Lessons Learned About Informed Consent in 9 Attempted NOTES Cases

Objective: the advent of the NOTES approach_ either transvaginal or transgastric_ has raised issues regarding the informed consent process_ required from an ethical and legal point of view_ as well as doubts from the patients regarding the indication and justification of the operation.

Methods and procedures: starting August 2007, we attempted to perform 9 NOTES procedures in the frame of a cooperation agreement between the Surgical Departments from the University of California, San Diego and the University of Buenos Aires. 8 cases were NOTES transvaginal cholecystectomies and 1 to a NOTES transgastric appendectomy. Information was provided by means of 2 interviews with the patients and their relatives, supported by printed information with diagrams and pictures and evacuation of doubts and further enquiries. Final decision was documented in a form with open spaces where the following points was included: a) nature of the disease and of the proposed operation, b) potential benefits, c) risks and complications and d) alternative treatment. Patients´competency was assessed by means of MMS (Mini- Mental- State examination) and psychological evaluations were performed to all patients

Results: 7 operations were completed as intended (77%). One transvaginal cholecystectomy was converted to laparoscopy due to the presence of intense pelvic adhesions and the only transgastric appendectomy was also converted because of pus (with a negative preoperative ultrasound). Average consultation time for complete fulfillment and documentation of the informed consent process was 45 minutes +/- 14 minutes. All the patients were satisfied with the provided information, though 2 of them considered it as excessive. Average MMS result was 27 (range 24-30) and the anxiety level was low in 8 of the 9 patients.

Conclusions: a) the development of new techniques imposes a refinement in the information provided as well as its paper-based documentation, b) compliance with ethical and legal regulations must be accomplished by the due process and interchange and doubt solving, c) expertise of the surgical team and training in experimental models is a “must” for this type of surgery

Session: Poster

Program Number: P205