Endometrial Polypectomy Performed With Bipolar Electrode Versapoint vs Microscissors or Graspers

Not Applicable

• Conditions: Endometrial Polyps
• Interventions: Procedure: Mechanical Polypectomy; Procedure: Bipolar Polypectomy; Device: Bipolar electrode; Device: Microscissors or graspers

• Registration Number: NCT02590666
• Lead Sponsor: University of Cagliari

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-10-25
• Study First Submitted QC: 2015-10-27
• Study First Posted: 2015-10-29
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-08
• Last Update Posted: 2016-03-09
• Study Start: 2016-06
• Primary Completion: 2017-06
• Study Completion: 2017-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bipolar electrode	Bipolar electrode	Polyps resection with bipolar electrode
Microscissors or graspers	Mechanical Polypectomy	Polyps resection with microscissors or graspers
Bipolar electrode	Bipolar Polypectomy	Polyps resection with bipolar electrode
Microscissors or graspers	Microscissors or graspers	Polyps resection with microscissors or graspers

Primary Outcome Measures

Name	Time	Method
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