Laparoscopic Isthmocele Repair

Not Applicable

• Conditions: Isthmocele

• Registration Number: NCT06918275
• Lead Sponsor: Kanuni Sultan Suleyman Training and Research Hospital

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.

Detailed Description

The global rise in cesarean section (CS) rates has led to an increased incidence of associated complications, presenting new challenges in gynecological practice. One of these complications is a cesarean scar defect, also known as isthmocele, which manifests as a pouch-like structure at the site of the previous CS scar. This defect often results in the accumulation of menstrual blood, inflammatory cells, and mucus, leading to symptoms such as postmenstrual bleeding, pelvic pain, and dyspareunia. Furthermore, isthmocele has been implicated in secondary infertility due to the inflammatory changes it induces in the endometrium. Additionally, the presence of an isthmocele increases the risk of complications in future pregnancies, including cesarean scar ectopic pregnancy, uterine rupture, and placenta accreta spectrum disorders.

Diagnosis of isthmocele relies on imaging modalities such as transvaginal ultrasound (TVUS), sonohysterography (SHG), or hysteroscopy. While asymptomatic cases generally do not require intervention, symptomatic patients may benefit from medical or surgical treatment. Due to limited evidence supporting medical therapy, surgical intervention has become the preferred approach, particularly for patients desiring future fertility. Various surgical techniques, including hysteroscopic, laparoscopic, vaginal, laparotomic, and combined procedures, have been proposed for isthmocele repair. Among these, laparoscopic isthmocele repair is favored for patients with fertility concerns as it enables complete excision of the defective myometrial tissue and reconstruction of the uterine wall.

Despite the advantages of laparoscopic isthmocele repair, no universally accepted cutoff value for residual myometrial thickness dictates surgical candidacy. Previous studies have suggested that laparoscopic repair is a safer and more practical option for cases with significant myometrial loss (\>80%). However, there is limited data on the impact of different suture materials used in laparoscopic repair on postoperative outcomes.

Study Timeline

• Study First Submitted: 2025-03-28
• Study Start: 2025-03-30
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-05
• Last Update Submitted: 2025-04-05
• Study First Posted: 2025-04-09
• Last Update Posted: 2025-04-09
• Primary Completion: 2026-02-15
• Study Completion: 2026-03-15

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• 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.

Exclusion Criteria

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:

Cycles longer than 35 days

Cycle variations of 2 weeks or more

Ongoing pregnancy

Presence of structural abnormalities such as:

Uterine or cervical polyps

Submucosal fibroids

Other similar conditions

Residual myometrial thickness > 2.5 mm

Retained placental tissue

Suspected malignancies

Uterine anomalies

Immunosuppressive diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Post-operative residual myometrial thickness	1 year	Ultrasonographic evaluation will be performed in the 12th postoperative month to measure residual myometrial thickness and assess the anatomical success of the repair.

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction and quality of life	1 year	Participants will complete the Female Sexual Function Index (FSFI) questionnaire in the postoperative 12th month to evaluate sexual function and overall health-related quality of life.
3.Patient satisfaction	1 year	Participants will complete the SF-36 questionnaire in the postoperative 12th month to evaluate sexual function and overall health-related quality of life.

Trial Locations

Locations (1)

Basaksehir Cam and Sakura City Hospital; 🇹🇷 İstanbul, Turkey