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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02373501
Acronym
EKAM
Enrollment
95
Registered
2015-02-27
Start date
2013-01-31
Completion date
2018-12-01
Last updated
2018-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean Wound Repair

Keywords

caesarean delivery, uterine incision repair

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

Interventions

PROCEDUREIntra-abdominal repair

Intra abdominal repair of uterine incision

PROCEDUREExtra-abdominal repair

Extra abdominal repair of uterine incision

Sponsors

Sheba Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 42 Years
Healthy volunteers
Yes

Inclusion criteria

* singleton pregnancy * term pregnancy

Exclusion criteria

* chorioamnionitis * uterine rupture * hysterotomy - adhesiolysis

Design outcomes

Primary

MeasureTime frame
Deathpost operative - untill release from hospitalization usually day 4
intraoperative hypotensionduring operation- 4 hours from anasthesia
intraoperative painduring operation- 4 hours from anasthesia
Blood transfusionduring operation- 4 hours from anasthesia
Venous thromboembolismdurind operation - 4 hours from anasthesia
Febrile Morbiditypost operative - untill release from hospitalization usually day 4
Endometritispost operative- untill release from hospitalization usually day 4
Wound Infectionpost operative- untill release from hospitalization usually day 4
nausea and vomitingduring operation- 4 hours from anasthesia

Secondary

MeasureTime frame
Operative timeoperative time - since anasthesia untill closure of skin
Estimated blood loss ( ebl ) - HGB levelsoperative- 4 hours from anasthesia
Hospital staypost operative

Other

MeasureTime frame
time from surgery until first walkingpost operative - during hospitalization
complain of pain 1-10 on day 1 post operativepost operative - on day 3 post operative
number of Days until having bowel movement,post operative - during hospitalization
overall satisfactorypost operative - during hospitalization

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026