We talked to Professor Dion Morton, chairing the Clinical Trials Update at Barcelona 2014, who highlights the importance of clinical trials in colorectal surgery…
“Historically, medicine was practised on a trial and error basis, by which I mean practitioners would treat patients and would base treatments on what worked and what didn’t work,” began professor Morton. “So the importance of clinical trials is based around the evolution of evidence-based medicine, and the highest qualities of evidence are randomised clinical trials. This is why, for example in the UK, the Department of health has placed randomised clinical trials as the central pillar of high quality medicine.”
He added that surgical trials answer more questions as to whether a device or procedure works or is more effective, due to the complex nature of surgical interventions these surgical trials also train centres in the intervention and in delivering a high quality care pathway.
“In general, a lot of surgical trials are based around increasing the safety and effectiveness of surgery and not exclusively about the disease specific outcomes,” he said. “For example, the outcomes from cancer are remarkably improved to what they were 10-15 years ago. As a consequence, the injury caused by surgery is a more substantial part of the patients overall recovery. Therefore, if we can reduce the injury, we will improve the patient’s outcomes from their different conditions.”
He cited the example of the CReST trial, which is comparing endoluminal stenting to traditional surgery for treating large bowel obstruction. According to Professor Morton, workshops and meetings have resulted in improvements in the delivery of endoluminal stenting. These improvements are beyond the primary endpoints of the trial, and demonstrate that surgical clinical trials do have the added benefit of improving the delivery of care for patients.
“Of course, clinical trials are not without their disadvantages and historically there have been instances that by the time the answer to the question of the trial has been answered, clinical practice had already changed,” explained Professor Morton. “However, more recently these issues are no longer of such concern with the introduction of increased participation of centres, especially across Europe, that has facilitated the rapid increase in recruitment. An example of this would be the current ROCSS trial that is been run through the ESCP. It has participation from four different countries and has recruited patients far ahead of target. This is the benefit of establishing larger clinical network through organisations such as the ESCP.”
Clinical Trials Update
At the Clinical Trials Update symposium in Barcelona, there will be updates from five colorectal surgical trials and Professor Morton highlighted the key questions these trials are seeking to answer:
- The first trial is the ‘Transanal total mesorectal excision vs laparoscopic total mesorectal excision - Randomized study comparing 30-day postoperative morbidity’, and is examining which procedure is more beneficial for the patient in terms of recovery time.
“Transanal total mesorectal excision can take a patients many months to recover, whereas a less invasive laparoscopic procedure take considerably less – this trial could have important implications as to how we limit injury to our patients and aid their recovery,” said Professor Morton.
- The ‘Randomised controlled trial of reinforcement of closure of stoma site using a biological mesh’ study is trying to reduce the formation of a full hernia at the stoma site that can occur in up to 30% of patients.
“The importance of this trial is whether we can prevent these hernias developing, and thereby reduce the morbidity in patients.”
- The ‘MARVEL molecular pathologic and MRI investigation of the predictive and prognostic importance of extramural venous invasion in rectal cancer’ trial, is a good example of a pan-European study involving a network of European centres, looking at the use of MR imaging before surgery to identify venous invasion a valuable marker for a bad prognosis tumour.
“Treatment of rectal cancer has been revolutionised over the past 20 years with advancements in radiotherapy. It is still important however that we can identify at the start of the process the high-risk and low-risk tumours.”
- The ‘Effect of anti-tumour necrosis factor agents on surgical stress response in patients with Crohn's disease undergoing abdominal surgery’ study, will provide some much needed answers as to whether for those patents who do not respond to anti-tumour necrosis factor treatment, does it influence their outcomes from surgery?
“Our treatments of inflammatory bowel disease such as Crohn’s disease have greatly improved using these targeted agents such as anti-tumour necrosis factor, these treatments are reducing the need for surgery and improving the quality of life for patients. This trial is going to provide much needed data regarding new medical treatment and existing surgical treatments – some of the major breakthrough questions in medical science today.”
- The ‘Hartmans versus intersphincteric abdominoperineal excision for rectal cancer HIP’ trial is another study trying to reduce the injury to the patient following surgery and aiding the patient in their recovery.
“For low rectal cancers it is traditional to remove the back passage and create a wound that is very sore for the patient during recovery. The wounds can also be difficult to heal particularly if the patient has received radiotherapy. So if we can avoid that bottom wound by preserving the very lower part of the rectum and closing it off, then we can improve the outcome and recovery for the patient.”
In addition to the clinical trial presentations, Professor Morton said that several key questions will be asked regarding the methodology of the trials that will raise important questions of standardisation.
“There is some debate surrounding standardisation – if you don’t standardise the control arm in a trial then the results are more open to criticism. If however you over standardise the control arm you are reducing the generalisability of the results. Therefore, we need to reach some consensus on pragmatic trail design with a minimum of standardisation and maximise the generalisability.”
Furthermore, he added that there may also be some delegates who may express an interest with regards how can European centres become involved in such trials and what is the ESCP doing to facilitate participation.
He revealed that the ESCP is helping to fund translation of the study protocols into different languages thereby encouraging pan-European collaboration of cooperation among colorectal surgical centres across the continent. If attendees wish to become involved in any trials across Europe, he advised them to visit the ESCP website for more information.
“Every surgeon should be involved in improving the care of their patients and this is best done by participation in clinical trials,” he concluded. “Come along to the Clinical Trials Update symposium to learn about new pan-European trials and participate to become a leader in your specialty.”