Anastomotic Leakage Following Laparoscopic Resection for Rectal Cancer
Laparoscopic resection for rectal cancer
Maladies du système digestif+12
+ Néoplasmes du système digestif
+ Maladies Gastro-intestinales
Autre étude
Résumé
Date de début de l'étude : 1 juin 2015
Date à laquelle le premier participant a commencé l'étude.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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.59 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Autre
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.Un seul groupe d'intervention est désigné dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
Objectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 2 sites
Mansoura University Hospitals
Al Mansurah, EgyptOuvrir Mansoura University Hospitals dans Google MapsPoliclinico Tor Vergata Hospital
Rome, Italy