Simethicone: Does it Improve Operative Field and Postoperative Pain?

NCT02984176 | Completed Phase 4

• 1 other identifier: Simethicone and laparoscopy
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Simethicone

Keywords

Simethicone; Laparoscopies; Pain

Outcome Measures

Primary Outcomes (1)

• five-point scale

  1 hour

Secondary Outcomes (3)

• The degree of bowel preparation

  1 hour

• VAS

  24 hours

• Patient satisfaction

  24 hours

Study Arms (2)

Simethicone

ACTIVE COMPARATOR

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

placebo

PLACEBO COMPARATOR

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

Interventions

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.

Also known as: Disflatyl

Simethicone

Placebo Tablets DRUG

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

Also known as: Placebo

placebo

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Infertile patients
• aged 20 - 40 years old
• scheduled for laparoscopy

You may not qualify if:

• 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

Sponsors & Collaborators

• Woman's Health University Hospital, Egypt: lead

MeSH Terms

Conditions

Pain

Interventions

Simethicone

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dimethylpolysiloxanes; Silicones; Siloxanes; Organosilicon Compounds; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of Obstetrics & Gynecology, Faculty of Medicine, Consultant and vice director, Women's Health Hospital, Assiut University, Egypt

Study Record Dates

• First Submitted: June 28, 2016
• First Posted: December 6, 2016
• Study Start: August 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: December 7, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will share