Back to resultsClosure of Peritoneum at Cesarean Section and Postoperative Adhesion (cs adhesions)
Primary Purpose
Cesarean Section, Adhesions
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Closure of the peritoneum at cs
Sponsored by
About this trial
This is an interventional prevention trial for Cesarean Section focused on measuring Formation of adhesions assessed at subsequent cs
Eligibility Criteria
Inclusion Criteria:
- Women undergoing primary CS
Exclusion Criteria:
- Lack of consent by the patient or an urgent cesarean not allowing time to elicit an informed consent
- Previous pelvic or abdominal surgery
Sites / Locations
- Barzilai Medical Center
- Barzilay University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
peritoneal closure
Non closure of the peritoneum
Arm Description
Outcomes
Primary Outcome Measures
Adhesion score
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01183000
Brief Title
Closure of Peritoneum at Cesarean Section and Postoperative Adhesion
Acronym
cs adhesions
Official Title
Effects of Closure Versus Non-closure of the Visceral and Parietal Peritoneum at Cesarean Section on Adhesions: A Prospective Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
January 16, 2010 (Actual)
Primary Completion Date
August 16, 2010 (Actual)
Study Completion Date
December 31, 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Barzilai Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Objective: To determine the effect of non-closure of the visceral and parietal peritoneum during Cesarean section on the formation of adhesions.
Study design: A prospective randomized trial of 533 women undergoing primary Cesarean section; 256 were randomized to non closure and 277 to closure of the peritoneum. At a subsequent cesarean,he presence of adhesions and their severity was evaluated at several sites: between the layers of the abdominal wall, between the bladder and the abdominal wall, between bladder and uterus, between the uterus and the abdominal wall, and between the bowels and the pelvic organs. A cumulative adhesion score was calculated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cesarean Section, Adhesions
Keywords
Formation of adhesions assessed at subsequent cs
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
533 (Actual)
8. Arms, Groups, and Interventions
Arm Title
peritoneal closure
Arm Type
Active Comparator
Arm Title
Non closure of the peritoneum
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
Closure of the peritoneum at cs
Intervention Description
Injection of 5 mg Marcaine (anesthetic solution) to the leg
Primary Outcome Measure Information:
Title
Adhesion score
Time Frame
6 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Women undergoing primary CS
Exclusion Criteria:
Lack of consent by the patient or an urgent cesarean not allowing time to elicit an informed consent
Previous pelvic or abdominal surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ofer Gemer, MD
Organizational Affiliation
Barzili Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barzilai Medical Center
City
Ashkelon
ZIP/Postal Code
78306
Country
Israel
Facility Name
Barzilay University Medical Center
City
Ashkelon
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Closure of Peritoneum at Cesarean Section and Postoperative Adhesion
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