Does Simethicone Improve Operative Field in Gynecological Operations

Phase 3

• Conditions: Benign Gynecologic Neoplasm
• Interventions: Drug: Enema; Drug: Simethicone

• Registration Number: NCT03009604
• Lead Sponsor: Assiut University

Brief Summary

Mechanical bowel preparation aims to decrease the volume fecal content in the colon, which thereby decreases the total colony count of bacteria, thus, decreasing peritoneal contamination in case of bowel injury, improving the access to the surgical field and facilitating intraoperative bowel manipulation

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-01
• Study Start: 2017-01
• Study First Submitted: 2017-01-02
• Study First Submitted QC: 2017-01-02
• Last Update Submitted: 2017-01-02
• Study First Posted: 2017-01-04
• Last Update Posted: 2017-01-04
• Primary Completion: 2017-04
• Study Completion: 2017-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

Gynecological operations for benign conditions as hysterectomy, ovarian cystectomy and myomectomy.

Exclusion Criteria

1. History of allergic reaction to study drugs.
2. More than one scar of previous operation.
3. Suspicious of malignancy.
4. Psychiatric disorders.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enema	Enema	women take 3 rectal Enema (8:00 pm, 12:00 am \& 8:00 am) and to fast over night before the operation.
Simethicone	Simethicone	women take 6 tablets (2 tablets after each meal) and to fast overnight before the operation

Primary Outcome Measures

Name	Time	Method
the degree of small & large bowel preparation	intraoperative

Trial Locations

Locations (1)

Assiut University; 🇪🇬 Assiut, Egypt