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TWO DİFFERENT ELECTROSURGERY DEVICES AS MONOPOLAR HOOC AND PLASMAKINETIC BIPOLAR SPATULA EFFECTIVENESS DURING COLPOTOMY

Primary Purpose

Uterine Fibroid, Ovary Cyst, Endometrial Hyperplasia

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
MONOPOLAR HOOC
PLASMAKINETIC BIPOLAR SPATULA
Sponsored by
Alkü Alanya Education and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Uterine Fibroid

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • APPROPIATE FOR TOTAL LAPAROSCOPIC HYSTERECTOMY

Exclusion Criteria:

  • MALIGNANCY

Sites / Locations

  • Alku Alanya Education and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

MONOPOLAR HOOC

PLASMAKINETIK BIPOLAR SPATULA

Arm Description

COLPOTOMY WITH USAGE MONOPOLAR HOOC

COLPOTOMY WITH USAGE MONOPOLAR HOOC

Outcomes

Primary Outcome Measures

VAGINAL DEHISSENS
AFTER LAPAROSCOPIC HYSTERECTOMY TWO DIFFERENT ELECTROSURGERY DEVICES RESULTS

Secondary Outcome Measures

Full Information

First Posted
December 4, 2019
Last Updated
June 21, 2020
Sponsor
Alkü Alanya Education and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04191603
Brief Title
TWO DİFFERENT ELECTROSURGERY DEVICES AS MONOPOLAR HOOC AND PLASMAKINETIC BIPOLAR SPATULA EFFECTIVENESS DURING COLPOTOMY
Official Title
THE EFFECTIVENESS OF MONOPOLAR HOOC VERSUS PLASMAKINETIC BİPOLAR SPATULA USAGE DURING COLPOTOMY PROCESS IN PATIENTS UNDERGOİNG TOTAL LAPAROSCOPIC HYSTERECTOMY
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 30, 2020 (Anticipated)
Primary Completion Date
December 1, 2021 (Anticipated)
Study Completion Date
December 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alkü Alanya Education and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
WE DECIDED TO COMPARE TWO DIFFERENT ELECTROSURGERY DEVİCES TO PROVIDE COLPOTOMY. ONE OF THEM İS MONOPOLAR HOOC, THE OTHER DEVİCE İS PLASMAKİNETİC BİPOLAR SPATULA. WE WİLL RANDOMİSE PATİENTS FİRSTLY THEN COMPARE THE RESULTS SUCH, VAGİNAL DEHİSSENS, COLPOTOMY DURATİON, AMOUNT OF MIST DURING COLPOTOMY, AMOUNT OF BLEEDİNG.
Detailed Description
COLPOTOMY IS A PROCESS DURING TOTAL LAPAROSCOPIC HYSTERECTOMY. WE CAN USE EİTHER ELECTROSURGERY INSTRUMENTS TO PROVIDE COLPOTOMY. IN OUR TRIAL WE WİLL RANDOMİSE PATİENTS FİRSTLY THEN COMPARE THE RESULTS SUCH, VAGİNAL DEHİSSENS, COLPOTOMY DURATİON, AMOUNT OF MIST DURING COLPOTOMY, AMOUNT OF BLEEDİNG.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Fibroid, Ovary Cyst, Endometrial Hyperplasia, Cervical Dysplasia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
MONOPOLAR HOOC VERSUS PLASMAKINETIC BIPOLAR SPATULA USAGE DURING COLPOTOMY
Masking
Investigator
Masking Description
MONOPOLAR HOOC VERSUS PLASMAKINETIC BIPOLAR SPATULA USAGE DURING COLPOTOMY
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MONOPOLAR HOOC
Arm Type
Active Comparator
Arm Description
COLPOTOMY WITH USAGE MONOPOLAR HOOC
Arm Title
PLASMAKINETIK BIPOLAR SPATULA
Arm Type
Active Comparator
Arm Description
COLPOTOMY WITH USAGE MONOPOLAR HOOC
Intervention Type
Device
Intervention Name(s)
MONOPOLAR HOOC
Intervention Description
COLPOTOMY WITH MONOPOLAR HOOC
Intervention Type
Device
Intervention Name(s)
PLASMAKINETIC BIPOLAR SPATULA
Intervention Description
COLPOTOMY WITH BIPOLAR SPATULA
Primary Outcome Measure Information:
Title
VAGINAL DEHISSENS
Description
AFTER LAPAROSCOPIC HYSTERECTOMY TWO DIFFERENT ELECTROSURGERY DEVICES RESULTS
Time Frame
0 DAY-365 DAYS

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: APPROPIATE FOR TOTAL LAPAROSCOPIC HYSTERECTOMY Exclusion Criteria: MALIGNANCY
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
MERAL TUĞBA ÇİMŞİR
Phone
05064742272
Email
dr.tugbaacar@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MERAL TUĞBA ÇİMŞİR
Organizational Affiliation
ALKU EDUCATİON AND RESEARCH HOSPITAL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alku Alanya Education and Research Hospital
City
Antalya
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MERAL TUĞBA ÇİMŞİR
Phone
05064742272
Email
DR.TUGBAACAR@GMAİL.COM

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
5 YEARS
IPD Sharing Time Frame
5 YEARS

Learn more about this trial

TWO DİFFERENT ELECTROSURGERY DEVICES AS MONOPOLAR HOOC AND PLASMAKINETIC BIPOLAR SPATULA EFFECTIVENESS DURING COLPOTOMY

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