Intra- and postoperative clinical evaluation for hysteroscopic surgery with the TRUCLEAR system (Prospective randomized single-blind parallel group comparison study)
- Conditions
- Submucous myoma Endometrial polyp
- Registration Number
- JPRN-UMIN000019649
- Lead Sponsor
- Teikyo University
- Brief Summary
The polyps were completely removed, and no adverse events were observed in all 67 patients. The average operating time (8.3 min vs. 12.0 min, P = 0.014), insertion time (5.0 min vs. 9.0 min, P < 0.001), and number of insertions (1.0 vs. 8.2, P < 0.001) were significantly lower in the morcellation arm than in the electrosurgical resection arm.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 70
Not provided
1. Patients with submucous myoma larger than 2 cm in diameter 2. Patients with FIGO type 2 submucous myoma 3. Patients who have received hysteroscopic myomectomy or polypectomy before 4. Patients with uterus bipartitus 5. Patients with intrauterine adhesion 6. Patients with endometrial carcinoma or suspected endometrial carcinoma 7. Patients who are judged ineligible by the principal investigator or sub-investigators
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Operating time
- Secondary Outcome Measures
Name Time Method 1. Removal success 2. Fluid deficit 3. Convenience with technique 4. Insertion time during surgery 5. Visibility of Operation Field 6. Recurrence of chief complaint 7. Adverse event 8. Pain, expectation, and satisfaction evaluated by patient