Closure of Peritoneum at Cesarean Section and Postoperative Adhesion

Overview

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.

Full Title of Study: “Effects of Closure Versus Non-closure of the Visceral and Parietal Peritoneum at Cesarean Section on Adhesions: A Prospective Randomized Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 16, 2010

Interventions

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

Arms, Groups and Cohorts

  • Active Comparator: peritoneal closure
  • No Intervention: Non closure of the peritoneum

Clinical Trial Outcome Measures

Primary Measures

  • Adhesion score
    • Time Frame: 6 years

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Barzilai Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: ofer gemer, Prof. Ofer Gemer – Barzilai Medical Center
  • Overall Official(s)
    • Ofer Gemer, MD, Principal Investigator, Barzili Medical Center

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