Long-term Follow-up of Patient Satisfaction, Reflux Control and Gastrointestinal Disorders in Patients Undergoing Laparoscopic Surgical Treatment for GERD, With Partial or Total Fundoplication
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 307
- 试验地点
- 1
- 主要终点
- Gastrointestinal Symptom Rating Scale (GSRS)
研究概览
简要总结
10 years of follow-up with SF-36 global (Quality of Life issues), GSRS (Gastrointestinal Symptom Rating Scale) and two reflux specific questionnaires.
详细描述
Long-term follow up with questionnaires after surgery with laparoscopic 270 degrees posterial partial fundoplication vs total fundoplication for the treatment of gastroesophageal reflux disease.
Quality of Life SF-36; physical and mental component scores. GSRS, five dimensions of abdominal symptoms; reflux, abdominal pain, indigestion, obstipation and diarrhea.
Reflux specificquestionnaries on various issues of reflux disease and frequency issues about reflux disease problems.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 100 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gastroesophageal Reflux 10 years follow-up after surgery informed consent
排除标准
- •Deceased patients patients who declined participation
结局指标
主要结局
Gastrointestinal Symptom Rating Scale (GSRS)
时间窗: 10 years after operation
GSRS Gastrointestinal Symptom Rating Scale Scoring;The questionnaire, which contains 15 items, uses a seven-graded Likert scale, where 1 represents the most positive option and 7 the most negative one. A mean value for the items in each dimension should be calculated: Diarrhoea syndrome: 11. Increased passage of stools 12. Loose stools 14. Urgent need for defecation Indigestion syndrome: 6. Borborygmus 7. Abdominal distension 8. Eructation 9. Increased flatus Constipation syndrome: 10. Decreased passage of stools 13. Hard stools 15. Feeling of incomplete evacuation. Abdominal pain syndrome: 1. Abdominal pain 4. Sucking sensations 5. Nausea and vomiting Reflux syndrome: 2. Heartburn 3. Acid regurgitation
SF-36 Quality of life
时间窗: 10 years
The SF-36 It is comprised of 36 items that assess eight health concepts: physical functioning, role limitations caused by physical health problems, role limitations caused by emotional problems, social functioning, emotional well-being, energy/fatigue, pain, and general health perceptions. Physical and mental health summary scores are also derived from the eight RAND-36 scales. Higher scores mean a better outcome.
次要结局
未报告次要终点
研究者
Anders Thorell
Professor
Karolinska Institutet
