MedTrace Logo

Laparoscopic Isthmocele Repair

NCT06918275 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-07-17

No results posted yet for this study

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

Interventions

PROCEDURE

Laparoscopic isthmocele repair using V-LocTM 180 barbed suture

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.

OTHER

Laparoscopic isthmocele repair using Polyglactin 910 vicryl suture

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.

Sponsors & Collaborators

  • Kanuni Sultan Suleyman Training and Research Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-30
Primary Completion
2026-02-15
Completion
2026-03-15

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06918275 on ClinicalTrials.gov