Functional and Mental Outcomes After Interdisciplinary Surgery for Patients With Obstructive Defecation Syndrome (ODS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Mental Health Outcome - Depression
研究概览
简要总结
Background: Obstructed Defecation Synsdrome (ODS) causes people to strain and sometimes need help to go to the toilet. They think about going to the toilet a lot, which makes their lives worse. People with Obstructed Defecation Synsdrome (ODS) are more likely to be anxious and depressed than people with other illnesses.
Aim of the study: This study looked at how mental health affects Obstructed Defecation Synsdrome (ODS) patients before and after surgery.
详细描述
Aim, design, and setting of the study:
This study measures the mental burden of Obstructed Defecation Synsdrome (ODS) in patients scheduled for surgery for Obstructed Defecation Synsdrome (ODS) before and 6 months after surgery. The results are linked to how well the bowel works. All scores are checked before surgery and at 6 months after.
What do the investigators do to find this out ? The investigators look at patients' age, sex, body mass index (BMI), and other health problems. Defecation symptoms are measured using a validated questionnaire, the Altomare score, which has a maximum of 30 points. The rectal toxicity score reflects abdominal and bowel discomfort, which is determined by questions related to bowel dysfunction symptoms, such as diarrhea, meteorism, bleeding, and abdominal pain during bowel movement and defecation, and has a maximum of 32 points. The Wexner score is a 20-point questionnaire for fecal incontinence symptoms. Higher scores indicate greater severity of symptoms. Mental disorders are evaluated using the Personal Health Questionnaire 9 (PHQ-9) and General Anxiety Disorder 7 (GAD-7). Higher scores mean more severe symptoms.
Surgical procedure: For laparoscopic surgery under general anaesthesia, the patient is kept in a dorsal lithotomy position with their head down. The procedure opens the rectum, removes a part of the bowel and then rebuilds bowel continuity.
The investigators collect data on how long the operation took, how long the patient stays in hospital, and how many people have complications after the operation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Obstructed Defecation Syndrome (ODS) scheduled for Surgery
- •Conservative treatment failure
- •Laparoscopic access possible
排除标准
- •Pregnancy
结局指标
主要结局
Mental Health Outcome - Depression
时间窗: 6 months
Depression in patients with Obstructed Defecation Syndrome (ODS) is measured with a questionnaire (score) before and after Surgery. The Personal Health Questionnaire 9 (PHQ-9) as an established score for depressive symptoms is used. It has a maximum of 27 points and higher scores mean a worse outcome. The score is divided into five subgroups of depression severity, namely, nonminimal (0-4 points), mild (5-9 points), moderate (10-14 points), moderately severe (15-19 points), and severe (20-27 points).
Mental Health Outcome - Anxiety
时间窗: 6 months
Anxiety in patients with Obstructed Defecation Syndrome (ODS) is measured with a questionnaire (score) before and after Surgery, as well, since this is another important outcome measure for mental health. Anxiety symptoms are measured by the General Anxiety Disorder 7 questionnaire (GAD-7), which has a maximum of 21 Points. Higher scores represent a higher burden and a worse outcome. GAD-7 is devided into four subgroups that differentiate the severity of anxiety into minimal (0-4 points), mild (5-9 points), moderate (10-14 points), and severe levels (15-21 points).
次要结局
- Bowel Function - Altomare Score(6 months)
- Bowel Function - rectal toxicity score(6 months)
- Bowel Function - Wexner incontinence score(6 months)
研究者
Claudia Rudroff
Head of the department of visceral surgery and functional surgery of the lower gastrointestinal tract
Evangelisches Klinikum Köln Weyertal gGmbH