Postoperative Ileus, Ileus
Conditions
Keywords
colorectal surgery, postoperative ileus, simethicone, randomized controlled trial, double blind, pilot study, anti-foaming agent, abdominal pain, abdominal distention, nausea vomiting, flatus, bowel movement, placebo, postoperative complications, polydimethylsiloxane, hydrated silica gel, gas bubbles, intestinal tract
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.
Interventions
DRUGSimethicone
Pharmacological category: antiflatulent 160mg Simethicone orally, 4 times a day for the first five postoperative days
DRUGOral 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
McMaster Surgical Associates
McMaster University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| time to first passage of flatus | 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
| Measure | Time frame | Description |
|---|---|---|
| length of hospital stay | participants will be followed for the duration of their hospital stay, an expected average of 7 days | — |
| postoperative pain | 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 |
| 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 | — |
| incidence of postoperative complications | 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. |
| postoperative narcotic requirements | participants will be followed for the duration of their hospital stay, an expected average of 7 days | — |
Countries
Canada
Outcome results
None listed