NCT02984176

Simethicone: Does it Improve Operative Field and Postoperative Pain?

Simethicone and Gynecological Laparoscopies: Does it Improve Operative Field and Postoperative Pain?

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Woman's Health University Hospital, Egypt · Academic / Other
• Sex: Female
• Age: 20 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

Simethicone is an oral anti-foaming agent that reduces bloating, abdominal discomfort, and abdominal pain by promoting the clearance of excessive gas along the gastrointestinal tract. The investigators objective is to evaluate the efficacy and safety of preoperative oral simethicone for bowel preparation in gynecological laparoscopies.

Detailed description

Introduction: Simethicone is an oral antifoaming agent that reduces bloating, abdominal discomfort, and abdominal pain by promoting the clearance of excessive gas along the gastrointestinal tract. Objective: to evaluate the efficacy and safety of preoperative oral simethicone for bowel preparation in gynecological laparoscopies. Methods: 100 infertile women will be scheduled for laparoscopy, patients randomized to receive either Simethicone (Group I) or placebo tablets (Group II). The primary outcome measure will be the overall exposure of the surgical field and pain scoring. Assessment of the overall exposure of the surgical field was done using a five-point scale (poor, sufficient, medium, good, and excellent). Visual analog score (VAS) will be used for assessment of postoperative pain and verbal analog scoring was used for assessment of patient satisfaction.

Conditions

• Simethicone

Interventions

Type	Name	Description
DRUG	Simethicone Tab 40 mg	3 tablets of Simethicone Tab 40 mg (one tablet after each meal) and to fast overnight the day before the operation.
DRUG	Placebo Tablets	3 tablets of Placebo Tablets (one tablet after each meal) and to fast overnight the day before the operation.

Timeline

• Start date: 2014-08-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2016-12-06
• Last updated: 2016-12-07