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Closure of Uterine Incision in Cesarean Section... paylaşan: ProfDrCemTuran

 

Short Term Comparison of Two Different Techniques of Uterine Cesarean Incision Closure
This study is currently recruiting participants.
Verified by Dr.Lütfi Kırdar Kartal Eğitim ve Araştırma Hastanesi, January 2011
First Received: January 26, 2011   Last Updated: February 2, 2011   History of Changes
Sponsor:Dr.Lütfi Kırdar Kartal Eğitim ve Araştırma Hastanesi
Information provided by:Dr.Lütfi Kırdar Kartal Eğitim ve Araştırma Hastanesi
ClinicalTrials.gov Identifier:NCT01287611

  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.


ConditionIntervention
Cesarean Section; Complications
Delayed Healing of Incision
 
Procedure: Purse string closure
Procedure: Continuously locked suturing
 

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:

MedlinePlus related topics: Cesarean Section
U.S. FDA Resources 
 

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

Primary Outcome Measures:
  • Healing of Kerr incision [ Time Frame: 6 weeks after C/S ] [ Designated as safety issue: No ]
    Length of incision, incisional defect (if present) and myometrial thickness in incision line will be measured by ultrasonography, and two groups will be compared.

     

Secondary Outcome Measures:
  • Blood loss [ Time Frame: One day and 6 weeks later ] [ Designated as safety issue: No ]
    It will be compared of two groups in terms of decreasing level of hematocrit levels.

     

Estimated Enrollment:100
Study Start Date:January 2011
Estimated Study Completion Date:November 2011
Estimated Primary Completion Date:September 2011 (Final data collection date for primary outcome measure)
ArmsAssigned Interventions
Purse string closure technique: Active Comparator
Intervention: Procedure: Purse string closure
Procedure: Purse string closure
Uterine Kerr incision will be closed with purse string suture
Other Name: Uterin incision in C/S
Continuously locked closure technique: Active Comparator
Intervention: Procedure: Continuously locked suturing
Procedure: Continuously locked suturing
Uterine Kerr incision will be closed with continuously locked suturing
Other Name: Uterin 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 and incision size. 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, myometrial thickness in Kerr incisional line will be measured and recorded in longitudinal and transverse axis separately. If any incisional 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 CS
  • 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

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

Contacts
Contact: M. Cem Turan, Prof. Dr.0090 532 3513423cemturan@gmail.com

Locations
Turkey
Dr. Lütfi Kirdar Kartal Education and Research HospitalRecruiting
Istanbul, Kartal, Turkey, 34050
Contact: Esra Esim Buyukbayrak     0090 532 7165649     esraesim@yahoo.com    
Sponsors and Collaborators
Dr.Lütfi Kırdar Kartal Eğitim ve Araştırma Hastanesi
Investigators
Study Chair:Yasemin KarsidağDr. Lutfi Kirdar Kartal Education and Research Hospital

  More Information


No publications provided 

Responsible Party:Dr Lutfi Kirdar Kartal Education and Research Hospital ( Hayreddin Yekeler / Medical Director )
ClinicalTrials.gov Identifier:NCT01287611     History of Changes
Other Study ID Numbers:Kartal1, 21.01.2011-02(1)
Study First Received:January 26, 2011
Last Updated:February 2, 2011
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 CS
continuous locked suturing in CS
 

ClinicalTrials.gov processed this record on March 09, 2011

 

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Long Term Comparison of Two Different Techniques of Uterine Cesarean Incision Closure
This study is currently recruiting participants.
Verified by Dr.Lütfi Kırdar Kartal Eğitim ve Araştırma Hastanesi, January 2011
First Received: February 2, 2011   No Changes Posted
Sponsor:Dr.Lütfi Kırdar Kartal Eğitim ve Araştırma Hastanesi
Information provided by:Dr.Lütfi Kırdar Kartal Eğitim ve Araştırma Hastanesi
ClinicalTrials.gov Identifier:NCT01289262
  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.


ConditionIntervention
Cesarean Section; Complications
Placenta Previa
Placenta Accreta
 
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: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

Resource links provided by NLM:

MedlinePlus related topics: Cesarean Section
U.S. FDA Resources 
 

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

Primary Outcome Measures:
  • Placenta previa [ Time Frame: Subsequent pregnancy within next 4 years ] [ Designated as safety issue: No ]
    It will be noted whether placenta previa in cesarean operation of the subsequent pregnancy within next 4 years, and two groups will be compared.

     

Secondary Outcome Measures:
  • Placenta insertion anomalies [ Time Frame: Subsequent pregnancy within 4 years ] [ Designated as safety issue: No ]
    It will be noted whether placenta insertion anomalies (placenta accreta and others) in cesarean operation of the subsequent pregnancy within next 4 years, and two groups will be compared.

     
  • Uterine rupture [ Time Frame: Subsequent pregnancy within next 4 years ] [ Designated as safety issue: No ]
    It will be noted whether uterine rupture (incomplete or complete, dehiscence of uterine incision) in cesarean operation of the subsequent pregnancy within next 4 years, and two groups will be compared.

     
  • Intra-abdominal adhesions [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
    It will be noted whether intra-abdominal adhesion in cesarean operation of the subsequent pregnancy within next 4 years, and two groups will be compared.

     

Estimated Enrollment:100
Study Start Date:January 2011
Estimated Study Completion Date:April 2015
Estimated Primary Completion Date:February 2015 (Final data collection date for primary outcome measure)
ArmsAssigned Interventions
Purse string closure technique: Active Comparator
Uterine Kerr incision will be closed with purse string suture.
Intervention: Procedure: Purse string closure technique
Procedure: Purse string closure technique
Uterine incision will be closed with purse string closure technique.
Other Name: Uterine incision in C/S
Continuously locked closure technique: Active Comparator
Uterine Kerr incision will be closed with continuously locked closure technique.
Intervention: Procedure: Continuously locked closure technique
Procedure: Continuously locked closure technique
Uterine incision will be closed with continuously locked closure technique
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.

Women will be followed for a subsequent pregnancy in the next 4 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.

  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 CS
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01289262

Contacts
Contact: M.Cem Turan, Prof. Dr.00905323513423cemturan@gmail.com

Locations
Turkey
Dr. Lütfi Kirdar Kartal Education and Research Hospital, KartalRecruiting
Istanbul, Turkey
Contact: Esra Esim Buyukbayrak     0090 532 7165649     esraesim@yahoo.com    
Sponsors and Collaborators
Dr.Lütfi Kırdar Kartal Eğitim ve Araştırma Hastanesi
Investigators
Study Chair:Yasemin KarsidagDr. Lutfi Kirdar Kartal Education and Research Hospital
  More Information

No publications provided 

Responsible Party:Dr Lutfi Kirdar Kartal Education and Research Hospital ( Hayreddin Yekeler / Medical Director )
ClinicalTrials.gov Identifier:NCT01289262     History of Changes
Other Study ID Numbers:Kartal2, 21.01.2011-02 (02)
Study First Received:February 2, 2011
Last Updated:February 2, 2011
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 CS
Continuous locked suturing in CS
 

Additional relevant MeSH terms:
Placenta Accreta
Placenta Previa
Obstetric Labor Complications
Pregnancy Complications
Placenta Diseases
 

ClinicalTrials.gov processed this record on March 09, 2011

 



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