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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01183000
First Posted: August 17, 2010
Last Update Posted: August 17, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Barzilai Medical Center
  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:


Further study details as provided by Barzilai Medical Center:

Primary Outcome Measures:
  • Adhesion score [ Time Frame: 6 years ]
  • Adhesion Score

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT01183000     History of Changes
Other Study ID Numbers: 1789
First Submitted: August 8, 2010
First Posted: August 17, 2010
Last Update Posted: August 17, 2010
Last Verified: August 2010

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

Additional relevant MeSH terms:
Tissue Adhesions
Cicatrix
Fibrosis
Pathologic Processes