Trials and research
We present a summary of currently recruiting trials in coloproctology (STAR-TREC, ROLARR, LAVA, FIAT, CapaCiTY, FOxTROT, HiP, PREPARE-ABC, FOFACT, CIPHER, SAILOR, CReST2, SaFaRI) as well as recently completed (TREC, LIR!C, ACCURE-UK) and reported (OnCoRe, HubBLe, eTHoS, AlaCaRT, ASOCOG, IVICA) trials.
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
ROLARR
RObotic Versus LAparoscopic Resection for Rectal Cancer (ROLARR) is an MRC/EME/NIHR funded international randomised controlled trial comparing robotic with laparoscopic rectal cancer resection. It recruited 471 patients and is due to complete with 3 year follow-up in October 2017. The primary outcome was conversion to open surgery. Secondary outcomes included safety, oncological outcomes, quality of life, bladder and sexual function, and healthcare economics.
- Sample size: 471 patients
- Start date: January 2011
- End date: October 2017
- Centres involved: 29 international sites across 10 countries
- Chief Investigator: Professor David Jayne
Contact details for enrolment:
ROLARR@leeds.ac.uk
Julie Croft, 0113 343 8394
LAVA
Liver resection surgery versus thermal ablation for colorectal liver metastases (LAVA) is a randomised controlled study to compare the effectiveness of liver resection surgery and thermal ablation for the treatment of colorectal liver metastases. Participants are randomly allocated to one of two treatment groups.
- Surgical resection: Surgical liver resection will be performed in accordance with each site’s usual practice. Patients may be offered open or laparoscopic liver resection depending on site and stage of disease.
- Thermal ablation: Either radiofrequency ablation (RFA) or microwave ablation (MWA) will be carried out according to the local availability of equipment and expertise
Disease free survival at 2 years is calculated from participant assessments at 3, 6, 12, 18 and 24 months post-randomisation.
- Sample size: 252 patients
- Start date: October 2016
- End date: September 2020
- Chief Investigator: Professor Brian Davidson
Contact details for enrolment:
LAVA@leeds.ac.uk
Ms Julie Croft, 0113 343 8394
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
CapaCiTY 1
A randomised trial to determine whether a complex nurse-led intervention (pelvic floor retraining using biofeedback: HTBF) is more clinically effective than standardised nurse-led habit training (HT) in unselected patients with Chronic Constipation and to determine whether clinical outcomes of such nurse-led interventions are improved by stratification to complex or standardised therapy based on prior knowledge of anorectal and colonic pathophysiology using standardised radiophysiological investigations (INVEST)
- Sample size: 394 patients
- Start date: March 2015
- End date: April 2018
- Centres involved: 10 UK centres
- Chief Investigator: Christine Norton and Anton Emmanuel
Contact details for enrolment:
n.stevens@qmul.ac.uk
CapaCiTY 2
A randomised trial to determine the impact upon patient disease specific quality of life of trans anal irrigation (TAI) initiated with a low-volume (LV) versus high-volume (HV) system in patients with Chronic Constipation
- Sample size: 315 patients
- Start date: November 2015
- End date: June 2018
- Centres involved: 6 UK centres
- Chief Investigator: Yan Yiannako
Contact details for enrolment:
s.taheri@qmul.ac.uk
Mrs Shiva Taheri, 020 7882 6031
CapaCiTY 3
A randomised trial to determine the efficacy of laparoscopic ventral mesh rectopexy (VMR) compared to controls at short-term follow up (24 weeks post-surgery)
- Sample size: 114 patients
- Start date: March 2016
- End date: June 2018
- Centres involved: 19 UK centres
- Chief Investigator: Steve Brown and John Lacy-Colson
Contact details for enrolment:
s.taheri@qmul.ac.uk
Mrs Shiva Taheri, 020 7882 6031
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
ALLEGRO : IV lidocaine in colorectal surgery trial
The IV lidocaine in colorectal surgery trial 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.