Laparoscopic Isthmocele Repair

NCT06918275 | Enrolling By Invitation DMC

• 1 other identifier: CSCHospital
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate postoperative outcomes in patients with isthmocele undergoing laparoscopic repair, comparing the efficacy of V-LocTM 180 and Polyglactin 910 Vicryl sutures. Patients were randomized to undergo laparoscopic isthmocele repair using one of the following suture materials: (1) V-LocTM 180 or (2) Polyglactin 910 Vicryl.

Conditions

Isthmocele

Keywords

isthmocele; laparoscopy; postmenstrual bleeding; V-LocTM 180; Polyglactin 910

Outcome Measures

Primary Outcomes (1)

• Post-operative residual myometrial thickness

  Ultrasonographic evaluation will be performed in the 12th postoperative month to measure residual myometrial thickness and assess the anatomical success of the repair.

  1 year

Secondary Outcomes (2)

• Patient satisfaction and quality of life

  1 year

• 3.Patient satisfaction

  1 year

Study Arms (2)

laparoscopic isthmocele repair using V-LocTM 180 barbed suture

ACTIVE COMPARATOR

The isthmocele area will be sutured using V-LocTM 180 barbed suture in a continuous, non-locked fashion. The repair was performed using a two-layer closure technique, ensuring precise reapproximation of the myometrial edges without breaching the uterine cavity, followed by closure of the serosal edges.

Procedure: Laparoscopic isthmocele repair using V-LocTM 180 barbed suture

laparoscopic isthmocele repair using Polyglactin 910 Vicryl sutures

ACTIVE COMPARATOR

The isthmocele area will be sutured using Polyglactin 910 Vicryl sutures in a continuous, non-locked fashion. The repair was performed using a two-layer closure technique, ensuring precise reapproximation of the myometrial edges without breaching the uterine cavity, followed by closure of the serosal edges.

Other: Laparoscopic isthmocele repair using Polyglactin 910 vicryl suture

Interventions

Laparoscopic isthmocele repair using V-LocTM 180 barbed suture PROCEDURE

The standardized surgical steps for the laparoscopic isthmocele repair were as follows; 1) A 30-degree telescope was introduced through a 10 mm trocar at the umbilicus following the establishment of pneumoperitoneum. 2) Three 5 mm trocars were inserted: two in the bilateral lower quadrants and one in the suprapubic region. 3) The bladder was distended with 300 cc of saline infusion to facilitate dissection of the vesicovaginal space and to allow inferior mobilization of the bladder, thereby ensuring optimal visualization of the isthmocele region. Dissection was performed laterally up to the level of the uterine arteries, thereby minimizing the risk of vascular injury. 4) The light source of the laparoscope was deactivated, enabling the identification of the isthmocele region by utilizing the illumination provided by the hysteroscope. 5) Excision of the abnormal tissue was carried out using an ultrasonic energy device (HARMONIC®), guided by the manipulator shaft as a landmark.

laparoscopic isthmocele repair using V-LocTM 180 barbed suture

Laparoscopic isthmocele repair using Polyglactin 910 vicryl suture OTHER

The standardized surgical steps for the laparoscopic isthmocele repair were as follows; 1) A 30-degree telescope was introduced through a 10 mm trocar at the umbilicus following the establishment of pneumoperitoneum. 2) Three 5 mm trocars were inserted: two in the bilateral lower quadrants and one in the suprapubic region. 3) The bladder was distended with 300 cc of saline infusion to facilitate dissection of the vesicovaginal space and to allow inferior mobilization of the bladder, thereby ensuring optimal visualization of the isthmocele region. Dissection was performed laterally up to the level of the uterine arteries, thereby minimizing the risk of vascular injury. 4) The light source of the laparoscope was deactivated, enabling the identification of the isthmocele region by utilizing the illumination provided by the hysteroscope. 5) Excision of the abnormal tissue was carried out using an ultrasonic energy device (HARMONIC®), guided by the manipulator shaft as a landmark.

laparoscopic isthmocele repair using Polyglactin 910 Vicryl sutures

Eligibility Criteria

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

You may qualify if:

• The study will include women aged 18-45 years who present with symptomatic isthmocele.
• Participants must have a residual myometrial thickness of less than 2.5 mm.
• Participants must desire future fertility.

You may not qualify if:

• Age below 18 or above 45 years
• Atypical endometrial cells or cervical dysplasia on cytology
• Asymptomatic isthmocele
• Candidacy for hysteroscopic surgery
• Cervical or pelvic infections
• Cervical dilation of 4 cm or more (emergency surgery)
• Conditions impairing tissue healing, such as:
• Type 1 or Type 2 diabetes mellitus
• Hematologic disorders associated with bleeding diathesis
• Contraindications for spinal or general anesthesia
• Continuous use of oral contraceptives (OCPs) or GnRH agonists that affect menstrual cycles
• Hydrosalpinx communicating with the uterine cavity
• Intrauterine device (IUD) in place
• Known connective tissue disorders
• Menstrual irregularities:

Sponsors & Collaborators

• Kanuni Sultan Suleyman Training and Research Hospital: lead

Study Sites (1)

Basaksehir Cam and Sakura City Hospital

Istanbul, Istanbul, 34480, Turkey (Türkiye)

Location

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: MD

Study Record Dates

• First Submitted: March 28, 2025
• First Posted: April 9, 2025
• Study Start: May 30, 2025
• Primary Completion: February 15, 2026
• Study Completion: March 15, 2026
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)