STUDY OBJECTIVE: To assess and compare efficacy, pain, and the learning curve associated with diagnostic therapeutic hysteroscopy using mechanical tissue removal versus bipolar electrical resection in the management of endometrial polyps in an ambulatory care setting. DESIGN: A randomized controlled clinical trial (Canadian Task Force classification I). SETTING: Hospital de Igulada, Barcelona, Spain. PATIENTS: A total of 133 patients diagnosed with endometrial polyp(s) were included and randomly assigned to 1 of the 2 hysteroscopic methods. Criteria assessed were total hysteroscopy time, full polypectomy procedure time, pain experienced by patients, and learning curve of staff in training. MEASUREMENTS AND MAIN RESULTS: The average time to perform total hysteroscopy using the mechanical tissue removal system (TRUCLEAR 5.0 System; Smith & Nephew Inc., Andover, MD) was 6 minutes 49 seconds versus 11 minutes 37 seconds required for the bipolar electrosurgery system (GYNECARE VERSAPOINT; Ethicon Inc, Somerville, NJ) (p < .01). Results for complete polypectomy time favored the TRUCLEAR System at 3 minutes 7 seconds over the VERSAPOINT System at 8 minutes 25 seconds (p < .01). If a successful procedure is predicated on access to cavity, visualization, and complete resection and excision of endometrial polyp, the mechanical TRUCLEAR Tissue Removal System shows a higher success rate than the VERSAPOINT Bipolar Electrosurgery System at 92% and 77%, respectively. Analysis of pain using the visual analog scale revealed no significant differences between the 2 techniques (p > .05). A study of the residents' learning curve showed a higher level of autonomy with hysteroscopy using the TRUCLEAR Tissue Removal System with which residents showed a higher level of confidence compared with hysteroscopy with the VERSAPOINT Bipolar Electrosurgery System. CONCLUSION: In hysteroscopic polypectomy, the mechanical tissue removal system was significantly faster, achieved a greater success rate for complete polypectomy, and required a shorter learning curve from staff being trained in the management of endometrial polyps when compared with bipolar electrical resection.
RCT Entities:
STUDY OBJECTIVE: To assess and compare efficacy, pain, and the learning curve associated with diagnostic therapeutic hysteroscopy using mechanical tissue removal versus bipolar electrical resection in the management of endometrial polyps in an ambulatory care setting. DESIGN: A randomized controlled clinical trial (Canadian Task Force classification I). SETTING: Hospital de Igulada, Barcelona, Spain. PATIENTS: A total of 133 patients diagnosed with endometrial polyp(s) were included and randomly assigned to 1 of the 2 hysteroscopic methods. Criteria assessed were total hysteroscopy time, full polypectomy procedure time, pain experienced by patients, and learning curve of staff in training. MEASUREMENTS AND MAIN RESULTS: The average time to perform total hysteroscopy using the mechanical tissue removal system (TRUCLEAR 5.0 System; Smith & Nephew Inc., Andover, MD) was 6 minutes 49 seconds versus 11 minutes 37 seconds required for the bipolar electrosurgery system (GYNECARE VERSAPOINT; Ethicon Inc, Somerville, NJ) (p < .01). Results for complete polypectomy time favored the TRUCLEAR System at 3 minutes 7 seconds over the VERSAPOINT System at 8 minutes 25 seconds (p < .01). If a successful procedure is predicated on access to cavity, visualization, and complete resection and excision of endometrial polyp, the mechanical TRUCLEAR Tissue Removal System shows a higher success rate than the VERSAPOINT Bipolar Electrosurgery System at 92% and 77%, respectively. Analysis of pain using the visual analog scale revealed no significant differences between the 2 techniques (p > .05). A study of the residents' learning curve showed a higher level of autonomy with hysteroscopy using the TRUCLEAR Tissue Removal System with which residents showed a higher level of confidence compared with hysteroscopy with the VERSAPOINT Bipolar Electrosurgery System. CONCLUSION: In hysteroscopic polypectomy, the mechanical tissue removal system was significantly faster, achieved a greater success rate for complete polypectomy, and required a shorter learning curve from staff being trained in the management of endometrial polyps when compared with bipolar electrical resection.
Authors: M Franchini; O Ceci; P Casadio; J Carugno; G Giarrè; G Gubbini; U Catena; M Chiara de Angelis; A Di Spiezio Sardo Journal: Facts Views Vis Obgyn Date: 2021-06-10