TWO DİFFERENT ELECTROSURGERY DEVICES AS MONOPOLAR HOOC AND PLASMAKINETIC BIPOLAR SPATULA EFFECTIVENESS DURING COLPOTOMY
THE EFFECTIVENESS OF MONOPOLAR HOOC VERSUS PLASMAKINETIC BİPOLAR SPATULA USAGE DURING COLPOTOMY PROCESS IN PATIENTS UNDERGOİNG TOTAL LAPAROSCOPIC HYSTERECTOMY
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 4, 2019
CompletedFirst Posted
Study publicly available on registry
December 10, 2019
CompletedStudy Start
First participant enrolled
October 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2021
CompletedJune 23, 2020
June 1, 2020
1.1 years
December 4, 2019
June 21, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
VAGINAL DEHISSENS
AFTER LAPAROSCOPIC HYSTERECTOMY TWO DIFFERENT ELECTROSURGERY DEVICES RESULTS
0 DAY-365 DAYS
Study Arms (2)
MONOPOLAR HOOC
ACTIVE COMPARATORCOLPOTOMY WITH USAGE MONOPOLAR HOOC
PLASMAKINETIK BIPOLAR SPATULA
ACTIVE COMPARATORCOLPOTOMY WITH USAGE MONOPOLAR HOOC
Interventions
Eligibility Criteria
You may qualify if:
- APPROPIATE FOR TOTAL LAPAROSCOPIC HYSTERECTOMY
You may not qualify if:
- MALIGNANCY
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Alku Alanya Education and Research Hospital
Antalya, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
MERAL TUĞBA ÇİMŞİR
ALKU EDUCATİON AND RESEARCH HOSPITAL
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Masking Details
- MONOPOLAR HOOC VERSUS PLASMAKINETIC BIPOLAR SPATULA USAGE DURING COLPOTOMY
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- ASSOCIATE PROFESSOR
Study Record Dates
First Submitted
December 4, 2019
First Posted
December 10, 2019
Study Start
October 30, 2020
Primary Completion
December 1, 2021
Study Completion
December 30, 2021
Last Updated
June 23, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- CSR
- Time Frame
- 5 YEARS
5 YEARS