In a series of interviews, we will be previewing this year’s 10th ESCP Annual Meeting in Dublin, Ireland, 23-25 September 2015. We talked to Professor Dion Morton, who highlights the clinical trials under discussion at the research sessions in Dublin…
International Trials Results Forum
The ESCP has as its central philosophy to improve the care of patients undergoing colorectal surgery across the whole of Europe,” explained professor Morton. “Research into colorectal surgery is designed to identify the best improvements in care and to ensure they are safely and effectively implemented. Clinical trials are the most effective and efficient way of demonstrating a benefit in care between two different types of treatment. They also provide researchers with the additional benefit of building a network of research teams across Europe, thereby providing a mechanism for disseminating best care and new therapies."
At the International Trials Results Forum, there will be updates from five colorectal surgical trials and Professor Morton highlighted the key questions these trials are seeking to answer:
The ROLARR (Robotic vs. Laparoscopic Resection for Rectal Cancer) Trial
This is the first trial comparing laparoscopic surgery and robotic assisted laparoscopic surgery treating colorectal cancer. The researchers are assessing whether robotic-assisted laparoscopic surgery is as good, or even better, at removing rectal cancers as standard laparoscopic surgery. It is also investigating whether using a robotic system can reduce the number of post operative complications and potentially improve disease-free survival. This will be the first time these results will have been presented in Europe.
This trial, which has been led by a research team from Leeds, UK, includes centres from the USA, the Far East and Europe. It is fair to say that the results from this trial are being eagerly awaited across the world to determine whether robotic assisted laparoscopic surgery should be more widely implemented.'
COLOFOL (Assessment of Frequency of Surveillance After Curative Resection in Patients With Stage II and III Colorectal Cancer) Trial
It is not known whether there is a beneficial effect on the overall mortality after intense compared to sporadic follow-up. This study evaluates the use of CT scanning, CEA and MRI follow-up programmes after radical surgery for colorectal cancer: The outcome from this trial will be presented for the first time in Europe.
Follow up after surgery is costly and time consuming for both patients and the healthcare systems. However, it has become more important as we have started to improve the cure rates from radical liver resection for metastatic disease and we need to ascertain the benefit of diagnosing any recurrence earlier.'
LOLA (Laparoscopic Peritoneal Lavage or Resection for Generalised Peritonitis for Perforated Diverticulitis (Ladies))
This is a Dutch trial looking at acute diverticular disease to determine whether laparoscopic lavage leads to better clinical outcomes compared to sigmoidectomy in patients with perforated diverticulitis with purulent peritonitis in terms of mortality and major morbidity.
This trial is examining radical versus conservative treatment for diverticular disease in patients who are critically ill to see whether radical treatment is doing more harm than good. With a mortality rate of one in six patients, the results to be presented in Dublin could have profound implications for patients throughout the whole of Europe.'
GRECCAR 5 (Drainage After Rectal Excision for Rectal Cancer)
The aim of the study is to assess the impact of pelvic drainage vs. non pelvic drainage on risk of pelvic sepsis after rectal excision for cancer with infraperitoneal anastomosis. The principal objective is to compare the rate of pelvic sepsis until 30 days between the two groups of patients who had a rectal excision with and without pelvic drainage.
Complication rates from this type of surgery can be as high as 35% and usually result from an infection. This will be the first presentation of data from the trial and it will be interesting to see whether pelvic drainage does in fact reduce infections and other complications.'
New Trials Forum
As well as the results from clinical trials, there will also be a New Trials Forum that will give researchers the opportunity to outline their ideas for new pan-European clinical trials, which will then be assessed by a panel of experts as well as an audience of 200-300 colorectal specialists. The trials under review are:
- COLOPEC (Adjuvant HIPEC in High Risk Colon Cancer), Dutch trial
- Less Sto.Re.S (Multicenter randomized controlled trial of trans-anal reinforcement of low rectal anastomosis versus protective ileostomy in the prevention of anastomotic leak after rectal), Italian trial
- HART (Hughes Abdominal Repair Trial), United Kingdom study
The idea behind the New Trials Forum is to identify new ways of collaboration between European centres and I hope that we can achieve lots of audience participation and excitement about the next, potentially ground-breaking European trial/s over the next few years,' he explained.
ESCP right hemicolectomy audit - presentation of results
In March 2015, the ESCP completed its first multi-centre, snapshot cohort study (or audit) of right hemicolectomy and ileo-caecal resection surgery over a two month period. The audit explored the differences in patients, techniques and outcomes across the entire cohort to identify areas of practice variability resulting in apparent differences in outcome/s deserving further study. The headline results from more than 3,200 operations from over 200 hospitals and across 38 countries, will be presented following the International Trials Results Forum in Dublin.
In particular, the audit will report on the outcomes of traditional hand-sewn versus stapler devices, as well as complication rates, survival and re-operation rates, and 30-day outcomes. This is the ESCP’s first such pan-European cohort study and we are very excited to be able to present this unique data for the first time in Dublin,” said Morton. “Whilst not providing true evidence of efficacy or the impact of a particular variable, they will be hypothesis-generating, identifying areas requiring further study in future randomised controlled trials.'
Professor Morton said that ESCP has taken several steps to try and increase collaboration between countries and centres in Europe. For example, the society has adopted a structure whereby each country has a National Representative and members are encouraged to contact them directly to express their interest/s in becoming involved in any studies or trials. The advantage of this structure means that members can talk directly to their representative in their native language so nothing is ‘lost in translation’, as well as facilitating the dissemination of information to all members.
In addition, the ESCP website has an open area for the numerous ESCP research programmes including the details (protocols, contacts details etc) on all the active trials that members can express an interest or participate in.
Technological advancements have really transformed how we carry out these international studies, and the ESCP right hemi-colectomy study was enabled by secure online submission,” concluded professor Morton. “I would encourage members who wish to express an interest, or become involved in, the ESCP’s research programmes to contact their National Representative or any member of the ESCP Research Committee.'
