Clinical trial NCT02373501: Extra - Abdominal Versus Intra - Abdominal Repair of the Uterine Incision at Cesarean Section
Official title: Extra - Abdominal Versus Intra - Abdominal Repair of the Uterine Incision at Cesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Wound Repair
Keywords: caesarean delivery
uterine incision repair
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2015-02-27
Enrollment: 95
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: Inclusion Criteria:

* singleton pregnancy
* term pregnancy

Exclusion Criteria:

* chorioamnionitis
* uterine rupture
* hysterotomy - adhesiolysis

Primary outcomes:
measure: nausea and vomiting
timeFrame: during operation- 4 hours from anasthesia
measure: intraoperative hypotension
timeFrame: during operation- 4 hours from anasthesia
measure: intraoperative pain
timeFrame: during operation- 4 hours from anasthesia
measure: Blood transfusion
timeFrame: during operation- 4 hours from anasthesia
measure: Venous thromboembolism
timeFrame: durind operation - 4 hours from anasthesia
measure: Febrile Morbidity
timeFrame: post operative - untill release from hospitalization usually day 4
measure: Endometritis
timeFrame: post operative- untill release from hospitalization usually day 4
measure: Wound Infection
timeFrame: post operative- untill release from hospitalization usually day 4
measure: Death
timeFrame: post operative - untill release from hospitalization usually day 4
Secondary outcomes:
measure: Operative time
timeFrame: operative time - since anasthesia untill closure of skin
measure: Estimated blood loss ( ebl ) - HGB levels
timeFrame: operative- 4 hours from anasthesia
measure: Hospital stay
timeFrame: post operative
Other outcomes:
measure: complain of pain 1-10 on day 1 post operative
timeFrame: post operative - on day 3 post operative
measure: time from surgery until first walking
timeFrame: post operative - during hospitalization
measure: number of Days until having bowel movement,
timeFrame: post operative - during hospitalization
measure: overall satisfactory
timeFrame: post operative - during hospitalization
Locations:
city: Ramat - Gan
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: Sheba Medical Center
name: Elias Castel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.