Extra - Abdominal Versus Intra - Abdominal Repair of the Uterine Incision at Cesarean Section (EKAM)

December 2, 2018 updated by: Dr. Elias Castel, Senior Resident Obstetrics and Gynocology, Sheba Medical Center

To evaluate the effects of extra-abdominal repair of the uterine incision compared to intra-abdominal repair, and to study is there superiority of one technique over the other in terms of primary outcomes - operative( up to 4 hours after beginning of anesthesia) and post operative ( until day 4 after operation ) measurements , secondary outcomes, long-term outcomes and subjective outcomes.

PRIMARY OUTCOMES:

Intra - operative ( during the operation up to 4 hours from anesthesia )

  • nausea and vomiting
  • intraoperative hypotension
  • intraoperative pain

Post operative ( 4 hours from anesthesia and until release from hospital )

  • Blood transfusion
  • Venous thromboembolism
  • Febrile Morbidity
  • Endometritis
  • Wound Infection
  • Death

Subjective measures:

  • complain of pain 1-10 on day 1 post operative
  • time until walking
  • number of Days until having bowel movement
  • overall satisfactory

SECONDARY OUTCOMES:

  • Operative time
  • Estimated blood loss ( ebl ) - hemoglobin levels
  • Hospital stay

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Cesarean section (CS) delivery is one of the most frequent surgical procedures to be performed worldwide and rates of CS delivery are increasing. In the late 80's, the rate of caesarean deliveries was 10-13 % in most of the big hospitals in Israel, and today it reaches up to 20-25% of all deliveries.

Numerous different surgical techniques for caesarean section delivery have been described, and the debate about the optimal caesarean technique to minimize surgical morbidity is ongoing.

One of the more controversial issues regarding caesarean technique is the manner by which uterine repair is conducted after delivery of the infant(s) and placenta.

Two techniques are being used depending on the uterus position during repairmen : In situ within the peritoneal cavity (intra- abdominal repair) or temporarily exteriorized onto the mother's abdomen (extra- abdominal repair).

Arguments in favor of temporary exteriorization include better visualization of any uterine extensions and more rapid uterine repair with consequent reductions in both operative time and intraoperative blood loss. Opponents of extraabdominal repair argue that this technique increases rates of intraoperative nausea and vomiting, adnexal trauma on replacement, possible infection, and venous air embolism (VAE) .

On this study the investigators prospectively recruit women who are about to be electively operated. The patients will be randomized into two groups - extra- abdominal versus intra-abdominal uterine repair using computer randomization. Different charts will be for first CS delivery versus recurrent CS delivery. The patient won't know to which group she was designated . On day three after operation - she will be asked to fill out questionnaire with one of the investigators for subjective measurements

Study Type

Interventional

Enrollment (Actual)

95

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Ramat - Gan, Israel
        • Sheba Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 42 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • singleton pregnancy
  • term pregnancy

Exclusion Criteria:

  • chorioamnionitis
  • uterine rupture
  • hysterotomy - adhesiolysis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intra-abdominal repair
intra-abdominal repair of uterine incision, after delivery of the fetus and the placenta.
Procedure: Intra-abdominal repair
Intra abdominal repair of uterine incision
Experimental: extra-abdominal repair
extra-abdominal repair of uterine incision, after delivery of the fetus and the placenta.
Procedure: Extra-abdominal repair
Extra abdominal repair of uterine incision

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
nausea and vomiting
Time Frame: during operation- 4 hours from anasthesia
during operation- 4 hours from anasthesia
intraoperative hypotension
Time Frame: during operation- 4 hours from anasthesia
during operation- 4 hours from anasthesia
intraoperative pain
Time Frame: during operation- 4 hours from anasthesia
during operation- 4 hours from anasthesia
Blood transfusion
Time Frame: during operation- 4 hours from anasthesia
during operation- 4 hours from anasthesia
Venous thromboembolism
Time Frame: durind operation - 4 hours from anasthesia
durind operation - 4 hours from anasthesia
Febrile Morbidity
Time Frame: post operative - untill release from hospitalization usually day 4
post operative - untill release from hospitalization usually day 4
Endometritis
Time Frame: post operative- untill release from hospitalization usually day 4
post operative- untill release from hospitalization usually day 4
Wound Infection
Time Frame: post operative- untill release from hospitalization usually day 4
post operative- untill release from hospitalization usually day 4
Death
Time Frame: post operative - untill release from hospitalization usually day 4
post operative - untill release from hospitalization usually day 4

Secondary Outcome Measures

Outcome Measure
Time Frame
Operative time
Time Frame: operative time - since anasthesia untill closure of skin
operative time - since anasthesia untill closure of skin
Estimated blood loss ( ebl ) - HGB levels
Time Frame: operative- 4 hours from anasthesia
operative- 4 hours from anasthesia
Hospital stay
Time Frame: post operative
post operative

Other Outcome Measures

Outcome Measure
Time Frame
complain of pain 1-10 on day 1 post operative
Time Frame: post operative - on day 3 post operative
post operative - on day 3 post operative
time from surgery until first walking
Time Frame: post operative - during hospitalization
post operative - during hospitalization
number of Days until having bowel movement,
Time Frame: post operative - during hospitalization
post operative - during hospitalization
overall satisfactory
Time Frame: post operative - during hospitalization
post operative - during hospitalization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Investigators

  • Principal Investigator: Elias Castel, MD, Sheba Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

July 29, 2013

First Submitted That Met QC Criteria

February 25, 2015

First Posted (Estimate)

February 27, 2015

Study Record Updates

Last Update Posted (Actual)

December 4, 2018

Last Update Submitted That Met QC Criteria

December 2, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHEBA-13-0494-EC-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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