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

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ClinicalTrials.gov Identifier: NCT02373501
Recruitment Status : Completed
First Posted : February 27, 2015
Last Update Posted : December 4, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Elias Castel, Senior Resident Obstetrics and Gynocology, Sheba Medical Center

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

Condition or disease Intervention/treatment Phase
Cesarean Wound Repair Procedure: Intra-abdominal repair Procedure: Extra-abdominal repair Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 95 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Extra - Abdominal Versus Intra - Abdominal Repair of the Uterine Incision at Cesarean Section
Study Start Date : January 2013
Actual Primary Completion Date : December 1, 2018
Actual Study Completion Date : December 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arm Intervention/treatment
Experimental: intra-abdominal repair
intra-abdominal repair of uterine incision, after delivery of the fetus and the placenta.
Procedure: Intra-abdominal repair
Intra abdominal repair of uterine incision

Experimental: extra-abdominal repair
extra-abdominal repair of uterine incision, after delivery of the fetus and the placenta.
Procedure: Extra-abdominal repair
Extra abdominal repair of uterine incision




Primary Outcome Measures :
  1. nausea and vomiting [ Time Frame: during operation- 4 hours from anasthesia ]
  2. intraoperative hypotension [ Time Frame: during operation- 4 hours from anasthesia ]
  3. intraoperative pain [ Time Frame: during operation- 4 hours from anasthesia ]
  4. Blood transfusion [ Time Frame: during operation- 4 hours from anasthesia ]
  5. Venous thromboembolism [ Time Frame: durind operation - 4 hours from anasthesia ]
  6. Febrile Morbidity [ Time Frame: post operative - untill release from hospitalization usually day 4 ]
  7. Endometritis [ Time Frame: post operative- untill release from hospitalization usually day 4 ]
  8. Wound Infection [ Time Frame: post operative- untill release from hospitalization usually day 4 ]
  9. Death [ Time Frame: post operative - untill release from hospitalization usually day 4 ]

Secondary Outcome Measures :
  1. Operative time [ Time Frame: operative time - since anasthesia untill closure of skin ]
  2. Estimated blood loss ( ebl ) - HGB levels [ Time Frame: operative- 4 hours from anasthesia ]
  3. Hospital stay [ Time Frame: post operative ]

Other Outcome Measures:
  1. complain of pain 1-10 on day 1 post operative [ Time Frame: post operative - on day 3 post operative ]
  2. time from surgery until first walking [ Time Frame: post operative - during hospitalization ]
  3. number of Days until having bowel movement, [ Time Frame: post operative - during hospitalization ]
  4. overall satisfactory [ Time Frame: post operative - during hospitalization ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • singleton pregnancy
  • term pregnancy

Exclusion Criteria:

  • chorioamnionitis
  • uterine rupture
  • hysterotomy - adhesiolysis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02373501


Locations
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Israel
Sheba Medical Center
Ramat - Gan, Israel
Sponsors and Collaborators
Sheba Medical Center
Investigators
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Principal Investigator: Elias Castel, MD Sheba Medical Center
Publications:
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Responsible Party: Dr. Elias Castel, Senior Resident Obstetrics and Gynocology, Dr. Elias Castel, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT02373501    
Other Study ID Numbers: SHEBA-13-0494-EC-CTIL
First Posted: February 27, 2015    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: December 2018
Keywords provided by Dr. Elias Castel, Senior Resident Obstetrics and Gynocology, Sheba Medical Center:
caesarean delivery
uterine incision repair
Additional relevant MeSH terms:
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Surgical Wound
Wounds and Injuries