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New study aims to take the guesswork out of emergency diverticulitis surgery

NCT ID NCT07651072

Knowledge-focused Sponsor: IRCCS San Raffaele Roma Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This observational study will collect detailed information from 150 adults undergoing emergency surgery for complicated diverticulitis. Researchers will analyze factors that influence surgeons' decisions to perform either a primary anastomosis (reconnecting the bowel) or a Hartmann's procedure (creating a colostomy). The goal is to build a tool that supports better surgical decision-making, but the study does not assign any treatment or change standard care.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could lead to a decision-support tool that helps surgeons choose the best surgical approach for each patient with complicated diverticulitis.
What could go wrong
This is an observational study, not a trial of a new treatment. It only collects data without changing care, so it cannot directly improve outcomes. The tool may not prove useful in practice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

diverticulitis diverticulitis of colon peritonitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute diverticulitis Complicated diverticulitis Perforated diverticulitis Peritonitis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • ASL Romagna

    Cesena, FC, Italy

More trials for these conditions

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