Development of Isthmocele Symptom Severity and Quality of Life Questionnaire
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 330
- 试验地点
- 1
- 主要终点
- Development of isthmocele symptom severity and quality of life scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with isthmocele symptoms three months after cesarean delivery will be included in the study.
排除标准
- •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.
结局指标
主要结局
Development of isthmocele symptom severity and quality of life scale
时间窗: 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.
次要结局
未报告次要终点
研究者
Hilal Yuvacı
Obstetrics and Gynecology
Sakarya University