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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mehmet Cem Turan, Dr.Lütfi Kırdar Kartal Eğitim ve Araştırma Hastanesi
ClinicalTrials.gov Identifier:
NCT01287611
First received: January 26, 2011
Last updated: August 28, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Cesarean Section Complications
Procedure: Purse string closure technique
Procedure: Continuously locked closure technique

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Dr.Lütfi Kırdar Kartal Eğitim ve Araştırma Hastanesi:

Primary Outcome Measures:
  • Cesarean Scar Defect in the Uterine Incisional Line [ Time Frame: 6 weeks after C/S ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 weeks after C/S ] [ Designated as safety issue: No ]
    Length of uterine incision after suturing will be examined and measured by ultrasonography, and two groups will be compared.


Enrollment: 168
Study Start Date: January 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Procedure: Purse string closure technique
Uterine Kerr incision will be closed with purse string suture
Other Name: Uterine incision in C/S
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.
Procedure: Continuously locked closure technique
Uterine Kerr incision will be closed with continuously locked suturing
Other Name: Uterine incision in C/S

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01287611

Locations
Turkey
Dr. Lütfi Kirdar Kartal Education and Research Hospital
Istanbul, Kartal, Turkey, 34050
Sponsors and Collaborators
Dr.Lütfi Kırdar Kartal Eğitim ve Araştırma Hastanesi
Investigators
Study Chair: Yasemin Karsidağ Dr. Lutfi Kirdar Kartal Education and Research Hospital
  More Information

No publications provided

Responsible Party: Mehmet Cem Turan, Chief Clinical, Dr.Lütfi Kırdar Kartal Eğitim ve Araştırma Hastanesi
ClinicalTrials.gov Identifier: NCT01287611     History of Changes
Other Study ID Numbers: Kartal1, 21.01.2011-02(1)
Study First Received: January 26, 2011
Results First Received: July 7, 2014
Last Updated: August 28, 2014
Health Authority: Turkey: Ministry of Health

Keywords provided by Dr.Lütfi Kırdar Kartal Eğitim ve Araştırma Hastanesi:
Cesarean section
Kerr incision
Purse string suturing in C/S
Continuous locked suturing in C/S

ClinicalTrials.gov processed this record on November 25, 2014