Endometrial Polypectomy Performed With Bipolar Electrode Versapoint vs Microscissors or Graspers
Comparative Study of Endometrial Polypectomy Performed With Bipolar Electrode Versapoint vs Microscissors or Graspers
1 other identifier
interventional
40
0 countries
N/A
Brief Summary
Hysteroscopy today is considered the gold standard for the diagnosis and treatment of endometrial polyps. Several hysteroscopic systems to resect endometrial polyps are currently available. Among Others bipolar systems and microscissors or graspers, both of theme make part of routine clinical practice and are universally accepted. The aim of the study is to compare the efficacy of bipolar resection energy polypectomy versus microscissors or graspers These procedures assume a lower cost and are associated with a lower surgical risk due to their realization without anesthesia . Hypothesis: Resection of polyps outpatient laser diode has a similar or superior to that of the bipolar electrode tolerability. The diode laser is a viable , quick , simple technique with a high percentage of resection and high degree of satisfaction of patients
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2016
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 25, 2015
CompletedFirst Posted
Study publicly available on registry
October 29, 2015
CompletedStudy Start
First participant enrolled
June 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2017
CompletedMarch 9, 2016
March 1, 2016
1 year
October 25, 2015
March 8, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
To assess the tolerability of polypectomy using a validated visual analogue pain scale
we measure pain after resection of endometrial polyps, with 5 minutes for the patient thinks
Other Outcomes (1)
Assess the recurrence of polyps after 3 months of resection (another hysteroscopy).
3 months after resection of the polyp, repeat hysteroscopy to assess recurrence
Study Arms (2)
Bipolar electrode
EXPERIMENTALPolyps resection with bipolar electrode
Microscissors or graspers
ACTIVE COMPARATORPolyps resection with microscissors or graspers
Interventions
Polyps resection with microscissors or graspers
Mechanical instruments used to performs polypectomy
Eligibility Criteria
You may qualify if:
- The patient must be informed about the study, and sign the informed consent
You may not qualify if:
- Positive Pap smear test
- Pregnancy
- Uterine malignancy
- Abnormal uterine bleeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
October 25, 2015
First Posted
October 29, 2015
Study Start
June 1, 2016
Primary Completion
June 1, 2017
Study Completion
September 1, 2017
Last Updated
March 9, 2016
Record last verified: 2016-03