Effect of Simethicone on Reducing Bowel Interference During Tubal Resection

Effect of Simethicone on Reducing Bowel Interference During Minilaparotomy for Tubal Resection : a Randomized Controlled Trial

Tubal ligation is an everyday procedure for permanent female sterilization. It is usually performed after a vaginal delivery. Minilaparotomy is generally performed by doing small incision at infraumbilical area. This minimal access surgery requires adequate operative field exposure. Bowel interference, which obscures visualization of the operative field has been recognized as one of the major obstacles during this procedure. We found problems while doing surgery in small space and one of them is bowel interferance which obscures vision. This could lead to prolonged operation and complications. Simethicone is an antifoaming agent that use in bowel preparation prior to various procedures including laparoscopy, colonoscopy, endoscopy, and open major abdominal operations. Simethicone is proven to break the bubble and reduce intraluminal gas. This effect could result in reduction of bowel dilatation that interfere with the proper identification of the adnexal area. Benefit of taking simethicone prior to do minilaparotomy for tubal resection has not been examined.

Objectives: To examine the effect of simethicone on reducing bowel interference during minilaparotomy for tubal resection.

Design: A randomized controlled trial in women, age 20-45 years, undergoing postpartum sterilization after vaginal delivery at Faculty of Medicine, Chiang Mai University hospital. The participants will be randomly assigned into one of two study groups: intervention (taking simethicone) and control (not taking simethicone). For the intervention group, each woman will take simethicone (80 mg) 2 tablet chewing with water 50 ml at 2-8 hours before surgery. Fasting at least 6 hours before surgery. For the control group, the women will receive the same standard perioperative care without taking simethicone. The primary outcome measure will be surgeon-rated operative difficulty score, which is a visual analog scale based on assess from exposure of to the operative field in visual analog scale by surgeon. The secondary outcome will be operative time and incidence of intraoperative and postoperative complications.

Study Overview

• Status: Completed
• Conditions: Sterility, Postpartum
• Intervention / Treatment: Drug: Simethicone 80 MG

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 3

Contacts and Locations

Study Locations

• Thailand
  • Chiang Mai, Thailand, 50200
    • Department of OB-GYN, Faculty of Medicine, Chiang Mai University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 41 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Women requesting postpartum sterilization by minilaparotomic tubal resection after vaginal delivery at Faculty of Medicine, Chiang Mai University

Exclusion Criteria:

• Pre-pregnancy BMI > 25 kg/m2
• Intraoperative general anesthesia or epidural anesthesia
• Previous abdominal surgery except for appendectomy
• Known bowel disorder including Crohn's disease, ulcerative colitis, previous bowel surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Simethicone; Each woman in the intervention group will be given Simethicone (Air-X®; 80 mg) 2 tablets chewing with water 50 ml at 2-8 hours before surgery.	Drug: Simethicone 80 MG; Simethicone (Air-X®; 80 mg) 2 tablets chewing with water 50 ml at 2-8 hours before surgery
No Intervention: No simethicone; The women will not be given Simethicone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative difficulty score	Operative difficulty scores will be assessed at the end of the operation by the operating surgeon. The surgeon will rate the difficulty of the operation from 0 to 10 according to the 10-cm visual analog scale with "0" represents the easiest operation and "10" represents the hardest operation.	At the end of operation (within 1 hour after the completion of the operation)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operation time (Total)	The time duration from skin incision to completion of skin closure	From the start of skin incision creation to the completion of skin closure (up to 2 hours)
Operation time (Intraabdominal)	The time duration from first entering abdominal cavity to start closing the abdominal peritoneum.	From first entering abdominal cavity to start closing the abdominal peritoneum (up to 2 hours)

Collaborators and Investigators

• Sponsor: Chiang Mai University
• Investigators: Principal Investigator: Kittipat Charoenkwan, MD, MSc, Faculty of Medicine, Chiang Mai University

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2018
• Primary Completion (Actual): February 28, 2019
• Study Completion (Actual): March 31, 2019

Study Registration Dates

• First Submitted: January 31, 2018
• First Submitted That Met QC Criteria: February 5, 2018
• First Posted (Actual): February 12, 2018

Study Record Updates

• Last Update Posted (Actual): February 5, 2020
• Last Update Submitted That Met QC Criteria: February 4, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility; Infertility, Female; Molecular Mechanisms of Pharmacological Action; Dermatologic Agents; Antifoaming Agents; Emollients; Simethicone
• Other Study ID Numbers: OBG-2560-05148

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No