Effect of Simethicone on Postoperative Ileus in Patients Undergoing Colorectal Surgery

Postoperative Ileus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02161367
• Other study ID #: Simethicone-CRSurgery-1415
• Status: Completed
• Phase: Phase 4
• First received: June 5, 2014
• Last updated: December 3, 2015
• Start date: October 2014
• Est. completion date: July 2015

Study information

• Verified date: December 2015
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaCanada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ileus
• Postoperative Ileus

Intervention

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

Locations

Country	Name	City	State
Canada	Juravinski Hospital	Hamilton	Ontario
Canada	St. Joseph's Healthcare Hamilton	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
McMaster University	McMaster Surgical Associates

Country where clinical trial is conducted

Canada, 

References & Publications (13)

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. — View Citation

Bauer AJ, Boeckxstaens GE. Mechanisms of postoperative ileus. Neurogastroenterol Motil. 2004 Oct;16 Suppl 2:54-60. Review. — View 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. Review. — View Citation

Danhof IE, Stavola JJ. Accelerated transit of intestinal gas with simethicone. Obstet Gynecol. 1974 Jul;44(1):148-54. — View Citation

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. Review. — View 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. — View 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. — View 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. — View Citation

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. — View Citation

Kehlet H, Holte K. Review of postoperative ileus. Am J Surg. 2001 Nov;182(5A Suppl):3S-10S. Review. — View Citation

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. Review. — View Citation

Sternini C, Patierno S, Selmer IS, Kirchgessner A. The opioid system in the gastrointestinal tract. Neurogastroenterol Motil. 2004 Oct;16 Suppl 2:3-16. — View Citation

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. Review. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	time to first bowel movement		participants will be followed for the duration of their hospital stay, an expected average of 7 days	No
Secondary	length of hospital stay		participants will be followed for the duration of their hospital stay, an expected average of 7 days	No
Secondary	postoperative pain	measured using the Visual Analogue Scale for pain	participants will be followed for the duration of their hospital stay, an expected average of 7 days	No
Secondary	postoperative narcotic requirements		participants will be followed for the duration of their hospital stay, an expected average of 7 days	No
Secondary	incidence of postoperative vomiting		participants will be followed for the duration of their hospital stay, an expected average of 7 days	No
Secondary	incidence of postoperative complications	including but not limited to wound and anastomotic occurences, bleeding, infections, readmission to hospital, death, etc.	within the first 30 days (plus or minus 3 days) after surgery	No