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| ID | Type | Description | Link |
|---|---|---|---|
| 21.01.2011-02(1) | Other Identifier | Ethics committee ID number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Purse string closure technique | Active Comparator | 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. |
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| Continuously locked closure technique | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Purse string closure technique | Procedure | Uterine Kerr incision will be closed with purse string suture |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 weeks after C/S |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 weeks after C/S |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yasemin Karsidağ | Dr. Lutfi Kirdar Kartal Education and Research Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Lütfi Kirdar Kartal Education and Research Hospital | Istanbul | Kartal | 34050 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25370526 | Background | 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. |
| Label | URL |
|---|---|
| Pubmed | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Purse String Closure Technique | Purse string closure: Uterine Kerr incision will be closed with purse string suture |
| FG001 | Continuously Locked Closure Technique | Continuously locked suturing: Uterine Kerr incision will be closed with continuously locked suturing |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Purse String Closure Technique | Purse string closure: Uterine Kerr incision will be closed with purse string suture |
| BG001 | Continuously Locked Closure Technique | Continuously locked suturing: Uterine Kerr incision will be closed with continuously locked suturing |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | participants | 6 weeks after C/S |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Purse String Closure Technique | Purse string closure: Uterine Kerr incision will be closed with purse string suture |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Cem Turan | DrLutfi | 00905323513423 | cemturan@gmail.com |
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| Continuously locked closure technique | Procedure | Uterine Kerr incision will be closed with continuously locked suturing |
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| The video of purse string uterine closure (Turan Technique) in cesarean section | View source |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | 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. | Posted | Mean | Standard Deviation | cm | 6 weeks after C/S |
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| 0 |
| 51 |
| 0 |
| 51 |
| EG001 | Continuously Locked Closure Technique | Continuously locked suturing: Uterine Kerr incision will be closed with continuously locked suturing | 0 | 65 | 0 | 65 |
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