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NCT01183000 Clinical Trial

Closure of Peritoneum at Cesarean Section and Postoperative Adhesion

Cesarean Section Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01183000
Other study ID # 1789
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 16, 2010
Est. completion date December 31, 2010

Study information
Verified date July 2019
Source Barzilai Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 533
Est. completion date December 31, 2010
Est. primary completion date August 16, 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Closure of the peritoneum at cs
Injection of 5 mg Marcaine (anesthetic solution) to the leg

Locations
Country Name City State
Israel Barzilai Medical Center Ashkelon
Israel Barzilay University Medical Center Ashkelon

Sponsors (1)
Lead Sponsor Collaborator
Barzilai Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Adhesion score 6 years
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