Neoplasms

Digestive System Diseases

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Gastrointestinal Neoplasms

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Intestinal Diseases

Digestive System Neoplasms

Rectal Diseases

Rectal Neoplasms

Rectal excision with aspiration pelvic drainage

Rectal excision without aspiration pelvic drainage

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.

Laying and management of the drain (strictly randomized arm with drainage)

no aspiration drain at the end of intervention

No pelvic drainage

Adélaïde Doussau, Dr

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.

Drainage After Rectal Excision for Rectal Cancer

Randomized Trial Comparing Drainage Versus no Drainage Following Rectal Excision With Low Anastomosis for Rectal Cancer

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 until 30 days (pelvic sepsis, wound abscess, urinary infection, pneumopathy, blood-poisoning)

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Drainage After Rectal Excision for Rectal Cancer	NCT01269567	Rectal Cancer S... Randomized Clin... Multicenter Stu... Pelvic Drainage	Laying and mana... No pelvic drain...	18 Years -	University Hospital, Bordeaux
Drainage After Rectal Excision for Rectal Cancer	NCT01269567	Rectal Cancer S... Randomized Clin... Multicenter Stu... Pelvic Drainage	Laying and mana... No pelvic drain...	18 Years -	University Hospital, Bordeaux
Drainage After Rectal Excision for Rectal Cancer	NCT01269567	Rectal Cancer S... Randomized Clin... Multicenter Stu... Pelvic Drainage	Laying and mana... No pelvic drain...	18 Years -	University Hospital, Bordeaux

Spots Global Cancer Trial Database for laying and management of the drain (strictly randomized arm with drainage)