Cesarean Section ComplicationsNCT01287611
Short Term Comparison of Two Different Techniques of Uterine Cesarean Incision Closure
A study testing Purse string closure technique and Continuously locked closure technique in people with Cesarean Section Complications, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Cesarean Section Complications
- What is being tested?
- Purse string closure technique and Continuously locked closure technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2011to Feb 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Singleton pregnancy
- Term (> 37 weeks) pregnancy
- Cervical dilatation < 4 cm
- Kerr incision
- Age > 18 years old
Who cannot join
- 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
Show all 10Show fewer
- Maternal connective tissue disease
- Uterine malformation
- Uterine fibroids on Kerr incision line
- Chorioamnionitis
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dr. Lütfi Kirdar Kartal Education and Research Hospital
Istanbul, Kartal, 34050
About this study
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
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.
Read the 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.
- Conditions
- Cesarean Section Complications
- Being tested
- Purse string closure technique, Continuously locked closure technique
- Keywords
- Cesarean section, Kerr incision, Purse string suturing in C/S, Continuous locked suturing in C/S
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Purse string closure techniqueProcedure or surgery
Also called Uterine incision in C/S
Uterine Kerr incision will be closed with purse string suture
Continuously locked closure techniqueProcedure or surgery
Also called Uterine incision in C/S
Uterine Kerr incision will be closed with continuously locked suturing
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Purse string closure technique |
| 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. Receives: Procedure: Continuously locked closure technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks after C/S
Secondary outcomes (1)
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.
Measured: 6 weeks after C/S
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2011 (estimated)
- Study startJan 2011
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cesarean Section ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mehmet Cem Turan, Dr. Lutfi Kirdar Kartal Training and Research Hospital
- Investigators
- Yasemin Karsidağ, Study chair, Dr. Lutfi Kirdar Kartal Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01287611
- Sponsor's protocol ID
- Kartal1
- Other IDs
- 21.01.2011-02(1)
- Status last verified
- Sep 2023
- First submitted
- 26 Jan 2011
- Last updated
- 28 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 25370526
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01287611
- Acronym / sponsor ID
- Kartal1
- Conditions
- Cesarean Section Complications
- Keywords
- Cesarean section, Kerr incision, Purse string suturing in C/S, Continuous locked suturing in C/S
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research HospitalOther government
- Study start
- Jan 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 1 Feb 2011 (estimated)
- Results
- Posted 29 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Purse string closure technique | Active comparator | Procedure: Purse string closure techniqueEighty 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. |
| Continuously locked closure technique | Active comparator | Procedure: Continuously locked closure techniqueEighty 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Singleton pregnancy
- Term (> 37 weeks) pregnancy
- Cervical dilatation < 4 cm
- Kerr incision
- Age > 18 years old
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Purse string closure techniqueAlso: Uterine incision in C/SUterine Kerr incision will be closed with purse string suture | Procedure or surgery | Purse string closure technique |
| Continuously locked closure techniqueAlso: Uterine incision in C/SUterine Kerr incision will be closed with continuously locked suturing | Procedure or surgery | Continuously locked closure technique |
Primary outcome
Cesarean Scar Defect in the Uterine Incisional Line
Time frame: 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.
1 secondary outcome
Length of Uterine Incision After Suturing
Time frame: 6 weeks after C/S
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25370526Turan 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.
- PubmedLink provided by the sponsor.
- The video of purse string uterine closure (Turan Technique) in cesarean sectionLink provided by the sponsor.
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Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
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Not yet recruiting
The Mepilex Cesarean Delivery Trial / MEPIDEL
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yasemin Karsidağ study chair
Dr. Lutfi Kirdar Kartal Education and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Purse string closure technique and Continuously locked closure technique in people with Cesarean Section Complications, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cesarean Scar Defect in the Uterine Incisional Line (time frame: 6 weeks after C/S). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01287611, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.