A multicentre randomised controlled trial to evaluate the efficacy, morbidity and functional outcome of endoscopic transanal proctectomy versus laparoscopic proctectomy for low-lying rectal cancer (ETAP-GRECCAR 11 TRIAL): rationale and design

Abstract

BackgroundTotal mesorectal excision is the standard surgical treatment for mid- and low-rectal cancer. Laparoscopy represents a clear leap forward in the management of rectal cancer patients, offering significant improvements in post-operative measures such as pain, first bowel movement, and hospital length of stay. However, there are still some limits to its applications, especially in difficult cases. Such cases may entail either conversion to an open procedure or positive resection margins. Transanal endoscopic proctectomy (ETAP) was recently described and could address the difficulties of approaching the lower third of the rectum. Early series and case-control studies have shown favourable short-term results, such as a low conversion rate, reduced hospital length of stay and oncological outcomes comparable to laparoscopic surgery. The aim of the proposed study is to compare the rate of positive resection margins (R1 resection) with ETAP versus laparoscopic proctectomy (LAP), with patients randomly assigned to each arm.Methods/designThe proposed study is a multicentre randomised trial using two parallel groups to compare ETAP and LAP. Patients with T3 lower-third rectal adenocarcinomas for whom conservative surgery with manual coloanal anastomosis is planned will be recruited. Randomisation will be performed immediately prior to surgery after ensuring that the patient meets the inclusion criteria and completing the baseline functional and quality of life tests. The study is designed as a non-inferiority trial with a main criterion of R0/R1 resection. Secondary endpoints will include the conversion rate, the minimal invasiveness of the abdominal approach, postoperative morbidity, the length of hospital stay, mesorectal macroscopic assessment, functional urologic and sexual results, faecal continence, global quality of life, stoma-free survival, and disease-free survival at 3 years. The inclusion period will be 3 years, and every patient will be followed for 3 years. The number of patients needed is 226.DiscussionThere is a strong need for optimal evaluation of the ETAP because of substancial changes in the operative technique. Assessment of oncological safety and septic risk, as well as digestive and urological functional results, is particularily mandatory. Moreover, benefits of the ETAP technique could be demonstrated in post-operative outcome.Trial registrationClinicalTrial.gov: NCT02584985. Date and version identifier: Version n°2 – 2015 July 6.

Locoregional recurrences after transanal total mesorectal excision of rectal cancer during implementation

“…As TaTME is substantially different from abdominal techniques in terms of open access to the tumour, purse-string closure and a subsequent endoluminal approach to the mesorectal dissection, it is especially important to assess long-term outcomes properly. RCTs such as COLOR III 13 and GRECCAR 11 14 are investigating long-term outcomes of TaTME, and are currently including patients. Recently, concern has been raised by the first report 15 of national Norwegian data which showed an increase in the incidence of local recurrence with an extensive or multifocal pattern following TaTME, leading to a national halt to TaTME 16 .…”

Is trans‐anal total mesorectal excision really safe and better than laparoscopic total mesorectal excision with a perineal approach first in patients with low rectal cancer? A learning curve with case‐matched study in 68 patients

“…Since the introduction of the TATME technique many authors have suggested, on the basis of retrospective and comparative studies, that this technique must be now considered as the new gold standard, not only for the management of low but also mid or even high rectal cancer [8][9][10][11][12][13][14][15][16]. However, no randomized trial has been reported so far (the COLOR III and the GRECCAR 11 studies are still in progress [17,18]), and some intra-operative complications (including urethral or vaginal injury) have been reported by others, due, at least in part, to the need for a better knowledge of anatomical landmarks, which are different from those used during LTME.…”

Transanal TME: new standard or fad?

“…According to reports in the study by Veltcamp and Koedam, quality of life including anal function after taTME was comparable with that after laparoscopic surgery 31,32) . There are two ongoing large randomized controlled trials comparing taTME and LapTME, namely the COLOR III and GRECCAR 11 studies 33,34) . Results of these studies, including long-term outcomes, are awaited for accurately evaluating the efficacy of taTME.…”