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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07625852
Enrollment
72
Registered
2026-06-04
Start date
2026-06-01
Completion date
2027-06-01
Last updated
2026-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Isthmocele

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.

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

PROCEDUREVertical Closure

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

PROCEDURETransverse Closure

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

Sponsors

Minia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Postoperative lower uterine segment scar thickness6 and 12 months post-surgery using transvaginal ultrasoundTo evaluate the thickness of the lower uterine segment scar at 6 and 12 months post-surgery using transvaginal ultrasound

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 5, 2026