Simethicone: Does it Improve Operative Field and Postoperative Pain?

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02984176

Enrollment

100

Registered

2016-12-06

Start date

2014-08-31

Completion date

2015-07-31

Last updated

2016-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Simethicone

Keywords

Simethicone, Laparoscopies, Pain

Brief 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.

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.

Interventions

DRUGSimethicone Tab 40 mg

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

DRUGPlacebo Tablets

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 40 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
five-point scale	1 hour

Secondary

Measure	Time frame
The degree of bowel preparation	1 hour
VAS	24 hours
Patient satisfaction	24 hours

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026