Bariatric Surgery CandidateNCT04945304
9-Step Magnetic Bariatric Revisional Surgery
An observational study of Bariatric Surgery Candidate and GERD, run by Unidad Internacional de Cirugia Bariatrica y Metabolica at 1 site in Venezuela.
Trial summary
RYGB represents one of the best alternatives for weight loss in obese patients achieving a weight loss of up to 60% and a resolution of comorbidities of 70%. Revision surgery contemplates multiple techniques including the conversion from one surgical technique to another, structural changes to the primary technique… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bariatric Surgery Candidate, GERD, Revisional Bariatric Surgery
- What is being tested?
- magnetic bariatric surgery and Magnetic gastric bypass
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteVenezuela
- Study dates
- 31 May 2021to 31 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Patients candidates to bariatric surgery in the international unit of bariatric and metabolic surgery
Who may be able to join
- Older than 18 years
- Candidate to bariatric surgery
- Obesity
- BMI Greater than 30 kg/m2
Who cannot join
- Uncontrolled co-morbidities
- patients with pacemakers, defibrillators, or other electromedical implants
- Abnormal coagulation blood tests
- Patients with hepatic diseases
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Venezuela1 site, 1 recruiting
- Recruiting
Unidad Internacional de Cirugía Bariátrica y Metabólica
Maracaibo, Zulia, 4002
Guillermo Borjas, MD. PhD, 4146863041 ext. 58, drguillermoborjas@hotmail.com
About this study
Official title: 9-Step Magnetic Assisted Conversion From Sleeve Gastrectomy to Roux-en-Y Gastric Bypass and Hiatoplasty by Single-Port.
RYGB represents one of the best alternatives for weight loss in obese patients achieving a weight loss of up to 60% and a resolution of comorbidities of 70%. Revision surgery contemplates multiple techniques including the conversion from one surgical technique to another, structural changes to the primary technique, among others. GERD is now a long-term problem for patients who have undergone LGS. RYGB is one of the best techniques to resolve this problem.
Read the detailed description
Roux-en-y gastric bypass is performed with the patient in the French position by a bariatric surgeon with 8 years of experience. A single port was placed in the umbilicus, an additional trocar (5mm) was placed in the right side of the abdomen. The surgery is started by performing the liver retraction with the grasper plus magnet attached to the border for the correct visualization of the surgical field. Later, the division of the major curvature of the omentum is started, and as it is performed in a superior direction, the magnet is positioned to retract the fundus and finishing exposing the esophageal hiatus where a hiatal hernia is visualized, which is decided to be repaired transoperatively. For the hiatoplasty, after placing a reference around the stomach, the magnet is positioned in that reference to retract the stomach and esophagus and to be able to suture the hernia defect. Then we proceed to perform the RYGB with the simplified technique, starting with the reference attached to the magnet but this time at the opposite end to start the resection of the lesser omentum, a minor step prior to the confection of the pouch. The pouch confection is done with 3 blue cartridges. Continuing with the procedure, the retraction of the transverse colon is performed with the use of the magnet to visualize the treitz angle and start the 60 cm measurement of the biliopancreatic limb. Later, gastrojejunal anastomosis is performed traditionally. Once this step is finished, the 100 cm alimentary limb is measured and then, the magnet-assisted jejunal anastomosis is performed. The Petersen defect and the intermesenteric defect is closed assisted by magnets. A methylene blue leak test is routinely performed, with negative results, this time testing both anastomoses. Finally, the magnet-assisted omega section is made with the retraction of the limb to finish the Roux-en-Y.
- Being tested
- magnetic bariatric surgery, Magnetic gastric bypass
- Keywords
- revisional surgery, bariatric surgery, gastric bypass, single port, sleeve gastrectomy, magnetic surgery
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnetic bariatric surgeryProcedure or surgery
Perform a roux-en-y gastric bypass, sleeve gastrectomy, nissen-sleeve or revisional bariatric procedure with magnetic assistance
Magnetic gastric bypassProcedure or surgery
Using the magnetic assistance to perform a gastric bypass
| Study group | Role | What they receive |
|---|---|---|
| Magnetic bariatric surgery | Bariatric procedure performed in a human using magnetic assistance in the steps of the surgery Receives: Procedure: magnetic bariatric surgery; Procedure: Magnetic gastric bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
complications
adverse surgical events
Measured: 30 days
device malfunction
any adverse event with the magnetic grasper
Measured: 1-2 hours
surgical time
report the surgical time using the magnetic assistance
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2021
- Study start31 May 2021
- Primary completion31 Oct 2026 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bariatric Surgery CandidateStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unidad Internacional de Cirugia Bariatrica y Metabolica
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guillermo Borjas, Unidad Internacional de Cirugia Bariatrica y Metabolica
- Investigators
- Guillermo Borjas, MD. PhD, Principal investigator, International Unit of Bariatric and Metabolic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04945304
- Sponsor's protocol ID
- BariatriaInternacional
- Status last verified
- Jul 2022
- First submitted
- 31 May 2021
- Last updated
- 11 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Guillermo B, Nestor S, Maria G, Ali U, Eduardo R, Andres M. 9-step magnetic assisted conversion from sleeve gastrectomy to roux-en-Y gastric bypass and hiatoplasty by single-port: Case report. Int J Surg Case Rep. 2021 Sep;86:106294. doi: 10.1016/j.ijscr.2021.106294. Epub 2021 Aug 11.
PubMed 34419721
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 9-Step Magnetic Assisted Conversion From Sleeve Gastrectomy to Roux-en-Y Gastric Bypass and Hiatoplasty by Single-Port.
- ClinicalTrials.gov ID
- NCT04945304
- Acronym / sponsor ID
- BariatriaInternacional
- Keywords
- revisional surgery, bariatric surgery, gastric bypass, single port, sleeve gastrectomy, magnetic surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Unidad Internacional de Cirugia Bariatrica y MetabolicaUniversity, hospital or other
- Study start
- 31 May 2021 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 30 Jun 2021 (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.
RYGB represents one of the best alternatives for weight loss in obese patients achieving a weight loss of up to 60% and a resolution of comorbidities of 70%. Revision surgery contemplates multiple techniques including the conversion from one surgical technique to another, structural changes to the primary technique, among others. GERD is now a long-term problem for patients who have undergone LGS. RYGB is one of the best techniques to resolve this problem.
Detailed description
Roux-en-y gastric bypass is performed with the patient in the French position by a bariatric surgeon with 8 years of experience. A single port was placed in the umbilicus, an additional trocar (5mm) was placed in the right side of the abdomen. The surgery is started by performing the liver retraction with the grasper plus magnet attached to the border for the correct visualization of the surgical field. Later, the division of the major curvature of the omentum is started, and as it is performed in a superior direction, the magnet is positioned to retract the fundus and finishing exposing the esophageal hiatus where a hiatal hernia is visualized, which is decided to be repaired transoperatively. For the hiatoplasty, after placing a reference around the stomach, the magnet is positioned in that reference to retract the stomach and esophagus and to be able to suture the hernia defect. Then we proceed to perform the RYGB with the simplified technique, starting with the reference attached to the magnet but this time at the opposite end to start the resection of the lesser omentum, a minor step prior to the confection of the pouch. The pouch confection is done with 3 blue cartridges. Continuing with the procedure, the retraction of the transverse colon is performed with the use of the magnet to visualize the treitz angle and start the 60 cm measurement of the biliopancreatic limb. Later, gastrojejunal anastomosis is performed traditionally. Once this step is finished, the 100 cm alimentary limb is measured and then, the magnet-assisted jejunal anastomosis is performed. The Petersen defect and the intermesenteric defect is closed assisted by magnets. A methylene blue leak test is routinely performed, with negative results, this time testing both anastomoses. Finally, the magnet-assisted omega section is made with the retraction of the limb to finish the Roux-en-Y.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Magnetic bariatric surgery | – | Procedure: magnetic bariatric surgery, Procedure: Magnetic gastric bypassBariatric procedure performed in a human using magnetic assistance in the steps of the surgery |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients candidates to bariatric surgery in the international unit of bariatric and metabolic surgery
Key inclusion criteria (4 listed)
- Older than 18 years
- Candidate to bariatric surgery
- Obesity
- BMI Greater than 30 kg/m2
Key exclusion criteria (4 listed)
- Uncontrolled co-morbidities
- patients with pacemakers, defibrillators, or other electromedical implants
- Abnormal coagulation blood tests
- Patients with hepatic diseases
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 |
|---|---|---|
| magnetic bariatric surgeryPerform a roux-en-y gastric bypass, sleeve gastrectomy, nissen-sleeve or revisional bariatric procedure with magnetic assistance | Procedure or surgery | Magnetic bariatric surgery |
| Magnetic gastric bypassUsing the magnetic assistance to perform a gastric bypass | Procedure or surgery | Magnetic bariatric surgery |
Primary outcome
complications
Time frame: 30 days
adverse surgical events
device malfunction
Time frame: 1-2 hours
any adverse event with the magnetic grasper
surgical time
Time frame: 30 days
report the surgical time using the magnetic assistance
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2022.
- Derived from this study: PubMed 34419721Guillermo B, Nestor S, Maria G, Ali U, Eduardo R, Andres M. 9-step magnetic assisted conversion from sleeve gastrectomy to roux-en-Y gastric bypass and hiatoplasty by single-port: Case report. Int J Surg Case Rep. 2021 Sep;86:106294. doi: 10.1016/j.ijscr.2021.106294. Epub 2021 Aug 11.
- Individual participant dataSharing planned: No
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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.
Guillermo Borjas, MD. PhD principal investigator
International Unit of Bariatric and Metabolic Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bariatric Surgery Candidate and GERD, run by Unidad Internacional de Cirugia Bariatrica y Metabolica at 1 site in Venezuela.
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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 11 Jul 2022. 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 Venezuela. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guillermo Borjas, MD. PhD (4146863041 ext. 58, drguillermoborjas@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complications (time frame: 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04945304, which also lists 1 linked publication.
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 11 Jul 2022; AzTrials last refreshed its copy on 1 Nov 2026.