Closure of Peritoneum at Cesarean Section and Postoperati... | NCT01183000

Studies
Closure of Peritoneum at Cesarean Section and Postoperative Adhesion

NCT01183000

Sponsor

Barzilai Medical Center

Status

Completed

Last Update Posted

Jul 12, 2019Actual

Enrollment

533Actual

Phase

Not Applicable

Conditions

Cesarean Section
Adhesions

Interventions

Closure of the peritoneum at cs

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 16, 2010Actual

Primary Completion Date

Aug 16, 2010Actual

Completion Date

Dec 31, 2010Actual

First Submitted Date

Aug 8, 2010

First Submission Date that Met QC Criteria

Aug 16, 2010

First Posted Date

Aug 17, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 10, 2019

Last Update Posted Date

Jul 12, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

533Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
peritoneal closure	Active Comparator		Procedure: Closure of the peritoneum at cs
Non closure of the peritoneum	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Closure of the peritoneum at cs	Procedure	Injection of 5 mg Marcaine (anesthetic solution) to the leg	peritoneal closure

Measure	Description	Time Frame
Adhesion score		6 years

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ofer Gemer, MD	Barzili Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Barzilai Medical Center		Ashkelon		78306	Israel
Barzilay University Medical Center

Condition Browse Module

MeSH Terms

ID	Term
D000267	Tissue Adhesions

Ancestor Terms

ID	Term
D002921	Cicatrix
D005355	Fibrosis
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided