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NCT04191603 Clinical Trial

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

Cervical Dysplasia Clinical Trial

Official title:
THE EFFECTIVENESS OF MONOPOLAR HOOC VERSUS PLASMAKINETIC BİPOLAR SPATULA USAGE DURING COLPOTOMY PROCESS IN PATIENTS UNDERGOİNG TOTAL LAPAROSCOPIC HYSTERECTOMY

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04191603
Other study ID # ALKU ERH
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 30, 2020
Est. completion date December 30, 2021

Study information
Verified date June 2020
Source Alkü Alanya Education and Research Hospital
Contact MERAL TUGBA ÇIMSIR
Phone 05064742272
Email dr.tugbaacar@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 100
Est. completion date December 30, 2021
Est. primary completion date December 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 30 Years to 70 Years
Eligibility Inclusion Criteria:

- APPROPIATE FOR TOTAL LAPAROSCOPIC HYSTERECTOMY

Exclusion Criteria:

- MALIGNANCY

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• MONOPOLAR HOOC
COLPOTOMY WITH MONOPOLAR HOOC
• PLASMAKINETIC BIPOLAR SPATULA
COLPOTOMY WITH BIPOLAR SPATULA

Locations
Country Name City State
Turkey Alku Alanya Education and Research Hospital Antalya

Sponsors (1)
Lead Sponsor Collaborator
Alkü Alanya Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary VAGINAL DEHISSENS AFTER LAPAROSCOPIC HYSTERECTOMY TWO DIFFERENT ELECTROSURGERY DEVICES RESULTS 0 DAY-365 DAYS
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