Outpatient Hysteroscopic Polypectomy: Bipolar Energy System (Versapoint®) versus Mechanical Energy System (TRUCLEAR System®) - Preliminary Results

Abstract

Hypothesis: The new hysteroscopic system with mechanical energy is an effective outpatient technique for diagnosis and treatment that has certain advantages over conventional hysteroscopy in the management of endometrial polyps. Objectives: Our primary objective was to assess the total duration of hysteroscopy and polypectomy performed in an outpatient setting comparing the new mechanical energy hysteroscopy to the bipolar energy system. Our secondary objective was to compare the level of safety of both hysteroscopic techniques using the procedure success rate, the need for subsequent referral to surgery, existing complications, and comfort experienced by the patient during the procedure. Patients and Methods: This randomized controlled trial included the first 90 patients with an ultrasound diagnosis of endometrial polyp (>1 cm) who underwent an outpatient diagnostic and operative hysteroscopy at the Igualada Hospital (Barcelona) and agreed to be included in the study by signing an informed consent. Results: We obtained a 91% success rate with the TRUCLEAR System® compared to a 69% success rate with the Versapoint® system. Total operating time was 6.36 min in the TRUCLEAR System group versus 10.82 min in the Versapoint system group (p < 0.05), with a polypectomy time of 3.06 and 7.91 min, respectively (p < 0.05). There were no significant differences between the two techniques when analyzing pain using the visual analogue scale. No complications were recorded for either technique. Conclusion: The mechanical energy system presents a significant decrease in the total duration of polypectomy and hysteroscopy when performed both by experienced staff and by staff in training, resulting in higher success rates without complications with respect to conventional hysteroscopy with bipolar energy.

A systematic review and meta‐analysis of randomized controlled trials comparing hysteroscopic morcellation with resectoscopy for patients with endometrial lesions

“…A report by Pampalona et al 15 referred to the same trial as another paper also published in 2015. 9 The first paper to be published 9 was used in meta-analysis.…”

“…Seven underwent full‐text review, after which one study was excluded because it compared the efficacy of hysteroscopic morcellation for intrauterine lesions between an office setting and an ambulatory surgical center, and another was excluded because it compared the operative outcomes of hysteroscopic polypectomy done using a mechanical system that did not perform morcellation with that done using bipolar electrosurgical instrumentation. A report by Pampalona et al . referred to the same trial as another paper also published in 2015 .…”

“…This finding is similar to the results from Emanuel et al., who compared hysteroscopic morcellation with resectoscopy in a retrospective study. Pampalona et al . compared the operative time in two groups of surgeons (senior surgeons vs residents) and found that both seniors and residents experienced a significant reduction of the operative time with hysteroscopic morcellation as compared with resectoscopy.…”

“…Pampalona et al 15 compared the operative time in two groups of surgeons (senior surgeons vs residents) and found that both seniors and residents experienced a significant reduction of the operative time with hysteroscopic morcellation as compared with resectoscopy.…”

Complications of Hysteroscopic and Uterine Resectoscopic Surgery

“…In a recent randomized controlled trial, Truclear was found to significantly decrease the operative time for hysteroscopic polypectomy in the outpatient setting as compared with polypectomy using a bipolar needle and extraction tools, with higher rates of success at total removal of the lesion. 92 Currently, there are few available data regarding long-term outcomes and operative complications specific to these electromechanical intrauterine morcellation systems. A recently published evaluation of the FDA's MAUDE database suggests that hysteroscopic morcellation is complicated by adverse events in <0.1% of cases, although such studies are extremely…”