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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01269567
Other study ID # CHUBX 2010/24
Secondary ID
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


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
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