- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02538328
Comparison of Harmonic Scalpel and Ligasure Devices in Laparoscopic Morbid Obesity Surgery
September 1, 2015 updated by: Serdar Kırmızı, Inonu University
Comparison of harmonic scalpel and ligasure devices in laparoscopic morbid obesity surgery especially in gastric bypass surgery patients.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The investigators' department performs 150 gastric bypass surgeries annually.
Surgeons use both harmonic scalpel and ligasure sealing device in cases.
Aim is to compare both of these devices over coming each other.
Benefits ease of these devices are compared.
Study Type
Interventional
Enrollment (Actual)
90
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- obesity
- BMI over 40 kg/m^2
Exclusion Criteria:
- Normal BMI cases
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: harmonic scapel
Obesity surgery cases where hamonic scalpel is used for the comparison of different surgical devices
|
different surgical devices used in the obesity surgery
Other Names:
Bipolar vessel sealing system used in obesity surgery
Other Names:
|
Placebo Comparator: Ligasure sealing device
Ligasure used in obesity surgery for the comparison of different surgical devices Randomly chosen cases where ligasure is used instead of hamonic scalpel in surgical procedures comparison of multiple dissectors
|
different surgical devices used in the obesity surgery
Other Names:
Bipolar vessel sealing system used in obesity surgery
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety and efficacy of sealing
Time Frame: 1 year
|
Aim to compare the fogging and the time spend performing the gastric resection to form the gastric pouch.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bleeding
Time Frame: During the operation
|
Amount of blood loss in the operation
|
During the operation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: cüneyt kayaalp, prof, GENERAL SURGERY CHİEF OF GASTROİNTESTİNAL SURGERY
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2014
Primary Completion (Actual)
July 1, 2015
Study Completion (Actual)
July 1, 2015
Study Registration Dates
First Submitted
August 10, 2015
First Submitted That Met QC Criteria
September 1, 2015
First Posted (Estimate)
September 2, 2015
Study Record Updates
Last Update Posted (Estimate)
September 2, 2015
Last Update Submitted That Met QC Criteria
September 1, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014/105
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Morbid Obesity
-
ClinTrio Ltd.UnknownMorbid Obesity Requiring Bariatric SurgeryBelgium, Germany, Portugal, Austria, Netherlands, Poland, Saudi Arabia
-
Centre Hospitalier Universitaire de NiceCompletedMorbid Obesity D009765France
-
Shanghai Jiao Tong University School of MedicineUnknown
-
Hospices Civils de LyonCentre de Recherche en Nutrition Humaine Rhone-Alpe; Institut National de Recherche... and other collaboratorsRecruiting
-
Endolumik, IncWest Virginia UniversityNot yet recruitingMorbid ObesityUnited States
-
Rijnstate HospitalRecruiting
-
Laval UniversityCentre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie...Recruiting
-
University of WashingtonUnited States Department of DefenseWithdrawn
-
Helsinki University Central HospitalActive, not recruiting
-
IHU StrasbourgWithdrawnMorbid Obesity
Clinical Trials on Harmonic scapel
-
St Andrew's Centre for Plastic SurgeryWithdrawnBreast ReconstructionUnited Kingdom
-
Aga Khan UniversityCompleted
-
Ethicon Endo-SurgeryRecruitingPediatric Procedures | Adult Hepato-pancreato-biliary (HPB) Procedures | Adult Lower Gastrointestinal Procedures | Adult Gastric Procedures | Adult Gynecological Procedures | Adult Urological Procedures | Adult Thoracic ProceduresUnited States, Canada, United Kingdom
-
Centre hospitalier de l'Université de Montréal...Johnson & JohnsonCompleted
-
Centre hospitalier de l'Université de Montréal...Centre de Recherche du Centre Hospitalier de l'Université de MontréalCompleted
-
Centre hospitalier de l'Université de Montréal...Centre de Recherche du Centre Hospitalier de l'Université de MontréalCompleted
-
Dartmouth-Hitchcock Medical CenterEthicon Endo-SurgeryTerminated
-
Brazilian Society of Head and Neck SurgeryJohnson & JohnsonUnknown
-
University of CalgaryCompleted
-
National Taiwan University HospitalNational Health Research Institutes, TaiwanRecruitingHealthy Participants With Different Skin Types and Different Ages | Diseased Participants With Different Skin Types and Different Ages | Participants Suffered From Diabetes With Different Skin Types and Different AgesTaiwan