A Prospective European Trial Comparing Laparotomy, Laparoscopy, Robotic-Assisted, and Transanal Total Mesorectal Excision Procedures in High-Risk Patients with Rectal Cancer: The RESET Trial.
Journal
Annals of surgery
ISSN: 1528-1140
Titre abrégé: Ann Surg
Pays: United States
ID NLM: 0372354
Informations de publication
Date de publication:
12 Sep 2024
12 Sep 2024
Historique:
medline:
12
9
2024
pubmed:
12
9
2024
entrez:
12
9
2024
Statut:
aheadofprint
Résumé
To compare total mesorectal excision (TME) techniques combined with sphincter-sparing procedure in high-risk patients (HRPs). TME is the standard treatment for rectal cancer, but can be challenging in HRPs. The available surgical approaches must be compared, especially in HRPs. Prospective, observational, multicenter trial to compare laparotomy (OTME), laparoscopy (LTME), robotic-assisted surgery (RTME), and transanal surgery (TaTME) in HRPs. The composite primary outcome included circumferential radial margin (CRM) ≥1mm, TME grade II-III, and absence of Clavien-Dindo grade III-IV complications. Three propensity score analyses were performed (LTME vs. RTME, RTME vs. TaTME, LTME vs. TaTME). 1078 HRPs (75% of men, median body mass index of 27 kg/m2, 50% of tumors in the lower third of the rectum) underwent surgery. The RTME and TaTME groups included patients with more advanced and lower tumors and coloanal anastomosis (P<0.001). Operative time was longer for RTME surgery (P<0.001). Conversion rate was similar for minimally invasive procedures (4.5%). The global R0 resection rate was 96% without difference among techniques. The primary outcome rates were 82.4%, 64.3%, 74.7%, and 80.3% for LTME, OTME, RTME, and TaTME, respectively. None achieved the expected success rate (85%), and propensity score analyses found no differences. Operative results were similar between high- and low-volume inclusion centers only for RTME. The RESET trial yielded high-quality results despite focusing on HRPs. Minimally invasive procedures showed similar sphincter-sparing procedure outcomes, but LTME included patients with more favorable tumors. Oncologic and functional outcomes will be evaluated at 2 years (ClinicalTrials.gov, ID: NCT03574493).
Sections du résumé
OBJECTIVE
OBJECTIVE
To compare total mesorectal excision (TME) techniques combined with sphincter-sparing procedure in high-risk patients (HRPs).
BACKGROUND
BACKGROUND
TME is the standard treatment for rectal cancer, but can be challenging in HRPs. The available surgical approaches must be compared, especially in HRPs.
METHODS
METHODS
Prospective, observational, multicenter trial to compare laparotomy (OTME), laparoscopy (LTME), robotic-assisted surgery (RTME), and transanal surgery (TaTME) in HRPs. The composite primary outcome included circumferential radial margin (CRM) ≥1mm, TME grade II-III, and absence of Clavien-Dindo grade III-IV complications. Three propensity score analyses were performed (LTME vs. RTME, RTME vs. TaTME, LTME vs. TaTME).
RESULTS
RESULTS
1078 HRPs (75% of men, median body mass index of 27 kg/m2, 50% of tumors in the lower third of the rectum) underwent surgery. The RTME and TaTME groups included patients with more advanced and lower tumors and coloanal anastomosis (P<0.001). Operative time was longer for RTME surgery (P<0.001). Conversion rate was similar for minimally invasive procedures (4.5%). The global R0 resection rate was 96% without difference among techniques. The primary outcome rates were 82.4%, 64.3%, 74.7%, and 80.3% for LTME, OTME, RTME, and TaTME, respectively. None achieved the expected success rate (85%), and propensity score analyses found no differences. Operative results were similar between high- and low-volume inclusion centers only for RTME.
CONCLUSIONS
CONCLUSIONS
The RESET trial yielded high-quality results despite focusing on HRPs. Minimally invasive procedures showed similar sphincter-sparing procedure outcomes, but LTME included patients with more favorable tumors. Oncologic and functional outcomes will be evaluated at 2 years (ClinicalTrials.gov, ID: NCT03574493).
Identifiants
pubmed: 39263755
doi: 10.1097/SLA.0000000000006534
pii: 00000658-990000000-01074
doi:
Banques de données
ClinicalTrials.gov
['NCT03574493']
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Investigateurs
Emre Özoran
(E)
Michele Carvello
(M)
Jesús Pedro Paredes-Cotoré
(JP)
Francesca Di Candido
(F)
Laura Lorenzon
(L)
Alejandro Solis
(A)
Andrea Coratti
(A)
Daniela Rega
(D)
Carmen Cagigas Fernández
(CC)
Matteo Palmeri
(M)
Jim Khan
(J)
María Fernández-Hevia
(M)
Andre D'Hoore
(A)
Roberto Coppola
(R)
Quentin Denost
(Q)
Ignacio Aguirre-Allende
(I)
Nerea Borda-Arrizabalaga
(N)
Guillaume Piessen
(G)
Leonardo Vincenti
(L)
Ibrahim Halil Özata
(IH)
Paolo Pietro Bianchi
(PP)
Alain Valverde
(A)
Eric Rullier
(E)
Matti Kairaluoma
(M)
Antonio Navarro-Sánchez
(A)
Gill Talvinder
(G)
Jaime Zorrilla Ortúzar
(JZ)
Benoit Romain
(B)
John A Conti
(JA)
Jorge Luis Otero-Díez
(JL)
Cécile de Chaisemartin
(C)
Adeline Germain
(A)
Mehrdad Jafari
(M)
Valeria Andriola
(V)
Frederic Dumont
(F)
Daniel Trigero-Cánovas
(D)
Juan Ocaña Jiménez
(JO)
Thalia Petropoulou
(T)
Vicente Simó Fernández
(VS)
Cécile Brigand
(C)
Fernando Mendoza-Moreno
(F)
Carlos Jezieniecki Fernández
(CJ)
Beatriz Martín-Pérez
(B)
Damiano Caputo
(D)
Pirita Varpe
(P)
Daniel Perez
(D)
Gianluca Pellino
(G)
Thierry Bensignor
(T)
Zaher Lakkis
(Z)
Filippos Sagias
(F)
Bertrand Celerier
(B)
Clément Dubois
(C)
Richard Douard
(R)
Veronika Zver
(V)
Bernard Lelong
(B)
Sandra Lario Perez
(SL)
Nader K Francis
(NK)
Jean-Luc Faucheron
(JL)
Antoine Brouquet
(A)
Federico Perna
(F)
Tero T Rautio
(TT)
Heikki Takala
(H)
Ester Kreisler Moreno
(EK)
Anna Lepisto
(A)
Simona Borin
(S)
Lucia Salvischiani
(L)
Luca Morelli
(L)
Serge Rohr
(S)
Maria José Alcaide
(MJ)
Alex Kartheuser
(A)
Aaron Quyn
(A)
Kamal Aryal
(K)
Orestis Ioannidis
(O)
Roel Hompes
(R)
Rogier Crolla
(R)
Informations de copyright
Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.
Déclaration de conflit d'intérêts
Conflicts of Interest and Source of Funding: RESET was endorsed by the European Society of Coloproctology (ESCP). Financial support was provided by Intuitive Surgical, Aubonne, Switzerland. RESET was designed and conducted independently at the Montpellier Cancer Institute. The funding institutions had no influence on the design or conduct of the study. PR received research and education grants from Intuitive Surgical. The other authors declare no other conflict of interest.