Simethicone: Does it Improve Operative Field and Postoperative Pain?

Study Overview
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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.

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

Conditions
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Simethicone

Intervention / Treatment
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* Drug: Simethicone Tab 40 mg
* Drug: Placebo Tablets


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Simethicone<br>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<br>* 3 tablets of Simethicone Tab 40 mg (one tablet after each meal) and to fast overnight the day before the operation.<br>* Other names: Disflatyl;|
| Placebo Comparator: placebo<br>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<br>* 3 tablets of Placebo Tablets (one tablet after each meal) and to fast overnight the day before the operation.<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| five-point scale |  | 1 hour | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Simethicone, Laparoscopies, Pain