Simethicone: Does it Improve Operative Field and Postoperative Pain?

Woman's Health University Hospital, Egypt

Status and phase: Completed; Phase 4

Conditions: Simethicone

Treatments: Drug: Placebo Tablets; Drug: Simethicone Tab 40 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT02984176

Simethicone and laparoscopy

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

Simethicone

Active Comparator group

Description:

Arm 1 or Group I or Simethicone 40mg. 3 tablets (one tablet after each meal) and to fast overnight the day before the operation.

Treatment:

Drug: Simethicone Tab 40 mg

placebo

Placebo Comparator group

Description:

Arm 2 or group 2 or placebo group. 3 tablets (one tablet after each meal) and to fast overnight the day before the operation.

Treatment:

Drug: Placebo Tablets