ObesityPhase 4NCT02050477
Clinical Study of Laparoscopic Non Banded Vertical Gastroplasty in Bariatric Surgery
A Phase 4 study testing Laparoscopic Vertical Gastroplasty in people with Obesity, run by University of Liege at 1 site in Belgium.
Trial summary
Evaluation of the laparoscopic approach of the Magenstrasse and Mill procedure in a prospective study of 100 patients Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obesity
- What is being tested?
- Laparoscopic Vertical Gastroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- Jun 2012to Jul 2014
- Phase
- Phase 4
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Assessment by a multidisciplinary team specialized in bariatric and metabolic surgery including surgeon, endocrinologist, psychologist and/or psychiatrist, dietician
- BMI>40
- BMI>35 with diabetes or sleep apnea syndrome or hypertension treated with 3 drugs for at least one year
- Male or female patients between 18 and 75 years of age; fertile female patients must use a reliable contraception method;
- No previous bariatric procedure
- Informed consent given by patient
Who cannot join
- Medical contra-indication for a general anesthesia, or abdominal surgery (allergies to anesthetic drugs, cardio-vascular, pulmonary, or renal conditions leading to an unacceptable risk for the procedure
- Psychological-Psychiatric (boulimia, severe depression, psychotic condition)
- Non stabilized endocrine disorder, with potential interference on weight and/or diabetic condition
- Unability to understand goal of the study, plan of treatment and follow-up
- Large hiatal hernia and/or severe esophageal reflux disease
- Grazer, Sweet eater behavior
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Dept of Abdominal Surgery and Transplantation, CHU Liège
Liège, Liège, 4000
About this study
Official title: Laparoscopic Non Banded Vertical (Magenstrasse and Mill) Gastroplasty In Bariatric Surgery. Morbidity and Results on Weight Loss and Associated Co-morbidities
Evaluation of the laparoscopic approach of the Magenstrasse and Mill procedure in a prospective study of 100 patients
Read the detailed description
The laparoscopy is performed under general anesthesia with a 5 ports access under 14mm Hg pressure. After opening of the gastrocolic ligament and division of any adhesions between stomach and pancreas a circular opening is performed at the junction of corpus and antrum of the stomach with a circular stapler. A tubular gastric pouch is then created along a calibration tube at the lesser curvature by a vertical stapling starting from the circular opening to the angle of Hiss.
- Conditions
- Obesity
- Being tested
- Laparoscopic Vertical Gastroplasty
- Keywords
- Obesity, Bariatric, Surgery, Sleeve, Gastroplasty, Laparoscopy
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic Vertical GastroplastyProcedure or surgery
The Magenstrasse and Mill procedure is a conservative vertical gastroplasty described in 1987 through a laparotomy. A tubular gastric pouch is created by a vertical stapling extending from the antrum to the angle of Hiss. In this study, we evaluate the laparoscopic technique of the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic Vertical Gastroplasty | Experimental | Not described Receives: Procedure: Laparoscopic Vertical Gastroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morbidity/Mortality
Measured: 1 month
Effect of the procedure on weight loss
Evaluation at 1,3,6 and 12 months through clinical evaluation.
Measured: 1 year
Secondary outcomes (2)
Reflux disease
Evaluation at 1,3,6 and 12 months through clinical evaluation, Gastroscopy if symptoms present. Upper GI opacification at one year will be performed for all patients.
Measured: 1 year
Effect of procedure on obesity associated co-morbidities
Co-morbidities include diabetes, hypertension, sleep apnea syndrome, dyslipemia Evaluation at 1,3,6 and 12 months through clinical evaluation and blood assessment
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2014 (estimated)
- Study startJun 2012
- Primary completionJul 2014 (estimated)
- Study completionJul 2014 (estimated)
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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arnaud De Roover, University of Liege
- Investigators
- Arnaud De Roover, MD, Principal investigator, Dept of Abdominal Surgery and Transplantation CHU Liège Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02050477
- Sponsor's protocol ID
- B707201214181
- Status last verified
- Jan 2014
- First submitted
- 25 Jan 2014
- Last updated
- 30 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Non Banded Vertical (Magenstrasse and Mill) Gastroplasty In Bariatric Surgery. Morbidity and Results on Weight Loss and Associated Co-morbidities
- ClinicalTrials.gov ID
- NCT02050477
- Acronym / sponsor ID
- B707201214181
- Conditions
- Obesity
- Keywords
- Obesity, Bariatric, Surgery, Sleeve, Gastroplasty, Laparoscopy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 30 Jan 2014 (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 the laparoscopic approach of the Magenstrasse and Mill procedure in a prospective study of 100 patients
Detailed description
The laparoscopy is performed under general anesthesia with a 5 ports access under 14mm Hg pressure. After opening of the gastrocolic ligament and division of any adhesions between stomach and pancreas a circular opening is performed at the junction of corpus and antrum of the stomach with a circular stapler. A tubular gastric pouch is then created along a calibration tube at the lesser curvature by a vertical stapling starting from the circular opening to the angle of Hiss.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic Vertical Gastroplasty | Experimental | Procedure: Laparoscopic Vertical Gastroplasty |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Assessment by a multidisciplinary team specialized in bariatric and metabolic surgery including surgeon, endocrinologist, psychologist and/or psychiatrist, dietician
- BMI>40
- BMI>35 with diabetes or sleep apnea syndrome or hypertension treated with 3 drugs for at least one year
- Male or female patients between 18 and 75 years of age; fertile female patients must use a reliable contraception method;
- No previous bariatric procedure
Key exclusion criteria (6 listed)
- Medical contra-indication for a general anesthesia, or abdominal surgery (allergies to anesthetic drugs, cardio-vascular, pulmonary, or renal conditions leading to an unacceptable risk for the procedure
- Psychological-Psychiatric (boulimia, severe depression, psychotic condition)
- Non stabilized endocrine disorder, with potential interference on weight and/or diabetic condition
- Unability to understand goal of the study, plan of treatment and follow-up
- Large hiatal hernia and/or severe esophageal reflux disease
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 |
|---|---|---|
| Laparoscopic Vertical GastroplastyThe Magenstrasse and Mill procedure is a conservative vertical gastroplasty described in 1987 through a laparotomy. A tubular gastric pouch is created by a vertical stapling extending from the antrum to the angle of Hiss. In this study, we evaluate the laparoscopic technique of the procedure. | Procedure or surgery | Laparoscopic Vertical Gastroplasty |
Primary outcome
Morbidity/Mortality
Time frame: 1 month
Effect of the procedure on weight loss
Time frame: 1 year
Evaluation at 1,3,6 and 12 months through clinical evaluation.
2 secondary outcomes
Reflux disease
Time frame: 1 year
Effect of procedure on obesity associated co-morbidities
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2014.
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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.
Arnaud De Roover, MD principal investigator
Dept of Abdominal Surgery and Transplantation CHU Liège Belgium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Laparoscopic Vertical Gastroplasty in people with Obesity, run by University of Liege at 1 site in Belgium.
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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 30 Jan 2014. 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 Belgium. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Morbidity/Mortality (time frame: 1 month). The study lists 2 primary outcomes in all. 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 30 Jan 2014.