Abstract
BackgroundDuring the last two decades the use of laparoscopic resection and a multimodal approach known as an enhanced recovery programme, have been major changes in colorectal perioperative care. Clinical outcome improves using laparoscopic surgery to resect colorectal cancer but until recently no multicentre trial evidence had been reported regarding whether the benefits of laparoscopy still exist when open surgery is optimized within an enhanced recovery programme. The EnROL trial (Enhanced Recovery Open versus Laparoscopic) examines the hypothesis that laparoscopic surgery within an enhanced recovery programme will provide superior postoperative outcomes when compared to conventional open resection of colorectal cancer within the same programme.Methods/designEnROL is a phase III, multicentre, randomised trial of laparoscopic versus open resection of colon and rectal cancer with blinding of patients and outcome observers to the treatment allocation for the first 7 days post-operatively, or until discharge if earlier. 202 patients will be recruited at approximately 12 UK hospitals and randomised using minimization at a central computer system in a 1:1 ratio. Recruiting surgeons will previously have performed >100 laparoscopic colorectal resections and >50 open total mesorectal excisions to minimize conversion. Eligible patients are those suitable for elective resection using either technique. Excluded patients include: those with acute intestinal obstruction and patients in whom conversion from laparoscopic to open procedure is likely. The primary outcome is physical fatigue as measured by the physical fatigue domain of the multidimensional fatigue inventory 20 (MFI-20) with secondary outcomes including postoperative hospital stay; complications; reoperation and readmission; quality of life indicators; cosmetic assessments; standardized performance indicators; health economic analysis; the other four domains of the MFI-20. Pathological assessment of surgical quality will also be undertaken and compliance with the enhanced recovery programme will be recorded for all patients.DiscussionShould this trial demonstrate that laparoscopic surgery confers a significant clinical and/or health economic benefit this will further support the transition to this type of surgery, with implications for the training of surgeons and resource allocation.Trial registrationISRCTN48516968.
Highlights
During the last two decades the use of laparoscopic resection and a multimodal approach known as an enhanced recovery programme, have been major changes in colorectal perioperative care
Should this trial demonstrate that laparoscopic surgery confers a significant clinical and/or health economic benefit this will further support the transition to this type of surgery, with implications for the training of surgeons and resource allocation
Unclear whether optimal results following elective colorectal resection are achieved by laparoscopy or by using open surgery which has been optimized within an Enhanced Recovery Programme
Summary
The EnROL trial has been set up to examine the hypothesis that laparoscopic surgery improves outcome when compared to open surgery for colorectal cancer resection, even when both methods are optimized within an ERP. The EnROL trial only involves very experienced laparoscopic surgeons; it will include patients with rectal carcinoma; it will not include patients with benign diagnoses; and there will be no attempt to randomise between ER care and non ER care, as happened in the LAFA trial The involvement in this trial of surgeons experienced in laparoscopy is important as it minimises the % conversion rate to open surgery, providing a more homogeneous laparoscopic group of patients (given the intention to treat analysis) and increasing the potential to demonstrate differences in outcome. In addition the procedure can take longer to perform than equivalent open operations, at least in the early stages of a surgeon’s laparoscopic experience For all these reasons and the potential for laparoscopic surgery to improve clinical outcomes when compared to open surgery, it is important that the EnROL trial examines this question within a multicentre setting.
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