Endometrial Polypectomy Performed With Bipolar Electrode Versapoint vs Microscissors or Graspers

Endometrial Polyps Clinical Trial

Official title:

Comparative Study of Endometrial Polypectomy Performed With Bipolar Electrode Versapoint vs Microscissors or Graspers

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02590666
• Other study ID #: PolypectomyCA
• Status: Not yet recruiting
• Phase: N/A
• First received: October 25, 2015
• Last updated: March 8, 2016
• Start date: June 2016
• Est. completion date: September 2017

Study information

• Verified date: March 2016
• Source: University of Cagliari
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: September 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• The patient must be informed about the study, and sign the informed consent

Exclusion Criteria:

• Positive Pap smear test

• Pregnancy

• Uterine malignancy

• Abnormal uterine bleeding

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endometrial Polyps

Intervention

Procedure:
• Bipolar Polypectomy
Polyps resection with bipolar electrode
• Mechanical Polypectomy
Polyps resection with microscissors or graspers

Device:
• Bipolar electrode
Bipolar electrode used to performs polypectomy
• Microscissors or graspers
Mechanical instruments used to performs polypectomy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Cagliari

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Assess the recurrence of polyps after 3 months of resection (another hysteroscopy).		3 months after resection of the polyp, repeat hysteroscopy to assess recurrence	Yes
Primary	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	Yes