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Anastomotic Leakage Following Laparoscopic Resection for Rectal Cancer

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Qué se está evaluando

Laparoscopic resection for rectal cancer

Procedimiento
Quiénes están siendo reclutados

Enfermedades del Sistema Digestivo+11

+ Neoplasias del sistema digestivo

+ Enfermedades Gastrointestinales

+7 Criterios de eligibilidad
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Cómo está diseñado el estudio

Otro tipo de estudio

Intervencional
Inicio del estudio: junio de 2015
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Resumen

Patrocinador PrincipalMansoura University
Última actualización: 28 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 1 de junio de 2015

Fecha en la que se inscribió al primer participante.

Study populations: all patients will sign an informed consent prior to the surgery to be included in the study, after explanation of the nature of the disease, possible treatment, and the possibility of stoma formation. Data recording: basic demographic data are recorded including age and sex of the patient as well as detailed information on history, risk factors, preoperative diagnostics, surgical procedure, intraoperative findings, histopathological work-up, and postoperative course. Variables analysis: the variables are divided into patient-related, tumor-related, therapy-related, and techniques-related variables. Preoperative workup: all patients will have detailed clinical history and physical examination including DRE. Routine laboratory investigations also are included e.g. CBC, blood glucose level, liver, and kidney function tests. Regular workup for rectal cancer are included; full colonoscopy with biopsy, gastrografin/barium enema, TRUS evaluate degree of invasion of the rectal wall and regional lymph nodes, abdominal and pelvic CT scan, Chest x-ray or CT scan, CEA level, and EORTC Quality of life Questionnaire. Level of the tumor: is measured from the lower border of the tumor to the anal verge by the rigid sigmoidoscope; considering it low < 6 cm, middle 6-12 cm, and upper > 12 cm. Preoperative preparation: all patients will have preoperative mechanical bowel preparation and adequate thromboembolic prophylaxis. Prophylactic antibiotics will be given 30 - 60 minutes before surgery. A surgeon or stoma therapist will mark the site of the stoma before the operation in all patients. Level of the anastomosis: is measured from the anastomosis to the anal verge by the rigid sigmoidoscope intraoperative; considering it low < 10 cm, middle 10-15 cm, and upper > 15 cm. The rectal anastomosis is tested intraoperative with: trans-anal air insufflation with the pelvis immersed with saline to detect bubbles, trans-anal introduction of dye, or competence of donuts in stapled anastomosis. Postoperative follow up: Access the postoperative condition locally and systemically by bedsides clinical parameters, and usual blood tests like leucocyte count and CRP level at the 3rd and the 7th day postoperative. Radiological follow up by Gastrografin enema around the 10th day or before dismissal from the hospital. Abdominal and pelvic CT scan is ordered in patients with clinical deterioration, abnormal abdominal findings, and turbid drainage secretion. Peritoneal samples are collected from the abdominal drains at the first, third, and fifth days postoperatively for peritoneal microbiological study and cytokines (IL-6, IL-10, and TNF) level measurement. Patients will receive a Quality of Life questionnaire (EORTC 30, 38) preoperatively, 30 days postoperative, and 30 days after stoma closure in case of diversion. Follow up of patients continue till discharge, and 30 days postoperative. In cases with diversion follow up will continue till closure of stoma and 30 days after closure. Stoma closure in an uneventful course will be scheduled 8-10 weeks after the primary operation. Diagnosis of leakage: 1. Fecal secretion via indwelling abdominal drainage, surgical wound or vagina. 2. Radiological via fluid collection adjacent to anastomosis associated with extraluminal contrast extravasation. Classification of leakage: patients classified according to leakage into: 1. Non leakage group. 2. Leakage group, radiological is asymptomatic and detected on imaging, localized is diagnosed on radiological findings of a pelvic collection and clinically do not require a laparotomy or laparoscopy, and generalized is confirmed at laparotomy or laparoscopy. Outcomes: Primary outcomes: Incidences of anastomotic leakage following laparoscopic resection for rectal cancer. 30 day's postoperative morbidity and mortality. secondary outcomes: The role of diversion on prevention of anastomotic leakage, are patients with diversion have low incidences of leakage. Management of anastomotic leakage. Effect of anastomotic leakage on oncological outcome, assessment of local recurrence after 24 months follow-up.

Título OficialAnastomotic Leakage Following Laparoscopic Resection for Rectal Cancer
Patrocinador PrincipalMansoura University
Última actualización: 28 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 59 pacientes

Número total de participantes que el ensayo clínico espera reclutar.

Otro Tipo de Estudio

Algunos estudios exploran temas que no encajan en una categoría específica. Pueden incluir investigaciones innovadoras, nuevas tecnologías o áreas emergentes en el ámbito de la salud.



Elegibilidad

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

Cualquier sexo

Sexo biológico de los participantes elegibles para inscribirse.

Voluntarios sanos no permitidos

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

Condiciones

Patología

Enfermedades del Sistema DigestivoNeoplasias del sistema digestivoEnfermedades GastrointestinalesNeoplasias GastrointestinalesEnfermedades IntestinalesNeoplasias IntestinalesNeoplasiasNeoplasias por SitioProcesos PatológicosComplicaciones PostoperatoriasNeoplasias RectalesEnfermedades RectalesCondiciones Patológicas, Signos y SíntomasNeoplasias colorrectales

Criterios

Un criterio de inclusión requerido para participar
All patients who undergo laparoscopic resection for biopsy proven rectal cancer.

6 criterios de exclusión impiden participar
Open surgery,

Emergency intervention,

Palliative resection,

Stage IV with distant metastasis,

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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

Un solo grupo de intervención está designado en este estudio

0% de probabilidad de ser asignado al grupo placebo

Grupos de Tratamiento

Grupo I

All patients who will fulfill the inclusions criteria. Patients will undergo formal curative radical Laparoscopic resection for rectal cancer

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.

Este estudio tiene 2 ubicaciones

Suspendido

Mansoura University Hospitals

Al Mansurah, EgyptAbrir Mansoura University Hospitals en Google Maps
Suspendido

Policlinico Tor Vergata Hospital

Rome, Italy
Completado2 Centros de Estudio