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

Not Applicable

• Conditions: Cervical Dysplasia; Uterine Fibroid; Ovary Cyst; Endometrial Hyperplasia
• Interventions: Device: PLASMAKINETIC BIPOLAR SPATULA; Device: MONOPOLAR HOOC

• Registration Number: NCT04191603
• Lead Sponsor: Alkü Alanya Education and Research Hospital

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.

Study Timeline

• Study First Submitted: 2019-12-04
• Study First Submitted QC: 2019-12-05
• Study First Posted: 2019-12-10
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-21
• Last Update Posted: 2020-06-23
• Study Start: 2020-10-30
• Primary Completion: 2021-12-01
• Study Completion: 2021-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• APPROPIATE FOR TOTAL LAPAROSCOPIC HYSTERECTOMY

Exclusion Criteria

• MALIGNANCY

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
PLASMAKINETIK BIPOLAR SPATULA	PLASMAKINETIC BIPOLAR SPATULA	COLPOTOMY WITH USAGE MONOPOLAR HOOC
MONOPOLAR HOOC	MONOPOLAR HOOC	COLPOTOMY WITH USAGE MONOPOLAR HOOC

Primary Outcome Measures

Name	Time	Method
VAGINAL DEHISSENS	0 DAY-365 DAYS	AFTER LAPAROSCOPIC HYSTERECTOMY TWO DIFFERENT ELECTROSURGERY DEVICES RESULTS

Trial Locations

Locations (1)

Alku Alanya Education and Research Hospital; 🇹🇷 Antalya, Turkey