Acute Complicated DiverticulitisNCT07601958
Management of Acute Complicated Diverticulitis: An Assessment of Current Practices
An observational study of Acute Complicated Diverticulitis and Colonic Diverticulitis, run by Jules Bordet Institute at 1 site in Belgium.
Trial summary
Acute complicated diverticulitis (ACD) is a frequent surgical emergency that can be life-threatening. It encompasses various clinical entities, including colonic perforations, abscesses (Hinchey II), fistulas, and purulent or fecal peritonitis (Hinchey III/IV). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Complicated Diverticulitis, Colonic Diverticulitis
- How many people
- 208 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Dec 2025to 30 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients older than 18 years who were treated for acute complicated diverticulitis between January 1, 2015 and December 31, 2024 at Erasme Hospital and Institut Jules Bordet.
Who may be able to join
- Patients presenting with a first episode or recurrence of acute complicated diverticulitis.
- CT scan confirmation of a Hinchey stage ≥ Ib (including stages Ib, II, III, and IV) at admission.
- Initial management performed within the HUB (Hôpital Universitaire de Bruxelles) network.
- Hospital admission between January 1, 2015, and December 31, 2024.
Who cannot join
- Uncomplicated acute diverticulitis, defined by a CT scan Hinchey stage of 0 or Ia.
- Patients in whom the diagnosis of acute diverticulitis was ultimately ruled out during medical chart review.
- Patients whose initial management occurred at another hospital facility (outside the HUB network).
- Incomplete medical records preventing the reliable extraction of clinical or follow-up data.
Trial locations and contacts
1 site in 1 country.
About this study
Acute complicated diverticulitis (ACD) is a frequent surgical emergency that can be life-threatening. It encompasses various clinical entities, including colonic perforations, abscesses (Hinchey II), fistulas, and purulent or fecal peritonitis (Hinchey III/IV). Historically, the Hartmann procedure (HP) was established as the standard of care for diffuse peritonitis, particularly in frail patients. However, this intervention is associated with high rates of permanent stomas, long-term complications, and impaired quality of life. Over the past decade, several randomized controlled trials (RCTs) have compared HP with sigmoid resection and primary anastomosis (PA), sometimes combined with a diverting ileostomy. Results from these studies, notably the LADIES and DIVERTI trials, indicate that in hemodynamically stable and immunocompetent patients, PA is associated with superior functional outcomes, fewer late complications, and higher stoma reversal rates. Other minimally invasive approaches, such as laparoscopic peritoneal lavage for Hinchey III, have also been explored, showing promise in reducing stomas and reinterventions. However, their efficacy relies on stringent patient selection, and their use is not recommended by current guidelines (e.g., HAS 2017) due to higher reintervention rates. Recent epidemiological data suggest a trend toward reducing emergency surgical interventions in favor of more conservative strategies in selected cases, such as initial medical management followed by elective surgery. In this context of diversifying therapeutic options, choosing the optimal treatment requires a delicate balance between efficacy, morbidity, mortality, quality of life, and long-term preservation of intestinal function. Despite these advances, several questions remain, particularly regarding patient selection criteria and the real-world long-term impact of these interventions. A potentially underestimated factor is the role of the operator, as a significant portion of emergency cases (nights and weekends) are handled by surgeons in training.
Primary Objective: To provide a comprehensive overview of current management strategies for acute complicated diverticulitis by identifying preferred therapeutic modalities (conservative management, emergency surgery, delayed surgery) at the HUB (Hôpital Universitaire de Bruxelles).
Secondary Objectives: To evaluate the adherence of these therapeutic approaches to international guidelines. To identify clinical and context-specific predictive factors influencing the choice of therapeutic strategy.
- Medical subject headings
- Diverticulitis, Colonic
What is being measured
The primary outcome is the main question the study is designed to answer.
Distribution of management strategies for acute complicated diverticulitis.
Percentage of patients treated by each of the following strategies: exclusive medical treatment, radiological drainage, immediate emergency surgery, rescue surgery following medical failure, or elective surgery.
Measured: From hospital admission up to 10 years (end of study period).
Secondary outcomes (7)
Surgical Procedure Type (Hartmann Procedure vs. Primary Anastomosis) based on Hinchey Classification and Clinical Status.
The study will evaluate the association between baseline clinical parameters (including age and immunosuppression status) and radiological severity, assessed by the Hinchey classification (stages Ib to IV on admission CT scan), with the final therapeutic choice. Logistic regression analysis will be used to identify independent predictors for: (1) failure of conservative treatment and (2) selection of surgical procedure type (Hartmann Procedure vs. Primary Anastomosis). Results will be reported as Odds Ratios (OR) with 95% Confidence Intervals.
Measured: Through study completion, an average of 14 days (duration of index hospitalization).
Success rate of conservative treatment for complicated diverticulitis.
Proportion of patients successfully managed without surgery during the index hospitalization.
Measured: During index hospitalization (average of 12.4 days).
Post-operative morbidity and mortality.
Percentage of patients with severe complications (Clavien-Dindo III-IV) and mortality rate at 30 days post-surgery.
Measured: 30 days post-surgery.
Stoma reversal rate.
Percentage of patients who received a temporary stoma and successfully underwent surgical restoration of bowel continuity during the follow-up period.
Measured: Up to 10 years.
Evolution of the Rate of Laparoscopic Approach.
Percentage of patients undergoing a laparoscopic approach (including converted laparoscopies) compared to open surgery. The trend will be analyzed across three time periods (2015-2017, 2018-2020, 2021-2024) to assess the adoption of minimally invasive techniques.
Measured: Perioperative (during initial surgery).
Length of Hospital Stay (LOS).
Number of days from hospital admission to discharge. The median length of stay will be compared across the three time periods (2015-2017, 2018-2020, 2021-2024) to evaluate the impact of changing clinical practices.
Measured: From hospital admission to discharge (average 10-14 days).
Adherence to Guidelines Regarding Peritoneal Lavage.
Percentage of surgical cases where peritoneal lavage was performed as a standalone treatment (without resection). The evolution of this practice will be assessed across the three time periods to evaluate adherence to international guidelines (EAES/WSES) recommending the abandonment of this technique.
Measured: Perioperative (during initial surgery).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start1 Dec 2025
- Primary completion30 Mar 2026
- Study completion30 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Complicated DiverticulitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jules Bordet Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriel Liberale, Jules Bordet Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07601958
- Sponsor's protocol ID
- SRB2025380
- Status last verified
- May 2026
- First submitted
- 11 May 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared in order to protect patient confidentiality and comply with European data protection regulations (GDPR) and institutional privacy policies.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Acute Complicated Diverticulitis: An Assessment of Current Practices
- ClinicalTrials.gov ID
- NCT07601958
- Acronym / sponsor ID
- SRB2025380
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Jules Bordet InstituteUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 30 Mar 2026 (actual)
- Study completion
- 30 Mar 2026 (actual)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Acute complicated diverticulitis (ACD) is a frequent surgical emergency that can be life-threatening. It encompasses various clinical entities, including colonic perforations, abscesses (Hinchey II), fistulas, and purulent or fecal peritonitis (Hinchey III/IV). Historically, the Hartmann procedure (HP) was established as the standard of care for diffuse peritonitis, particularly in frail patients. However, this intervention is associated with high rates of permanent stomas, long-term complications, and impaired quality of life. Over the past decade, several randomized controlled trials (RCTs) have compared HP with sigmoid resection and primary anastomosis (PA), sometimes combined with a diverting ileostomy. Results from these studies, notably the LADIES and DIVERTI trials, indicate that in hemodynamically stable and immunocompetent patients, PA is associated with superior functional outcomes, fewer late complications, and higher stoma reversal rates. Other minimally invasive approaches, such as laparoscopic peritoneal lavage for Hinchey III, have also been explored, showing promise in reducing stomas and reinterventions. However, their efficacy relies on stringent patient selection, and their use is not recommended by current guidelines (e.g., HAS 2017) due to higher reintervention rates. Recent epidemiological data suggest a trend toward reducing emergency surgical interventions in favor of more conservative strategies in selected cases, such as initial medical management followed by elective surgery. In this context of diversifying therapeutic options, choosing the optimal treatment requires a delicate balance between efficacy, morbidity, mortality, quality of life, and long-term preservation of intestinal function. Despite these advances, several questions remain, particularly regarding patient selection criteria and the real-world long-term impact of these interventions. A potentially underestimated factor is the role of the operator, as a significant portion of emergency cases (nights and weekends) are handled by surgeons in training.
Primary Objective: To provide a comprehensive overview of current management strategies for acute complicated diverticulitis by identifying preferred therapeutic modalities (conservative management, emergency surgery, delayed surgery) at the HUB (Hôpital Universitaire de Bruxelles).
Secondary Objectives: To evaluate the adherence of these therapeutic approaches to international guidelines. To identify clinical and context-specific predictive factors influencing the choice of therapeutic strategy.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients older than 18 years who were treated for acute complicated diverticulitis between January 1, 2015 and December 31, 2024 at Erasme Hospital and Institut Jules Bordet.
Key inclusion criteria (4 listed)
- Patients presenting with a first episode or recurrence of acute complicated diverticulitis.
- CT scan confirmation of a Hinchey stage ≥ Ib (including stages Ib, II, III, and IV) at admission.
- Initial management performed within the HUB (Hôpital Universitaire de Bruxelles) network.
- Hospital admission between January 1, 2015, and December 31, 2024.
Key exclusion criteria (4 listed)
- Uncomplicated acute diverticulitis, defined by a CT scan Hinchey stage of 0 or Ia.
- Patients in whom the diagnosis of acute diverticulitis was ultimately ruled out during medical chart review.
- Patients whose initial management occurred at another hospital facility (outside the HUB network).
- Incomplete medical records preventing the reliable extraction of clinical or follow-up data.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Distribution of management strategies for acute complicated diverticulitis.
Time frame: From hospital admission up to 10 years (end of study period).
Percentage of patients treated by each of the following strategies: exclusive medical treatment, radiological drainage, immediate emergency surgery, rescue surgery following medical failure, or elective surgery.
7 secondary outcomes
Surgical Procedure Type (Hartmann Procedure vs. Primary Anastomosis) based on Hinchey Classification and Clinical Status.
Time frame: Through study completion, an average of 14 days (duration of index hospitalization).
Success rate of conservative treatment for complicated diverticulitis.
Time frame: During index hospitalization (average of 12.4 days).
Post-operative morbidity and mortality.
Time frame: 30 days post-surgery.
Stoma reversal rate.
Time frame: Up to 10 years.
Evolution of the Rate of Laparoscopic Approach.
Time frame: Perioperative (during initial surgery).
Length of Hospital Stay (LOS).
Time frame: From hospital admission to discharge (average 10-14 days).
Adherence to Guidelines Regarding Peritoneal Lavage.
Time frame: Perioperative (during initial surgery).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared in order to protect patient confidentiality and comply with European data protection regulations (GDPR) and institutional privacy policies.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Complicated Diverticulitis and Colonic Diverticulitis, run by Jules Bordet Institute at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distribution of management strategies for acute complicated diverticulitis. (time frame: From hospital admission up to 10 years (end of study period).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.