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Development of Isthmocele Symptom Severity and Quality of Life Scale

Development of Isthmocele Symptom Severity and Quality of Life Questionnaire

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06562231
Enrollment
330
Registered
2024-08-20
Start date
2023-01-01
Completion date
2025-12-30
Last updated
2024-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Quality of Life

Keywords

isthmocele, quality of life, questionnaire, abnormal uterine bleeding

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.

Interventions

This study will be conducted on women diagnosed with symptomatic isthmocele after cesarean section. Researchers will prepare scale questions, and the survey questions will be developed after obtaining an expert opinion from 20 experts to be evaluated by psychiatry, obstetrics, and public health experts. The patient will fill out the questionnaire form with the diagnosis of isthmocele. Oral and written consent will be obtained from the patients.

Sponsors

Hilal Yuvacı
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Development of isthmocele symptom severity and quality of life scale3 yearIn 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.

Countries

Turkey (Türkiye)

Contacts

Primary ContactHilal Uslu Yuvacı
hilaly@sakarya.edu.tr+905056236937

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026