Simethicone: Does it Improve Operative Field and Postoperative Pain?

Simethicone Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02984176
• Other study ID #: Simethicone and laparoscopy
• Status: Completed
• Phase: Phase 4
• First received: June 28, 2016
• Last updated: December 5, 2016
• Start date: August 2014
• Est. completion date: July 2015

Study information

• Verified date: December 2016
• Source: Woman's Health University Hospital, Egypt
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Simethicone

Intervention

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.
• Placebo Tablets
3 tablets of Placebo Tablets (one tablet after each meal) and to fast overnight the day before the operation.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Woman's Health University Hospital, Egypt

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	five-point scale		1 hour	Yes
Secondary	The degree of bowel preparation		1 hour	Yes
Secondary	VAS		24 hours	Yes
Secondary	Patient satisfaction		24 hours	Yes