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

NCT ID: NCT04191603

Last Updated: 2020-06-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-30

Study Completion Date

2021-12-30

Brief Summary

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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

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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.

Conditions

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Uterine Fibroid Ovary Cyst Endometrial Hyperplasia Cervical Dysplasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

MONOPOLAR HOOC VERSUS PLASMAKINETIC BIPOLAR SPATULA USAGE DURING COLPOTOMY
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators
MONOPOLAR HOOC VERSUS PLASMAKINETIC BIPOLAR SPATULA USAGE DURING COLPOTOMY

Study Groups

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MONOPOLAR HOOC

COLPOTOMY WITH USAGE MONOPOLAR HOOC

Group Type ACTIVE_COMPARATOR

MONOPOLAR HOOC

Intervention Type DEVICE

COLPOTOMY WITH MONOPOLAR HOOC

PLASMAKINETIK BIPOLAR SPATULA

COLPOTOMY WITH USAGE MONOPOLAR HOOC

Group Type ACTIVE_COMPARATOR

PLASMAKINETIC BIPOLAR SPATULA

Intervention Type DEVICE

COLPOTOMY WITH BIPOLAR SPATULA

Interventions

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MONOPOLAR HOOC

COLPOTOMY WITH MONOPOLAR HOOC

Intervention Type DEVICE

PLASMAKINETIC BIPOLAR SPATULA

COLPOTOMY WITH BIPOLAR SPATULA

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* APPROPIATE FOR TOTAL LAPAROSCOPIC HYSTERECTOMY

Exclusion Criteria

* MALIGNANCY
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Alkü Alanya Education and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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MERAL TUĞBA ÇİMŞİR

ASSOCIATE PROFESSOR

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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MERAL TUĞBA ÇİMŞİR

Role: PRINCIPAL_INVESTIGATOR

ALKU EDUCATİON AND RESEARCH HOSPITAL

Locations

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Alku Alanya Education and Research Hospital

Antalya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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MERAL TUĞBA ÇİMŞİR

Role: CONTACT

05064742272

Facility Contacts

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MERAL TUĞBA ÇİMŞİR

Role: primary

Other Identifiers

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ALKU ERH

Identifier Type: -

Identifier Source: org_study_id

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