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Effect of Simethicone on Postoperative Ileus in Patients Undergoing Colorectal Surgery

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ClinicalTrials.gov Identifier: NCT02161367
Recruitment Status : Completed
First Posted : June 11, 2014
Last Update Posted : December 4, 2015
Sponsor:
Collaborator:
McMaster Surgical Associates
Information provided by (Responsible Party):
McMaster University

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.

Condition or disease Intervention/treatment Phase
Postoperative Ileus Ileus Drug: Simethicone Drug: Oral Suspending Vehicle Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of the Effect of Simethicone on Postoperative Ileus in Patients Undergoing Colorectal Surgery: A Pilot Study
Study Start Date : October 2014
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Simethicone

Arm Intervention/treatment
Experimental: 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.
Drug: Simethicone

Pharmacological category: antiflatulent

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

Other Name: OVOL®

Placebo Comparator: 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.
Drug: Oral 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

Other Name: ORA-Plus®




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02161367


Locations
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Canada, Ontario
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada, L8N 4A6
Juravinski Hospital
Hamilton, Ontario, Canada, L8V 1C3
Sponsors and Collaborators
McMaster University
McMaster Surgical Associates
Investigators
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Principal Investigator: Shawn S Forbes, MD, MSc McMaster University
Principal Investigator: Cagla Eskicioglu, MD, MSc McMaster University
Publications:

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Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT02161367    
Other Study ID Numbers: Simethicone-CRSurgery-1415
First Posted: June 11, 2014    Key Record Dates
Last Update Posted: December 4, 2015
Last Verified: December 2015
Keywords provided by McMaster University:
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
Additional relevant MeSH terms:
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Ileus
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Simethicone
Antifoaming Agents
Molecular Mechanisms of Pharmacological Action
Emollients
Dermatologic Agents