Drainage After Rectal Excision for Rectal Cancer (GRECCAR 5)

• Pelvic sepsis [ Time Frame: within the first 30 days after surgery ] [ Designated as safety issue: Yes ]
  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.
  
  

• Overall sepsis [ Time Frame: up to 30 days after surgery ] [ Designated as safety issue: Yes ]
  Overall sepsis until 30 days (pelvic sepsis, wound abscess, urinary infection, pneumopathy, blood-poisoning)
  
  
• Peri-operative mortality [ Time Frame: up to 30 days after surgery ] [ Designated as safety issue: Yes ]
  Peri-operative mortality (hospital mortality and/or until 30 days after surgery if the patient is already going out of hospital)
  
  
• Surgical morbidity according to Dindo classification [ Time Frame: within the first 6 months after surgery ] [ Designated as safety issue: Yes ]
  Surgical morbidity according to Dindo classification
  
  
• Re-surgery during the hospitalization [ Time Frame: during the hospitalization ] [ Designated as safety issue: Yes ]
  
• Rate of closure of stoma [ Time Frame: within the first 6 months after surgery ] [ Designated as safety issue: Yes ]
  Rate of closure of stoma at 6 months
  
  

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.