Does Simethicone Improve Operative Field in Gynecological Operations

• Sponsor: Assiut University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03009604
• Collaborator: (none)
• Enrollment: 90
• Location: 1
• Arms: 2
• Duration (Months): 3.9
• Patients Per Site Per Month: 22.8

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Benign Gynecologic Neoplasm	Drug: Simethicone; Drug: Enema	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Study Start Date: Jan 1, 2017
• Anticipated Primary Completion Date: Apr 1, 2017
• Anticipated Study Completion Date: May 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Simethicone women take 6 tablets (2 tablets after each meal) and to fast overnight before the operation	Drug: Simethicone; Simethicone 40mg oral tablets
Active Comparator: Enema women take 3 rectal Enema (8:00 pm, 12:00 am & 8:00 am) and to fast over night before the operation.	Drug: Enema; sodium dihydrogen phosphate dihydrate 19.2 gram & disodium hydrogen phosphate dodecahydrate 7.2 gram, in addition to purified water

Outcome Measures

Primary Outcome Measures

1. the degree of small & large bowel preparation [intraoperative]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 60 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assiut University	Assiut		Egypt

Sponsors and Collaborators

• Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Altayeb Abd alal Mostafa Mohammad, Dr, Assiut University
• ClinicalTrials.gov Identifier: NCT03009604
• Other Study ID Numbers: SIM
• First Posted: Jan 4, 2017
• Last Update Posted: Jan 4, 2017
• Last Verified: Jan 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Additional relevant MeSH terms: Genital Neoplasms, Female; Simethicone

Study Results

No Results Posted as of Jan 4, 2017