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Completed

NCT Number: NCT02984176

Simethicone: 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.

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Key information

Conditions

Simethicone Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Simethicone Tab 40 mg

Drug

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 tablets

Drug

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

Other names: Placebo

Primary outcomes

  1. five-point scale

    Time frame: 1 hour

Secondary outcomes

  1. The degree of bowel preparation

    Time frame: 1 hour

  2. VAS

    Time frame: 24 hours

  3. Patient satisfaction

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Woman's Health University Hospital, Egypt

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 6, 2016
Registry last updated
Dec 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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