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Not yet recruiting NCT07625852

Impact of Vertical vs. Transverse Closure on Outcomes of Laparoscopic Correction of Isthmocele

No phase Interventional Isthmocele

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Vertical Closure, Transverse Closure.
Who it may be relevant to
Registry conditions: Isthmocele. Basic parameters: 18 years — 45 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Detailed description

Isthmocele, also known as a cesarean scar defect (CSD), is a common complication following cesarean section, characterized by a myometrial defect at the site of the hysterotomy scar. It can lead to various symptoms including abnormal uterine bleeding, dysmenorrhea, pelvic pain, and infertility.

Laparoscopic repair 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.

Interventions

  • Procedure Vertical Closure
    The hysterotomy defect will be closed in two layers using interrupted or continuous sutures along the longitudinal axis of the uterus
  • Procedure Transverse Closure
    The hysterotomy defect will be closed in two layers using interrupted or continuous sutures perpendicular to the longitudinal axis of the uterus

Primary outcome measures

  • Postoperative lower uterine segment scar thickness [Time frame: 6 and 12 months post-surgery using transvaginal ultrasound]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07625852 · 1704-9-2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗