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

ConditionIsthmocele
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorMinia University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

Asymptomatic isthmocele.

Active pelvic infection or malignancy.

Significant medical comorbidities contraindicating laparoscopic surgery.

Coagulopathy.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Vertical Closure

    Procedure/Surgery

    The hysterotomy defect will be closed in two layers using interrupted or continuous sutures along the longitudinal axis of the uterus

  • Transverse Closure

    Procedure/Surgery

    The hysterotomy defect will be closed in two layers using interrupted or continuous sutures perpendicular to the longitudinal axis of the uterus

Treatment groups

72 Participants
are divided into 2 treatment groups
Group A: Vertical Closure GroupActive comparator 1 intervention
Group B: Transverse Closure GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Postoperative lower uterine segment scar thickness

To evaluate the thickness of the lower uterine segment scar at 6 and 12 months post-surgery using transvaginal ultrasound

Time frame
6 and 12 months post-surgery using transvaginal ultrasound

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Minia University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: