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

August 8, 2010
August 16, 2010
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  • Adhesion score [ Time Frame: 6 years ]
  • Adhesion Score [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01183000 on ClinicalTrials.gov Archive Site
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Closure of Peritoneum at Cesarean Section and Postoperative Adhesion
Effects of Closure Versus Non-closure of the Visceral and Parietal Peritoneum at Cesarean Section on Adhesions: A Prospective Randomized Study

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.

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Interventional
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Primary Purpose: Prevention
  • Cesarean Section
  • Adhesions
Procedure: Closure of the peritoneum at cs
  • Active Comparator: peritoneal closure
    Intervention: Procedure: Closure of the peritoneum at cs
  • No Intervention: Non closure of the peritoneum
    Intervention: Procedure: Closure of the peritoneum at cs
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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
Female
18 Years and older
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Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT01183000
1789
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Barzilai Medical Center
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Principal Investigator: Ofer Gemer, MD Barzili Medical Center
Barzilai Medical Center
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP