Effect of Simethicone on Postoperative Ileus in Patients Undergoing Colorectal Surgery

NCT02161367 | Completed Phase 4

• 1 other identifier: Simethicone-CRSurgery-1415
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (1)

• time to first passage of flatus

  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)

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

Secondary Outcomes (6)

• time to first bowel movement

  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

• postoperative pain

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

• postoperative narcotic requirements

  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

Study Arms (2)

Simethicone, OVOL

EXPERIMENTAL

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

Oral Suspending Vehicle, Ora-Plus

PLACEBO COMPARATOR

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

Interventions

Simethicone DRUG

Pharmacological category: antiflatulent 160mg Simethicone orally, 4 times a day for the first five postoperative days

Also known as: OVOL®

Simethicone, 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

Also known as: ORA-Plus®

Oral Suspending Vehicle, Ora-Plus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• McMaster University: lead
• McMaster Surgical Associates: collaborator

Study Sites (2)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

Juravinski Hospital

Hamilton, Ontario, L8V 1C3, Canada

Location

Related Publications (13)

• Doorly MG, Senagore AJ. Pathogenesis and clinical and economic consequences of postoperative ileus. Surg Clin North Am. 2012 Apr;92(2):259-72, viii. doi: 10.1016/j.suc.2012.01.010.

  PMID: 22414412 BACKGROUND

• Story SK, Chamberlain RS. A comprehensive review of evidence-based strategies to prevent and treat postoperative ileus. Dig Surg. 2009;26(4):265-75. doi: 10.1159/000227765. Epub 2009 Jul 3.

  PMID: 19590205 BACKGROUND

• Kehlet H, Holte K. Review of postoperative ileus. Am J Surg. 2001 Nov;182(5A Suppl):3S-10S. doi: 10.1016/s0002-9610(01)00781-4.

  PMID: 11755891 BACKGROUND

• Senagore AJ. Pathogenesis and clinical and economic consequences of postoperative ileus. Am J Health Syst Pharm. 2007 Oct 15;64(20 Suppl 13):S3-7. doi: 10.2146/ajhp070428.

  PMID: 17909274 BACKGROUND

• Barletta JF, Asgeirsson T, Senagore AJ. Influence of intravenous opioid dose on postoperative ileus. Ann Pharmacother. 2011 Jul;45(7-8):916-23. doi: 10.1345/aph.1Q041. Epub 2011 Jul 5.

  PMID: 21730280 BACKGROUND

• Sternini C, Patierno S, Selmer IS, Kirchgessner A. The opioid system in the gastrointestinal tract. Neurogastroenterol Motil. 2004 Oct;16 Suppl 2:3-16. doi: 10.1111/j.1743-3150.2004.00553.x.

  PMID: 15357847 BACKGROUND

• Bauer AJ, Boeckxstaens GE. Mechanisms of postoperative ileus. Neurogastroenterol Motil. 2004 Oct;16 Suppl 2:54-60. doi: 10.1111/j.1743-3150.2004.00558.x.

  PMID: 15357852 BACKGROUND

• Hocevar BJ, Robinson B, Gray M. Does chewing gum shorten the duration of postoperative ileus in patients undergoing abdominal surgery and creation of a stoma? J Wound Ostomy Continence Nurs. 2010 Mar-Apr;37(2):140-6. doi: 10.1097/WON.0b013e3181d0b92b.

  PMID: 20228654 BACKGROUND

• Danhof IE, Stavola JJ. Accelerated transit of intestinal gas with simethicone. Obstet Gynecol. 1974 Jul;44(1):148-54. No abstract available.

  PMID: 4600627 BACKGROUND

• 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.

  PMID: 4937581 BACKGROUND

• 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.

  PMID: 17710495 BACKGROUND

• 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.

  PMID: 18722937 BACKGROUND

• 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.

  PMID: 21596413 BACKGROUND

MeSH Terms

Conditions

Ileus; Abdominal Pain; Flatulence; Postoperative Complications

Interventions

Simethicone; Excipients

Condition Hierarchy (Ancestors)

Intestinal Obstruction; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Pathologic Processes

Intervention Hierarchy (Ancestors)

Dimethylpolysiloxanes; Silicones; Siloxanes; Organosilicon Compounds; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Pharmaceutical Vehicles; Pharmaceutic Aids; Pharmaceutical Preparations; Specialty Uses of Chemicals; Chemical Actions and Uses

Study Officials

• Shawn S Forbes, MD, MSc

  McMaster University

  PRINCIPAL INVESTIGATOR

• Cagla Eskicioglu, MD, MSc

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2014
• First Posted: June 11, 2014
• Study Start: October 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: December 4, 2015

Record last verified: 2015-12

Locations

CA (2)