Short Term Comparison of Two Different Techniques of Uterine Cesarean Incision Closure

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Cesarean Section Complications

Intervention / Treatment
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* Procedure: Purse string closure technique
* Procedure: Continuously locked closure technique


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Purse string closure technique<br>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. | Procedure: Purse string closure technique<br>* Uterine Kerr incision will be closed with purse string suture<br>* Other names: Uterine incision in C/S;|
| Active Comparator: Continuously locked closure technique<br>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. | Procedure: Continuously locked closure technique<br>* Uterine Kerr incision will be closed with continuously locked suturing<br>* Other names: Uterine incision in C/S;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cesarean Scar Defect in the Uterine Incisional Line | 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 | Length of uterine incision after suturing will be examined and measured by ultrasonography, and two groups will be compared. | 6 weeks after C/S | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cesarean section, Kerr incision, Purse string suturing in C/S, Continuous locked suturing in C/S