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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Cesarean Wound Repair

Intervention / Treatment
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* Procedure: Intra-abdominal repair
* Procedure: Extra-abdominal repair


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: singleton pregnancy term pregnancy Exclusion Criteria: chorioamnionitis uterine rupture hysterotomy - adhesiolysis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 42 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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caesarean delivery, uterine incision repair