STUDY OBJECTIVE: To compare the use of vaginoscopic vs traditional hysteroscopy in evaluation of the endometrial cavity. DESIGN: Prospective, randomized, single blinded, clinical trial (Canadian Task Force classification I). SETTING: University-affiliated hospital in Hong Kong. PATIENTS: Ninety women scheduled to undergo diagnostic hysteroscopy without anesthesia. INTERVENTIONS: Women were randomized to undergo either vaginoscopic hysteroscopy using the H Pipelle for endometrial sampling (n = 45) or traditional hysteroscopy using the standard Pipelle (n = 45). Both procedures were performed without anesthesia and using a rigid 4.5-mm hysteroscope. Main outcome measures analyzed were pain scores using a 10-point visual analog scale during hysteroscopy, endometrial biopsy, and overall pain score of the procedure, success and duration of each procedure, and adequacy of the endometrial sample obtained. MEASUREMENTS AND MAIN RESULTS: The success rates for vaginoscopic and traditional hysteroscopy were 93.33% and 100%, respectively (p = .24). There was no significant difference in the mean pain score and procedure duration between the 2 hysteroscopic approaches. Endometrial sampling using the H Pipelle was significantly quicker by about 45 seconds compared with use of the standard Pipelle (mean [SD] duration, 1.46 [0.72] min vs 2.20 [1.19] min, respectively; p = .001), with similar biopsy adequacy. Most women (95.5% in both approaches) found the procedure acceptable. There were no intraoperative or postoperative complications. CONCLUSIONS:Vaginoscopic and traditional hysteroscopic approaches are similar in safety, feasibility, and associated pain. Although the time needed to obtain an endometrial sample using the H Pipelle was quicker than with the standard Pipelle, there is no difference in overall procedure duration. Copyright Â
RCT Entities:
STUDY OBJECTIVE: To compare the use of vaginoscopic vs traditional hysteroscopy in evaluation of the endometrial cavity. DESIGN: Prospective, randomized, single blinded, clinical trial (Canadian Task Force classification I). SETTING: University-affiliated hospital in Hong Kong. PATIENTS: Ninety women scheduled to undergo diagnostic hysteroscopy without anesthesia. INTERVENTIONS:Women were randomized to undergo either vaginoscopic hysteroscopy using the H Pipelle for endometrial sampling (n = 45) or traditional hysteroscopy using the standard Pipelle (n = 45). Both procedures were performed without anesthesia and using a rigid 4.5-mm hysteroscope. Main outcome measures analyzed were pain scores using a 10-point visual analog scale during hysteroscopy, endometrial biopsy, and overall pain score of the procedure, success and duration of each procedure, and adequacy of the endometrial sample obtained. MEASUREMENTS AND MAIN RESULTS: The success rates for vaginoscopic and traditional hysteroscopy were 93.33% and 100%, respectively (p = .24). There was no significant difference in the mean pain score and procedure duration between the 2 hysteroscopic approaches. Endometrial sampling using the H Pipelle was significantly quicker by about 45 seconds compared with use of the standard Pipelle (mean [SD] duration, 1.46 [0.72] min vs 2.20 [1.19] min, respectively; p = .001), with similar biopsy adequacy. Most women (95.5% in both approaches) found the procedure acceptable. There were no intraoperative or postoperative complications. CONCLUSIONS: Vaginoscopic and traditional hysteroscopic approaches are similar in safety, feasibility, and associated pain. Although the time needed to obtain an endometrial sample using the H Pipelle was quicker than with the standard Pipelle, there is no difference in overall procedure duration. Copyright Â