Drainage After Rectal Excision for Rectal Cancer

Phase 3

Completed

• Conditions: Pelvic Drainage; Randomized Clinical Trial; Rectal Cancer Surgery; Multicenter Study
• Interventions: Procedure: No pelvic drainage; Procedure: Laying and management of the drain (strictly randomized arm with drainage)

• Registration Number: NCT01269567
• Lead Sponsor: University Hospital, Bordeaux

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.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-03
• Study First Submitted QC: 2011-01-03
• Study First Posted: 2011-01-04
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-22
• Last Update Posted: 2015-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 494

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No drainage	No pelvic drainage	Rectal excision without aspiration pelvic drainage
Drainage	Laying and management of the drain (strictly randomized arm with drainage)	Rectal excision with aspiration pelvic drainage

Primary Outcome Measures

Name	Time	Method
Pelvic sepsis	within the first 30 days after surgery	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.

Secondary Outcome Measures

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

Trial Locations

Locations (22)

Centre Hospitalier Lyon Sud; 🇫🇷 Lyon, France

Service de Chirurgie Digestive - Hôpital A. Michallon; 🇫🇷 La Tronche, France

Service de Chirurgie Digestive et Viscérale - CHU Timone; 🇫🇷 Marseille, France

Service de Chirurgie Digestive - CHU de Nantes - Hôtel Dieu; 🇫🇷 Nantes, France

CH de BEAUVAIS; 🇫🇷 Beauvais, France

Département de Chirurgie Oncologique - Centre Oscar Lambret; 🇫🇷 Lille, France

CHRU Lille; 🇫🇷 Lille, France

CHU d'AMIENS; 🇫🇷 Amiens, France

Département de Chirurgie Oncologique - CRLC Val d'Aurelle; 🇫🇷 Montpellier, France

Service de Chirurgie Viscérale - CHU Pontchaillou; 🇫🇷 Rennes, France

Service de Chirurgie Générale et Digestive - Hôpital Saint-Antoine; 🇫🇷 Paris, France

Service de Chirurgie Digestive - Hôpital des Diaconnesses - La Croix Saint-Simon; 🇫🇷 Paris, France

Service de Chirurgie Digestive - Hôpital Purpan - Pavillon Dieulafoy; 🇫🇷 Toulouse, France

CHU Poitiers; 🇫🇷 Poitiers, France

CHRU de Strasbourg; 🇫🇷 Strasbourg, France

Service de Chirurgie Digestive et Générale - Brabois; 🇫🇷 Vandoeuvre Les Nancy, France

APHP- Saint Joseph; 🇫🇷 Paris, France

Service de Chirurgie Digestive - Hôpital Saint-André - CHU de Bordeaux; 🇫🇷 Bordeaux, France

Service de Chirurgie Générale et Digestive - Hôpital Beaujon; 🇫🇷 Clichy, France

APHP-Kremlin Bicetre; 🇫🇷 Le Kremlin-bicetre, France

Département de Chirurgie Oncologique - Institut Paoli Calmette; 🇫🇷 Marseille, France

Service de Chirurgie Digestive - CHU Charles Nicolle; 🇫🇷 Rouen, France