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Effect of Simethicone on Postoperative Ileus in Patients Undergoing Colorectal Surgery

NCT02161367 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2015-12-04

No results posted yet for this study

Summary

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.

Conditions

  • Postoperative Ileus
  • Ileus

Interventions

DRUG

Simethicone

Pharmacological category: antiflatulent 160mg Simethicone orally, 4 times a day for the first five postoperative days

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

Sponsors & Collaborators

Principal Investigators

  • Shawn S Forbes, MD, MSc · McMaster University

  • Cagla Eskicioglu, MD, MSc · McMaster University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • Canada

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02161367 on ClinicalTrials.gov