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

Primary Purpose

Cesarean Section Complications

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Purse string closure technique
Continuously locked closure technique
Sponsored by
Dr. Lutfi Kirdar Kartal Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cesarean Section Complications focused on measuring Cesarean section, Kerr incision, Purse string suturing in C/S, Continuous locked suturing in C/S

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Dr. Lütfi Kirdar Kartal Education and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Purse string closure technique

Continuously locked closure technique

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
January 26, 2011
Last Updated
September 22, 2023
Sponsor
Dr. Lutfi Kirdar Kartal Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01287611
Brief Title
Short Term Comparison of Two Different Techniques of Uterine Cesarean Incision Closure
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dr. Lutfi Kirdar Kartal Training and Research Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cesarean Section Complications
Keywords
Cesarean section, Kerr incision, Purse string suturing in C/S, Continuous locked suturing in C/S

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
168 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Purse string closure technique
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Continuously locked closure technique
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Purse string closure technique
Other Intervention Name(s)
Uterine incision in C/S
Intervention Description
Uterine Kerr incision will be closed with purse string suture
Intervention Type
Procedure
Intervention Name(s)
Continuously locked closure technique
Other Intervention Name(s)
Uterine incision in C/S
Intervention Description
Uterine Kerr incision will be closed with continuously locked suturing
Primary Outcome Measure Information:
Title
Cesarean Scar Defect in the Uterine Incisional Line
Description
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.
Time Frame
6 weeks after C/S
Secondary Outcome Measure Information:
Title
Length of Uterine Incision After Suturing
Description
Length of uterine incision after suturing will be examined and measured by ultrasonography, and two groups will be compared.
Time Frame
6 weeks after C/S

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yasemin Karsidağ
Organizational Affiliation
Dr. Lutfi Kirdar Kartal Education and Research Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Dr. Lütfi Kirdar Kartal Education and Research Hospital
City
Istanbul
State/Province
Kartal
ZIP/Postal Code
34050
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
25370526
Citation
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.
Results Reference
background
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/25370526/
Description
Pubmed
URL
http://www.dailymotion.com/video/x2fxlgp_closure-of-uterine-incision-in-cesarean-section-with-turan-technique_school
Description
The video of purse string uterine closure (Turan Technique) in cesarean section

Learn more about this trial

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

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