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Simethicone: Does it Improve Operative Field and Postoperative Pain?

NCT ID: NCT02984176

Last Updated: 2016-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2015-07-31

Brief Summary

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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

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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

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Simethicone

Keywords

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Simethicone Laparoscopies Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Simethicone Tab 40 mg

Intervention Type DRUG

3 tablets of Simethicone Tab 40 mg (one tablet after each meal) and to fast overnight the day before the operation.

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.

Group Type PLACEBO_COMPARATOR

Placebo Tablets

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

Placebo Tablets

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

Intervention Type DRUG

Other Intervention Names

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Disflatyl Placebo

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Woman's Health University Hospital, Egypt

OTHER

Sponsor Role lead

Responsible Party

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Kamal Mohamed Zahran

Assistant professor of Obstetrics & Gynecology, Faculty of Medicine, Consultant and vice director, Women's Health Hospital, Assiut University, Egypt

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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Simethicone and laparoscopy

Identifier Type: -

Identifier Source: org_study_id