跳至主要内容
临床试验/NCT05942833
NCT05942833招募中不适用

DATE Trial: Outcomes and Quality of Life in Patients With Early Versus Elective Resection in Acute Complicated and Chronic Recurrent Left-sided Diverticulitis

Kepler University Hospital8 个研究点 分布在 2 个国家目标入组 136 人开始时间: 2023年1月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
136
试验地点
8
主要终点
Gastrointestinal Quality of Life Index

研究概览

简要总结

Patients presenting in hospital with symptoms of acute diverticulitis. Acute inflammation of the left-sided colon is confirmed with CT scan or ultrasound in experienced centers and diagnosis is defined according to the "Classification of Diverticular Disease (CDD)". CDD Type 2a, 2b and 3b will be included and then randomized in two groups. Group A will get an early left hemicolectomy 7 to 10 days after admission and initial antibiotic therapy and/or drainage of the abscess. Group B is designated for an elective resection 6 to 8 weeks after dismissal at the earliest and initial conservative treatment and/or after drainage of the abscess. Six weeks after the operation patients of Group A will be asked for their present quality of life with a standardized scoring system (Gastrointestinal Quality of Life Index = GIQLI; Short-form 36 Score = SF-36 Score; Low anterior resection syndrome = LARS Score). Group B (elective resection) will be asked at their readmission prior to elective surgery is done. This survey package will be repeated again 6 to 8 weeks later in both groups. Primary endpoints will be the two GIQLI at the said examination times. Secondary endpoints will be SF-36 score, LARS-score, GIQLI-Domains, anastomosis insufficiency and other complications, mortality and length of hospital stay. Comparisons between the groups are made at the said examination times but also 6-8 weeks after the operation.

详细描述

Primary endpoints:

Gastrointestinal Quality of Life Index (GIQLI)

Secondary endpoints:

SF-36 score (physical and mental health summary scores), LARS score, GIQLI-domains, anastomosis insufficiency and other complications, exitus and length of hospital stay

Treatment strategy:

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Informed consent to participate in the study
  • CDD Type 2a, 2b: acute complicated left-sided diverticulitis
  • CDD Type 3b: relapsing diverticulitis without complications (>2 episodes within 2 years)
  • Acute presentation
  • Inflammation located in the left-sided colon
  • Inflammation is CT proven or ultrasound confirmed from experienced radiologists

排除标准

  • < 18 years
  • Pregnancy
  • BMI > 55kg/m2
  • Current colorectal carcinoma in the left-sided colon
  • Oral and/or intravenous corticosteroid
  • Ongoing chemotherapy
  • Status post left hemicolectomy
  • Patients who cannot take care of themselves at home or are unable to follow instructions
  • Patients who are not fit for surgery (anesthesia, expert knowledge from specialists) and will not benefit from surgery

研究组 & 干预措施

Group A (Early)

Experimental

Early left hemicolectomy immediately up to a maximum of 2 days after 7-10 days lasting initial conservative or interventional treatment (e.g: antibiotics, analgesics, drainage) and CT scan/ultrasound proven left-sided colonic diverticulitis

干预措施: Sigmoid resection (Procedure)

Group B (Late)

Other

Elective left hemicolectomy 6 to 8 weeks after 7-10 days lasting initial conservative or interventional treatment (e.g: antibiotics, analgesics, drainage) and CT scan/ultrasound proven left-sided colonic diverticulitis

干预措施: Sigmoid resection (Procedure)

结局指标

主要结局

Gastrointestinal Quality of Life Index

时间窗: Up to 18 weeks

Quality of Life

次要结局

  • SF-36 score (Short form score)(Up to 18 weeks)
  • Low anterior resection syndrome score(Up to 18 weeks)
  • Anastomosis insufficiency(Up to 18 weeks)
  • Exitus(Up to 18 weeks)
  • Length of stay (sum of days in hospital until end of study)(Up to 18 weeks)
  • Earlier readmission due to recurrence while waiting for surgery(Up to 18 weeks)
  • Postoperative complication(Up to 18 weeks)
  • Intraoperative complication(Up to 18 weeks)

研究者

发起方
Kepler University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (8)

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