Development of Isthmocele Symptom Severity and Quality of Life Scale

Recruiting

• Conditions: Quality of Life

• Registration Number: NCT06562231
• Lead Sponsor: Hilal Yuvacı

Brief Summary

Isthmocele, also known as cesarean scar defect (CSD), is the disruption of the integrity of the myometrium in the cesarean section incision and the indentation of the opening in the myometrium towards the visceral peritoneum. Residual menstrual blood accumulating in the isthmocele sac can cause chronic endometritis, anormal uterine bleeding, infertility and chronic pelvic pain.

There is currently no quality of life scale that assesses isthmocele symptoms. A scale is needed to determine the positive effect on the patient's quality of life after the surgeries are performed. This study it is aimed to develop a scale that evaluates the severity of isthmocele symptoms and the impact on quality of life due to isthmocele.

Detailed Description

Patients with isthmocele symptoms three months after cesarean delivery will be included in the study.The study will not include findings that may be confused with isthmocele symptoms, such as uterine fibroids and endometrial polyps. Patients with acute vaginitis and pelvic inflammatory disease will not be included in the study.

Study Timeline

• Study First Submitted: 2022-12-20
• Study Start: 2023-01-01
• Status Verified: 2024-08
• Study First Submitted QC: 2024-08-15
• Last Update Submitted: 2024-08-15
• Study First Posted: 2024-08-20
• Last Update Posted: 2024-08-20
• Primary Completion: 2025-06-01
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 330

Inclusion Criteria

• Patients with isthmocele symptoms three months after cesarean delivery will be included in the study.

Exclusion Criteria

• The study will not include findings that may be confused with isthmocele symptoms, such as uterine fibroids and endometrial polyps.
• Patients with acute vaginitis and pelvic inflammatory disease will not be included in the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Development of isthmocele symptom severity and quality of life scale	3 year	In the literature review, there is currently no quality of life scale for isthmocele symptoms. There is a need for a scale to detect changes in patients' quality of life after surgery due to isthmocele.This study aimed to create a questionnaire that can be administered immediately before surgery and six weeks after surgery to assess the severity of isthmocele symptoms and the impact of isthmocele on quality of life.

Trial Locations

Locations (1)

Sakarya University School of Medicine; 🇹🇷 Sakarya, Turkey

Sakarya University School of Medicine

🇹🇷Sakarya, Turkey

Hilal Uslu Yuvacı

Contact

+905056236937

hilaly@sakarya.edu.tr