An interventional study of Intra-abdominal repair and Extra-abdominal repair in Cesarean Wound Repair, sponsored by Sheba Medical Center. Completed at 1 site in Israel. Open to female participants aged 18 Years to 42 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-12-04.
Sponsored by Sheba Medical Center · Not applicable, Interventional, and Treatment
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 )
Post operative ( 4 hours from anesthesia and until release from hospital )
Subjective measures:
SECONDARY OUTCOMES:
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
519 studies on the registry are indexed under Surgical Wound; 71 are open to participants now.
This study's enrollment of 95 is above the median of 80 across 412 interventional studies indexed under Surgical Wound.
Browse Surgical Wound studies →Sheba Medical Center is the lead sponsor of 660 studies on the registry; 63 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
intra-abdominal repair of uterine incision, after delivery of the fetus and the placenta.
Procedure: Intra-abdominal repair
extra-abdominal repair of uterine incision, after delivery of the fetus and the placenta.
Procedure: Extra-abdominal repair
Intra abdominal repair of uterine incision
Extra abdominal repair of uterine incision
nausea and vomiting
Time frame: during operation- 4 hours from anasthesia
intraoperative hypotension
Time frame: during operation- 4 hours from anasthesia
intraoperative pain
Time frame: during operation- 4 hours from anasthesia
Blood transfusion
Time frame: during operation- 4 hours from anasthesia
Venous thromboembolism
Time frame: durind operation - 4 hours from anasthesia
Febrile Morbidity
Time frame: post operative - untill release from hospitalization usually day 4
Endometritis
Time frame: post operative- untill release from hospitalization usually day 4
Wound Infection
Time frame: post operative- untill release from hospitalization usually day 4
Death
Time frame: post operative - untill release from hospitalization usually day 4
Operative time
Time frame: operative time - since anasthesia untill closure of skin
Estimated blood loss ( ebl ) - HGB levels
Time frame: operative- 4 hours from anasthesia
Hospital stay
Time frame: post operative
complain of pain 1-10 on day 1 post operative
Time frame: post operative - on day 3 post operative
time from surgery until first walking
Time frame: post operative - during hospitalization
number of Days until having bowel movement,
Time frame: post operative - during hospitalization
overall satisfactory
Time frame: post operative - during hospitalization
This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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