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

Long 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: Placenta Accreta; Placenta Previa; Cesarean Section; Complications
• Intervention / Treatment: Procedure: Purse string closure technique; Procedure: Continuously locked closure technique

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.

Women will be followed for a subsequent pregnancy in the next average 6 years. If they become pregnant again they will be followed up during pregnancy for comparison of long-term effects of the two suture techniques. Patients will be followed especially from the aspects of placental anomalies. Presence of intra-abdominal adhesions, uterine dehiscence, placenta previa, placental invasion anomalies (eg, placenta accreta and others)and incomplete or complete rupture will be compared between two groups.

• Study Type: Interventional
• Enrollment (Actual): 168
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Health Institutes of Turkey ISTANBUL, TURKEY

Participation Criteria

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 CS
• Extension of Kerr incision
• Multiple pregnancy
• Maternal diabetes mellitus
• Maternal connective tissue disease
• Uterine malformation
• Uterine fibroids on Kerr incision line
• Chorioamnionitis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Purse string closure technique; Uterine Kerr incision will be closed with purse string suture.	Procedure: Purse string closure technique; Uterine incision will be closed with purse string closure technique.; Other Names: Uterine incision in C/S
Active Comparator: Continuously locked closure technique; Uterine Kerr incision will be closed with continuously locked closure technique.	Procedure: Continuously locked closure technique; Uterine incision will be closed with continuously locked closure technique; Other Names: Uterine incision in C/S

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Placenta Previa	It will be noted whether placenta previa in cesarean operation of the subsequent pregnancy within next average 6 years, and two groups will be compared.	Subsequent pregnancy within next average 6 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Placenta Insertion Anomalies	It will be noted whether placenta insertion anomalies (placenta accreta and others) in cesarean operation of the subsequent pregnancy within next average 6 years, and two groups will be compared.	Subsequent pregnancy within next average 6 years
Uterine Rupture	It will be noted whether uterine rupture (incomplete or complete, dehiscence of uterine incision) in cesarean operation of the subsequent pregnancy within next average 6 years, and two groups will be compared.	Subsequent pregnancy within next average 6 years
Intra-abdominal Adhesions	It will be noted whether intra-abdominal adhesion in cesarean operation of the subsequent pregnancy within next average 6 years, and two groups will be compared.	Up to average 6 years

Collaborators and Investigators

• Sponsor: Dr. Lutfi Kirdar Kartal Training and Research Hospital
• Investigators: Study Director: Cem Turan, Health Institutes of Turkey ISTANBUL, TURKEY

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2011
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): August 1, 2023

Study Registration Dates

• First Submitted: February 2, 2011
• First Submitted That Met QC Criteria: February 2, 2011
• First Posted (Estimated): February 3, 2011

Study Record Updates

• Last Update Posted (Actual): August 19, 2024
• Last Update Submitted That Met QC Criteria: March 23, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Cesarean section; Kerr incision; Purse string suturing in CS; Continuous locked suturing in CS
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Placenta Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Placenta Accreta; Placenta Previa
• Other Study ID Numbers: Kartal2; 21.01.2011-02 (02) (Other Identifier: Ethics committee ID number)