BACKGROUND AND STUDY AIMS: Unsedated transnasal upper endoscopy (TNE) has been suggested as a more comfortable and safer method than unsedated transoral endoscopy (TOE). However, the numbers of comparative trials are limited. The current study aimed to assess the tolerability, safety, and efficacy of TNE in endoscopy naïve patients. PATIENTS AND METHODS: The current study was designed as a randomized, prospective, parallel arm trial including all eligible patients referred for upper endoscopy. Patients were randomized with a 1:1 ratio to undergo either unsedated TOE using a standard endoscope or unsedated TNE using an ultrathin endoscope. Postprocedure, all patients were asked to complete a questionnaire to assess pain, discomfort, distress and tolerability using a 10 cm visual analog scale (VAS). Patients' expectations and future preferences were also determined by multiple choice questions. Endoscope insertion rate, procedure duration, and side-effects were recorded for each patient. RESULTS:Each group included 200 patients. With the exception of nasal pain, mean VAS scores were significantly lower in TNE patients when compared to TOE patients (p = 0.0001). 85% and 54.5% of patients in TNE and TOE groups, respectively, found the procedure better than expected (p = 0001). A repeat procedure was significantly more acceptable for TNE than TOE (82.4% and 60.5%, respectively). Endoscope insertion failed in 3.5% of TNE patients. Mild epistaxis was observed in 4% of TNE patients. CONCLUSION:Unsedated TNE was tolerated better in endoscopy naive patients than unsedated TOE in a large parallel arm trial.
RCT Entities:
BACKGROUND AND STUDY AIMS: Unsedated transnasal upper endoscopy (TNE) has been suggested as a more comfortable and safer method than unsedated transoral endoscopy (TOE). However, the numbers of comparative trials are limited. The current study aimed to assess the tolerability, safety, and efficacy of TNE in endoscopy naïve patients. PATIENTS AND METHODS: The current study was designed as a randomized, prospective, parallel arm trial including all eligible patients referred for upper endoscopy. Patients were randomized with a 1:1 ratio to undergo either unsedated TOE using a standard endoscope or unsedated TNE using an ultrathin endoscope. Postprocedure, all patients were asked to complete a questionnaire to assess pain, discomfort, distress and tolerability using a 10 cm visual analog scale (VAS). Patients' expectations and future preferences were also determined by multiple choice questions. Endoscope insertion rate, procedure duration, and side-effects were recorded for each patient. RESULTS: Each group included 200 patients. With the exception of nasal pain, mean VAS scores were significantly lower in TNE patients when compared to TOE patients (p = 0.0001). 85% and 54.5% of patients in TNE and TOE groups, respectively, found the procedure better than expected (p = 0001). A repeat procedure was significantly more acceptable for TNE than TOE (82.4% and 60.5%, respectively). Endoscope insertion failed in 3.5% of TNE patients. Mild epistaxis was observed in 4% of TNE patients. CONCLUSION: Unsedated TNE was tolerated better in endoscopy naive patients than unsedated TOE in a large parallel arm trial.