Ileus Clinical Trial - Effect of Simethicone on Postoperative Ileus in

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02161367
Study type	Interventional
Source	McMaster University
Contact
Status	Completed
Phase	Phase 4
Start date	October 2014
Completion date	July 2015

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04205058` - Coffee After Pancreatic Surgery	N/A
Completed	`NCT02232893` - Effect of TU-100 in Patients Undergoing Laparoscopic Colectomy	Phase 2
Not yet recruiting	`NCT05001763` - Prucalopride for Postoperative Ileus in Patients Undergoing Robot-assisted Laparoscopic Radical Cystectomy	Phase 2
Active, not recruiting	`NCT04547868` - Can Coffee/Caffeine Improve Post-Operative Gastrointestinal Recovery	N/A
Completed	`NCT02815956` - Tibial Nerve Stimulation and Postoperative Ileus	N/A
Completed	`NCT02947269` - Prucalopride in Postoperative Ileus	Phase 3
Recruiting	`NCT05512741` - Intestinal Microbiota and Postoperative Ileus After Colorectal Surgery
Recruiting	`NCT04675606` - Implementing a Low Fiber Diet vs. Regular Diet in Postoperative Colorectal Patients With Ileostomies	N/A
Completed	`NCT01956643` - Effect of Sham Feeding on Postoperative Ileus After Elective Liver Transplantation	N/A
Completed	`NCT00464425` - Electroacupuncture for Postoperative Ileus After Laparoscopic Colorectal Surgery	Phase 3
Completed	`NCT00402961` - Trial of Acupuncture for Reduction of Post-Colectomy Ileus	Phase 2
Terminated	`NCT04100265` - ANTERO-5: Gastric Motility in Postoperative Ileus	N/A
Recruiting	`NCT04090073` - Electroacupuncture Combined With Fast-track Perioperative Program for Laparoscopic Colorectal Surgery	N/A
Recruiting	`NCT03222557` - Electroacupuncture for Postoperative Ileus After Laparoscopic Surgery for Mid and Low Rectal Cancer	N/A
Withdrawn	`NCT02261454` - RCT Gum Chewing on Bowel Function After Abdominal Surgery in Children	N/A
Completed	`NCT02004652` - Prucalopride for Postoperative Ileus in Patients Undergoing Gastrointestinal Surgery	Phase 2
Completed	`NCT02639728` - The Effect of Coffee Consumption in Enhancing Recovery of Bowel Function Following Colorectal Surgery.	N/A
Completed	`NCT00509327` - Randomized Clinical Trial of Bisacodyl Versus Placebo on Postoperative Bowel Motility in Elective Colorectal Surgery	Phase 4
Completed	`NCT03097900` - Does Caffeine Enhance Bowel Recovery After Colorectal Surgery?	Phase 2
Completed	`NCT03143621` - The Effect of Coffee After Resection of Small Bowel	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Effect of Simethicone on Postoperative Ileus in Patients Undergoing Colorectal Surgery

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms