Etude : RESET /



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Acronyme
Nom
Traitement
Type d'étude
MÀJ
Présentation de l'étude
Acronyme : RESET

Nom :

Traitement : Chirurgie

Type d'étude : Qualité de vie / Observationnelle

Dernière MÀJ : 11/10/2019
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : Rectal Surgery Evaluation Trial (RESET): Laparotomy vs Laparoscopy vs Robotic vs TaTME Rectal Surgery Matched Parallel Cohort Trial for High Surgical Risk Cancer Patients, With Mid- to Low Rectal Cancer

Spécialité : Organes digestifs
Localisation : C20 - Tumeur maligne du rectum
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : The Rectal Surgery Evaluation Trial will be a prospective, observational, case-matched, four-cohort, multicenter trial designed to study TME with LAR using open laparotomy, laparoscopy, robot-assisted surgery, or transanal surgery in high-surgical-risk patients with mid-to-low, non-metastatic rectal cancer. All surgeries will be performed by surgeons experienced in a technique.

Oncologic, morbidity and functional outcomes will be assessed in a composite primary outcome, with success defined as:
- circumferential resection margin ≥1 mm,
- TME grade III,
- minimal postoperative morbidity (absence of Clavien-Dindo grade III-IV complications within 30 days after surgery).

Secondary endpoints will include:
- the co-primary endpoints over the long-term (2 years),
- quality of surgery
- quality of life
- length of hospital stay
- operative time
- rate of unplanned conversions.


study arms:
- Open laparotomy
A surgical procedure involving a large incision through the abdominal wall to gain access into the abdominal cavity.
Intervention: Procedure: TME with LAR
- Laparoscopic surgery
A minimally-invasive technique in which operations are performed via small incisions (usually 0.5-1.5 cm) at a location distant to the site of interest.
Intervention: Procedure: TME with LAR
- Robot-assisted surgery using the da Vinci® Surgical System
A minimally-invasive approach that allows good precision, flexibility, and control.
Intervention: Procedure: TME with LAR
- Transanal surgery through the anus
Where the protectomy is performed down to up until the Douglas pouch
Intervention: Procedure: TME with LAR

Phase : NA

Stade : Localisé à Localement avancé

NA
Informations libres de droit
Critères d'inclusion
Critères de non-inclusion
Informations libres de droit
Critères d'inclusion et de non-inclusion
Critères d'inclusion : - Age ≥ 18 years old
- Rectal adenocarcinoma from middle and lower third (less than 10 cm from the anal verge) with a sphincter saving procedure
- High risk operative patients (two of these factors as assessed on MRI):
* Obese patient with a BMI > 30 (male or female)
* Narrow pelvis: inter-tuberous distance < 10 cm
* Large tumoral volume with suspicion of close predictive margin (CRM ≤ 1 mm) at diagnosis
* Expected coloanal or ultra-low colorectal anastomosis
- Patients with adequate performance status (Eastern Cooperative Oncology Group Scale score of ≤2)
- Patient has signed and dated the informed consent before inclusion in the study.

Critères de non-inclusion : - Patient with a comorbid illness or condition that would preclude the use of surgery.
- Patients with T4b tumors which impose a pelvectomy
- Patient requires an abdominal perineal resection (APR)
- Patients with concurrent or previous invasive pelvic malignant tumors (cervical, uterine, or rectal; excluding the prostate) within 5 years before study enrollment
- Patient undergoing emergency procedures
- Planned rectal surgery along with major concomitant procedures (e.g. hepatectomies, other intestinal resections)
- Metastatic disease
- Pregnant or suspected pregnancy
- Patients unwilling to comply with all follow-up study requirements
- Patient included in another study which impact on the surgical technique or its choice.
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT03574493
Promoteur :
Institut du Cancer de Montpellier - Val d'Aurelle
Type de sponsor : Institutionnel
Institut du Cancer de Montpellier - Val d'Aurelle
34000 MONTPELLIER

Coordonnateur :
Docteur Jean-Pierre BLEUSE
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
Centre Hospitalier Universitaire de Lille - 2 Avenue Oscar Lambret - 59000 LILLE

Investigateur :
Professeur Guillaume PIESSEN

TEC / ARC / IDE :
Justine LEROOY
justine.lerooy@
chru-lille.fr
Tel: 03 20 44 47 86 (ou 03 20 44 59 62) Fax: 03 20 44 59 14

Ouverture de l'essai : OUVERT

MAJ : 11/10/2019