Closure of Peritoneum at Cesarean Section and Postoperative Adhesion

NCT ID: NCT01183000

Last Updated: 2019-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

533 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-16

Study Completion Date

2010-12-31

Brief Summary

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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

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Conditions

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Cesarean Section Adhesions

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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peritoneal closure

Group Type ACTIVE_COMPARATOR

Closure of the peritoneum at cs

Intervention Type PROCEDURE

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

Non closure of the peritoneum

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Closure of the peritoneum at cs

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Barzilai Medical Center

OTHER

Sponsor Role lead

Responsible Party

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ofer gemer

Prof. Ofer Gemer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ofer Gemer, MD

Role: PRINCIPAL_INVESTIGATOR

Barzili Medical Center

Locations

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Barzilai Medical Center

Ashkelon, , Israel

Site Status

Barzilay University Medical Center

Ashkelon, , Israel

Site Status

Countries

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Israel

Other Identifiers

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1789

Identifier Type: -

Identifier Source: org_study_id

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