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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Isthmocele
• Intervention / Treatment: Procedure: Vertical Closure; Procedure: Transverse Closure

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.

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Vertical Closure Group; The hysterotomy defect will be closed in two layers using interrupted or continuous sutures along the longitudinal axis of the uterus	Procedure: Vertical Closure; The hysterotomy defect will be closed in two layers using interrupted or continuous sutures along the longitudinal axis of the uterus
Active Comparator: Transverse Closure Group; 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; The hysterotomy defect will be closed in two layers using interrupted or continuous sutures perpendicular to the longitudinal axis of the uterus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Minia University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: May 29, 2026
• First Submitted That Met QC Criteria: May 29, 2026
• First Posted (Actual): June 4, 2026

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 1704-9-2025

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No