- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07601958
Management of Acute Complicated Diverticulitis: An Assessment of Current Practices
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.
Przegląd badań
Status
Typ studiów
Zapisy (Rzeczywisty)
Kontakty i lokalizacje
Lokalizacje studiów
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Brussels Capital
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Anderlecht, Brussels Capital, Belgia, 1070
- Institut Jules Bordet
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Metoda próbkowania
Badana populacja
Opis
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Distribution of management strategies for acute complicated diverticulitis.
Ramy czasowe: From hospital admission up to 10 years (end of study period).
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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.
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From hospital admission up to 10 years (end of study period).
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Surgical Procedure Type (Hartmann Procedure vs. Primary Anastomosis) based on Hinchey Classification and Clinical Status.
Ramy czasowe: Through study completion, an average of 14 days (duration of index hospitalization).
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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.
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Through study completion, an average of 14 days (duration of index hospitalization).
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Success rate of conservative treatment for complicated diverticulitis.
Ramy czasowe: During index hospitalization (average of 12.4 days).
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Proportion of patients successfully managed without surgery during the index hospitalization.
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During index hospitalization (average of 12.4 days).
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Post-operative morbidity and mortality.
Ramy czasowe: 30 days post-surgery.
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Percentage of patients with severe complications (Clavien-Dindo III-IV) and mortality rate at 30 days post-surgery.
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30 days post-surgery.
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Stoma reversal rate.
Ramy czasowe: Up to 10 years.
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Percentage of patients who received a temporary stoma and successfully underwent surgical restoration of bowel continuity during the follow-up period.
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Up to 10 years.
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Evolution of the Rate of Laparoscopic Approach.
Ramy czasowe: Perioperative (during initial surgery).
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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.
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Perioperative (during initial surgery).
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Length of Hospital Stay (LOS).
Ramy czasowe: From hospital admission to discharge (average 10-14 days).
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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.
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From hospital admission to discharge (average 10-14 days).
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Adherence to Guidelines Regarding Peritoneal Lavage.
Ramy czasowe: Perioperative (during initial surgery).
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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.
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Perioperative (during initial surgery).
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Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- SRB2025380
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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