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

NCT07625852 | Not Yet Recruiting

• 1 other identifier: 1704-9-2025
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Isthmocele

Outcome Measures

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

  6 and 12 months post-surgery using transvaginal ultrasound

Study Arms (2)

Vertical Closure Group

ACTIVE COMPARATOR

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

Procedure: Vertical Closure

Transverse Closure Group

ACTIVE COMPARATOR

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

Procedure: Transverse Closure

Interventions

Vertical Closure PROCEDURE

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

Vertical Closure Group

Transverse Closure PROCEDURE

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

Transverse Closure Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Minia University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Obstetrics and Gynecology

Study Record Dates

• First Submitted: May 29, 2026
• First Posted: June 4, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: June 4, 2026

Record last verified: 2026-05