Clinical trial NCT01269567: Drainage After Rectal Excision for Rectal Cancer
Official title: Randomized Trial Comparing Drainage Versus no Drainage Following Rectal Excision With Low Anastomosis for Rectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rectal Cancer Surgery
Randomized Clinical Trial
Multicenter Study
Pelvic Drainage
Keywords: RectalNeoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2011-01-04
Enrollment: 494
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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)

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Rectal adenocarcinoma, histopathologically proved, with or without neoadjuvant treatment
* Stapler or manual infraperitoneal anastomosis
* With or without stoma
* With bowel preparation
* Open or laparoscopic approach
* Stage T1-T4 Nx Mx
* Age 18 years old or older
* Information of the patient and signature of informed consent
* Affiliation to a regime of social insurance

Exclusion Criteria:

* Colonic cancer (\> 15 cm from anal verge)
* Abdominoperineal resection
* Associated resection (prostate, seminal bladder, vagina...)
* Simultaneous liver resection
* Total coloproctectomy
* Emergency
* Infected rectal tumour
* Pregnant women, suitable to be, or current suckling
* Persons deprived of freedom or under guardianship
* Persons under protection of justice
* Impossibility to accept the medical follow-up of the study for geographic , social or psychic reasons.

Primary outcomes:
measure: Pelvic sepsis
timeFrame: within the first 30 days after surgery
Secondary outcomes:
measure: Overall sepsis
timeFrame: up to 30 days after surgery
measure: Peri-operative mortality
timeFrame: up to 30 days after surgery
measure: Surgical morbidity according to Dindo classification
timeFrame: within the first 6 months after surgery
measure: Re-surgery during the hospitalization
timeFrame: during the hospitalization
measure: Rate of closure of stoma
timeFrame: within the first 6 months after surgery
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU d'AMIENS
city: Beauvais
country: France
facility: CH de BEAUVAIS
city: Bordeaux
country: France
facility: Service de Chirurgie Digestive - Hôpital Saint-André - CHU de Bordeaux
city: Clichy
country: France
facility: Service de Chirurgie Générale et Digestive - Hôpital Beaujon
city: La Tronche
country: France
facility: Service de Chirurgie Digestive - Hôpital A. Michallon
city: Le Kremlin-bicetre
country: France
facility: APHP-Kremlin Bicetre
city: Lille
country: France
facility: Département de Chirurgie Oncologique - Centre Oscar Lambret
city: Lille
country: France
facility: CHRU Lille
city: Lyon
country: France
facility: Centre Hospitalier Lyon Sud
city: Marseille
country: France
facility: Département de Chirurgie Oncologique - Institut Paoli Calmette
city: Marseille
country: France
facility: Service de Chirurgie Digestive et Viscérale - CHU Timone
city: Montpellier
country: France
facility: Département de Chirurgie Oncologique - CRLC Val d'Aurelle
city: Nantes
country: France
facility: Service de Chirurgie Digestive - CHU de Nantes - Hôtel Dieu
city: Paris
country: France
facility: Service de Chirurgie Générale et Digestive - Hôpital Saint-Antoine
city: Paris
country: France
facility: APHP- Saint Joseph
city: Paris
country: France
facility: Service de Chirurgie Digestive - Hôpital des Diaconnesses - La Croix Saint-Simon
city: Poitiers
country: France
facility: CHU Poitiers
city: Rennes
country: France
facility: Service de Chirurgie Viscérale - CHU Pontchaillou
city: Rouen
country: France
facility: Service de Chirurgie Digestive - CHU Charles Nicolle
city: Strasbourg
country: France
facility: CHRU de Strasbourg
city: Toulouse
country: France
facility: Service de Chirurgie Digestive - Hôpital Purpan - Pavillon Dieulafoy
city: Vandoeuvre Les Nancy
country: France
facility: Service de Chirurgie Digestive et Générale - Brabois
Study officials:
affiliation: University Hospital, Bordeaux
name: Adélaïde Doussau, Dr
role: STUDY_CHAIR
References: