Clinical trial NCT02161367: Effect of Simethicone on Postoperative Ileus in Patients Undergoing Colorectal Surgery
Official title: A Randomized Controlled Trial of the Effect of Simethicone on Postoperative Ileus in Patients Undergoing Colorectal Surgery: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Ileus
Ileus
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
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: McMaster Surgical Associates
First posted: 2014-06-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: time to first passage of flatus
timeFrame: participants will be followed for the duration of their hospital stay, an expected average of 7 days
Secondary outcomes:
measure: time to first bowel movement
timeFrame: participants will be followed for the duration of their hospital stay, an expected average of 7 days
measure: length of hospital stay
timeFrame: participants will be followed for the duration of their hospital stay, an expected average of 7 days
measure: postoperative pain
timeFrame: participants will be followed for the duration of their hospital stay, an expected average of 7 days
measure: postoperative narcotic requirements
timeFrame: participants will be followed for the duration of their hospital stay, an expected average of 7 days
measure: incidence of postoperative vomiting
timeFrame: participants will be followed for the duration of their hospital stay, an expected average of 7 days
measure: incidence of postoperative complications
timeFrame: within the first 30 days (plus or minus 3 days) after surgery
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton
state: Ontario
city: Hamilton
country: Canada
facility: Juravinski Hospital
state: Ontario
Study officials:
affiliation: McMaster University
name: Shawn S Forbes, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University
name: Cagla Eskicioglu, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Danhof IE, Stavola JJ. Accelerated transit of intestinal gas with simethicone. Obstet Gynecol. 1974 Jul;44(1):148-54. No abstract available.
citation: Gibstein A, Cooper JJ, Wisot AL, Rosenthal AH. Prevention of postoperative abdominal distention and discomfort with simethicone. Obstet Gynecol. 1971 Sep;38(3):386-90. No abstract available.
citation: Chan MK, Law WL. Use of chewing gum in reducing postoperative ileus after elective colorectal resection: a systematic review. Dis Colon Rectum. 2007 Dec;50(12):2149-57. doi: 10.1007/s10350-007-9039-9.
citation: Forbes SS, Stephen WJ, Harper WL, Loeb M, Smith R, Christoffersen EP, McLean RF. Implementation of evidence-based practices for surgical site infection prophylaxis: results of a pre- and postintervention study. J Am Coll Surg. 2008 Sep;207(3):336-41. doi: 10.1016/j.jamcollsurg.2008.03.014. Epub 2008 May 19.
citation: Eskicioglu C, Gagliardi A, Fenech DS, Victor CJ, McLeod RS. Can a tailored knowledge translation strategy improve short term outcomes? A pilot study to increase compliance with bowel preparation recommendations in general surgery. Surgery. 2011 Jul;150(1):68-74. doi: 10.1016/j.surg.2011.02.010. Epub 2011 May 18.