- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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.
Descripción general del estudio
Estado
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Brussels Capital
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Anderlecht, Brussels Capital, Bélgica, 1070
- Institut Jules Bordet
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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 de estudios
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Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Distribution of management strategies for acute complicated diverticulitis.
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Surgical Procedure Type (Hartmann Procedure vs. Primary Anastomosis) based on Hinchey Classification and Clinical Status.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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).
Periodo de tiempo: 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.
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- SRB2025380
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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