Postoperative Ileus Clinical Trial
Official title:
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.
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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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 |