoperative pain will be evaluated at those visits. A two-week, and 30-day phone call to patients discharged from hospital will be done to assess for outcomes after discharge. Follow-up will end after the 30th postoperative day. | Drug: Simethicone<br>* Pharmacological category: antiflatulent 160mg Simethicone orally, 4 times a day for the first five postoperative days<br>* Other names: OVOL®;|
| Placebo Comparator: Oral Suspending Vehicle, Ora-Plus<br>Patients in the control arm will receive, in a blinded fashion, 160mg of the placebo orally four times a day for the first five postoperative days. The placebo will be prepared by pharmacy to be identical to the test drug formulation except for being pharmacologically inert. Patients will be evaluated by a trained research assistant on a daily basis while in hospital. Passage of flatus, bowel movements, and postoperative pain will be evaluated at those visits. A two-week, and 30-day phone call to patients discharged from hospital will be done to assess for outcomes after discharge. Follow-up will end after the 30th postoperative day. | Drug: Oral Suspending Vehicle<br>* ORA-Plus is an aqueous-based vehicle. Identical to the test drug formulation except for being pharmacologically inert. 160mg Ora-Plus orally, 4 times a day for the first five postoperative days<br>* Other names: ORA-Plus®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to first passage of flatus | passage of flatus (measured in hours) is considered an acceptable sign of the return of gut function and a criterion for discharge from hospital (bowel movement is not) | participants will be followed for the duration of their hospital stay, an expected average of 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to first bowel movement |  | participants will be followed for the duration of their hospital stay, an expected average of 7 days | 
| length of hospital stay |  | participants will be followed for the duration of their hospital stay, an expected average of 7 days | 
| postoperative pain | measured using the Visual Analogue Scale for pain | participants will be followed for the duration of their hospital stay, an expected average of 7 days | 
| postoperative narcotic requirements |  | participants will be followed for the duration of their hospital stay, an expected average of 7 days | 
| incidence of postoperative vomiting |  | participants will be followed for the duration of their hospital stay, an expected average of 7 days | 
| incidence of postoperative complications | including but not limited to wound and anastomotic occurences, bleeding, infections, readmission to hospital, death, etc. | within the first 30 days (plus or minus 3 days) after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hydrated silica gel, colorectal surgery, postoperative ileus, simethicone, randomized controlled trial, double blind, pilot study, anti-foaming agent, abdominal pain, abdominal distention, nausea vomiting, flatus, bowel movement, placebo, postoperative complications, polydimethylsiloxane, gas bubbles, intestinal tract