NCT01183000

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
533

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2010

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 16, 2010

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 8, 2010

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 16, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 17, 2010

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2010

Completed
Last Updated

July 12, 2019

Status Verified

July 1, 2019

Enrollment Period

7 months

First QC Date

August 8, 2010

Last Update Submit

July 10, 2019

Conditions

Cesarean SectionAdhesions

Keywords

Formation of adhesions assessed at subsequent cs

Outcome Measures

Primary Outcomes (1)

  • Adhesion score

    6 years

Study Arms (2)

peritoneal closure

ACTIVE COMPARATOR
Procedure: Closure of the peritoneum at cs

Non closure of the peritoneum

NO INTERVENTION

Interventions

Closure of the peritoneum at csPROCEDURE

Injection of 5 mg Marcaine (anesthetic solution) to the leg

peritoneal closure

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women undergoing primary CS

You may not qualify if:

  • Lack of consent by the patient or an urgent cesarean not allowing time to elicit an informed consent
  • Previous pelvic or abdominal surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Barzilai Medical Center

Ashkelon, 78306, Israel

Location

Barzilay University Medical Center

Ashkelon, Israel

Location

MeSH Terms

Conditions

Tissue Adhesions

Condition Hierarchy (Ancestors)

CicatrixFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ofer Gemer, MD

    Barzili Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Ofer Gemer

Study Record Dates

First Submitted

August 8, 2010

First Posted

August 17, 2010

Study Start

January 16, 2010

Primary Completion

August 16, 2010

Study Completion

December 31, 2010

Last Updated

July 12, 2019

Record last verified: 2019-07

Locations

IL(2)