A Randomized Controlled Trial of the Effect of Simethicone on Postoperative Ileus in Patients Undergoing Colorectal Surgery: A Pilot Study
Overview
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- McMaster University
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- time to first passage of flatus
Overview
Brief 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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
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.
Intervention: Simethicone (Drug)
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.
Intervention: Oral Suspending Vehicle (Drug)
Outcomes
Primary Outcomes
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)
Secondary Outcomes
- postoperative narcotic requirements(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)
- incidence of postoperative complications(within the first 30 days (plus or minus 3 days) after surgery)
- postoperative pain(participants will be followed for the duration of their hospital stay, an expected average of 7 days)
- time to first bowel movement(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)