IsthmoceleNCT06918275
Laparoscopic Isthmocele Repair
A study testing Laparoscopic isthmocele repair using V-LocTM 180 barbed suture and Laparoscopic isthmocele repair using Polyglactin 910 vicryl suture in people with Isthmocele, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
To evaluate postoperative outcomes in patients with isthmocele undergoing laparoscopic repair, comparing the efficacy of V-LocTM 180 and Polyglactin 910 Vicryl sutures. Patients were randomized to undergo laparoscopic isthmocele repair using one of the following suture materials: (1) V-LocTM 180 or (2) Polyglactin 910… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Isthmocele
- What is being tested?
- Laparoscopic isthmocele repair using V-LocTM 180 barbed suture and Laparoscopic isthmocele repair using Polyglactin 910 vicryl suture
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 May 2025to 15 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- The study will include women aged 18-45 years who present with symptomatic isthmocele.
- Participants must have a residual myometrial thickness of less than 2.5 mm.
- Participants must desire future fertility.
Who cannot join
- Age below 18 or above 45 years
- Atypical endometrial cells or cervical dysplasia on cytology
- Asymptomatic isthmocele
- Candidacy for hysteroscopic surgery
- Cervical or pelvic infections
- Cervical dilation of 4 cm or more (emergency surgery)
Show all 27Show fewer
- Conditions impairing tissue healing, such as:
- Type 1 or Type 2 diabetes mellitus
- Hematologic disorders associated with bleeding diathesis
- Contraindications for spinal or general anesthesia
- Continuous use of oral contraceptives (OCPs) or GnRH agonists that affect menstrual cycles
- Hydrosalpinx communicating with the uterine cavity
- Intrauterine device (IUD) in place
- Known connective tissue disorders
- Menstrual irregularities:
- Cycles longer than 35 days
- Cycle variations of 2 weeks or more
- Ongoing pregnancy
- Presence of structural abnormalities such as:
- Uterine or cervical polyps
- Submucosal fibroids
- Other similar conditions
- Residual myometrial thickness > 2.5 mm
- Retained placental tissue
- Suspected malignancies
- Uterine anomalies
- Immunosuppressive diseases
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Basaksehir Cam and Sakura City Hospital
Istanbul, Istanbul, 34480
About this study
Official title: Efficacy and Safety of V-LocTM 180 Barbed Sutures Compared to Polyglactin 910 Vicryl in Laparoscopic Isthmocele Repair: A Prospective Randomized Study
To evaluate postoperative outcomes in patients with isthmocele undergoing laparoscopic repair, comparing the efficacy of V-LocTM 180 and Polyglactin 910 Vicryl sutures.
Patients were randomized to undergo laparoscopic isthmocele repair using one of the following suture materials: (1) V-LocTM 180 or (2) Polyglactin 910 Vicryl.
Read the detailed description
The global rise in cesarean section (CS) rates has led to an increased incidence of associated complications, presenting new challenges in gynecological practice. One of these complications is a cesarean scar defect, also known as isthmocele, which manifests as a pouch-like structure at the site of the previous CS scar. This defect often results in the accumulation of menstrual blood, inflammatory cells, and mucus, leading to symptoms such as postmenstrual bleeding, pelvic pain, and dyspareunia. Furthermore, isthmocele has been implicated in secondary infertility due to the inflammatory changes it induces in the endometrium. Additionally, the presence of an isthmocele increases the risk of complications in future pregnancies, including cesarean scar ectopic pregnancy, uterine rupture, and placenta accreta spectrum disorders.
Diagnosis of isthmocele relies on imaging modalities such as transvaginal ultrasound (TVUS), sonohysterography (SHG), or hysteroscopy. While asymptomatic cases generally do not require intervention, symptomatic patients may benefit from medical or surgical treatment. Due to limited evidence supporting medical therapy, surgical intervention has become the preferred approach, particularly for patients desiring future fertility. Various surgical techniques, including hysteroscopic, laparoscopic, vaginal, laparotomic, and combined procedures, have been proposed for isthmocele repair. Among these, laparoscopic isthmocele repair is favored for patients with fertility concerns as it enables complete excision of the defective myometrial tissue and reconstruction of the uterine wall.
Despite the advantages of laparoscopic isthmocele repair, no universally accepted cutoff value for residual myometrial thickness dictates surgical candidacy. Previous studies have suggested that laparoscopic repair is a safer and more practical option for cases with significant myometrial loss (>80%). However, there is limited data on the impact of different suture materials used in laparoscopic repair on postoperative outcomes.
- Conditions
- Isthmocele
- Being tested
- Laparoscopic isthmocele repair using V-LocTM 180 barbed suture, Laparoscopic isthmocele repair using Polyglactin 910 vicryl suture
- Keywords
- isthmocele, laparoscopy, postmenstrual bleeding, V-LocTM 180, Polyglactin 910
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic isthmocele repair using V-LocTM 180 barbed sutureProcedure or surgery
The standardized surgical steps for the laparoscopic isthmocele repair were as follows; 1) A 30-degree telescope was introduced through a 10 mm trocar at the umbilicus following the establishment of pneumoperitoneum. 2) Three 5 mm trocars were inserted: two in the bilateral lower quadrants and one in the suprapubic region. 3) The bladder was distended with 300 cc of saline infusion to facilitate dissection of the vesicovaginal space and to allow inferior mobilization of the bladder, thereby ensuring optimal visualization of the isthmocele region. Dissection was performed laterally up to the level of the uterine arteries, thereby minimizing the risk of vascular injury. 4) The light source of the laparoscope was deactivated, enabling the identification of the isthmocele region by utilizing the illumination provided by the hysteroscope. 5) Excision of the abnormal tissue was carried out using an ultrasonic energy device (HARMONIC®), guided by the manipulator shaft as a landmark.
Laparoscopic isthmocele repair using Polyglactin 910 vicryl sutureOther
The standardized surgical steps for the laparoscopic isthmocele repair were as follows; 1) A 30-degree telescope was introduced through a 10 mm trocar at the umbilicus following the establishment of pneumoperitoneum. 2) Three 5 mm trocars were inserted: two in the bilateral lower quadrants and one in the suprapubic region. 3) The bladder was distended with 300 cc of saline infusion to facilitate dissection of the vesicovaginal space and to allow inferior mobilization of the bladder, thereby ensuring optimal visualization of the isthmocele region. Dissection was performed laterally up to the level of the uterine arteries, thereby minimizing the risk of vascular injury. 4) The light source of the laparoscope was deactivated, enabling the identification of the isthmocele region by utilizing the illumination provided by the hysteroscope. 5) Excision of the abnormal tissue was carried out using an ultrasonic energy device (HARMONIC®), guided by the manipulator shaft as a landmark.
| Study group | Role | What they receive |
|---|---|---|
| laparoscopic isthmocele repair using V-LocTM 180 barbed suture | Active comparator | The isthmocele area will be sutured using V-LocTM 180 barbed suture in a continuous, non-locked fashion. The repair was performed using a two-layer closure technique, ensuring precise reapproximation of the myometrial edges without breaching the uterine cavity, followed by closure of the serosal edges. Receives: Procedure: Laparoscopic isthmocele repair using V-LocTM 180 barbed suture |
| laparoscopic isthmocele repair using Polyglactin 910 Vicryl sutures | Active comparator | The isthmocele area will be sutured using Polyglactin 910 Vicryl sutures in a continuous, non-locked fashion. The repair was performed using a two-layer closure technique, ensuring precise reapproximation of the myometrial edges without breaching the uterine cavity, followed by closure of the serosal edges. Receives: Other: Laparoscopic isthmocele repair using Polyglactin 910 vicryl suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative residual myometrial thickness
Ultrasonographic evaluation will be performed in the 12th postoperative month to measure residual myometrial thickness and assess the anatomical success of the repair.
Measured: 1 year
Secondary outcomes (2)
Patient satisfaction and quality of life
Participants will complete the Female Sexual Function Index (FSFI) questionnaire in the postoperative 12th month to evaluate sexual function and overall health-related quality of life.
Measured: 1 year
3.Patient satisfaction
Participants will complete the SF-36 questionnaire in the postoperative 12th month to evaluate sexual function and overall health-related quality of life.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start30 May 2025
- Primary completion15 Feb 2026 (estimated)
- Study completion15 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IsthmoceleStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozan Karadeniz, Başakşehir Çam & Sakura City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06918275
- Sponsor's protocol ID
- CSCHospital
- Status last verified
- Jul 2025
- First submitted
- 28 Mar 2025
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of V-LocTM 180 Barbed Sutures Compared to Polyglactin 910 Vicryl in Laparoscopic Isthmocele Repair: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT06918275
- Acronym / sponsor ID
- CSCHospital
- Conditions
- Isthmocele
- Keywords
- isthmocele, laparoscopy, postmenstrual bleeding, V-LocTM 180, Polyglactin 910
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 30 May 2025 (actual)
- Primary completion
- 15 Feb 2026 (estimated)
- Study completion
- 15 Mar 2026 (estimated)
- First posted
- 9 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate postoperative outcomes in patients with isthmocele undergoing laparoscopic repair, comparing the efficacy of V-LocTM 180 and Polyglactin 910 Vicryl sutures.
Patients were randomized to undergo laparoscopic isthmocele repair using one of the following suture materials: (1) V-LocTM 180 or (2) Polyglactin 910 Vicryl.
Detailed description
The global rise in cesarean section (CS) rates has led to an increased incidence of associated complications, presenting new challenges in gynecological practice. One of these complications is a cesarean scar defect, also known as isthmocele, which manifests as a pouch-like structure at the site of the previous CS scar. This defect often results in the accumulation of menstrual blood, inflammatory cells, and mucus, leading to symptoms such as postmenstrual bleeding, pelvic pain, and dyspareunia. Furthermore, isthmocele has been implicated in secondary infertility due to the inflammatory changes it induces in the endometrium. Additionally, the presence of an isthmocele increases the risk of complications in future pregnancies, including cesarean scar ectopic pregnancy, uterine rupture, and placenta accreta spectrum disorders.
Diagnosis of isthmocele relies on imaging modalities such as transvaginal ultrasound (TVUS), sonohysterography (SHG), or hysteroscopy. While asymptomatic cases generally do not require intervention, symptomatic patients may benefit from medical or surgical treatment. Due to limited evidence supporting medical therapy, surgical intervention has become the preferred approach, particularly for patients desiring future fertility. Various surgical techniques, including hysteroscopic, laparoscopic, vaginal, laparotomic, and combined procedures, have been proposed for isthmocele repair. Among these, laparoscopic isthmocele repair is favored for patients with fertility concerns as it enables complete excision of the defective myometrial tissue and reconstruction of the uterine wall.
Despite the advantages of laparoscopic isthmocele repair, no universally accepted cutoff value for residual myometrial thickness dictates surgical candidacy. Previous studies have suggested that laparoscopic repair is a safer and more practical option for cases with significant myometrial loss (>80%). However, there is limited data on the impact of different suture materials used in laparoscopic repair on postoperative outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| laparoscopic isthmocele repair using V-LocTM 180 barbed suture | Active comparator | Procedure: Laparoscopic isthmocele repair using V-LocTM 180 barbed sutureThe isthmocele area will be sutured using V-LocTM 180 barbed suture in a continuous, non-locked fashion. The repair was performed using a two-layer closure technique, ensuring precise reapproximation of the myometrial edges without breaching the uterine cavity, followed by closure of the serosal edges. |
| laparoscopic isthmocele repair using Polyglactin 910 Vicryl sutures | Active comparator | Other: Laparoscopic isthmocele repair using Polyglactin 910 vicryl sutureThe isthmocele area will be sutured using Polyglactin 910 Vicryl sutures in a continuous, non-locked fashion. The repair was performed using a two-layer closure technique, ensuring precise reapproximation of the myometrial edges without breaching the uterine cavity, followed by closure of the serosal edges. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- The study will include women aged 18-45 years who present with symptomatic isthmocele.
- Participants must have a residual myometrial thickness of less than 2.5 mm.
- Participants must desire future fertility.
Key exclusion criteria (27 listed)
- Age below 18 or above 45 years
- Atypical endometrial cells or cervical dysplasia on cytology
- Asymptomatic isthmocele
- Candidacy for hysteroscopic surgery
- Cervical or pelvic infections
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 |
|---|---|---|
| Laparoscopic isthmocele repair using V-LocTM 180 barbed sutureThe standardized surgical steps for the laparoscopic isthmocele repair were as follows; 1) A 30-degree telescope was introduced through a 10 mm trocar at the umbilicus following the establishment of pneumoperitoneum. 2) Three 5 mm trocars were inserted: two in the bilateral lower quadrants and one in the suprapubic region. 3) The bladder was distended with 300 cc of saline infusion to facilitate dissection of the vesicovaginal space and to allow inferior mobilization of the bladder, thereby ensuring optimal visualization of the isthmocele region. Dissection was performed laterally up to the level of the uterine arteries, thereby minimizing the risk of vascular injury. 4) The light source of the laparoscope was deactivated, enabling the identification of the isthmocele region by utilizing the illumination provided by the hysteroscope. 5) Excision of the abnormal tissue was carried out using an ultrasonic energy device (HARMONIC®), guided by the manipulator shaft as a landmark. | Procedure or surgery | laparoscopic isthmocele repair using V-LocTM 180 barbed suture |
| Laparoscopic isthmocele repair using Polyglactin 910 vicryl sutureThe standardized surgical steps for the laparoscopic isthmocele repair were as follows; 1) A 30-degree telescope was introduced through a 10 mm trocar at the umbilicus following the establishment of pneumoperitoneum. 2) Three 5 mm trocars were inserted: two in the bilateral lower quadrants and one in the suprapubic region. 3) The bladder was distended with 300 cc of saline infusion to facilitate dissection of the vesicovaginal space and to allow inferior mobilization of the bladder, thereby ensuring optimal visualization of the isthmocele region. Dissection was performed laterally up to the level of the uterine arteries, thereby minimizing the risk of vascular injury. 4) The light source of the laparoscope was deactivated, enabling the identification of the isthmocele region by utilizing the illumination provided by the hysteroscope. 5) Excision of the abnormal tissue was carried out using an ultrasonic energy device (HARMONIC®), guided by the manipulator shaft as a landmark. | Other | laparoscopic isthmocele repair using Polyglactin 910 Vicryl sutures |
Primary outcome
Post-operative residual myometrial thickness
Time frame: 1 year
Ultrasonographic evaluation will be performed in the 12th postoperative month to measure residual myometrial thickness and assess the anatomical success of the repair.
2 secondary outcomes
Patient satisfaction and quality of life
Time frame: 1 year
3.Patient satisfaction
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic isthmocele repair using V-LocTM 180 barbed suture and Laparoscopic isthmocele repair using Polyglactin 910 vicryl suture in people with Isthmocele, run by Kanuni Sultan Suleyman 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 3 inclusion and 27 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: enrolling by invitation, as of the sponsor's last update on 17 Jul 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Post-operative residual myometrial thickness (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jul 2025; AzTrials last refreshed its copy on 26 Oct 2026.