- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01287611
Short Term Comparison of Two Different Techniques of Uterine Cesarean Incision Closure
September 22, 2023 updated by: Mehmet Cem Turan, Dr. Lutfi Kirdar Kartal Training and Research Hospital
Short Term Comparison of Double Layer Continuously Locked Closure of Uterine Incision in Cesarean Section Versus Double Layer Purse String Closure (Turan Technique): A Prospective Randomized Study
Cesarean section (C/S) is an operation most commonly performed in Obstetrics and Gynecology Clinics.
Complications related with incomplete healing of Kerr uterine incision after C/S (adhesions, separation (dehiscence), endometritis, endometriosis, anomalous placentation in subsequent pregnancies, incomplete or complete uterine rupture in subsequent pregnancies, ...) are very important issues.
Classically Kerr incision is repaired with continuous locked suturing.
Purse string suturing of Kerr incision may reduce the size of the incision and in turn may reduce short and long term complications.
For this reason, the investigators aimed to compare two closure techniques.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
In the clinic, patients undergoing cesarean section that meet the criteria for inclusion into the study and agreed to participate in the study will be randomized into two groups (computer-assisted randomization method will be used.)
In the first group of patients classical closure method of Kerr incision (double layered continuously locked suturing) will be used.
In the second group of patients double layered purse string closure technique will be used.
The two groups will be compared after 6 weeks in terms of healing, operation time, blood loss, incision size and incisional scar defect( if present).
A physician who does not know the method of closure will evaluate incision size by transabdominal and/or transvaginal ultrasound.
The length of the incision and myometrial thickness in Kerr incisional line will be measured and recorded in longitudinal and transverse axis separately.
If any incisional scar defect is determined it will be measured and recorded also.
Study Type
Interventional
Enrollment (Actual)
168
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Kartal
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Istanbul, Kartal, Turkey, 34050
- Dr. Lütfi Kirdar Kartal Education and Research Hospital
-
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Singleton pregnancy
- Term (> 37 weeks) pregnancy
- Cervical dilatation < 4 cm
- Kerr incision
- Age > 18 years old
Exclusion Criteria:
- Being in active phase of labor
- Emergency situations (fetal distress, cord prolapse, placental abruption,severe pre-eclampsia, eclampsia, placenta previa, vasa previa )
- Having a history of uterine surgery (myomectomy, hysterotomy)other than C/S
- Extension of Kerr incision
- Multiple pregnancy
- Maternal diabetes mellitus
- Maternal connective tissue disease
- Uterine malformation
- Uterine fibroids on Kerr incision line
- Chorioamnionitis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Purse string closure technique
Eighty four patients were allocated to the study group.
Due to expanded Kerr incisions 4 patients in study group did not receive their allocated intervention.
In addition, 29 patients in the study group were lost to follow up and did not come to the sixth week check up.
Statistical analysis is based on data from the remaining 51 study group.
|
Uterine Kerr incision will be closed with purse string suture
Other Names:
|
Active Comparator: Continuously locked closure technique
Eighty four patients were allocated to the control group.
Due to expanded Kerr incisions 3 patients in control group did not receive their allocated intervention.
In addition, 16 patients in the control group were lost to follow up and did not come to the sixth week check up.
Statistical analysis is based on data from the remaining 65 study group.
|
Uterine Kerr incision will be closed with continuously locked suturing
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cesarean Scar Defect in the Uterine Incisional Line
Time Frame: 6 weeks after C/S
|
A wedge-shaped distortion in the integrity of the uterine incision scar during transvaginal ultrasonographic examination at 6 weeks after C/S was accepted as cesarean scar defect in the uterine incisional line and recorded as primary outcome measure, and two groups will be compared.
|
6 weeks after C/S
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Length of Uterine Incision After Suturing
Time Frame: 6 weeks after C/S
|
Length of uterine incision after suturing will be examined and measured by ultrasonography, and two groups will be compared.
|
6 weeks after C/S
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Yasemin Karsidağ, Dr. Lütfi Kirdar Kartal Education and Research Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2011
Primary Completion (Actual)
February 1, 2012
Study Completion (Actual)
February 1, 2012
Study Registration Dates
First Submitted
January 26, 2011
First Submitted That Met QC Criteria
January 31, 2011
First Posted (Estimated)
February 1, 2011
Study Record Updates
Last Update Posted (Actual)
September 28, 2023
Last Update Submitted That Met QC Criteria
September 22, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Kartal1
- 21.01.2011-02(1) (Other Identifier: Ethics committee ID number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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