EAES recommendations on methodology of innovation management in endoscopic surgery

Abstract

Innovations into clinical practice should be introduced with the highest possible grade of safety for the patient (nil nocere: do no harm). The recommendations can contribute to the attainment of this objective without preventing future promising diagnostic and therapeutic innovations in the field of surgery and allied techniques.

A novel single-port technique for transanal rectosigmoid resection and colorectal anastomosis on an ex vivo experimental model

“…Thus, the indications of the technique would be limited to smaller and middle-size tumors. guidelines for methodology of surgical innovation also suggest that for preclinical evaluation of new innovation, the simulation is to be performed in animal organs or organ blocks with similarity to human organs and integrated into human anatomical surroundings [20]. For training of laparoscopic colorectal surgery in our institute, we have used the young bovine lower gastrointestinal organ block for more than 10 years [11].…”

Laparoscopic extraperitoneal rectal cancer surgery: the clinical practice guidelines of the European Association for Endoscopic Surgery (EAES)

“…No available data with regard to SILS and NOTES on rectal cancer exist. (100% [Strong consensus]) According to the EAES recommendations on methodology of innovation management in endoscopic surgery, feasibility and preclinical safety must be established before innovations such as NOTES and SILS become subject of clinical research [145].…”

Reply to: doi:10.1007/s00464-013-2958-8: Re: Prospective randomized clinical trial comparing laparoscopic cholecystectomy and hybrid natural orifice transluminal endoscopic surgery (NOTES) (NCT00835250)

“…When we designed our noninferiority pilot study, the EAES recommendations had been cited in order to perform safer surgical studies in the field of surgical innovative techniques [3]. The first problem with the design of a pilot study is to know the correct sample size [4], i.e., how many patients you must enroll to yield some valid information.…”