Clinical experience with the OPERAStarSL using saline irrigation fluid for OPERA

Abstract

Objective: To present clinical results using a new hysteroscopic resectoscope, the OPERAStar SL with PEARL technology, which cuts and coagulates uterine tissue in a physiologic, conductive fluid environment in order to perform OPERA, Out-Patient Endometrial Resection/Ablation. Use of physiologic normal saline in resectoscopy has not previously been feasible. Use of normal saline prevents complications such as hyponatremia and cerebral edema due to excessive absorption of traditional nonphysiologic fluids. Methods: Patients suffering from abnormal uterine bleeding with or without submucosal fibroids who were scheduled for surgical intervention underwent OPERA for treatment of their condition. The OPERAStar SL resectoscope with PEARL technology was used with a 0.9% saline distention medium. The PEARL technology insulates the active electrode so that a noninsulating fluid, such as 0.9% saline or lactated ringers, can be used while maintaining the ability to cut and coagulate tissue using a standard monopolar electrosurgery unit. Operative data recorded include uterine size, presence and size of fibroids, pretreatment with endometrial thinning agents, operative time, cutting/coagulating power levels, estimated blood loss, and calculated fluid deficit. Additional data include the ability to cut and coagulate tissue as compared to standard resectoscopes used in the physician’s clinical practice. Results: A total of 22 patients underwent operative hysteroscopy with the described resectoscope. Average age of all patients was 45 years (range 30–70), and average weight was 158 pounds (range 106–258). Eighteen (82%) patients underwent OPERA while the remaining 4 (18%) patients underwent fibroid resections. The average uterine size was 7 weeks (range 4–14). Average operative time was 26 minutes, and all procedures were successfully completed without complications. Fluid deficit averaged 480 mL (range 0.0–1.54 L) as reported by the Flo-Stat Fluid Management System. A Likert scale was used to rate the device’s ability to cut and coagulate tissue with results indicating the OPERAStar SL accomplishes the same clinical results to standard resectoscopic devices used in the physician’s clinical practice. Conclusion: Complete uterine tissue resection and ablation can now be accomplished in a saline environment. The unique PEARL technology with the OPERAStar SL resectoscope is effective in cutting and coagulating uterine tissue. Operating in a saline environment eliminates the most prevalent potential complication of operative hysteroscopy when using nonphysiologic irrigation solutions, dilutional hyponatremia, and secondary cerebral edema.