Diverticulitis Recurrences or Continuing symptoms : Operative versus Conservative Treatment, A MULTICENTER RANDOMISED CLINICAL TRIAL - DIRECT-trial

Meander Medisch Centrum0 个研究点目标入组 214 人开始时间: 待定最近更新: 2024年5月6日

试验速览

暂无简介。

•- Age 18-75 years.
•- A well documented (CT-scan, sonography or endoscopy) previous episode of diverticulitis.
•- Patients presenting with either persisting abdominal complaints and/or frequently recurring diverticulitis after an episode of diverticulitis.
•Persisting abdominal complaints may include patients with:
•- continuing lower left abdominal pain AND/OR persistent change in bowel habits AND/OR persistent blood loss.
•- Symptoms must exist longer than 3 months after a previous episode of diverticulitis.
•- Symptoms must be accompanied by changes in the colonic wall on a recent CT-scan,
•sonography or endoscopy.
•Frequently recurring diverticulitis is defined as:
•- A total of three or more in-hospital presentations for an episode of diverticulitis within 2
•years. As described previously, (at least) one episode must be well documented (CT-scan,
•sonography or endoscopy).
•- A minimal interval of 3 months between the episodes is mandatory.
•- ASA I-III

•- Patients with elective or emergency surgery for acute diverticulitis in the past.
•- Patients with an absolute operation indication (perforation with purulent/fecal peritonitis, symptomatic bowel stenosis or fistula).
•- Patients with colorectal malignancies.
•- Patients with a psychiatric disease or other conditions making them incapable of filling out the questionnaires or completing the objective follow up tests.
•- Patients in ASA class III who are at high risk for per- and postoperative complications due o severe co-morbidity as regarded by the surgeon and/or the patients specialists

发起方

Meander Medisch Centrum