Evidence map›Paper›PMID 40276906›Full record

ArticleBJS open2025

Perineal wound complications after total neoadjuvant therapy or chemoradiotherapy followed by abdominoperineal excision in patients with high-risk locally advanced rectal cancer in the RAPIDO trial.

Wouter H Zwart, Esmée A Dijkstra, Geke A P Hospers, Corrie A M Marijnen, Hein Putter, Joakim Folkesson, Cornelis J H Van de Velde, Annet G H Roodvoets, Elma Meershoek-Klein Kranenbarg, Bengt Glimelius and 2 more

Registry-linked trialAbstract readComparative Study
In one paragraph

Article in BJS open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01558921 (Randomized Multicentre Phase III Study of Short Course Radiation Therapy Followed by Prolonged Pre-operative Chemotherapy and Surgery in Primary High Risk Rectal Cancer Compared to Standard Chemoradiotherapy and Surgery and Optional Adjuvant Chemotherapy.), which is not on this map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

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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.

NCT01558921 phase3active not recruitingnot on this map

Randomized Multicentre Phase III Study of Short Course Radiation Therapy Followed by Prolonged Pre-operative Chemotherapy and Surgery in Primary High Risk Rectal Cancer Compared to Standard Chemoradiotherapy and Surgery and Optional Adjuvant Chemotherapy.

TypeinterventionalSponsorUniversity Medical Center GroningenRan2011 to 2026Enrolled920ConditionsRectal CancerArmsM1 scheme, standard long course chemoradiotherapy
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
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

12 authors.

Wouter H ZwartDepartment of Medical Oncology, University Medical Centre Groningen, Groningen, the Netherlands.ORCID 0000-0002-3372-537X
Esmée A DijkstraDepartment of Medical Oncology, University Medical Centre Groningen, Groningen, the Netherlands.
Geke A P HospersDepartment of Medical Oncology, University Medical Centre Groningen, Groningen, the Netherlands.
Corrie A M MarijnenDepartment of Radiation Oncology, Netherlands Cancer Institute, Amsterdam, the Netherlands.
Hein PutterDepartment of Biomedical Data Sciences, Leiden University Medical Centre, Leiden, the Netherlands.ORCID 0000-0001-5395-1422
Joakim FolkessonDepartment of Surgical Sciences, Uppsala University, Uppsala, Sweden.
Cornelis J H Van de VeldeDepartment of Surgery, Leiden University Medical Centre, Leiden, the Netherlands.
Annet G H RoodvoetsDepartment of Surgery, Leiden University Medical Centre, Leiden, the Netherlands.
Elma Meershoek-Klein KranenbargDepartment of Surgery, Leiden University Medical Centre, Leiden, the Netherlands.
Bengt GlimeliusDepartment of Immunology, Genetics and Pathology, Uppsala University, Uppsala, Sweden.
Boudewijn Van EttenDepartment of Surgery, University Medical Centre Groningen, Groningen, the Netherlands.
Per J NilssonDepartment of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden.

Funding

Carlos III Health Institute EC11-423Dutch Cancer Foundation CKS-2011-4997European Regional Development FundEuropean Union's Horizon 2020Marie Skłodowska-Curie 857894Spanish Clinical Research Network SCReN-PT13/0002/0031Spanish Ministry of Economy and CompetitivenessSwedish Cancer SocietySwedish Research Council K2014-99X-22481-01-3
6 · The paper itself

Abstract

backgroundPerineal wound complications (PWCs) occur in 15-30% of patients after abdominoperineal excision (APE) and are associated with adverse events, such as delayed wound healing, prolonged hospitalization, a delay in initiating postoperative chemotherapy, and decreased quality of life. Preoperative radiotherapy and chemotherapy are risk factors for wound complications. It is unknown whether total neoadjuvant treatment (TNT) affects the risk of PWCs compared with chemoradiotherapy (CRT).

methodsThis study compared patients from the experimental (EXP; short-course radiotherapy, chemotherapy, and surgery as TNT) and standard-of-care (STD; CRT, surgery, and postoperative chemotherapy depending on hospital policy) treatment arms of the RAPIDO trial who underwent APE within 6 months after preoperative treatment. The primary outcome was the incidence of PWCs (infection, abscess, dehiscence, wound discharge, presacral abscess affecting the perineum) of any grade ≤ 30 days after APE. Secondary outcomes were the incidence of PWCs >30 days after APE, length of hospital stay, characteristics associated with PWCs, and oncological outcomes in patients with versus without PWC.

resultsOf the 901 patients who started treatment (460 in EXP arm, 441 in STD arm), 153 (33%) and 160 (36%) underwent APE after TNT and CRT, respectively. After TNT and CRT, the incidence of PWCs ≤30 days after APE, readmission, and reoperation was 54 of 153 (35%) versus 53 of 160 (33%) (P = 0.69), 9% versus 12% (P = 0.54), and 7% versus 8% (P = 0.75), respectively. The median length of hospital stay was 2-3 days longer for patients with PWC. Univariable analysis revealed that pretreatment albumin <35 g/l, hypertension, and haemoglobin ≤ 8.0 mmol/l were associated with PWC. Oncological outcomes were similar between patients with and without PWCs.

conclusionIn the RAPIDO trial, TNT and CRT resulted in a similar incidence of PWCs among patients with high-risk locally advanced rectal cancer who underwent APE.

Indexed as

ChemoradiotherapyNeoadjuvant TherapyPerineumPostoperative ComplicationsProctectomyRectal NeoplasmsAgedClinical Trials, Phase III as TopicFemaleHumansIncidenceLength of StayMaleMiddle AgedMulticenter Studies as TopicRandomized Controlled Trials as Topic

Identifiers

PMID40276906
PMCPMC12022605

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Registered trials

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.