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Damage ControlProspectively Randomized Controlled Trial on Damage Control Surgery for Perforated Diverticulitis With Generalized Peritonitis

0 criterios cumplidosConsulta de un vistazo cómo tu perfil cumple con cada criterio de elegibilidad.
Qué se está evaluando

Damage control surgery

Procedimiento
Quiénes están siendo reclutados

A partir de 18 años
+8 Criterios de eligibilidad
Ver todos los criterios de elegibilidad
Cómo está diseñado el estudio

Estudio de Tratamiento

Intervencional
Inicio del estudio: octubre de 2013
Ver detalles del protocolo

Resumen

Patrocinador PrincipalMedical University Innsbruck
Última actualización: 27 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 14 de octubre de 2013

Fecha en la que se inscribió al primer participante.

Inclusion criteria: All patients with clinical and radiological suspicion of colonic perforation and generalized Peritonitis with indication for emergency surgery were included in the study. Exclusion criteria: * Covered perforation or peritonitis limited to one quadrant * No colonic perforation (gastric perforation, appendicitis, ...) * Malignancy as cause of perforation * Age < 18 years * Pregnancy * Preoperative anal incontinence * No patient consent Primary endpoint: Reconstructed bowel continuity at discharge and 6 months. Secondary endpoint: * Permanent stoma rate * 30-day mortality rate * Postoperative complications Randomisation was performed intraoperatively in all patients after the performing surgeon confirmed a colonic perforation with generalized Peritonitis. All patients preoperatively granted their consent to participate in the study. Surgical strategy: In the damage control surgery (DCS) group the surgeon was asked to perform rapid source control by stapling the perforated segment leaving blind ends or suturing the perforation site if possible, doing a thorough lavage of the abdominal cavity and placing an intra-abdominal negative pressure system avoiding the retraction of the abdominal wall with dynamic sutures as published. The second-look operation was scheduled for a time 24-48 hours after primary surgery that would be during regular working hours with a colorectal surgeon on hand to make the decision for either anastomosis or ostomy. In the conventional treatment group (Group C), the decision to reconstruct the colon or perform a Hartmann procedure was made by the surgeon during the emergency operation. After performing the anastomosis or the Hartmann procedure, patients with advanced peritonitis received an intraabdominal negative pressure system at the discretion of the operating surgeon. Data collection and statistics: Data were collected by our study nurse, who visited the patients, and statistical calculations were performed with SPSS 20. Assuming a reconstruction rate of 80% in the study group and 50% in the conventional treatment group, we calculated that 70 patients would be needed to prove our hypothesis. Statistical calculation was performed with Chi-square for distribution of clinical data and stoma rate and the Mann-Whitney U test was used to compare numeric and nonparametric data. The study was approved by our local ethics committee (EC No.: UN5157).

Título OficialProspectively Randomized Controlled Trial on Damage Control Surgery for Perforated Diverticulitis With Generalized Peritonitis
NCT04034407
Patrocinador PrincipalMedical University Innsbruck
Última actualización: 27 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño

Se reclutarán 22 pacientes

Número total de participantes que el ensayo clínico espera reclutar.

Estudio de Tratamiento

Estos estudios prueban nuevas formas de tratar una enfermedad, condición o problema de salud. El objetivo es determinar si un nuevo medicamento, terapia o enfoque funciona mejor o tiene menos efectos secundarios que las opciones existentes.



Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Criterios

Cualquier sexo

Sexo biológico de los participantes elegibles para inscribirse.

A partir de 18 años

Rango de edades de los participantes que pueden unirse al estudio.

Voluntarios sanos no permitidos

Indica si personas sanas, sin la condición que se estudia, pueden participar.

Criterios

Un criterio de inclusión requerido para participar
All patients with clinical and radiological suspicion of colonic perforation and generalized Peritonitis with indication for emergency surgery were included in the study and intraoperatively confirmed generalized peritonitis

7 criterios de exclusión impiden participar
Covered perforation or peritonitis limited to one quadrant

No colonic perforation (gastric perforation, appendicitis, ...)

Malignancy as cause of perforation

Age < 18 years

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Plan de Estudio

Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.
Grupos de Tratamiento
Objetivos del Estudio

2 grupos de intervención están designados en este estudio

0% de probabilidad de ser asignado al grupo placebo

Grupos de Tratamiento

Grupo I

Comparador Activo
In the conventional treatment group (Group C), the decision to reconstruct the colon or perform a Hartmann procedure was made by the surgeon during the emergency operation. After performing the anastomosis or the Hartmann procedure, patients with advanced peritonitis received an intraabdominal negative pressure system at the discretion of the operating surgeon.

Grupo II

Experimental
In the damage control surgery (DCS) group the surgeon was asked to perform rapid source control by stapling the perforated segment leaving blind ends or suturing the perforation site if possible, doing a thorough lavage of the abdominal cavity and placing an intra-abdominal negative pressure system avoiding the retraction of the abdominal wall with dynamic sutures as published. The second-look operation was scheduled for a time 24-48 hours after primary surgery that would be during regular working hours with a colorectal surgeon on hand to make the decision for either anastomosis or ostomy.

Objetivos del Estudio

Objetivos Primarios

Objetivos Secundarios

Centros del Estudio

Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.
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CompletadoNingun centro de estudio