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BackgroundTo evaluate the feasibility and clinical outcomes of vaginoplasties using a neovaginal polylactic acid prosthesis made with 3-dimensional (3D) printing technology as an intraneovaginal mould.MethodsThis was an interventionist, prospective, and multicentre clinical pilot investigation of a sanitary product (PACIENA prosthesis (R)) aiming to recruit and operate on 8 patients over 6months with a follow-up period of 6months. Only six patients with Rokitansky syndrome and one patient with Morris syndrome (7 patients in total) were operated on in two university hospitals: "La Fe", Valencia (H1) and "Arrixaca", Murcia (H2). Interventions: Extensive surgical dissection of a defined space between the urethra and bladder in the front and of the rectum in the back as well as insertion of the PACIENA prosthesis (R) covered with Interceed (R) were performed. After 12days, the prosthesis was changed to the silicone-covered version for daily application.ResultsIn the 6 patients with Rokitansky syndrome (86%), the primary endpoint (satisfactory vaginal outcome in terms of appearance, function, and sensation without relevant additional morbidity) was achieved, although only 2 patients (28%) were sexually active at the end of 6months of follow-up. The patient with Morris syndrome withdrew from the study after 1month. Patients without bacterial colonization showed positive Schiller tests at 1month, and subsequent biopsies showed adequate keratinization and epidermization. Epithelization and iodopositivity were delayed in the patients who developed inflammatory granulomas.ConclusionsGood anatomical and functional results can be achieved with the PACIENA prosthesis (R) for vaginoplasties without skin grafts. However, adequate patient selection and education, good surgical techniques and haemostasis, postoperative support, and prevention of bacterial colonization are important.Trial registrationThis clinical study was approved by the Ethical Clinical Investigation Committee of San Juan University Hospital on September 27, 2016, to be conducted in the participating centres; it was authorized by the Spanish Agency of Medicines and Health Products (AEMPS) on April 24, 2017 (exp. no. 585/16/EC), to be carried out in that hospitals.

OBJECTIVE: Tobii glasses can record corneal infrared light reflection to track pupil position and to map gaze focusing in the video recording. Eye tracking has been proposed for use in training and coaching as a visually guided control interface. The aim of our study was to test the potential use of these glasses in various situations: explanations of anatomical structures on tablet-type electronic devices, explanations of anatomical models and dissected cadavers, and during the prosection thereof. An additional aim of the study was to test the use of the glasses during laparoscopies performed on Thiel-embalmed cadavers (that allows pneumoinsufflation and exact reproduction of the laparoscopic surgical technique). The device was also tried out in actual surgery (both laparoscopy and open surgery). DESIGN: We performed a pilot study using the Tobii glasses. SETTING: Dissection room at our School of Medicine and in the operating room at our Hospital. PARTICIPANTS: To evaluate usefulness, a survey was designed for use among students, instructors, and practicing physicians. RESULTS: The results were satisfactory, with the usefulness of this tool supported by more than 80% positive responses to most questions. There was no inconvenience for surgeons and that patient safety was ensured in the real laparoscopy. CONCLUSION: To our knowledge, this is the first publication to demonstrate the usefulness of eye tracking in practical instruction of human anatomy, as well as in teaching clinical anatomy and surgical techniques in the dissection and operating rooms. (C) 2017 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.