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

• Sponsor: Dr. Lutfi Kirdar Kartal Training and Research Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01287611
• Collaborator: (none)
• Enrollment: 168
• Location: 1
• Arms: 2
• Duration (Months): 13
• Patients Per Site Per Month: 12.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cesarean Section Complications	Procedure: Purse string closure technique; Procedure: Continuously locked closure technique	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 168 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, 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
• Study Start Date: Jan 1, 2011
• Actual Primary Completion Date: Feb 1, 2012
• Actual Study Completion Date: Feb 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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 Names: Uterine incision in C/S

Outcome Measures

Primary Outcome Measures

1. Cesarean Scar Defect in the Uterine Incisional Line [6 weeks after C/S]

   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

1. Length of Uterine Incision After Suturing [6 weeks after C/S]

   Length of uterine incision after suturing will be examined and measured by ultrasonography, and two groups will be compared.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Dr. Lütfi Kirdar Kartal Education and Research Hospital	Istanbul	Kartal	Turkey	34050

Sponsors and Collaborators

• Dr. Lutfi Kirdar Kartal Training and Research Hospital

Investigators

• Study Chair: Yasemin Karsidağ, Dr. Lutfi Kirdar Kartal Education and Research Hospital

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Original Article in the Wiley Online Library
• The video of purse string uterine closure (Turan Technique) in cesarean section

Publications

• Turan C, Büyükbayrak 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.

• Responsible Party: Mehmet Cem Turan, Chief Clinical, Dr. Lutfi Kirdar Kartal Training and Research Hospital
• ClinicalTrials.gov Identifier: NCT01287611
• Other Study ID Numbers: Kartal1; 21.01.2011-02(1)
• First Posted: Feb 1, 2011
• Last Update Posted: Mar 23, 2022
• Last Verified: Mar 1, 2022

• Keywords provided by Mehmet Cem Turan, Chief Clinical, Dr. Lutfi Kirdar Kartal Training and Research Hospital: Cesarean section; Kerr incision; Purse string suturing in C/S; Continuous locked suturing in C/S
• Additional relevant MeSH terms: Surgical Wound

Study Results

Participant Flow

Arm/Group Title	Purse String Closure Technique	Continuously Locked Closure Technique
Arm/Group Description	Purse string closure: Uterine Kerr incision will be closed with purse string suture	Continuously locked suturing: Uterine Kerr incision will be closed with continuously locked suturing
Period Title: Overall Study
STARTED	84	84
The Number of Patients Who Underwent C/S	84	84
COMPLETED	51	65
NOT COMPLETED	33	19

Baseline Characteristics

Arm/Group Title	Purse String Closure Technique	Continuously Locked Closure Technique	Total
Arm/Group Description	Purse string closure: Uterine Kerr incision will be closed with purse string suture	Continuously locked suturing: Uterine Kerr incision will be closed with continuously locked suturing	Total of all reporting groups
Overall Participants	51	65	116
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	29.6 (5.0)	28.5 (5.3)	29.05 (5.15)
Sex: Female, Male (Count of Participants)
Female	51 100%	65 100%	116 100%
Male	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
Turkey	51 100%	65 100%	116 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Purse String Closure Technique	Continuously Locked Closure Technique
Arm/Group Description	Purse string closure: Uterine Kerr incision will be closed with purse string suture	Continuously locked suturing: Uterine Kerr incision will be closed with continuously locked suturing
Measure Participants	51	65
Number [participants]	12 (4.38) 23.5%	39 (6.11) 60%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Purse String Closure Technique, Continuously Locked Closure Technique
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence (legacy)
	Comments	Group sample sizes of 51 in study group and 65 in control group achieve 98% power to detect a difference between the group proportions of -0.3300. The proportion in study group is assumed to be 0.4800 under the null hypothesis and 0.1500 under the alternative hypothesis. The proportion in control group is 0.4800. The test statistic used is the two-sided Z test with pooled variance. The significance level of the test was targeted at 0.0500.
Statistical Test of Hypothesis	p-Value	0.0001
	Comments
	Method	Chi-squared
	Comments

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Purse String Closure Technique	Continuously Locked Closure Technique
Arm/Group 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. Purse string closure technique: Uterine Kerr incision will be closed with purse string suture	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. Continuously locked closure technique: Uterine Kerr incision will be closed with continuously locked suturing
Measure Participants	51	65
Mean (Standard Deviation) [cm]	3.7 (0.9)	8.5 (1.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Purse String Closure Technique, Continuously Locked Closure Technique
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence (legacy)
	Comments	Group sample sizes of 51 in study group and 65 in control group achieve 98% power to detect a difference between the group proportions of -0.3300. The proportion in study group is assumed to be 0.4800 under the null hypothesis and 0.1500 under the alternative hypothesis. The proportion in control group is 0.4800. The test statistic used is the two-sided Z test with pooled variance. The significance level of the test was targeted at 0.0500.
Statistical Test of Hypothesis	p-Value	0.001
	Comments
	Method	t-test, 2 sided
	Comments

Adverse Events

Arm/Group Title	Purse String Closure Technique		Continuously Locked Closure Technique
Arm/Group Description	Purse string closure: Uterine Kerr incision will be closed with purse string suture		Continuously locked suturing: Uterine Kerr incision will be closed with continuously locked suturing
All Cause Mortality
	Purse String Closure Technique		Continuously Locked Closure Technique
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Purse String Closure Technique		Continuously Locked Closure Technique
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/51 (0%)		0/65 (0%)
Other (Not Including Serious) Adverse Events
	Purse String Closure Technique		Continuously Locked Closure Technique
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/51 (0%)		0/65 (0%)

Limitations/Caveats

The present trial is a single-center study. The similar results should be supported in a multicenter study. Another limitation of this study is the more than 25% overall rate of loss to follow-up.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.