NCT07601958

Brief 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). 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
208

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 11, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 22, 2026

Completed
Last Updated

May 22, 2026

Status Verified

May 1, 2026

Enrollment Period

4 months

First QC Date

May 11, 2026

Last Update Submit

May 15, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    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.

    Through study completion, an average of 14 days (duration of index hospitalization).

  • Success rate of conservative treatment for complicated diverticulitis.

    During index hospitalization (average of 12.4 days).

  • Post-operative morbidity and mortality.

    30 days post-surgery.

  • Stoma reversal rate.

    Up to 10 years.

  • Evolution of the Rate of Laparoscopic Approach.

    Perioperative (during initial surgery).

  • +2 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Jules Bordet

Anderlecht, Brussels Capital, 1070, Belgium

Location

MeSH Terms

Conditions

Diverticulitis, Colonic

Condition Hierarchy (Ancestors)

DiverticulitisDiverticular DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesDiverticulosis, ColonicColonic DiseasesIntestinal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 11, 2026

First Posted

May 22, 2026

Study Start

December 1, 2025

Primary Completion

March 30, 2026

Study Completion

March 30, 2026

Last Updated

May 22, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

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.

Locations