François Stoll1, Lise Lecointre2, Nicolas Meyer2, Emilie Faller2, Aline Host2, Michel Hummel2, Thomas Boisrame2, Cherif Akladios2, Olivier Garbin2. 1. Department of Obstetrics and Gynecology (Drs. Stoll, Lecointre, Faller, Host, Hummel, Boisrame, Akladios, and Garbin); Medical Information Department (Dr. Meyer), Hôpitaux Universitaires de Strasbourg, Strasbourg, France. Electronic address: francois.stoll@gmail.com. 2. Department of Obstetrics and Gynecology (Drs. Stoll, Lecointre, Faller, Host, Hummel, Boisrame, Akladios, and Garbin); Medical Information Department (Dr. Meyer), Hôpitaux Universitaires de Strasbourg, Strasbourg, France.
Abstract
STUDY OBJECTIVE: To compare a reusable hysteroscopic morcellator and standard resectoscopes in the hysteroscopic management of uterine polyps. DESIGN: Single-center randomized prospective single-blind trial (resectoscope-morcellator study). SETTING:Centre Médico-chirurgical Obstétrique teaching hospital, Strasbourg University Hospitals, France. PATIENTS: All patients presenting with a single endometrial polyp of size 1 cm or larger. INTERVENTIONS: After consent, the patients were randomized into 2 groups: hysteroscopic morcellation (HM) group or standard resection (SR) group. Office-based review hysteroscopy was performed 6 weeks to 8 weeks after surgery. Primary end point: time of morcellation or resection. SECONDARY OUTCOMES: total operating time (minutes), volume of fluid used (mL), fluid deficit (mL), number of morcellator or resectoscope insertions, operator comfort (visual analog scale: 0 to 10) and quality of vision (0 to 5), perioperative complications, completeness of resection, need to convert to another technique, pain assessment (visual analog scale), and length of hospitalization. At review hysteroscopy, we noted whether the resection or morcellation had been effective and if synechiae were present or absent. Statistical analyses followed Bayesian methods. MEASUREMENTS AND MAIN RESULTS:Ninety patients were randomized: 45 in the HM group and 45 in the SR group. The average size of polyps at hysteroscopy was 13.3 mm. Morcellation time was lower than resection time (6.1 minutes vs 9 minutes; p [HM < SR] = .996). This also applied to total operating time (12.7 minutes vs 15.6 minutes; p [HM < SR] = .985), number of device insertions (1.50 vs 6; p [HM < SR] > .999), volume of fluid used (766.9 mL vs 1118.9 mL; p [HM < SR] = .994), and fluid deficit (60.2 mL vs 169.8 mL; p [HM < SR] = .989). Operator comfort was better in the HM group (8.4 vs 7.4; p [HM > SR] = .999) as was visualization (4 vs 3.7; p [HM > SR] = .911, highly probable). Operative complications were higher in the SR group (5 vs 0; p [HM < SR] = .989]. One patient in the SR group died after surgery owing to an anesthetic complication (anaphylactic shock complicated by pulmonary embolism). No differences were noted between the groups for pain assessment, length of hospitalization, and outcome on review hysteroscopy. CONCLUSION: The reusable morcellator is quicker, uses less fluid with less deficit and fewer introductory maneuvers, and offers better comfort and visualization than the resectoscope while being as effective for the hysteroscopic treatment of uterine polyps.
RCT Entities:
STUDY OBJECTIVE: To compare a reusable hysteroscopic morcellator and standard resectoscopes in the hysteroscopic management of uterine polyps. DESIGN: Single-center randomized prospective single-blind trial (resectoscope-morcellator study). SETTING: Centre Médico-chirurgical Obstétrique teaching hospital, Strasbourg University Hospitals, France. PATIENTS: All patients presenting with a single endometrial polyp of size 1 cm or larger. INTERVENTIONS: After consent, the patients were randomized into 2 groups: hysteroscopic morcellation (HM) group or standard resection (SR) group. Office-based review hysteroscopy was performed 6 weeks to 8 weeks after surgery. Primary end point: time of morcellation or resection. SECONDARY OUTCOMES: total operating time (minutes), volume of fluid used (mL), fluid deficit (mL), number of morcellator or resectoscope insertions, operator comfort (visual analog scale: 0 to 10) and quality of vision (0 to 5), perioperative complications, completeness of resection, need to convert to another technique, pain assessment (visual analog scale), and length of hospitalization. At review hysteroscopy, we noted whether the resection or morcellation had been effective and if synechiae were present or absent. Statistical analyses followed Bayesian methods. MEASUREMENTS AND MAIN RESULTS: Ninety patients were randomized: 45 in the HM group and 45 in the SR group. The average size of polyps at hysteroscopy was 13.3 mm. Morcellation time was lower than resection time (6.1 minutes vs 9 minutes; p [HM < SR] = .996). This also applied to total operating time (12.7 minutes vs 15.6 minutes; p [HM < SR] = .985), number of device insertions (1.50 vs 6; p [HM < SR] > .999), volume of fluid used (766.9 mL vs 1118.9 mL; p [HM < SR] = .994), and fluid deficit (60.2 mL vs 169.8 mL; p [HM < SR] = .989). Operator comfort was better in the HM group (8.4 vs 7.4; p [HM > SR] = .999) as was visualization (4 vs 3.7; p [HM > SR] = .911, highly probable). Operative complications were higher in the SR group (5 vs 0; p [HM < SR] = .989]. One patient in the SR group died after surgery owing to an anesthetic complication (anaphylactic shock complicated by pulmonary embolism). No differences were noted between the groups for pain assessment, length of hospitalization, and outcome on review hysteroscopy. CONCLUSION: The reusable morcellator is quicker, uses less fluid with less deficit and fewer introductory maneuvers, and offers better comfort and visualization than the resectoscope while being as effective for the hysteroscopic treatment of uterine polyps.