Effect of Simethicone on Postoperative Ileus in Patients Undergoing Colorectal Surgery

December 3, 2015 updated by: McMaster University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8N 4A6
        • St. Joseph's Healthcare Hamilton
      • Hamilton, Ontario, Canada, L8V 1C3
        • Juravinski Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Simethicone, OVOL
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

Pharmacological category: antiflatulent

160mg Simethicone orally, 4 times a day for the first five postoperative days

Other Names:
  • OVOL®
Placebo Comparator: Oral Suspending Vehicle, Ora-Plus
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

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

Other Names:
  • ORA-Plus®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time to first passage of flatus
Time Frame: participants will be followed for the duration of their hospital stay, an expected average of 7 days
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
Time Frame: participants will be followed for the duration of their hospital stay, an expected average of 7 days
participants will be followed for the duration of their hospital stay, an expected average of 7 days
length of hospital stay
Time Frame: participants will be followed for the duration of their hospital stay, an expected average of 7 days
participants will be followed for the duration of their hospital stay, an expected average of 7 days
postoperative pain
Time Frame: participants will be followed for the duration of their hospital stay, an expected average of 7 days
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
Time Frame: participants will be followed for the duration of their hospital stay, an expected average of 7 days
participants will be followed for the duration of their hospital stay, an expected average of 7 days
incidence of postoperative vomiting
Time Frame: participants will be followed for the duration of their hospital stay, an expected average of 7 days
participants will be followed for the duration of their hospital stay, an expected average of 7 days
incidence of postoperative complications
Time Frame: within the first 30 days (plus or minus 3 days) after surgery
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McMaster University

Collaborators

McMaster Surgical Associates

Investigators

  • Principal Investigator: Shawn S Forbes, MD, MSc, McMaster University
  • Principal Investigator: Cagla Eskicioglu, MD, MSc, McMaster University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

June 5, 2014

First Submitted That Met QC Criteria

June 9, 2014

First Posted (Estimate)

June 11, 2014

Study Record Updates

Last Update Posted (Estimate)

December 4, 2015

Last Update Submitted That Met QC Criteria

December 3, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Simethicone-CRSurgery-1415

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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