Transanal minimally invasive surgery (TAMIS) versus endoscopic submucosal dissection (ESD) for resection of non-pedunculated rectal lesions (TRIASSIC study): study protocol of a European multicenter randomised controlled trial.

BACKGROUND: In the recent years two innovative approaches have become available for minimally invasive en bloc resections of large non-pedunculated rectal lesions (polyps and early cancers). One is Transanal Minimally Invasive Surgery (TAMIS), the other is Endoscopic Submucosal Dissection (ESD). Both techniques are standard of care, but a direct randomised comparison is lacking. The choice between either of these procedures is dependent on local expertise or availability rather than evidence-based. The European Society for Endoscopy has recommended that a comparison between ESD and local surgical resection is needed to guide decision making for the optimal approach for the removal of large rectal lesions in Western countries. The aim of this study is to directly compare both procedures in a randomised setting with regard to effectiveness, safety and perceived patient burden. METHODS: Multicenter randomised trial in 15 hospitals in the Netherlands. Patients with non-pedunculated lesions > 2 cm, where the bulk of the lesion is below 15 cm from the anal verge, will be randomised between either a TAMIS or an ESD procedure. Lesions judged to be deeply invasive by an expert panel will be excluded. The primary endpoint is the cumulative local recurrence rate at follow-up rectoscopy at 12 months. Secondary endpoints are: 1) Radical (R0-) resection rate; 2) Perceived burden and quality of life; 3) Cost effectiveness at 12 months; 4) Surgical referral rate at 12 months; 5) Complication rate; 6) Local recurrence rate at 6 months. For this non-inferiority trial, the total sample size of 198 is based on an expected local recurrence rate of 3% in the ESD group, 6% in the TAMIS group and considering a difference of less than 6% to be non-inferior. DISCUSSION: This is the first European randomised controlled trial comparing the effectiveness and safety of TAMIS and ESD for the en bloc resection of large non-pedunculated rectal lesions. This is important as the detection rate of these adenomas is expected to further increase with the introduction of colorectal screening programs throughout Europe. This study will therefore support an optimal use of healthcare resources in the future. TRIAL REGISTRATION: Netherlands Trial Register, NL7083 , 06 July 2018.

Comparing quality, safety, and costs of colonoscopies performed by nurse vs physician trainees.

BACKGROUND & AIMS: We evaluated the quality and safety of colonoscopies performed by nurse and physician endoscopy trainees as well as the cost differences. METHODS: We performed a study of 7 nurse and 8 physician (gastroenterology fellows) endoscopy trainees at 2 medical centers in the Netherlands from September 2008 through April 2012. At the beginning of the study, the subjects had no experience in endoscopy; they were trained in gastrointestinal endoscopy according to the regulations of the Dutch Society of Gastroenterology, performing a minimum of 100 colonoscopies. Each trainee then performed 135 consecutive colonoscopies (866 total by nurse trainees and 1080 by physician trainees) under supervision of a gastroenterologist; the colonoscopies were evaluated for quality and safety. We performed statistical analyses of data, assessing multilevel and cost minimization. The mean age of the patients was 57 years, and about half were women in each group. RESULTS: The endoscopic quality and safety were comparable between nurse and physician trainees. Overall rates of cecal intubation were 95% for nurses and 93% for physicians (P = .38), including procedures that required assistance from a supervisor; mean withdrawal times were 10.4 and 9.8 minutes, respectively (P = .44). Each group detected 27% of adenomas and had a 0.5% rate of complication. In both groups, the rates of unassisted cecal intubation gradually increased with the number of colonoscopies performed, from 70% for nurses and 74% for physicians at the beginning to 89% and 86%, respectively, at the end of the assessment period. Using a strategy in which 1 gastroenterologist supervises 3 nurses, the personnel costs decreased from $64.65 to $54.58. CONCLUSIONS: In a supervised setting, nurse endoscopists perform colonoscopies according to quality and safety standards that are comparable with those of physician endoscopist and can substantially reduce costs.