Development of Isthmocele Symptom Severity and Quality of Life Scale
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: quality of life scale.
- Who it may be relevant to
- Registry conditions: Quality of Life. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Development of Isthmocele Symptom Severity and Quality of Life Questionnaire
Overview
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
- Other quality of life scale
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.
Primary outcome measures
- Development of isthmocele symptom severity and quality of life scale [Time frame: 3 year]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Turkey (Türkiye) · 1 center
- Sakarya University School of Medicine — Sakarya
Identifiers
NCT: NCT06562231 · isthmocele and quality of life