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COMPLETED
NCT01269567
PHASE3

Drainage After Rectal Excision for Rectal Cancer

Sponsor: University Hospital, Bordeaux

View on ClinicalTrials.gov

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)

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

494

Start Date

2011-01

Completion Date

2015-01

Last Updated

2026-05-14

Healthy Volunteers

No

Interventions

PROCEDURE

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.

PROCEDURE

No pelvic drainage

no aspiration drain at the end of intervention

Locations (22)

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

CHRU de Strasbourg

Strasbourg, France

Service de Chirurgie Digestive - Hôpital Purpan - Pavillon Dieulafoy

Toulouse, France

Service de Chirurgie Digestive et Générale - Brabois

Vandœuvre-lès-Nancy, France