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.
Who can participate
Age range
18 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
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)
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Post-operative residual myometrial thickness
Timeframe: 1 year
Trial details
NCT IDNCT06918275
SponsorKanuni Sultan Suleyman Training and Research Hospital