Cesarean Wound Repair Clinical Trial
Official title:
Extra - Abdominal Versus Intra - Abdominal Repair of the Uterine Incision at Cesarean Section
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
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
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