Evidence map›Paper›PMID 34855063›Full record

Observational studyAnnals of surgical oncology2022

Rectal Sparing Approach After Neoadjuvant Therapy in Patients with Rectal Cancer: The Preliminary Results of the ReSARCh Trial.

Francesco Marchegiani, Valeria Palatucci, Giulia Capelli, Mario Guerrieri, Claudio Belluco, Daniela Rega, Emilio Morpurgo, Claudio Coco, Angelo Restivo, Silvia De Franciscis and 13 more

Open access · bronzeAbstract readMulticenter StudyObservational Study
PubMed Publisher
In one paragraph

Observational study in Annals of surgical oncology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed
2.5field-weighted citation impact, top 8% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 36 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

23 authors at 13 institutions in 1 country.

Francesco MarchegianiDepartment of Surgical, Oncological and Gastroenterological Sciences, First Surgical Clinic, University of Padova, Padua, Italy.
Valeria PalatucciDepartment of Surgical, Oncological and Gastroenterological Sciences, First Surgical Clinic, University of Padova, Padua, Italy.
Giulia CapelliDepartment of Surgical, Oncological and Gastroenterological Sciences, First Surgical Clinic, University of Padova, Padua, Italy.
Mario GuerrieriSurgery Clinic, Marche Polytechnic University, Ancona, Italy.
Claudio BellucoOncological Surgery Department, Centro di Riferimento Oncologico, National Cancer Institute, Aviano, Italy.
Daniela RegaNational Cancer Institute, IRCCS Fondazione "G.Pascale", Naples, Italy.
Emilio MorpurgoDepartment of Surgery, Regional Center for Laparoscopic and Robotic Surgery, Camposampiero Hospital, Padua, Italy.
Claudio CocoDepartment of Surgical Sciences, Catholic University of Rome, Rome, Italy.
Angelo RestivoDepartment of Surgery, Colorectal Surgery Center, University of Cagliari, Cagliari, Italy.
Silvia De FranciscisNational Cancer Institute, IRCCS Fondazione "G.Pascale", Naples, Italy.
Carlo AscheleSant'Andrea Hospital, La Spezia, Italy.
Alessandro PerinDepartment of Surgical, Oncological and Gastroenterological Sciences, First Surgical Clinic, University of Padova, Padua, Italy.
Michele BonomoSan Bortolo Hospital, Vicenza, Italy.
Andrea MuratoreDivision of General Surgery, E. Agnelli Hospital, Pinerolo, Turin, Italy.
Antonino SpinelliColon and Rectal Surgery Unit, Humanitas Clinical and Research Center, Rozzano, Milan, Italy.
Salvatore RamuscelloSurgical Department, Chioggia Hospital, Venice, Italy.
Francesca BergamoIstituto Oncologico Veneto - IRCCS, Padua, Italy.
Giampaolo MontesiRadiation Oncology Unit, Santa Maria della Misericordia Hospital, Rovigo, Italy.
Gaya SpolveratoDepartment of Surgical, Oncological and Gastroenterological Sciences, First Surgical Clinic, University of Padova, Padua, Italy. gaya.spolverato@unipd.it.
Paola Del BiancoIstituto Oncologico Veneto - IRCCS, Padua, Italy.
Maria Antonietta GambacortaAgostino Gemelli Hospital, Rome, Italy.
Paolo DelrioNational Cancer Institute, IRCCS Fondazione "G.Pascale", Naples, Italy.
Salvatore PucciarelliDepartment of Surgical, Oncological and Gastroenterological Sciences, First Surgical Clinic, University of Padova, Padua, Italy.
University of Padua · ITIstituto Nazionale Tumori IRCCS "Fondazione G. Pascale" · ITIstituto Oncologico Veneto · ITAgostino Gemelli University Polyclinic · ITCentro di Riferimento Oncologico · ITCTO Andrea Alesini · ITHumanitas University · ITMarche Polytechnic University · ITOspedale Civile Edoardo Agnelli · ITOspedale San Bortolo · ITOspedale Santa Maria della Misericordia di Rovigo · ITUniversità Cattolica del Sacro Cuore · ITUniversity of Cagliari · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRectum-preservation for locally advanced rectal cancer has been proposed as an alternative to total mesorectal excision (TME) in patients with major (mCR) or complete clinical response (cCR) after neoadjuvant therapy. The purpose of this study was to report on the short-term outcomes of ReSARCh (Rectal Sparing Approach after preoperative Radio- and/or Chemotherapy) trial, which is a prospective, multicenter, observational trial that investigated the role of transanal local excision (LE) and watch-and-wait (WW) as integrated approaches after neoadjuvant therapy for rectal cancer.

methodsPatients with mid-low rectal cancer who achieved mCR or cCR after neoadjuvant therapy and were fit for major surgery were enrolled. Clinical response was evaluated at 8 and 12 weeks after completion of chemoradiotherapy. Treatment approach, incidence, and reasons for subsequent TME were recorded.

resultsFrom 2016 to 2019, 160 patients were enrolled; mCR or cCR at 12 weeks was achieved in 64 and 96 of patients, respectively. Overall, 98 patients were managed with LE and 62 with WW. In the LE group, Clavien-Dindo 3+ complications occurred in three patients. The rate of cCR increased from 8- to 12-week restaging. Thirty-three (94.3%) of 35 patients with cCR had ypT0-1 tumor. At a median 24 months follow-up, a tumor regrowth was found in 15 (24.2%) patients undergoing WW.

conclusionsLE for patients achieving cCR or mCR is safe. A 12-week interval from chemoradiotherapy completion to LE is correlated with an increased cCR rate. The risk of ypT > is reduced when LE is performed after cCR.

Indexed as

Neoadjuvant TherapyRectal NeoplasmsChemoradiotherapyHumansNeoplasm Recurrence, LocalProspective StudiesRectumTreatment OutcomeWatchful Waiting

Identifiers

PMID34855063
OpenAlexW3216566526

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.