Etude : GRECCAR-9 /



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Acronyme / Nom
Situation thérapeutique
Traitement
Cadre réglementaire
MÀJ
Présentation de l'étude
Acronyme / Nom : GRECCAR-9

Situation thérapeutique :

Traitement : Chirurgie

Cadre réglementaire : RIPH2

Dernière MÀJ : 30/11/2021
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : Évaluation coût-utilité de deux stratégies de reconstruction périnéale après résection abdominopérinéale pour carcinome colorectal : remplissage périnéal avec des mailles biologiques vs fermeture primaire classique de la plaie périnéale

Spécialité : Organes digestifs
Localisation : C21 - Tumeur maligne de l'anus et du canal anal

Spécialité : Organes digestifs
Localisation : C20 - Tumeur maligne du rectum
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : Perineal wound problems after abdominoperineal resection (APR) in the context of cancer are frequent. These types of resection problems occur because of wound complications caused by large perineal defects. Indeed, perineal wound complications, perineal abscess, wound dehiscences, chronic fistulas and sinuses lengthen the hospital stays. Futhermore, the standardization of the surgery since the late 2000s and the extralevator technique lead a larger defect and increase i perineal complications.

Several strategies are used to decrease the complication rate. Closure by direct approximation of the pelvic muscles leads to a rate of major complication up to 57% depending on the series. Musculocutaneous flaps help to reduce this rate (16- 65%) but they generate their own morbidity, require experience and increase the costs of care. Finally, the use of biologic meshes since the beginning of 2010 seems to have improve the healing process. However, results are still variable and the only randomized study comparing direct closure and mesh closure showed no significant results at one year. Another ongoing randomized trial is comparing gluteus maximus flap to mesh closure and focusing on physical performances.

This increase in post-operative complications and their consequences causes an increase in costs. In addition, they affect the patients' quality of life and lead to a loss of productivity. From an oncological point of view, perineal scarring problems can cause a delay in the adjuvant therapeutic sequence. Few studies have highlighted the efficiency of perineal wound complications, using cost-effectiveness analyses. In order to clarify the best strategy comparing primary and mesh closure in term of cost effectiveness on perineal healing after ELAPE, we designed this randomized controlled trial.

STUDY ARMS:
- Experimental: Arm with biological mesh
The intervention consists of perinal reconstruction using biological mesh (Cellis prosthesis from Meccellis Biotech, reference C1015E size 10x15cm)
The intervention consists of suturing a biological mesh in the pelvic floor defect. The mesh will be sutured at each side of the coccyx or distal sacrum and directly to the residual pelvic floor muscle and fascia by using interrupted or continuous hand-sewn sutures with an appropriate amount of tension. The mesh that will be used is the Cellis prosthesis from Meccellis Biotech, reference C1015E which size is 10x15cm.

- Active Comparator: Arm with primary perineal wound closure
The intervention consists of perinal reconstruction by primary perineal wound closure
The intervention consists of stitching the ischioanal and subcutaneous fat using interrupted Vicryl sutures in one or two layers similar to primary perineal closure

PRIMARY OUTCOME:
- Incremental Cost-Utility Ratio (ICUR) [ Time Frame: At 12 months ]
- Cost Utility evaluation as assessed by quality-adjusted life year [ Time Frame: At 12 months ]

Phase : NA

Stade : Localisé à Localement avancé

NA
Critères d'inclusion
Critères de non-inclusion
Critères d'inclusion et de non-inclusion
Critères d'inclusion : - Age ≥ 18
- Eastern Cooperative Oncology Group performance status score of 2 or less
- Histologically proven rectal adenocarcinoma or anal canal epidermoïd carcinoma
- Abdominoperineal resection indication after multidisciplinary team discussion:
* for rectal adenocarcinoma: circumferential MRI margin equal or less than 1 mm from closest tumoral structure and a striated muscular layer (levator ani or external anal sphincter)
* for epidermoid carcinoma: residual or recurrent tumour after chemoradiotherapy.
- Voluntary written informed consent
- Patients with social security insurance or equivalent social protection

Critères de non-inclusion :
T4 tumour needing a surgical extensive resection with reconstruction by a musculocutaneous flap
Metastasis disease deemed unresectable with curative intent
Previous pelvic radiotherapy for another disease than the rectal or anal cancer
Immunosuppressive drugs treatment
Uncontrolled diabetes (glycosylated hemoglobin (HbA1c) > 8 % despite adequate therapy)
Patient under juridical protection.
Sensitivity to porcine derived products.
Enrolment in trial with overlapping primary endpoint.
Pregnant women
Breastfeeding women
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT02841293
Promoteur :
CHU de Toulouse
Type de sponsor : Institutionnel
31000 TOULOUSE

Coordonnateur :
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
Centre Oscar Lambret - 3 Rue Frédéric Combemale - 59000 LILLE

Investigateur :
Docteur Mehrdad JAFARI

TEC / ARC / IDE :
Unité Intégrée de Recherche Clinique
investigation@
o-lambret.fr
03.20.29.59.35

Statut de l'essai : OUVERT

MAJ : 14/04/2021

Centre investigateur :
Centre Hospitalier Universitaire de Lille - 2 Avenue Oscar Lambret - 59000 LILLE

Investigateur :
Docteur Clarisse EVENO

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

Statut de l'essai : OUVERT

MAJ : 15/04/2021