After rectal excision, the rate of anastomotic leak and abscess is higher than after colic surgery. In order to limit and avoid the risk of pelvic sepsis after rectal excision, a prophylactic pelvic drainage is usually used. If current data have confirmed the uselessness of drainage in colic surgery, the question stay in abeyance in rectal surgery. This practice had never been evaluated in patients with rectal excision and low anastomosis (patients with a high risk of pelvic sepsis)
After rectal excision, the rate of anastomotic leak and abscess is higher than after colic surgery. In order to limit and avoid the risk of pelvic sepsis after rectal excision, a prophylactic pelvic drainage is usually used. If current data have confirmed the uselessness of drainage in colic surgery, the question stay in abeyance in rectal surgery. This practice had never been evaluated in patients with rectal excision and low anastomosis (patients with a high risk of pelvic sepsis) The aim of the study is to assess the impact of pelvic drainage vs. non pelvic drainage on risk of pelvic sepsis after rectal excision for cancer with infraperitoneal anastomosis. The principal objective is to compare the rate of pelvic sepsis until 30 days between the 2 groups of patients who had a rectal excision with and without pelvic drainage. It is a randomized clinical trial of superiority, multicentric, without blinding, in 2 parallel groups with ratio (1:1): distribution of the number of patients in the groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
494
At the end of intervention, the surgeon will position an aspiration drain in order to permit a postoperative pelvic drainage. The drain will be positioned forward sacrum, behind anastomosis. The drain will be leaved in place between 3 and 5 days. The criteria of drain ablation are the absence of haemorrhagic liquid and/or un daily debit \< 100ml. Nursing care will be daily with change of bottle for collect pelvic serosity, accounting of quantity of collected liquid and realization of a dried bandage through contact with penetration of the drain.
no aspiration drain at the end of intervention
CHU d'AMIENS
Amiens, France
CH de BEAUVAIS
Beauvais, France
Service de Chirurgie Digestive - Hôpital Saint-André - CHU de Bordeaux
Bordeaux, France
Service de Chirurgie Générale et Digestive - Hôpital Beaujon
Clichy, France
Service de Chirurgie Digestive - Hôpital A. Michallon
La Tronche, France
APHP-Kremlin Bicetre
Le Kremlin-Bicêtre, France
Département de Chirurgie Oncologique - Centre Oscar Lambret
Lille, France
CHRU Lille
Lille, France
Centre Hospitalier Lyon Sud
Lyon, France
Département de Chirurgie Oncologique - Institut Paoli Calmette
Marseille, France
...and 12 more locations
Pelvic sepsis
Pelvic sepsis until 30 days after rectal excision is the primary end point. It is defined as the occurrence of an anastomotic leak revealed by peritonitis or discharge of gas, stools or pus, the vagina or the abdominal wound, and/or a pelvic abscess, between J0 and J30.
Time frame: within the first 30 days after surgery
Overall sepsis
Overall sepsis until 30 days (pelvic sepsis, wound abscess, urinary infection, pneumopathy, blood-poisoning)
Time frame: up to 30 days after surgery
Peri-operative mortality
Peri-operative mortality (hospital mortality and/or until 30 days after surgery if the patient is already going out of hospital)
Time frame: up to 30 days after surgery
Surgical morbidity according to Dindo classification
Surgical morbidity according to Dindo classification
Time frame: within the first 6 months after surgery
Re-surgery during the hospitalization
Time frame: during the hospitalization
Rate of closure of stoma
Rate of closure of stoma at 6 months
Time frame: within the first 6 months after surgery
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