Endometrial Polyp Clinical Trial
Official title:
Hand Driven Versus Motor Driven Hysteroscopic Tissue Removal System for Polypectomy: Long-term Results
In this study, a comparison is made between two types of polyp resection methods (hand driven and motor driven morcellation). More specifically, the effects of the resection on symptoms such as abnormal uterine bleeding, and on the recurrence of polyps. The aim of the study is to find a superior method in terms of symptom relieve and polyp recurrence so this method can be used in gynaecological practice.
- Rationale: several techniques for hysteroscopic removal of intrauterine polyps exist today. Hysteroscopic morcellation is an effective, fast, and safe method for this. However, the differences between two different systems of hysteroscopic morcellation, motor-driven (Truclear incisor mini device) and hand-driven (Resectr 9fr) morcellation, are still unclear. The REMOvE9 study, in which women with a polyp were randomized between both techniques, is currently investigating the differences in short-term effectiveness between the two techniques. - Research question/goal: To investigate the long-term results of the effectiveness of a hysteroscopic morcellation of intrauterine polyps. The two systems are compared with each other. - Study design: This is a prospective cohort study. The patients previously participated in a randomized controlled trial (REMOvE9) and will now be contacted again for the completion of a one-time questionnaire. The study has an observational design. - Study population: Women with a history of endometrial polyp that was previously removed via hysteroscopic morcellation in the REMOvE9 study. - Primary and secondary endpoints: The primary endpoint is the risk of recurrence of abnormal uterine bleeding at post-surgery follow-up. Secondary endpoints include recurrence of other symptoms, time to recurrence, symptom relief, onset of new symptoms, onset of new polyp, satisfaction with regards to symptoms, satisfaction with regards to the treatment in general, need for additional treatments for blood loss and occurrence of pregnancy (in subfertility group). ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT03309709 -
Endometrial Polyps Regression With Progesterone Therapy
|
Phase 3 | |
| Completed |
NCT00247923 -
Endometrial Polyps: Pathophysiology and Clinical Consequences
|
N/A | |
| Not yet recruiting |
NCT06295510 -
Observational Study of the Association Between Food Intake and Endometrial Polyps
|
||
| Recruiting |
NCT03207126 -
Pilot Study: Can Ultrasound Guided Biopsy be Used as an Alternative to Hysteroscopy?
|
N/A | |
| Completed |
NCT04706000 -
Autophagy Markers in Endometrial Polyps
|
||
| Completed |
NCT06316206 -
The Use of Ethinylestradiol/Dienogest in Random Start Rapid Endometrial Preparation
|
Phase 4 | |
| Completed |
NCT06316180 -
The Use of Drospirenone/Estetrol in Random Start Rapid Endometrial Preparation
|
Phase 4 | |
| Completed |
NCT06324851 -
The Use of Drospirenone/Estetrol, Nomegestrol Acetate/Estradiol and Ethinylestradiol/Dienogest in Random Start Rapid Endometrial Preparation
|
Phase 4 | |
| Completed |
NCT06316219 -
The Use of Nomegestrol Acetate/Estradiol in Random Start Rapid Endometrial Preparation
|
Phase 4 | |
| Completed |
NCT03790215 -
Dydrogesterone in the Treatment of Endometrial Polyps
|
Phase 4 | |
| Recruiting |
NCT01637974 -
Efficiency of INTERCOAT (Oxiplex/AP Gel) in Preventing Intrauterine Adhesion Formation in Hysteroscopic Surgery
|
N/A | |
| Completed |
NCT05337046 -
Hysteroscopic Tissue Removal System Versus Bipolar Resectoscopy for Polypectomy: Long-term Results
|