Effect of Simethicone on Reducing Bowel Interference During Tubal Resection

NCT03429621 | Completed Phase 3

• 1 other identifier: OBG-2560-05148
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sterility, Postpartum

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Operation time (Total)

  From the start of skin incision creation to the completion of skin closure (up to 2 hours)

• Operation time (Intraabdominal)

  From first entering abdominal cavity to start closing the abdominal peritoneum (up to 2 hours)

Study Arms (2)

Simethicone

EXPERIMENTAL

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

No simethicone

NO INTERVENTION

The women will not be given Simethicone.

Interventions

Simethicone 80 MG DRUG

Simethicone (Air-X®; 80 mg) 2 tablets chewing with water 50 ml at 2-8 hours before surgery

Simethicone

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chiang Mai University: lead

Study Sites (1)

Department of OB-GYN, Faculty of Medicine, Chiang Mai University

Chiang Mai, 50200, Thailand

Location

MeSH Terms

Conditions

Infertility, Female

Interventions

Simethicone

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Intervention Hierarchy (Ancestors)

Dimethylpolysiloxanes; Silicones; Siloxanes; Organosilicon Compounds; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Kittipat Charoenkwan, MD, MSc

  Faculty of Medicine, Chiang Mai University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 31, 2018
• First Posted: February 12, 2018
• Study Start: March 8, 2018
• Primary Completion: February 28, 2019
• Study Completion: March 31, 2019
• Last Updated: February 5, 2020

Record last verified: 2020-02

Locations

TH (1)