Does Simethicone Improve Operative Field in Gynecological Operations

Benign Gynecologic Neoplasm Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03009604
• Other study ID #: SIM
• Status: Recruiting
• Phase: Phase 3
• First received: January 2, 2017
• Last updated: January 2, 2017
• Start date: January 2017
• Est. completion date: May 2017

Study information

• Verified date: January 2017
• Source: Assiut University
• Contact: Altayeb Mostafa, MBBCh
• Phone: 00201003722811
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: May 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Benign Gynecologic Neoplasm
• Genital Neoplasms, Female

Intervention

Drug:
• Simethicone
Simethicone 40mg oral tablets
• Enema
sodium dihydrogen phosphate dihydrate 19.2 gram & disodium hydrogen phosphate dodecahydrate 7.2 gram, in addition to purified water

Locations

Country	Name	City	State
Egypt	Assiut University	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the degree of small & large bowel preparation		intraoperative	Yes