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

NCT ID: NCT01287611

Last Updated: 2023-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 168 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2012-02-29

Brief Summary

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

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.

Conditions

Cesarean Section Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Purse string closure technique

Intervention Type: PROCEDURE

Uterine Kerr incision will be closed with purse string suture

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.

Group Type: ACTIVE_COMPARATOR

Continuously locked closure technique

Intervention Type: PROCEDURE

Uterine Kerr incision will be closed with continuously locked suturing

Interventions

Purse string closure technique

Uterine Kerr incision will be closed with purse string suture

Intervention Type: PROCEDURE

Continuously locked closure technique

Uterine Kerr incision will be closed with continuously locked suturing

Intervention Type: PROCEDURE

Other Intervention Names

Uterine incision in C/S; Uterine incision in C/S

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Dr. Lutfi Kirdar Kartal Training and Research Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Mehmet Cem Turan

Chief Clinical

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yasemin Karsidağ

Role: STUDY_CHAIR

Dr. Lutfi Kirdar Kartal Education and Research Hospital

Locations

Dr. Lütfi Kirdar Kartal Education and Research Hospital

Istanbul, Kartal, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Turan C, Buyukbayrak EE, Yilmaz AO, Karsidag YK, Pirimoglu M. Purse-string double-layer closure: a novel technique for repairing the uterine incision during cesarean section. J Obstet Gynaecol Res. 2015 Apr;41(4):565-74. doi: 10.1111/jog.12593. Epub 2014 Nov 5.

Reference Type: BACKGROUND

PMID: 25370526 (View on PubMed)

Related Links

https://pubmed.ncbi.nlm.nih.gov/25370526/

Pubmed

http://www.dailymotion.com/video/x2fxlgp_closure-of-uterine-incision-in-cesarean-section-with-turan-technique_school

The video of purse string uterine closure (Turan Technique) in cesarean section

Other Identifiers

21.01.2011-02(1)

Identifier Type: OTHER

Identifier Source: secondary_id

Kartal1

Identifier Type: -

Identifier Source: org_study_id