Drainage After Rectal Excision for Rectal Cancer

NCT ID: NCT01269567

Last Updated: 2015-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 494 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2015-01-31

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.

Conditions

Rectal Cancer Surgery; Randomized Clinical Trial; Multicenter Study; Pelvic Drainage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Drainage

Rectal excision with aspiration pelvic drainage

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: PROCEDURE

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 drainage

Rectal excision without aspiration pelvic drainage

Group Type: EXPERIMENTAL

No pelvic drainage

Intervention Type: PROCEDURE

no aspiration drain at the end of intervention

Interventions

Laying and management of the drain (strictly randomized arm with 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.

Intervention Type: PROCEDURE

No pelvic drainage

no aspiration drain at the end of intervention

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adélaïde Doussau, Dr

Role: STUDY_CHAIR

University Hospital, Bordeaux

Locations

CHRU de Strasbourg

Strasbourg, , France

Service de Chirurgie Digestive - Hôpital Purpan - Pavillon Dieulafoy

Toulouse, , France

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

Service de Chirurgie Digestive et Viscérale - CHU Timone

Marseille, , France

Département de Chirurgie Oncologique - CRLC Val d'Aurelle

Montpellier, , France

Service de Chirurgie Digestive - CHU de Nantes - Hôtel Dieu

Nantes, , France

Service de Chirurgie Générale et Digestive - Hôpital Saint-Antoine

Paris, , France

APHP- Saint Joseph

Paris, , France

Service de Chirurgie Digestive - Hôpital des Diaconnesses - La Croix Saint-Simon

Paris, , France

CHU Poitiers

Poitiers, , France

Service de Chirurgie Viscérale - CHU Pontchaillou

Rennes, , France

Service de Chirurgie Digestive - CHU Charles Nicolle

Rouen, , France

Service de Chirurgie Digestive et Générale - Brabois

Vandœuvre-lès-Nancy, , France

Countries

France

Other Identifiers

CHUBX 2010/24

Identifier Type: -

Identifier Source: org_study_id