NCT02174926进行中（未招募）不适用
LASER Trial. LAparoscopic Elective Sigmoid Resection Following divERticulitis - a Multicenter, Prospective, Randomized Clinical Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 133
- 试验地点
- 11
- 主要终点
- Gastrointestinal quality of life-index change at 6 months
研究概览
简要总结
The purpose of this study is to find out whether elective sigmoid resection will improve quality of life compared to conservative treatment with lifestyle guidance and fiber supplement in patients with a recurrent or complicated diverticulitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recurrent left colon diverticulitis (minimum 3 within 2 years, at least 1 confirmed with CT)
- •Earlier complicated left colon diverticulitis
- •Prolonged (over 3 months) pain or disturbance in bowel habits after a CT-confirmed left colon diverticulitis
排除标准
- •Multimorbidity that prevents elective surgery
- •Contraindication to laparoscopy
- •Colonic stricture
- •Fistula (e.g. colocutaneous, colovaginal, colovesical)
- •Active malignancy
- •Earlier resection of sigmoid colon or rectum
- •Acute diverticulitis that has not settled
- •Colonoscopy/sigmoidoscopy/virtual colonoscopy not performed within 2 years
- •Age < 18 or > 75 years
- •Pregnancy
- •Inability to answer health surveys (e.g. dementia, psychiatric condition)
结局指标
主要结局
Gastrointestinal quality of life-index change at 6 months
时间窗: 6 months from randomization
Difference in gastrointestinal quality of life-index (GIQLI) at randomization and 6 months from randomization.
次要结局
- GIQLI at 12, 24, 48, and 96 months(12, 24, 48, and 96 months from randomization)
- Short form (SF) 36 Health survey score at 6, 12, 24, 48, and 96 months(6, 12, 24, 48, and 96 months from randomization)
- Recurrence and severity of recurrent diverticulitis(0 - 96 months from randomization)
- Need of emergency surgery due to diverticulitis(0 - 96 months from randomization)
- Need of elective sigmoid resection due to diverticulitis (conservative arm)(0 - 96 months from randomization)
- Complications due to elective sigmoid resection(0 - 96 months from randomization)
- Mortality(0 - 96 months)
- Complications of diverticular disease(0 - 96 months)
- Stoma rate(0 - 96 months from randomization)
研究者
Ville Sallinen
M.D., Ph.D.
Helsinki University Central Hospital
研究点 (11)
Loading locations...
相似试验
招募中
3 期
Safety Study of Totally Laparoscopic Resection With Natural Orifice Specimen Extraction (NOSE) for Rectosigmoid CancerColorectal CancerNCT02635503Cancer Institute and Hospital, Chinese Academy of Medical Sciences366
已完成
不适用
Prospective Evaluation of the Efficacy of Pascal Laser Iridotomy and Pascal Laser Peripheral Iridoplasty: A Pilot StudyGlaucomaNCT01020071National University Hospital, Singapore22
进行中（未招募）
3 期
Trial of Modifications to Radical ProstatectomyProstate CancerNCT01407263Memorial Sloan Kettering Cancer Center3,204
Unknown
不适用
ESM Versus OM ：A Randomized Controlled TrialEndoscopic Subcutaneous MastectomyNCT04461847Beijing Friendship Hospital287
终止
不适用
Extended-release Epidural Morphine for Acute Post-operative Analgesia Following Selective Dorsal Rhizotomy in ChildrenSpastic Cerebral PalsyNCT00955877Washington University School of Medicine13