Obesity, MorbidNCT03240367
Comparison of Stapler Line Bleeding Control Techniquessurgery
A study testing Coutery in people with Obesity, Morbid, run by Ersin Gündoğan at 1 site in Turkey (Türkiye).
Trial summary
Introduction RYGB surgeon; Have become increasingly morbid obesity treatment methods with improvements in minimally invasive surgery. Ensuring patient comfort and early return to life are the criteria that should be given priority in this treatment method.The purpose of this study; Emphasizing that the cautery… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Morbid
- What is being tested?
- Coutery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Dec 2016to 14 Jul 2017
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Morbid obese patients
Who cannot join
- Cirrhotic patients, those under 18 years of age, additional intraabdominal surgeries during LRYGBP and those who had previously undergone obesity surgery (revision surgery)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Stapler Line Bleeding Control Techniques in Laparoscopic Gastric Bypass
Introduction RYGB surgeon; Have become increasingly morbid obesity treatment methods with improvements in minimally invasive surgery. Ensuring patient comfort and early return to life are the criteria that should be given priority in this treatment method.The purpose of this study; Emphasizing that the cautery technique of the stapler line bleeding control methods is as successful as the other methods.
Read the detailed description
The question of the availability of cautery in RYGB surgeons
- Conditions
- Obesity, Morbid
- Being tested
- Coutery
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CouteryOther
Stapler line bleeding control with coutery
| Study group | Role | What they receive |
|---|---|---|
| coutery | Experimental | Stapler bloom will be stopped with cautery Receives: Other: Coutery |
| clips | No intervention | Stapler bloom will be stopped with clipping |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-item drainage control
Bleeding quantities to be noted
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2017
- Study start4 Dec 2016
- Primary completion14 Jul 2017
- Study completion14 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, MorbidStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ersin Gündoğan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ersin Gündoğan, Inonu University
- Investigators
- Ersin Gündoğan, MD, Study director, study principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03240367
- Sponsor's protocol ID
- 2016/180
- Status last verified
- Jul 2017
- First submitted
- 14 Jul 2017
- Last updated
- 7 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Stapler Line Bleeding Control Techniques in Laparoscopic Gastric Bypass
- ClinicalTrials.gov ID
- NCT03240367
- Acronym / sponsor ID
- 2016/180
- Conditions
- Obesity, Morbid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ersin GündoğanUniversity, hospital or other
- Study start
- 4 Dec 2016 (actual)
- Primary completion
- 14 Jul 2017 (actual)
- Study completion
- 14 Jul 2017 (actual)
- First posted
- 7 Aug 2017 (actual)
- 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.
Introduction RYGB surgeon; Have become increasingly morbid obesity treatment methods with improvements in minimally invasive surgery. Ensuring patient comfort and early return to life are the criteria that should be given priority in this treatment method.The purpose of this study; Emphasizing that the cautery technique of the stapler line bleeding control methods is as successful as the other methods.
Detailed description
The question of the availability of cautery in RYGB surgeons
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| coutery | Experimental | Other: CouteryStapler bloom will be stopped with cautery |
| clips | No intervention | –Stapler bloom will be stopped with clipping |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Morbid obese patients
Key exclusion criteria (1 listed)
- Cirrhotic patients, those under 18 years of age, additional intraabdominal surgeries during LRYGBP and those who had previously undergone obesity surgery (revision surgery)
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 |
|---|---|---|
| CouteryStapler line bleeding control with coutery | Other | coutery |
Primary outcome
3-item drainage control
Time frame: 8 months
Bleeding quantities to be noted
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 7 Aug 2017.
- Individual participant dataSharing planned: No
Related trials for Obesity, Morbid
RecruitingPhase 3
Fiber and Metformin Combination Therapy in Adolescents With Severe Obesity and Insulin Resistance
Obesity, Childhood, Insulin Resistance
RecruitingPhase 3
A Study Evaluating Mibavademab Treatment of Obesity Due to Leptin (LEP) Gene Mutations in Children, Adolescents and Adults
Monogenic Obesity
RecruitingPhase 4
Optimizing Portal Hypertension With TIPS and Interval Metabolic Surgery for Advanced Liver Disease
Liver Cirrhoses, Portal Hypertension Related to Cirrhosis
Enrolling by invitation
Biometabolic Outcomes After Weight Loss Surgery: An Individualized Approach
Obesity, Morbid, Metabolic Syndrome
RecruitingPhase 4
Impact GLP-1 Agonists Following Bariatric
Morbid Obesity, Metabolic Syndrome
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.
Ersin Gündoğan, MD study director
study principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coutery in people with Obesity, Morbid, run by Ersin Gündoğan at 1 site in Turkey (Türkiye).
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 1 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 7 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
3-item drainage control (time frame: 8 months). 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 7 Aug 2017.