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

NCT ID: NCT02373501

Last Updated: 2018-12-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 95 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2018-12-01

Brief Summary

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

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

Conditions

Cesarean Wound Repair

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

intra-abdominal repair

intra-abdominal repair of uterine incision, after delivery of the fetus and the placenta.

Group Type: EXPERIMENTAL

Intra-abdominal repair

Intervention Type: PROCEDURE

Intra abdominal repair of uterine incision

extra-abdominal repair

extra-abdominal repair of uterine incision, after delivery of the fetus and the placenta.

Group Type: EXPERIMENTAL

Extra-abdominal repair

Intervention Type: PROCEDURE

Extra abdominal repair of uterine incision

Interventions

Intra-abdominal repair

Intra abdominal repair of uterine incision

Intervention Type: PROCEDURE

Extra-abdominal repair

Extra abdominal repair of uterine incision

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• singleton pregnancy
• term pregnancy

Exclusion Criteria

• chorioamnionitis
• uterine rupture
• hysterotomy - adhesiolysis

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 42 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Sheba Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Dr. Elias Castel, Senior Resident Obstetrics and Gynocology

Dr. Elias Castel

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elias Castel, MD

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center

Locations

Sheba Medical Center

Ramat Gan, , Israel

Countries

Israel

References

Jacob CE, Pasquier JC. Extraabdominal vs intraabdominal uterine repair at cesarean delivery: a metaanalysis. Am J Obstet Gynecol. 2010 Apr;202(4):e10-1; author reply e11. doi: 10.1016/j.ajog.2009.10.879. Epub 2009 Dec 22. No abstract available.

Reference Type: BACKGROUND

PMID: 20022585 (View on PubMed)

Other Identifiers

SHEBA-13-0494-EC-CTIL

Identifier Type: -

Identifier Source: org_study_id