Cesarean Wound RepairEKAMNCT02373501
Extra - Abdominal Versus Intra - Abdominal Repair of the Uterine Incision at Cesarean Section
A study testing Intra-abdominal repair and Extra-abdominal repair in people with Cesarean Wound Repair, run by Sheba Medical Center at 1 site in Israel.
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 )… Read more about this study
- Who is it for?
- Ages 18 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Wound Repair
- What is being tested?
- Intra-abdominal repair and Extra-abdominal repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2013to 1 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 42 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- singleton pregnancy
- term pregnancy
Who cannot join
- chorioamnionitis
- uterine rupture
- hysterotomy - adhesiolysis
Trial locations and contacts
1 site in 1 country.
About this study
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:
Read more
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
Read the 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
- Conditions
- Cesarean Wound Repair
- Being tested
- Intra-abdominal repair, Extra-abdominal repair
- Keywords
- caesarean delivery, uterine incision repair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-abdominal repairProcedure or surgery
Intra abdominal repair of uterine incision
Extra-abdominal repairProcedure or surgery
Extra abdominal repair of uterine incision
| Study group | Role | What they receive |
|---|---|---|
| intra-abdominal repair | Experimental | intra-abdominal repair of uterine incision, after delivery of the fetus and the placenta. Receives: Procedure: Intra-abdominal repair |
| extra-abdominal repair | Experimental | extra-abdominal repair of uterine incision, after delivery of the fetus and the placenta. Receives: Procedure: Extra-abdominal repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
nausea and vomiting
Measured: during operation- 4 hours from anasthesia
intraoperative hypotension
Measured: during operation- 4 hours from anasthesia
intraoperative pain
Measured: during operation- 4 hours from anasthesia
Blood transfusion
Measured: during operation- 4 hours from anasthesia
Venous thromboembolism
Measured: durind operation - 4 hours from anasthesia
Febrile Morbidity
Measured: post operative - untill release from hospitalization usually day 4
Endometritis
Measured: post operative- untill release from hospitalization usually day 4
Wound Infection
Measured: post operative- untill release from hospitalization usually day 4
Death
Measured: post operative - untill release from hospitalization usually day 4
Secondary outcomes (3)
Operative time
Measured: operative time - since anasthesia untill closure of skin
Estimated blood loss ( ebl ) - HGB levels
Measured: operative- 4 hours from anasthesia
Hospital stay
Measured: post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2015 (estimated)
- Study startJan 2013
- Primary completion1 Dec 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cesarean Wound RepairStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Elias Castel, Senior Resident Obstetrics and Gynocology, Sheba Medical Center
- Investigators
- Elias Castel, MD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02373501
- Sponsor's protocol ID
- SHEBA-13-0494-EC-CTIL
- Acronym
- EKAM
- Status last verified
- Dec 2018
- First submitted
- 29 Jul 2013
- Last updated
- 4 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20022585
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extra - Abdominal Versus Intra - Abdominal Repair of the Uterine Incision at Cesarean Section
- ClinicalTrials.gov ID
- NCT02373501
- Acronym / sponsor ID
- EKAM / SHEBA-13-0494-EC-CTIL
- Conditions
- Cesarean Wound Repair
- Keywords
- caesarean delivery, uterine incision repair
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Jan 2013
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 27 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intra-abdominal repair | Experimental | Procedure: Intra-abdominal repairintra-abdominal repair of uterine incision, after delivery of the fetus and the placenta. |
| extra-abdominal repair | Experimental | Procedure: Extra-abdominal repairextra-abdominal repair of uterine incision, after delivery of the fetus and the placenta. |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- singleton pregnancy
- term pregnancy
Key exclusion criteria (3 listed)
- chorioamnionitis
- uterine rupture
- hysterotomy - adhesiolysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intra-abdominal repairIntra abdominal repair of uterine incision | Procedure or surgery | intra-abdominal repair |
| Extra-abdominal repairExtra abdominal repair of uterine incision | Procedure or surgery | extra-abdominal repair |
Primary outcome
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
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2018.
- Background: PubMed 20022585Jacob 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.
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Effect of Methotrexate on Blood Loss During Laparoscopic Management of CS Scar Pregnancy
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Timing of Cesarean Wound Dressing Removal on Wound Healing in Women With BMI ≥ 30 kg/m²
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elias Castel, MD principal investigator
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intra-abdominal repair and Extra-abdominal repair in people with Cesarean Wound Repair, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
nausea and vomiting (time frame: during operation- 4 hours from anasthesia). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02373501, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2018.