AIDE: Decision Support for Anastomosis or Colostomy in Emergency Surgery for Complicated Acute Di… (NCT07651072) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
AIDE: Decision Support for Anastomosis or Colostomy in Emergency Surgery for Complicated Acute Diverticulitis
Italy150 participantsStarted 2026-05-31
Plain-language summary
The AIDE/OBS study is a multicenter, observational, non-interventional study designed to collect standardized clinical, radiological, intraoperative visual, and surgical reasoning data from adult patients undergoing non-elective surgery for complicated acute diverticulitis.
The study focuses on patients requiring urgent or emergency operative management, including cases following failure of non-operative management. The main intraoperative decision of interest is the choice between sigmoid resection with primary anastomosis, with or without diverting stoma, and Hartmann's procedure.
The current phase aims to build a structured multimodal dataset and to validate and refine a preliminary expert-informed decision-support tool. The study does not modify standard clinical practice, surgical indication, operative strategy, or postoperative management. All treatment decisions remain at the discretion of the treating surgical team according to local practice.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 18 years or older
* Diagnosis of acute complicated diverticulitis requiring non-elective operative management
* Emergency or urgent surgery for complicated diverticulitis, including surgery after failure of non-operative management
* Minimally invasive approach: laparoscopic/robotic surgery
* Patients undergoing sigmoid resection with primary anastomosis, Hartmann's procedure, or other operative strategy according to local practice
* Availability of clinical and operative data
* Local ethical approval, authorization, or waiver according to national and institutional regulations
Exclusion Criteria:
* Age younger than 18 years
* Elective surgery for diverticular disease
* Uncomplicated diverticulitis managed non-operatively
* Surgery performed for conditions not related to diverticulitis
* Surgical procedures performed via primary open approach (i.e., no attempt at minimally invasive surgery), unless converted intraoperatively.
* Lack of required consent or authorization for data use, when required by local regulations
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Clinical, radiological, intraoperative visual, and surgeon-reported factors associated with the intraoperative decision to perform primary anastomosis versus Hartmann's procedure
Timeframe: Assessed intraoperatively during the index emergency surgical procedure and recorded at completion of operative case data entry.