Sterility, Postpartum Clinical Trial
Official title:
Effect of Simethicone on Reducing Bowel Interference During Minilaparotomy for Tubal Resection : a Randomized Controlled Trial
| Verified date | February 2020 |
| Source | Chiang Mai University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 120 |
| Est. completion date | March 31, 2019 |
| Est. primary completion date | February 28, 2019 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 20 Years to 45 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Thailand | Department of OB-GYN, Faculty of Medicine, Chiang Mai University | Chiang Mai |
| Lead Sponsor | Collaborator |
|---|---|
| Chiang Mai University |
Thailand,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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) | |
| Secondary | 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) |