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

Primary Purpose

Cesarean Wound Repair

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Intra-abdominal repair
Extra-abdominal repair
Sponsored by
Sheba Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cesarean Wound Repair focused on measuring caesarean delivery, uterine incision repair

Eligibility Criteria

18 Years - 42 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • singleton pregnancy
  • term pregnancy

Exclusion Criteria:

  • chorioamnionitis
  • uterine rupture
  • hysterotomy - adhesiolysis

Sites / Locations

  • Sheba Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

intra-abdominal repair

extra-abdominal repair

Arm Description

intra-abdominal repair of uterine incision, after delivery of the fetus and the placenta.

extra-abdominal repair of uterine incision, after delivery of the fetus and the placenta.

Outcomes

Primary Outcome Measures

nausea and vomiting
intraoperative hypotension
intraoperative pain
Blood transfusion
Venous thromboembolism
Febrile Morbidity
Endometritis
Wound Infection
Death

Secondary Outcome Measures

Operative time
Estimated blood loss ( ebl ) - HGB levels
Hospital stay

Full Information

First Posted
July 29, 2013
Last Updated
December 2, 2018
Sponsor
Sheba Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02373501
Brief Title
Extra - Abdominal Versus Intra - Abdominal Repair of the Uterine Incision at Cesarean Section
Acronym
EKAM
Official Title
Extra - Abdominal Versus Intra - Abdominal Repair of the Uterine Incision at Cesarean Section
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
December 1, 2018 (Actual)
Study Completion Date
December 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sheba Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cesarean Wound Repair
Keywords
caesarean delivery, uterine incision repair

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
95 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intra-abdominal repair
Arm Type
Experimental
Arm Description
intra-abdominal repair of uterine incision, after delivery of the fetus and the placenta.
Arm Title
extra-abdominal repair
Arm Type
Experimental
Arm Description
extra-abdominal repair of uterine incision, after delivery of the fetus and the placenta.
Intervention Type
Procedure
Intervention Name(s)
Intra-abdominal repair
Intervention Description
Intra abdominal repair of uterine incision
Intervention Type
Procedure
Intervention Name(s)
Extra-abdominal repair
Intervention Description
Extra abdominal repair of uterine incision
Primary Outcome Measure Information:
Title
nausea and vomiting
Time Frame
during operation- 4 hours from anasthesia
Title
intraoperative hypotension
Time Frame
during operation- 4 hours from anasthesia
Title
intraoperative pain
Time Frame
during operation- 4 hours from anasthesia
Title
Blood transfusion
Time Frame
during operation- 4 hours from anasthesia
Title
Venous thromboembolism
Time Frame
durind operation - 4 hours from anasthesia
Title
Febrile Morbidity
Time Frame
post operative - untill release from hospitalization usually day 4
Title
Endometritis
Time Frame
post operative- untill release from hospitalization usually day 4
Title
Wound Infection
Time Frame
post operative- untill release from hospitalization usually day 4
Title
Death
Time Frame
post operative - untill release from hospitalization usually day 4
Secondary Outcome Measure Information:
Title
Operative time
Time Frame
operative time - since anasthesia untill closure of skin
Title
Estimated blood loss ( ebl ) - HGB levels
Time Frame
operative- 4 hours from anasthesia
Title
Hospital stay
Time Frame
post operative
Other Pre-specified Outcome Measures:
Title
complain of pain 1-10 on day 1 post operative
Time Frame
post operative - on day 3 post operative
Title
time from surgery until first walking
Time Frame
post operative - during hospitalization
Title
number of Days until having bowel movement,
Time Frame
post operative - during hospitalization
Title
overall satisfactory
Time Frame
post operative - during hospitalization

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: singleton pregnancy term pregnancy Exclusion Criteria: chorioamnionitis uterine rupture hysterotomy - adhesiolysis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elias Castel, MD
Organizational Affiliation
Sheba Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheba Medical Center
City
Ramat - Gan
Country
Israel

12. IPD Sharing Statement

Citations:
PubMed Identifier
20022585
Citation
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. No abstract available.
Results Reference
background

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

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