In a series of interviews, we will be previewing this year’s ACPGBI annual meeting in Dublin, 1-3 July. We talked to Professor Dion Morton, Professor of Surgery and Director of the University of Birmingham’s Experimental Cancer Medicine Centre (ECMC), who previewed the Research Sessions at this year’s meeting.
“We live in an everchanging world and nowhere in medical practice is changing faster than surgery and it is imperative that surgeons are involved in the evaluation of new surgical techniques and new pathways of care for their patients,” Professor Dion Morton explained. “Clinical trials provide the best possible platform for evaluating and delivering these changes.”
During the Research Sessions in Dublin on Tuesday 2 July (Main Hall), chaired by Austin Acheson and Simon Bach, delegates will witness several presentations, which Professor Dion Morton summarised as some of the most important randomised controlled trials current underway in colorectal surgery anywhere in the world. Below is a summary of the clinical trials to be presented.
FOXTROT (Fluoropyrimidine, Oxaliplatin and Targeted Receptor pre-Operative Therapy for high risk colon cancer) Trial – presented by Professor Dion Morton: FOXTROT is an international randomised controlled trial evaluating neoadjuvant chemotherapy (NAC) for colon cancer.
“The outcomes from this study were presented for the first time in Chicago at the Annual Meeting of the American Society of Clinical Oncology. It is the first trial in the world to examine the benefits of giving patients chemotherapy before surgery for patients with colon cancer. The outcomes demonstrate that three cycles of chemotherapy, which is a very short course, improves surgical outcomes, shrinks the tumour and improves the completion of resection of the cancer and strongly suggests that patients will be cancer free more frequently, compared to a strategy of surgery first. We believe the outcomes from this trial could be the first step in changing the whole process in treating patients with colon cancer, representing a major changing in clinical practice across the world.”
PREVENTT (Preoperative Intravenous Iron to Treat Anaemia in Major Surgery) Trial – presented by Dr Ravi Baikady: PREVENTT is comparing the use of intravenous ferric carboxymaltose with placebo before major open abdominal surgery in patients with anaemia.
“Prevention is better than cure – this trial seeks to treat patients with iron to prevent anaemia at the time of major abdominal surgery. Patients are often anaemic because of their illness or may become anaemic as a result of the surgical procedure. Preventing the onset of anaemia should improve their recovery and their ability to respond to their surgery. PREVENTT is the first major trial in the UK to address this question.
CLOSE-IT (CLOSurE of Ileostomy Timing) Study – presented by Mr Peter Vaughan-Shaw: CLOSE-IT is investigating the time to ileostomy closure following anterior resection for rectal cancer and exploring the reasons for delay.
“This is a more technical surgical study and is examining whether patients can undergo a secondary procedure to close a stoma after an initial bowel operation. Often, the stoma is left for months after the first procedure, which prolongs the patient’s recovery and can delay secondary treatment (such as chemotherapy). This study is looking at whether we can accelerate this process and safely and effectively close the stoma earlier.”
HIP (Hartmann’s Procedure Versus Intersphincetric Abdominoperineal Excision) Study – presented by Mr Dale Vimalachandran: HIP is designed 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.
“This study is comparing how surgeons manage the distal bowel after the creation of a stoma and whether we can reduce the operation size (and thus adverse outcomes) operation by avoiding more major surgery. If the procedure can be performed safely and effectively, it will make the surgery less traumatic for the patient and improve their recovery.”
CReaTE (Colorectal Research and Trial Engagement) session moderated by Jared Torkington: CReaTE is an initiative established by the ACPGBI to train to all members of the colorectal team interested in research how to recruit, set up and bring in resources for colorectal trials, as well as highlighting the pitfalls and challenges investigators and the research team face.
“CReaTE is a very important initiative from the ACPGBI designed to disseminate expertise on opening and recruiting patients for randomised controlled trials. It is the first initiative of its kind in the UK and is a fantastic enterprise that helps to train the colorectal multi-disciplinary team to increase patient recruitment into trials. Ultimately, through the CReaTE initiative, it is hoped we can maximise patient opportunities by delivering these trials across the NHS and beyond.”
Cipher (UK Cohort study to Investigate the prevention of Parastomal Hernia) Study – presented by Mr Neil Smart: Cipher is designed to establish the incidence of symptomatic and radiological parastomal hernia, as well as evaluate the effects of key technical surgical steps during index stoma formation on the risk of subsequent parastomal hernia formation.
“Cipher is a major National Institute for Health Research funded study across the UK and is looking at an ongoing challenge in colorectal practice namely, avoiding problems around the formation of stomas, the most common of which are parastomal hernias. The study will look at their frequency, complications and the surgical strategies deployed in their prevention and treatment.”
Sunrise (Single Use Negative pRessure dressing for Reduction In Surgical site infection following Emergency laparotomy) and Rossini2 (Reduction of Surgical Site Infection Using Several Novel Interventions 2) – presented by Mr Tom Pinkney: Sunrise aims to determine whether there is difference in wound infection rates in patients who receive portable single-use negative pressure dressings compared to standard dressings - Rossini2 is evaluating the use of three in-theatre interventions to reduce SSI rates in patients undergoing surgery with an abdominal incision.
“Sunrise and Rossini2 are both studies with major trainee and surgeon engagement which are exploring many different ways of preventing surgical site infections. They are investigating some ten different combinations of measures that can be taken to prevent wound infection to see how different interventions can best work together and what their collective benefits and advantages for patients might be. In my opinion, Rossini2 is the most ambitious surgical trial launched anywhere in the world – it is the first trial randomising up to 6,000 patients into nine different combined intervention groups. The trial’s design has created a platform for colorectal departments throughout the United Kingdom to work together for the benefit of all our patients.” Success for these trials will need support from the trainee collaboratives in the UK. Sunrrise is also being launched in Australia where the newly established trainee collaboratives will be leading the trial.
Allegro (A Placebo-Controlled Randomised Trial Of Intravenous Lidocaine In Accelerating Gastrointestinal Recovery After Colorectal Surgery) – presented by Mr Hugh Paterson: Allegro is investigating if intravenous Lidocaine improves recovery of gut function after colorectal surgery for NHS patients.
“Surgery is not simply just completing a procedure safely and effectively, but also ensuring the patients recover as quickly as possible. Allegro is investigating how we might use Lidocaine to more rapidly ensure bowel function returns after bowel surgery. At the moment, approximately two out of every five patients who undergo major bowel surgery will have a delay in their bowel recovery – this means they cannot eat, drink and therefore return to normal activities – and their stay in hospital is prolonged and this has an impact their quality of life, the lives of their families and on their long-term recovery. Primarily, this trial is seeking to improve the recovery times for patients, but if successful, it will also have a secondary benefit of freeing up valuable NHS resources for other patients.”
Pitstop (Pilonidal Sinus Treatment: Studying The Options) – presented by Professor Steve Brown: Pitstop is looking at the treatment outcomes for pilonidal sinus disease including excision (minimal, major, curettage) and closure (none, midline, lateral, flap, glue, phenol injection).
“There are a number of conditions in colorectal surgery that surgery does not treat well. Pilonidal disease is a common problem affecting thousands of patients throughout the UK every year, however, the best surgical treatment for this condition are not known. Consequently, there are many different procedures used, but surgeons remain uncertain as to which is the most effective and which treatment is optimal for which patient. Pitstop is the first major trial to look at all the different methods available and examine how we might better employ and improve these techniques.”
“If I was a patient, I would find it inconceivable that any specialist in colorectal surgery was not actively involved in the investigation and delivery of improved care for their patients – and that absolutely means involvement in clinical trials. The trials presented at this year’s meeting will involve tens of thousands of patients and more than one hundred different hospitals, and as a patient I would expect my surgical team to be actively involved in these trials,” Professor Morton concluded. “The best way to for surgeons to get involved is to attend the session in Dublin. It will provide a unique overview of the current status of the most important current surgical colorectal research in the UK. It provides a unique opportunity to benefit your patients.”