Drainage After Rectal Excision for Rectal Cancer

Randomized Clinical Trial Clinical Trial

— GRECCAR 5  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01269567
• Other study ID #: CHUBX 2010/24
• Status: Completed
• Phase: Phase 3
• First received: January 3, 2011
• Last updated: July 22, 2015
• Start date: January 2011
• Est. completion date: January 2015

Study information

• Verified date: July 2015
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 494
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Multicenter Study
• Pelvic Drainage
• Randomized Clinical Trial
• Rectal Cancer Surgery
• Rectal Neoplasms

Intervention

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.
• No pelvic drainage
no aspiration drain at the end of intervention

Locations

Country	Name	City	State
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-bicetre
France	CHRU Lille	Lille
France	Département de Chirurgie Oncologique - Centre Oscar Lambret	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	APHP- Saint Joseph	Paris
France	Service de Chirurgie Digestive - Hôpital des Diaconnesses - La Croix Saint-Simon	Paris
France	Service de Chirurgie Générale et Digestive - Hôpital Saint-Antoine	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

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

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