Trials and research

We present a summary of currently recruiting trials in coloproctology (STAR-TREC, FIAT, FOxTROT, HiP, PREPARE-ABC, FOFACT, CIPHER, LEGO, SAILOR, CReST2, SaFaRI) as well as recently completed (TREC, LIR!C, ACCURE-UK) and reported (OnCoRe, HubBLe, eTHoS, AlaCaRT, ASOCOG, IVICA) trials.

Trials and research

Please do get in touch if you have information to add to this list.

Current trials


STAR-TREC

The aim of this study is to assess the feasibility of successfully recruiting to a large, multi-centre randomised trial comparing radical surgery versus organ saving treatment using chemoradiotherapy followed by selective transanal microsurgery, to evaluate whether it is possible to accelerate patient recruitment from two per month, as attained in the previous TREC study, to six per month over a two-year period.

  • Sample size: 120 patients
  • Start date: November 2016
  • End date: July 2021
  • Centres involved: Manchester M20 4BX and M13 9WL, University Hospitals Birmingham NHS Foundation Trust, St James University Hospital, Department of Neurology, Freeman Hospital, The Clatterbridge Cancer Centre NHS Foundation Trust, Pfizer Investigational Site, Birmingham Heartlands Hospital
  • Chief Investigator: Simon Bach

Contact details for enrolment:
STAR-TREC@trials.bham.ac.uk
Dr Laura Magill, 0121 415 9104


FIAT

The FIAT trial will compare the Surgisis® anal fistula plug with the surgeon’s preference; advancement flap, fistulotomy or cutting seton, for the treatment of transsphincteric fistula-in-ano.

  • Sample size: 500 patients
  • Start date: November 2010
  • End date: May 2017
  • Centres involved: around 50 across the UK
  • Chief Investigator: David Jayne

Closed for enrolment

Contact details:
FIAT@contacts.bham.ac.uk
Dr Laura Magill, 0121 415 9104, e.l.magill@bham.ac.uk


FOxTROT

A multi-centre RCT to determine: whether giving the first 6 weeks of chemotherapy pre-operatively compared with the standard 24-weeks post-operatively reduces the risk of disease recurrence at 2 years; and whether adding panitumumab to preoperative chemotherapy of KRAS wildtype tumours produces a measurable increase in anti-tumour efficacy as measured by tumour shrinkage.

  • Sample size: 1,050 patients
  • Start date: January 2007
  • End date: March 2018
  • Centres involved: 94 across the UK, Denmark and Sweden
  • Chief Investigator: Dion Morton

Contact details for enrolment:
FOxTROT-trial@contacts.bham.ac.uk
Ladan Adie (Trial Coordinator) 0121 414 9013, l.adie@bham.ac.uk
Andy Palmer (Trial Administrator) 0121 414 9013, a.palmer@bham.ac.uk
Georgia Kennedy (Data Manager) 0121 414 2279, g.kennedy@bham.ac.uk
Laura Magill (Colorectal Trials Team Leader) 0121 415 9105, e.l.magill@bham.ac.uk


HiP

Hartmann’s Versus Intersphincetric APE. A prospective, multicentre study aiming to determine the difference in surgical complication rates between HP and IAPE and to assess the effect of IAPE technique on intra operative tumour perforation rate.

  • Sample size: 200 patients
  • Start date: March 2016
  • End date: March 2019
  • Centres involved: Kingsmill, Chesterfield, James Paget, Musgrove Park, Peterborough, Valencia, Basingstoke, South Manchester, Chester
  • Chief Investigator: Dale Vimalachadran

Contact for enrolment:
Dale Vimalachandran, Countess of Chester NHS Foundation Trust, dale.vimalachandran@nhs.net


PREPARE-ABC

A multi-center three-arm parallel randomized controlled trial of standard care alone versus standard care plus supervised hospital based exercise and standard care plus supported home-based exercise pre and post hospital discharge in cancer patients awaiting curative colorectal surgery.

  • Sample size: 1,146 patients
  • Start date: 21 November 2016
  • End date: September 2019
  • Centres involved: Norfolk and Norwich University Hospital
  • Chief Investigator: James Hernon

Contact details for enrolment:
Prepare.ABC@uea.ac.uk
Mr James Hernon, 01603287688, james.hernon@nnuh.nhs.uk


FOFACT

This project will measure quality of life from the patient’s perspective following current treatment for anal cancer. It will also gather preliminary data on quality of life after using a new technique (called IMRT) for more precise and 3D targeting of radiotherapy at the cancer.

  • Sample size: 176 patients
  • Start date: December 2014
  • End date: September 2017
  • Centres involved: Manchester, M20 4BX, GSK Investigational Site Cambridge, CB2 0QQ
  • Chief Investigator: Nicola Fearnhead

Contact details for enrolment:
Adam Stearns, MA DPhil BMBCh MRCS, 01603 286 286
Nicola Fearnhead, nicola.fearnhead@addenbrookes.nhs.uk


CIPHER

CIPHER is a prospective observational study, over an initial 2 year recruitment period, that aims to establish the incidence of symptomatic and radiological parastomal hernia during a minimum of 2 years follow up and to evaluate the effects of key technical surgical steps during index stoma formation on the risk of subsequent parastomal hernia formation

  • Start date: October 2016
  • Sample size: 4000 patients
  • Chief Investigator: Neil Smart

This study is co-ordinated by the Clinical Trials Unit at Bristol University, in conjunction with three consultant colorectal surgeons from Royal Devon & Exeter Hospital and QE Hospital Birmingham.

Contact details for enrolment:
Colin Steer, colin.steer@bristol.ac.uk


LEGO

The LEGO trial (Lidocaine in Enhancing Gastrointestinal Outcomes) is a multi-centre placebo-controlled randomised trial assessing the impact of intravenous lidocaine on gastrointestinal recovery after colorectal surgery.

  • Sample size: 562 patients
  • Start date: 2017
  • Centres involved: Edinburgh; multi-centre UK
  • Chief Investigator: Hugh Paterson

Contact details for enrolment:
Hugh Paterson, Hugh.Paterson@ed.ac.uk


SAILOR

SAILOR (early Surgery Alone In LOw Rectal cancer) is a multi-centre randomised feasibility trial evaluating straight to surgery versus neoadjuvant chemoradiotherapy followed by surgery in patients with T3 low rectal cancer undergoing abdominoperineal excision of rectum. The feasibility study has been funded by BDRF and Cancer Research UK.

  • Recruitment start date: 29 June 2016
  • Recruitment end date: 01 July 2019
  • Chief Investigator: Dean Harris

Contact details for enrolment:
Anne-Claire Owen, Anne-Claire.Owen@wales.nhs.uk


CReST2

CReST2 aims to examine the role of endoluminal stenting of malignant large bowel obstruction in patients treated with palliative intent. The design is a phase III, multi-centre, double-blind randomised controlled trial with an internal 12 month feasibility study to assess recruitment and clinical equipoise. A total of 350 patients will be randomised. The primary outcomes of CReST2 trial are quality of life and efficacy of stenting.

  • Recruitment start date: January 2017
  • Recruitment end date: June 2021
  • Chief Investigator: James Hill

Contact details for enrolment:
Birmingham Clinical Trials Unit, crest2@trials.bham.ac.uk
Suzanne Lockyer, 0121 415 9103


SaFaRi

The purpose of the SaFaRI study is to look at two different surgical treatments for patients suffering from faecal incontinence: surgery to implant the FENIX Magnetic Sphincter Augmentation, a string of magnetic beads implanted around the anal sphincter, versus Sacral Nerve Stimulation (SNS), which involves implanting an electrode and battery to stimulate the nerves that control bowel continence.

  • Recruitment start date: 1 January 2015
  • Recruitment end date: 31 December 2018
  • Chief Investigator: David Jayne

Contact details for enrolment:
Julie Croft, safari@leeds.ac.uk

2016 Annual Meeting presentation

Completed trials


TREC

A randomised Phase II feasibility study to compare radical TME surgery versus short course preoperative radiotherapy with delayed local excision for treatment of early rectal cancer.

  • Sample size: 46 patients
  • Start date: 2012
  • End date: December 2014
  • Centres involved: 31 across England and Wales

Contact details:
Dr Laura Magill, 0121 415 9104 e.l.magill@bham.ac.uk


LIR!C

The objective of this study is to compare infliximab treatment with laparoscopic ileocolic resection in patients with recurrent Crohn’s disease of the distal ileum with respect to quality of life and costs.

  • Sample size: 130 patients
  • Start date: December 2007
  • End date: December 2010
  • Centres involved: 18 Hospitals in The Netherlands

ACCURE-UK

ACCURE-UK is a 6 centre feasibility randomised controlled trial examining the role of Appendicectomy to impact upon the Clinical Course of UlceRativE colitis. It will assess the acceptability of the appendicectomy operation and inform the design of a phase III multi-centre randomised trial comparing appendicectomy plus standard medical therapy versus standard medical therapy alone.

  • Sample size: 53 patients
  • Start date: November 2014
  • End date: June 2015

Contact details:
Rebecca Howard ACCURE@trials.bham.ac.uk

Recently reported trials


CReST

Aims to determine if endoluminal stenting for obstructing colonic cancers can result in reduced perioperative morbidity as assessed by length of hospital stay, and reduced 30-day mortality.

  • Sample size: 246 patients (aim 400)
  • Start date: June 2009
  • End date: December 2014

Results presented at ASCO 2016

Findings:
Self expanding metal stents as a bridge to surgery had a clinical success rate of 80%, did not affect mortality and length of stay, did reduce rate of stoma formation compared to emergency surgery (46% vs 69%). Cancer specific survival was not worse. Self expanding metal stents are a reasonable alternative to emergency surgery.


OnCoRe

The aim of this prospective case-control study was to evaluate the oncological safety of a wait-and-see policy for patients diagnosed with rectal cancer with a clinical complete response to chemoradiotherapy in an ‘off-trial’ multi-centred setting in the North West of England.

  • Sample size: 129 patients
  • Start date: January 2011
  • End date: April 2013

Published in Lancet Oncology, February 2016

Findings:
A substantial proportion of patients with rectal cancer managed by watch and wait avoided major surgery and averted permanent colostomy without loss of oncological safety at 3 years. These findings should inform decision making at the outset of chemoradiotherapy. CCR rate 12%. Of these approximately two-thirds of patients managed by watch and wait avoided radical surgery without an apparent loss in oncological safety.


HubBLe

This study compared recurrence after haemorrhoidal artery ligation versus rubber band ligation in patients with grade II–III haemorrhoids.

  • Sample size: 372
  • Start date: September 2012
  • End date: May 2014
  • Centres involved: 17 UK trusts

Results reported in the Lancet, July 2016

Findings:
Recurrence after hameorrhoidal artery ligation was lower than a single episode of rubber band but haemorrhoidal artery ligation was more painful than rubber band ligation. The difference in recurrence was due to the need for repeat bandings in the rubber band ligation group.


eTHoS

A pragmatic multicentre randomised controlled trial comparing stapled haemorrhoidopexy to traditional excisional surgery for haemorrhoidal disease. The eTHoS trial was designed to establish the clinical effectiveness and cost-effectiveness of stapled haemorrhoidopexy compared with traditional excisional surgery for severe (grade II–IV) haemorrhoids

  • Sample size: 777 patients
  • Start date: January 2011
  • End date: August 2014

Reported in The Lancet, November 2016

Findings:
Similar adverse events rate. Quality of life at 2 years was better in patients undergoing excisional haemorrhoidectomy.


AlaCaRT

To determine whether laparoscopic resection is noninferior to open rectal cancer resection for adequacy of cancer clearance.

  • Sample size: 475 patients
  • Start date: March 2010
  • End date: November 2014
  • Centres involved: 24 sites across Australia and New Zealand

Reported in JAMA, October 2015

Findings:
Among patients with T1-T3 rectal tumors, noninferiority of laparoscopic surgery compared with open surgery for successful resection was not established. Although the overall quality of surgery was high, these findings do not provide sufficient evidence for the routine use of laparoscopic surgery. Longer follow-up of recurrence and survival is currently being acquired.


ASOCOG

Aims to determine whether laparoscopic resection is noninferior to open resection, as determined by gross pathologic and histologic evaluation of the resected proctectomy specimen.

  • Sample size: 486
  • Start date: October 2008
  • End date: September 2013
  • 35 hospitals across the US and Canada

Reported in JAMA, October 2015

Findings:
Among patients with stage II or III rectal cancer, the use of laparoscopic resection compared with open resection failed to meet the criterion for noninferiority for pathologic outcomes. Pending clinical oncologic outcomes, the findings do not support the use of laparoscopic resection in these patients.


IVICA

Aims to compare the efficacy of intravenous and oral iron in the preoperative management of anaemia in colorectal cancer.

  • Sample size: 116 patients

Accepted for publication in the BJS

Findings:
Intravenous iron did not minimise blood transfusion requirement across the study but was more effective than oral iron at treating preoperative anaemia and iron deficiency in patients undergoing colorectal cancer surgery.