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

Cesarean Wound Repair Clinical Trial

— EKAM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02373501
• Other study ID #: SHEBA-13-0494-EC-CTIL
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Est. completion date: December 1, 2018

Study information

• Verified date: December 2018
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: December 1, 2018
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

Inclusion Criteria:

• singleton pregnancy

• term pregnancy

Exclusion Criteria:

• chorioamnionitis

• uterine rupture

• hysterotomy - adhesiolysis

Related Conditions & MeSH terms

• Cesarean Wound Repair
• Surgical Wound

Intervention

Procedure:
• Intra-abdominal repair
Intra abdominal repair of uterine incision
• Extra-abdominal repair
Extra abdominal repair of uterine incision

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Ramat - Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	complain of pain 1-10 on day 1 post operative		post operative - on day 3 post operative
Other	time from surgery until first walking		post operative - during hospitalization
Other	number of Days until having bowel movement,		post operative - during hospitalization
Other	overall satisfactory		post operative - during hospitalization
Primary	nausea and vomiting		during operation- 4 hours from anasthesia
Primary	intraoperative hypotension		during operation- 4 hours from anasthesia
Primary	intraoperative pain		during operation- 4 hours from anasthesia
Primary	Blood transfusion		during operation- 4 hours from anasthesia
Primary	Venous thromboembolism		durind operation - 4 hours from anasthesia
Primary	Febrile Morbidity		post operative - untill release from hospitalization usually day 4
Primary	Endometritis		post operative- untill release from hospitalization usually day 4
Primary	Wound Infection		post operative- untill release from hospitalization usually day 4
Primary	Death		post operative - untill release from hospitalization usually day 4
Secondary	Operative time		operative time - since anasthesia untill closure of skin
Secondary	Estimated blood loss ( ebl ) - HGB levels		operative- 4 hours from anasthesia
Secondary	Hospital stay		post operative