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NCT Number: NCT02161367

Effect of Simethicone on Postoperative Ileus in Patients Undergoing Colorectal Surgery

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.

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Key information

Conditions

Postoperative Ileus Abdominal Pain Digestive System Diseases Flatulence Gastrointestinal Diseases Ileus Intestinal Diseases Intestinal Obstruction Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Juravinski Hospital, Hamilton, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Simethicone

Drug

Pharmacological category: antiflatulent

160mg Simethicone orally, 4 times a day for the first five postoperative days

Other names: OVOL®

Oral Suspending Vehicle

Drug

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

Other names: ORA-Plus®

Primary outcomes

  1. 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

  1. time to first bowel movement

    Time frame: participants will be followed for the duration of their hospital stay, an expected average of 7 days

  2. length of hospital stay

    Time frame: participants will be followed for the duration of their hospital stay, an expected average of 7 days

  3. postoperative pain

    Time frame: 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

  4. postoperative narcotic requirements

    Time frame: participants will be followed for the duration of their hospital stay, an expected average of 7 days

  5. incidence of postoperative vomiting

    Time frame: participants will be followed for the duration of their hospital stay, an expected average of 7 days

  6. incidence of postoperative complications

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

  • McMaster Surgical Associates

Registry information

Official study title

A Randomized Controlled Trial of the Effect of Simethicone on Postoperative Ileus in Patients Undergoing Colorectal Surgery: A Pilot Study

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 11, 2014
Registry last updated
Dec 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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