Simethicone: Does it Improve Operative Field and Postoperative Pain?

December 5, 2016 updated by: Kamal Mohamed Zahran, Woman's Health University Hospital, Egypt

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Simethicone
Arm 1 or Group I or Simethicone 40mg. 3 tablets (one tablet after each meal) and to fast overnight the day before the operation.
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.
Other Names:
  • Disflatyl
Placebo Comparator: placebo
Arm 2 or group 2 or placebo group. 3 tablets (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.
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
five-point scale
Time Frame: 1 hour
1 hour

Secondary Outcome Measures

Outcome Measure
Time Frame
The degree of bowel preparation
Time Frame: 1 hour
1 hour
VAS
Time Frame: 24 hours
24 hours
Patient satisfaction
Time Frame: 24 hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Woman's Health University Hospital, Egypt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

June 28, 2016

First Submitted That Met QC Criteria

December 1, 2016

First Posted (Estimate)

December 6, 2016

Study Record Updates

Last Update Posted (Estimate)

December 7, 2016

Last Update Submitted That Met QC Criteria

December 5, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Simethicone and laparoscopy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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