The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Brief Title: 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 ID: NCT01269567
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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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-bicetre, , 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, Vandoeuvre Les Nancy, , France
Name: Adélaïde Doussau, Dr
Affiliation: University Hospital, Bordeaux
Role: STUDY_CHAIR