Back to resultsDoes Simethicone Improve Operative Field in Gynecological Operations
Primary Purpose
Benign Gynecologic Neoplasm
Status
Unknown status
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Simethicone
Enema
Sponsored by
About this trial
This is an interventional prevention trial for Benign Gynecologic Neoplasm
Eligibility Criteria
Inclusion Criteria:
Gynecological operations for benign conditions as hysterectomy, ovarian cystectomy and myomectomy.
Exclusion Criteria:
- History of allergic reaction to study drugs.
- More than one scar of previous operation.
- Suspicious of malignancy.
- Psychiatric disorders.
Sites / Locations
- Assiut UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Simethicone
Enema
Arm Description
women take 6 tablets (2 tablets after each meal) and to fast overnight before the operation
women take 3 rectal Enema (8:00 pm, 12:00 am & 8:00 am) and to fast over night before the operation.
Outcomes
Primary Outcome Measures
the degree of small & large bowel preparation
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03009604
Brief Title
Does Simethicone Improve Operative Field in Gynecological Operations
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (undefined)
Primary Completion Date
April 2017 (Anticipated)
Study Completion Date
May 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Data Monitoring Committee
Yes
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Gynecologic Neoplasm
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Simethicone
Arm Type
Experimental
Arm Description
women take 6 tablets (2 tablets after each meal) and to fast overnight before the operation
Arm Title
Enema
Arm Type
Active Comparator
Arm Description
women take 3 rectal Enema (8:00 pm, 12:00 am & 8:00 am) and to fast over night before the operation.
Intervention Type
Drug
Intervention Name(s)
Simethicone
Intervention Description
Simethicone 40mg oral tablets
Intervention Type
Drug
Intervention Name(s)
Enema
Intervention Description
sodium dihydrogen phosphate dihydrate 19.2 gram & disodium hydrogen phosphate dodecahydrate 7.2 gram, in addition to purified water
Primary Outcome Measure Information:
Title
the degree of small & large bowel preparation
Time Frame
intraoperative
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Gynecological operations for benign conditions as hysterectomy, ovarian cystectomy and myomectomy.
Exclusion Criteria:
History of allergic reaction to study drugs.
More than one scar of previous operation.
Suspicious of malignancy.
Psychiatric disorders.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Altayeb Mostafa, MBBCh
Phone
00201003722811
Facility Information:
Facility Name
Assiut University
City
Assiut
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Altayeb Mostafa
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Does Simethicone Improve Operative Field in Gynecological Operations
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