Endometrial Polypectomy Performed With Bipolar Electrode Versapoint vs Microscissors or Graspers

• Sponsor: University of Cagliari (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02590666
• Collaborator: (none)
• Enrollment: 40
• Arms: 2
• Duration (Months): 15

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Endometrial Polyps	Procedure: Bipolar Polypectomy; Procedure: Mechanical Polypectomy; Device: Bipolar electrode; Device: Microscissors or graspers	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Comparative Study of Endometrial Polypectomy Performed With Bipolar Electrode Versapoint vs Microscissors or Graspers
• Study Start Date: Jun 1, 2016
• Anticipated Primary Completion Date: Jun 1, 2017
• Anticipated Study Completion Date: Sep 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bipolar electrode Polyps resection with bipolar electrode	Procedure: Bipolar Polypectomy; Polyps resection with bipolar electrode; Device: Bipolar electrode; Bipolar electrode used to performs polypectomy
Active Comparator: Microscissors or graspers Polyps resection with microscissors or graspers	Procedure: Mechanical Polypectomy; Polyps resection with microscissors or graspers; Device: Microscissors or graspers; Mechanical instruments used to performs polypectomy

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Cagliari

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Stefano Angioni, Associate Professor, University of Cagliari
• ClinicalTrials.gov Identifier: NCT02590666
• Other Study ID Numbers: PolypectomyCA
• First Posted: Oct 29, 2015
• Last Update Posted: Mar 9, 2016
• Last Verified: Mar 1, 2016

Study Results

No Results Posted as of Mar 9, 2016