ObesityNCT02926885
Efficacy Evaluation of the Esophagogastric Junction Exposure Obtained by the Flexible Liver Retractor in Gastroplasty
A study testing CONVENTIONAL LIVER RETRACTOR DEVICE, FLEXIBLE LIVER RETRACTOR DEVICE and LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS SURGERY in people with Obesity, run by Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara at 1 site in Brazil.
Trial summary
Evaluation of a new technique of liver retraction for the exposure of the His angle in gastric bypass Roux-en-Y surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- CONVENTIONAL LIVER RETRACTOR DEVICE, FLEXIBLE LIVER RETRACTOR DEVICE and LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS SURGERY
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2015to Aug 2016
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between 18 - 65 years, both genders, with indication of bariatric surgery according to IFSO criteria.
- Agreed to participate and signed informed consent form.
Who cannot join
- Patients who did not agree to participate and / or any other condition that the investigator judged relevant for not participating in the study were excluded.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Nucleo de Pesquisa e Desenvolvimento da Universidade Federal do Ceara
Fortaleza, Ceará, 60430-275
About this study
Official title: Efficacy Evaluation of the Esophagogastric Junction Exposure Obtained by the Flexible Liver Retractor in Gastroplasty for Obesity
Evaluation of a new technique of liver retraction for the exposure of the His angle in gastric bypass Roux-en-Y surgery.
Read the detailed description
Obesity is a chronic disease of clinical treatment initially, but with precise surgical indications regulated by national and international health organizations. Among the surgical techniques, the gastric bypass Roux-en-Y is considered the "gold standard" for its efficiency and low morbidity and mortality. In gastric laparoscopic surgery it is necessary to move the liver in order to ensure adequate working space and a good view. Conventional laparoscopic retractors surgery are generally coarse, require an additional incision for its installation, or handling by an assistant during surgery and involve risk of liver injury. The objective of this study was to evaluate the efficacy of a flexible liver retractor in the exposure of the His angle in Roux-en-Y gastric bypass for morbid obesity. This was a prospective, controlled, open and comparative study, with 100 patients randomly divided into two groups (conventional and flexible retractor), with medical indication for bariatric surgery. Data were recorded during surgery in both groups for comparison of the two hepatic retraction techniques.
- Conditions
- Obesity
- Being tested
- CONVENTIONAL LIVER RETRACTOR DEVICE, FLEXIBLE LIVER RETRACTOR DEVICE, LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS SURGERY
- Keywords
- liver, laparoscopy, Bariatric Surgery, Esophagogastric Junction, obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CONVENTIONAL LIVER RETRACTOR DEVICEDevice
LIVER RETRACTION FOR THE EXPOSURE OF THE ESOPHAGOGASTRIC JUNCTION USING CONVENTIONAL RETRACTOR DEVICE
FLEXIBLE LIVER RETRACTOR DEVICEDevice
LIVER RETRACTION FOR THE EXPOSURE OF THE ESOPHAGOGASTRIC JUNCTION USING FLEXIBLE LIVER RETRACTOR DEVICE
LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS SURGERYProcedure or surgery
LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS SURGERY
| Study group | Role | What they receive |
|---|---|---|
| CONVENTIONAL LIVER RETRACTOR DEVICE | Active comparator | USE OF CONVENTIONAL LIVER RETRACTOR FOR THE LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS SURGERY Receives: Device: CONVENTIONAL LIVER RETRACTOR DEVICE; Procedure: LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS SURGERY |
| FLEXIBLE LIVER RETRACTOR DEVICE | Experimental | USE OF THE FLEXIBLE LIVER RETRACTOR FOR THE LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS SURGERY Receives: Device: FLEXIBLE LIVER RETRACTOR DEVICE; Procedure: LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS SURGERY |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of incisions made during laparoscopic surgery using flexible retractor when compared to conventional retractor
Measured: during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2016 (estimated)
- Study startAug 2015
- Primary completionJul 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RODRIGO FEITOSA DE ALBUQUERQUE LIMA BABADOPULOS, Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara
- Investigators
- Rodrigo Babadopulos, MD, Principal investigator, Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02926885
- Sponsor's protocol ID
- RB001
- Status last verified
- Oct 2016
- First submitted
- 5 Oct 2016
- Last updated
- 7 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Evaluation of the Esophagogastric Junction Exposure Obtained by the Flexible Liver Retractor in Gastroplasty for Obesity
- ClinicalTrials.gov ID
- NCT02926885
- Acronym / sponsor ID
- RB001
- Conditions
- Obesity
- Keywords
- liver, laparoscopy, Bariatric Surgery, Esophagogastric Junction, obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do CearaUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 6 Oct 2016 (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.
Evaluation of a new technique of liver retraction for the exposure of the His angle in gastric bypass Roux-en-Y surgery.
Detailed description
Obesity is a chronic disease of clinical treatment initially, but with precise surgical indications regulated by national and international health organizations. Among the surgical techniques, the gastric bypass Roux-en-Y is considered the "gold standard" for its efficiency and low morbidity and mortality. In gastric laparoscopic surgery it is necessary to move the liver in order to ensure adequate working space and a good view. Conventional laparoscopic retractors surgery are generally coarse, require an additional incision for its installation, or handling by an assistant during surgery and involve risk of liver injury. The objective of this study was to evaluate the efficacy of a flexible liver retractor in the exposure of the His angle in Roux-en-Y gastric bypass for morbid obesity. This was a prospective, controlled, open and comparative study, with 100 patients randomly divided into two groups (conventional and flexible retractor), with medical indication for bariatric surgery. Data were recorded during surgery in both groups for comparison of the two hepatic retraction techniques.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CONVENTIONAL LIVER RETRACTOR DEVICE | Active comparator | Device: CONVENTIONAL LIVER RETRACTOR DEVICE, Procedure: LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS SURGERYUSE OF CONVENTIONAL LIVER RETRACTOR FOR THE LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS SURGERY |
| FLEXIBLE LIVER RETRACTOR DEVICE | Experimental | Device: FLEXIBLE LIVER RETRACTOR DEVICE, Procedure: LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS SURGERYUSE OF THE FLEXIBLE LIVER RETRACTOR FOR THE LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS SURGERY |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Between 18 - 65 years, both genders, with indication of bariatric surgery according to IFSO criteria.
- Agreed to participate and signed informed consent form.
Key exclusion criteria (1 listed)
- Patients who did not agree to participate and / or any other condition that the investigator judged relevant for not participating in the study were excluded.
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 |
|---|---|---|
| CONVENTIONAL LIVER RETRACTOR DEVICELIVER RETRACTION FOR THE EXPOSURE OF THE ESOPHAGOGASTRIC JUNCTION USING CONVENTIONAL RETRACTOR DEVICE | Device | CONVENTIONAL LIVER RETRACTOR DEVICE |
| FLEXIBLE LIVER RETRACTOR DEVICELIVER RETRACTION FOR THE EXPOSURE OF THE ESOPHAGOGASTRIC JUNCTION USING FLEXIBLE LIVER RETRACTOR DEVICE | Device | FLEXIBLE LIVER RETRACTOR DEVICE |
| LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS SURGERYLAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS SURGERY | Procedure or surgery | CONVENTIONAL LIVER RETRACTOR DEVICE, FLEXIBLE LIVER RETRACTOR DEVICE |
Primary outcome
Number of incisions made during laparoscopic surgery using flexible retractor when compared to conventional retractor
Time frame: during surgery
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 Oct 2016.
- 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. This study is not recruiting at the moment.
Rodrigo Babadopulos, MD principal investigator
Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CONVENTIONAL LIVER RETRACTOR DEVICE, FLEXIBLE LIVER RETRACTOR DEVICE and LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS SURGERY in people with Obesity, run by Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara at 1 site in Brazil.
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 7 Oct 2016. 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 Brazil. 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?
Number of incisions made during laparoscopic surgery using flexible retractor when compared to conventional retractor (time frame: during surgery). 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 Oct 2016.