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Closure of Peritoneum at Cesarean Section and Postoperative Adhesion (cs adhesions)

This study has been completed.
Sponsor:
Information provided by:
Barzilai Medical Center
ClinicalTrials.gov Identifier:
NCT01183000
First received: August 8, 2010
Last updated: August 16, 2010
Last verified: August 2010
History of Changes
  Purpose

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.


Condition Intervention
Cesarean Section
Adhesions
 Procedure: Closure of the peritoneum at cs

Study Type: Interventional
Study Design: Primary Purpose: Prevention
Official Title: Effects of Closure Versus Non-closure of the Visceral and Parietal Peritoneum at Cesarean Section on Adhesions: A Prospective Randomized Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Barzilai Medical Center:

Primary Outcome Measures:
  • Adhesion score [ Time Frame: 6 years ]
  • Adhesion Score [ Designated as safety issue: No ]

Arms Assigned Interventions
Active Comparator: peritoneal closure Procedure: Closure of the peritoneum at cs
No Intervention: Non closure of the peritoneum Procedure: Closure of the peritoneum at cs

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01183000

Locations
Israel
Barzilai Medical Center
Ashkelon, Israel, 78306
Sponsors and Collaborators
Barzilai Medical Center
Investigators
Principal Investigator: Ofer Gemer, MD Barzili Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01183000     History of Changes
Other Study ID Numbers: 1789
Study First Received: August 8, 2010
Last Updated: August 16, 2010
Health Authority: Israel: Ministry of Health

Keywords provided by Barzilai Medical Center:
Formation of adhesions assessed at subsequent cs

Additional relevant MeSH terms:
Tissue Adhesions
Cicatrix
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on October 17, 2012