AIDE: Decision Support for Anastomosis or Colostomy in Emergency Surgery for Complicated Acute Diverticulitis
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIRCCS San Raffaele Roma
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Age younger than 18 years
Elective surgery for diverticular disease
Uncomplicated diverticulitis managed non-operatively
Surgery performed for conditions not related to diverticulitis
Trial population
Adult patients undergoing non-elective surgery for acute complicated diverticulitis at participating centers. Eligible patients include those requiring emergency or urgent operative management, including cases after failure of non-operative treatment, according to local clinical practice.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Primary anastomosis
Procedure/SurgeryObserved surgical strategy consisting of sigmoid resection with colorectal anastomosis, with or without diverting stoma, performed according to standard clinical practice. The study does not assign this procedure.
Hartmann's procedure
Procedure/SurgeryObserved surgical strategy consisting of sigmoid resection with end colostomy and rectal stump closure, performed according to standard clinical practice. The study does not assign this procedure.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Primary Anastomosis Group1 intervention
Group B: Hartmann's Procedure Group1 intervention
Trial outcomes
Primary outcomes
1
Clinical, radiological, intraoperative visual, and surgeon-reported factors associated with the intraoperative decision to perform primary anastomosis versus Hartmann's procedure
Structured analysis of patient-related, disease-related, imaging-related, intraoperative, and surgeon-reported factors influencing the choice between primary anastomosis and Hartmann's procedure in non-elective surgery for complicated diverticulitis.
Time frame
Assessed intraoperatively during the index emergency surgical procedure and recorded at completion of operative case data entry.Secondary outcomes
1
Rate of primary anastomosis versus Hartmann's procedure
Proportion of patients undergoing primary anastomosis, with or without diverting stoma, compared with Hartmann's procedure.
Time frame
Assessed intraoperatively during the index emergency surgical procedure.2
Completeness of standardized intraoperative visual data acquisition
Proportion of cases with uploaded anonymized intraoperative images or videos according to the predefined study phases.
Time frame
From the start of the index emergency surgical procedure until completion of intraoperative image or video acquisition, assessed up to the end of the operation.3
Anastomotic leak rate
Rate of clinically or radiologically diagnosed anastomotic leak among patients receiving primary anastomosis.
Time frame
From the date of surgery until 30 postoperative days.4
Postoperative morbidity
Rate of postoperative complications after non-elective surgery for complicated diverticulitis.
Time frame
Assessed during index hospitalization and up to 30 postoperative days.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: