Simethicone: Does it Improve Operative Field and Postoperative Pain?

Phase 4

Completed

• Conditions: Simethicone
• Interventions: Drug: Simethicone Tab 40 mg; Drug: Placebo Tablets

• Registration Number: NCT02984176
• Lead Sponsor: Woman's Health University Hospital, Egypt

Brief 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.

Study Timeline

• Study Start: 2014-08
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Study First Submitted: 2016-06-28
• Status Verified: 2016-12
• Study First Submitted QC: 2016-12-01
• Last Update Submitted: 2016-12-05
• Study First Posted: 2016-12-06
• Last Update Posted: 2016-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Infertile patients
• aged 20 - 40 years old
• scheduled for laparoscopy

Exclusion Criteria

• Women were excluded from the study if patients had one or more of the following:

  • scar of previous operation, uterine mass, severe endometriosis, suspicion of malignancy, history of allergic reaction to study drugs, psychiatric disorders and patient refusal

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Simethicone	Simethicone Tab 40 mg	Arm 1 or Group I or Simethicone 40mg. 3 tablets (one tablet after each meal) and to fast overnight the day before the operation.
placebo	Placebo Tablets	Arm 2 or group 2 or placebo group. 3 tablets (one tablet after each meal) and to fast overnight the day before the operation.

Primary Outcome Measures

Name	Time	Method
five-point scale	1 hour

Secondary Outcome Measures

Name	Time	Method
VAS	24 hours
Patient satisfaction	24 hours
The degree of bowel preparation	1 hour