Evidence map›Paper›PMID 27872117›Full record

Trial reportBMJ open2016

Protocol for a multicentre randomised feasibility trial evaluating early Surgery Alone In LOw Rectal cancer (SAILOR).

Dean A Harris, Kymberley Thorne, Hayley Hutchings, Saiful Islam, Gail Holland, Olivia Hatcher, Sarah Gwynne, Ian Jenkins, Peter Coyne, Michael Duff and 9 more

Abstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMJ open, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
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

4 citing papers in PubMed.

  1. A profile of heart failure in the James and Hudson's Bay region of Ontario: A retrospective cohort study.Canadian journal of public health = Revue canadienne de sante publique · 2026
    Article
  2. Review
  3. Facility Variation in Local Staging of Rectal Adenocarcinoma and its Contribution to Underutilization of Neoadjuvant Therapy.Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract · 2019
    Article
  4. Review
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

19 authors.

Dean A HarrisDepartment of Colorectal Surgery, Singleton Hospital, Swansea, UK.ORCID 0000-0003-2673-8946
Kymberley ThorneSwansea Trials Unit, Swansea University, Swansea, UK.
Hayley HutchingsSwansea Trials Unit, Swansea University, Swansea, UK.
Saiful IslamSwansea Trials Unit, Swansea University, Swansea, UK.
Gail HollandSwansea Trials Unit, Swansea University, Swansea, UK.
Olivia HatcherSouth West Wales Cancer Centre, Singleton Hospital, Swansea, UK.
Sarah GwynneSouth West Wales Cancer Centre, Singleton Hospital, Swansea, UK.
Ian JenkinsDepartment of Colorectal Surgery, St Marks Hospital, London, UK.
Peter CoyneDepartment of Colorectal Surgery, Royal Victoria Infirmary, Newcastle, UK.
Michael DuffDepartment of Colorectal Surgery, Western General Hospital, Edinburgh, UK.
Melanie FeldmanDepartment of Colorectal Surgery, Royal Cornwall Hospital, Truro, UK.
Des C WinterDepartment of Colorectal Surgery, St Vincent's Hospital, Dublin, Ireland.
Simon GollinsDepartment of Oncology, North Wales Cancer Treatment Centre, Rhyl, UK.
Phil QuirkePathology and Tumour Biology, Leeds Institute of Oncology and Pathology, Wellcome Trust Brenner Building, St James Hospital, Leeds, UK.
Nick WestPathology and Tumour Biology, Leeds Institute of Oncology and Pathology, Wellcome Trust Brenner Building, St James Hospital, Leeds, UK.
Gina BrownDepartment of Radiology, Royal Marsden Hospital, London, UK.
Deborah FitzsimmonsSwansea Centre for Health Economics, Swansea University, Swansea, UK.
Alan BrownInvolving People Network, Health and Care Research Wales.
John BeynonDepartment of Colorectal Surgery, Singleton Hospital, Swansea, UK.

Funding

Cancer Research UK CRUKE/14/050
6 · The paper itself

Abstract

introductionThere are 11 500 rectal cancers diagnosed annually in the UK. Although surgery remains the primary treatment, there is evidence that preoperative radiotherapy (RT) improves local recurrence rates. High-quality surgery in rectal cancer is equally important in minimising local recurrence. Advances in MRI-guided prediction of resection margin status and improvements in abdominoperineal excision of the rectum (APER) technique supports a reassessment of the contribution of preoperative RT. A more selective approach to RT may be appropriate given the associated toxicity. METHODS AND ANALYSIS: This trial will explore the feasibility of a definitive trial evaluating the omission of RT in resectable low rectal cancer requiring APER. It will test the feasibility of randomising patients to (1) standard care (neoadjuvant long course RT±chemotherapy and APER, or (2) APER surgery alone for cT2/T3ab N0/1 low rectal cancer with clear predicted resection margins on MRI. RT schedule will be 45 Gy over 5 weeks as current standard, with restaging and surgery after 8-12 weeks. Recruitment will be for 24 months with a minimum 12-month follow-up.

objectivesObjectives include testing the ability to recruit, consent and retain patients, to quantify the number of patients eligible for a definitive trial and to test feasibility of outcomes measures. These include locoregional recurrence rates, distance to circumferential resection margin, toxicity and surgical complications including perineal wound healing, quality of life and economic analysis. The quality of MRI staging, RT delivery and surgical specimen quality will be closely monitored. ETHICS AND DISSEMINATION: The trial is approved by the Regional Ethics Committee and Health Research Authority (HRA) or equivalent. Written informed consent will be obtained. Serious adverse events will be reported to Swansea Trials Unit (STU), the ethics committee and trial sites. Trial results will be submitted for peer review publication and to trial participants. TRIAL REGISTRATION NUMBER: ISRCTN02406823.

Indexed as

Digestive System Surgical ProceduresAdultAgedFeasibility StudiesFemaleHumansMagnetic Resonance ImagingMaleMargins of ExcisionMiddle AgedMilitary PersonnelNeoadjuvant TherapyNeoplasm Recurrence, LocalQuality of LifeRadiotherapyRectal Neoplasms

Identifiers

PMID27872117
PMCPMC5129046

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

None linked

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.