Impact of Vertical vs. Transverse Closure on Outcomes of Laparoscopic Correction of Isthmocele (NCT07625852) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Impact of Vertical vs. Transverse Closure on Outcomes of Laparoscopic Correction of Isthmocele
72 participantsStarted 2026-06-01
Plain-language summary
Laparoscopic repair of Isthmocele aims to restore the anatomical integrity and physiological function of the lower uterine segment.
* Vertical Closure: This technique involves closing the defect along the longitudinal axis of the uterus. Proponents suggest it may be more anatomically aligned with the muscle fibers of the lower uterine segment, potentially leading to stronger scar formation and reduced tension.
* Transverse Closure: This technique involves closing the defect perpendicular to the long axis of the uterus. This approach is more commonly used during primary cesarean sections.
Arguments for transverse closure in isthmocele repair include familiarity for surgeons and potentially less shortening of the lower uterine segment.
However, the actual impact of these different closure methods on long-term outcomes such as defect recurrence, scar integrity, and fertility, remains largely unexplored in a randomized controlled trial setting.
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:
* Women aged 18-45 years.
* Diagnosis of symptomatic isthmocele confirmed by transvaginal ultrasound (myometrial thickness at the defect \< 2.5 mm).
* History of at least one prior cesarean section.
* Symptoms attributable to isthmocele (e.g., abnormal uterine bleeding, pelvic pain, dysmenorrhea, secondary infertility).
* Desire for surgical correction of isthmocele.
* Ability to understand and provide informed consent
Exclusion Criteria:
* Asymptomatic isthmocele.
* Active pelvic infection or malignancy.
* Significant medical comorbidities contraindicating laparoscopic surgery.
* Coagulopathy.
* Known uterine anomalies (e.g., bicornuate uterus).
* Pregnancy at the time of recruitment.
* Inability to comply with follow-up protocol.
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.