Morbid ObesityNCT02538328
Comparison of Harmonic Scalpel and Ligasure Devices in Laparoscopic Morbid Obesity Surgery
A study testing Harmonic scapel and Ligasure in people with Morbid Obesity, run by Inonu University.
Trial summary
Comparison of harmonic scalpel and ligasure devices in laparoscopic morbid obesity surgery especially in gastric bypass surgery patients. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- Harmonic scapel and Ligasure
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Jul 2014to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- obesity
- BMI over 40 kg/m^2
Who cannot join
- Normal BMI cases
About this study
Comparison of harmonic scalpel and ligasure devices in laparoscopic morbid obesity surgery especially in gastric bypass surgery patients.
Read the 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.
- Conditions
- Morbid Obesity
- Being tested
- Harmonic scapel, Ligasure
- Keywords
- laparoscopy, obesity, harmonic scalpel, ligasure
- Medical subject headings
- Obesity, Morbid, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Harmonic scapelDevice
Also called ultrasonic dissector
different surgical devices used in the obesity surgery
LigasureDevice
Also called Bipolar Vessel sealing device
Bipolar vessel sealing system used in obesity surgery
| Study group | Role | What they receive |
|---|---|---|
| harmonic scapel | Active comparator | Obesity surgery cases where hamonic scalpel is used for the comparison of different surgical devices Receives: Device: Harmonic scapel; Device: Ligasure |
| Ligasure sealing device | Placebo comparator | 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 Receives: Device: Harmonic scapel; Device: Ligasure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and efficacy of sealing
Aim to compare the fogging and the time spend performing the gastric resection to form the gastric pouch.
Measured: 1 year
Secondary outcomes (1)
Bleeding
Amount of blood loss in the operation
Measured: During the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2015 (estimated)
- Study startJul 2014
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serdar Kırmızı, Inonu University
- Investigators
- cüneyt kayaalp, prof, Principal investigator, GENERAL SURGERY CHİEF OF GASTROİNTESTİNAL SURGERY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02538328
- Sponsor's protocol ID
- 2014/105
- Status last verified
- Aug 2015
- First submitted
- 10 Aug 2015
- Last updated
- 2 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Harmonic Scalpel and Ligasure Devices in Laparoscopic Morbid Obesity Surgery
- ClinicalTrials.gov ID
- NCT02538328
- Acronym / sponsor ID
- 2014/105
- Conditions
- Morbid Obesity
- Keywords
- laparoscopy, obesity, harmonic scalpel, ligasure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 2 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparison of harmonic scalpel and ligasure devices in laparoscopic morbid obesity surgery especially in gastric bypass surgery patients.
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 design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| harmonic scapel | Active comparator | Device: Harmonic scapel, Device: LigasureObesity surgery cases where hamonic scalpel is used for the comparison of different surgical devices |
| Ligasure sealing device | Placebo comparator | Device: Harmonic scapel, Device: LigasureLigasure 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- obesity
- BMI over 40 kg/m^2
Key exclusion criteria (1 listed)
- Normal BMI cases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Harmonic scapelAlso: ultrasonic dissectordifferent surgical devices used in the obesity surgery | Device | Ligasure sealing device, harmonic scapel |
| LigasureAlso: Bipolar Vessel sealing deviceBipolar vessel sealing system used in obesity surgery | Device | Ligasure sealing device, harmonic scapel |
Primary outcome
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 secondary outcome
Bleeding
Time frame: During the operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
cüneyt kayaalp, prof principal investigator
GENERAL SURGERY CHİEF OF GASTROİNTESTİNAL SURGERY
Questions about this trial
What is this clinical trial studying?
A study testing Harmonic scapel and Ligasure in people with Morbid Obesity, run by Inonu University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and efficacy of sealing (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2015.