Extra - Abdominal Versus Intra - Abdominal Repair of the Uterine Incision at Cesarean Section
Condition: Cesarean Wound Repair
MeSH terms: Surgical Wound
Study type: Interventional

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
    

Intervention name(s): Intra-abdominal repair; Extra-abdominal repair
Intervention type(s): Procedure; Procedure
Intervention description(s): Intra abdominal repair of uterine incision; Extra abdominal repair of uterine incision
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: caesarean delivery; uterine incision repair