Obesity, MorbidQUALISLEEVENCT01550601
Impact of the Preservation of the Gastric Antrum in the Technique of Sleeve Gastrectomy for the Treatment of the Morbid Obesity
A study testing bariatric surgery in people with Obesity, Morbid, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The bariatric surgery is recognized, at present, as the only effective therapeutic for the patients with morbid obesity. Two surgical procedures (said restrictive) are considered as consensual: the adjustable calibrated horizontal gastroplasty under laparoscopy (ring périgastric) and Gastric Bypass under laparoscopy… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Morbid
- What is being tested?
- bariatric surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 346 participants
- Where
- 1 siteFrance
- Study dates
- 30 Sep 2011to 17 May 2019
- 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
- Patients with an indication of bariatric surgery (Recommendations HAS) defined as follows:
- IMC = 40kg/m² with failure of the dietary treatments during at least 1 year, or
- IMC = 35kg/m ² if associated comorbidity (HTA, diabetes, gonarthrose, sleep apnea, dyslipidemia, severe respiratory diseases)
- Patients motivated by this surgery and to accept the post-operative constraints.
- Age: > 18 years and < 65 years.
- patient having received an favorable opinion to the multidisciplinary meeting
- patient with his/her consent.
- patient with French insurance
Who cannot join
- Women Patients presenting a current pregnancy (not effective contraception during the first year after surgery) or in age to procreate and without means of effective contraception (oestroprogestational)
- patient with a contraindication to the anesthesia
- patient with grave psychiatric disorders (psychotic, paranoid)
- Emotionally unstable Patient or showing psychiatric characteristics which according to the opinion of the psychologist or the surgeon are incompatible with this type of surgery
- patient with surgical histories esogastric
- Patient with an inflammation of the digestive system (severe esophagitis, gastrointestinal ulcer, CROHN disease)
Show all 13Show fewer
- Patient with a severe cardiopulmonary affection or other severe organic affection
- patient with a risk of bleedings in the superior gastrointestinal part (esophageal varice)
- Patient with gastrointestinal congenital defects (stenosis, atresia)
- Patient with chronic alcoholism or drug addiction
- patient having a serious infection (HIV)
- Patient who refuses categorically the diet imposed by this surgery
- patient with a food of type "sweet eaters" (sweet food, high calorie liquid).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of the Preservation of the Gastric Antrum in the Technique of Sleeve Gastrectomy for the Treatment of the Morbid Obesity: a Prospective,Controlled, Randomized, Multicentrique Study.
The bariatric surgery is recognized, at present, as the only effective therapeutic for the patients with morbid obesity. Two surgical procedures (said restrictive) are considered as consensual: the adjustable calibrated horizontal gastroplasty under laparoscopy (ring périgastric) and Gastric Bypass under laparoscopy (LGBP). The longitudinal gastrectomy (sleeve gastrectomy) is a technique of bariatric surgery recently validated (HAS on 2008). It consists of the realization of a partial gastrectomy of 2/3 (Fundus, gastric Body +/- antrum). However, lot of technical disagreements are brought back by expert teams. The most important disagreement concerns the conservation or the exeresis of the gastric antrum. In fact, the conservation of gastric antrum could facilitate the gastric emptying and to decrease the RGO (main complication) and act on the regulations of hormones modulators of the insulino-secretion.
A prospective,randomized study comparing these both techniques is necessary to determine a unique consensual technique
Read the detailed description
The main objective of this study is to compare the frequency of post-operative gastronomic appearance of gastroesophageal reflux(RGO) between two techniques of longitudinal gastrectomy under laparoscopy (gastrectomy coupling sleeve with antrum conservation or without antrum conservation) at patients with morbid obesity.
There are lot of secondary outcomes assessed in this study. In fact, one of secondary objectives is to compare between both techniques of longitudinal gastrectomy under laparoscopy described in the literature the efficiency on the loss of weight and global post-operative morbidity.
This study assess the impact of these surgery techniques on the comorbidity of the obesity and their treatments (type 2 diabetes, arterial hypertension, sleep apnea syndrome, arthralgia, dyslipemia).
- Conditions
- Obesity, Morbid
- Being tested
- bariatric surgery
- Keywords
- morbid obesity, gastrectomy, gastrinaemia, comorbidity, gastric antrum
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bariatric surgeryProcedure or surgery
The longitudinal gastrectomy (sleeve gastrectomy) is a technique of bariatric surgery recently validated (HAS on 2008).It consists of the realization of a partial gastrectomy of 2/3 (Fundus, gastric Body +/- antrum). However, lot of technical disagreements are brought back by expert teams. The most important disagreement concerns the conservation or the exeresis of the gastric antrum. In fact, the conservation of gastric antrum could facilitate the gastric emptying and to decrease the RGO (main complication) and act on the regulations of hormones modulators of the insulino-secretion.
| Study group | Role | What they receive |
|---|---|---|
| bariatric surgery 1 | Other | Longitudinal gastrectomy (sleeve gastrectomy) is a technique of bariatric surgery. In this arm, patients have a bariatric surgery with conservation of gastric antrum. Receives: Procedure: bariatric surgery |
| bariatric surgery 2 | Experimental | Longitudinal gastrectomy (sleeve gastrectomy) is a technique of bariatric surgery. In this arm, patients have a bariatric surgery with ablation of gastric antrum. Receives: Procedure: bariatric surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the frequency appearance of RGO after surgery intervention (between two techniques longitudinal gastrectomy) in patients of morbid obesity
The main objective of this study is to compare the frequency of post-operative gastronomic appearance of gastroesophagal reflux(RGO) between both techniques of longitudinal gastrectomy under laparoscopy (gastrectomy coupling sleeve with antrum conservation or without antrum conservation) at patients with morbid obesity.
Measured: 12 months
Secondary outcomes (3)
Assessment of efficiency on loss of weight and global post-operative morbidity between both surgery techniques.
Comparison between both techniques of longitudinal gastrectomy under laparoscopy described in the literature in terms of efficiency on the loss of weight and global post-operative morbidity
Measured: 12 months
Impact assessment of both types' surgery on the comorbidity and treatments of obesity
Assess the impact of these surgery techniques on the comorbidity of the obesity and their treatments (type 2 diabetes, arterial hypertension, sleep apnea syndrom, arthralgia, dyslipemia)
Measured: 12 months
Assessment of gastrinemia between both groups (efficacy assessment)
Assess the variations of the gastrinaemia according to the used technique (in fact, this hormone is partially secreted by the gastric antrum)
Measured: at 1,3,12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2012 (estimated)
- Study start30 Sep 2011
- Primary completion28 Mar 2017
- Study completion17 May 2019
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.
- More trials run by University Hospital, MontpellierThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 346 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Marseille, Centre Hospitalier Universitaire de Nice
- Responsible party
- Sponsor
- Investigators
- Nocca David, PU-PH, Principal investigator, CHRU de Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01550601
- Sponsor's protocol ID
- 8643
- Other IDs
- 2010-A01021-38
- Acronym
- QUALISLEEVE
- Status last verified
- Jan 2020
- First submitted
- 27 Feb 2012
- Last updated
- 10 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Preservation of the Gastric Antrum in the Technique of Sleeve Gastrectomy for the Treatment of the Morbid Obesity: a Prospective,Controlled, Randomized, Multicentrique Study.
- ClinicalTrials.gov ID
- NCT01550601
- Acronym / sponsor ID
- QUALISLEEVE / 8643
- Conditions
- Obesity, Morbid
- Keywords
- morbid obesity, gastrectomy, gastrinaemia, comorbidity, gastric antrum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 346 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- University Hospital, Marseille, Centre Hospitalier Universitaire de Nice
- Study start
- 30 Sep 2011 (actual)
- Primary completion
- 28 Mar 2017 (actual)
- Study completion
- 17 May 2019 (actual)
- First posted
- 12 Mar 2012 (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.
The bariatric surgery is recognized, at present, as the only effective therapeutic for the patients with morbid obesity. Two surgical procedures (said restrictive) are considered as consensual: the adjustable calibrated horizontal gastroplasty under laparoscopy (ring périgastric) and Gastric Bypass under laparoscopy (LGBP). The longitudinal gastrectomy (sleeve gastrectomy) is a technique of bariatric surgery recently validated (HAS on 2008). It consists of the realization of a partial gastrectomy of 2/3 (Fundus, gastric Body +/- antrum). However, lot of technical disagreements are brought back by expert teams. The most important disagreement concerns the conservation or the exeresis of the gastric antrum. In fact, the conservation of gastric antrum could facilitate the gastric emptying and to decrease the RGO (main complication) and act on the regulations of hormones modulators of the insulino-secretion.
A prospective,randomized study comparing these both techniques is necessary to determine a unique consensual technique
Detailed description
The main objective of this study is to compare the frequency of post-operative gastronomic appearance of gastroesophageal reflux(RGO) between two techniques of longitudinal gastrectomy under laparoscopy (gastrectomy coupling sleeve with antrum conservation or without antrum conservation) at patients with morbid obesity.
There are lot of secondary outcomes assessed in this study. In fact, one of secondary objectives is to compare between both techniques of longitudinal gastrectomy under laparoscopy described in the literature the efficiency on the loss of weight and global post-operative morbidity.
This study assess the impact of these surgery techniques on the comorbidity of the obesity and their treatments (type 2 diabetes, arterial hypertension, sleep apnea syndrome, arthralgia, dyslipemia).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bariatric surgery 1 | Other | Procedure: bariatric surgeryLongitudinal gastrectomy (sleeve gastrectomy) is a technique of bariatric surgery. In this arm, patients have a bariatric surgery with conservation of gastric antrum. |
| bariatric surgery 2 | Experimental | Procedure: bariatric surgeryLongitudinal gastrectomy (sleeve gastrectomy) is a technique of bariatric surgery. In this arm, patients have a bariatric surgery with ablation of gastric antrum. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with an indication of bariatric surgery (Recommendations HAS) defined as follows:
- IMC = 40kg/m² with failure of the dietary treatments during at least 1 year, or
- IMC = 35kg/m ² if associated comorbidity (HTA, diabetes, gonarthrose, sleep apnea, dyslipidemia, severe respiratory diseases)
- Patients motivated by this surgery and to accept the post-operative constraints.
- Age: > 18 years and < 65 years.
Key exclusion criteria (13 listed)
- Women Patients presenting a current pregnancy (not effective contraception during the first year after surgery) or in age to procreate and without means of effective contraception (oestroprogestational)
- patient with a contraindication to the anesthesia
- patient with grave psychiatric disorders (psychotic, paranoid)
- Emotionally unstable Patient or showing psychiatric characteristics which according to the opinion of the psychologist or the surgeon are incompatible with this type of surgery
- patient with surgical histories esogastric
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 |
|---|---|---|
| bariatric surgeryThe longitudinal gastrectomy (sleeve gastrectomy) is a technique of bariatric surgery recently validated (HAS on 2008).It consists of the realization of a partial gastrectomy of 2/3 (Fundus, gastric Body +/- antrum). However, lot of technical disagreements are brought back by expert teams. The most important disagreement concerns the conservation or the exeresis of the gastric antrum. In fact, the conservation of gastric antrum could facilitate the gastric emptying and to decrease the RGO (main complication) and act on the regulations of hormones modulators of the insulino-secretion. | Procedure or surgery | bariatric surgery 1, bariatric surgery 2 |
Primary outcome
Comparison of the frequency appearance of RGO after surgery intervention (between two techniques longitudinal gastrectomy) in patients of morbid obesity
Time frame: 12 months
The main objective of this study is to compare the frequency of post-operative gastronomic appearance of gastroesophagal reflux(RGO) between both techniques of longitudinal gastrectomy under laparoscopy (gastrectomy coupling sleeve with antrum conservation or without antrum conservation) at patients with morbid obesity.
3 secondary outcomes
Assessment of efficiency on loss of weight and global post-operative morbidity between both surgery techniques.
Time frame: 12 months
Impact assessment of both types' surgery on the comorbidity and treatments of obesity
Time frame: 12 months
Assessment of gastrinemia between both groups (efficacy assessment)
Time frame: at 1,3,12 months
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 10 Jan 2020.
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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.
Nocca David, PU-PH principal investigator
CHRU de Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bariatric surgery in people with Obesity, Morbid, run by University Hospital, Montpellier at 1 site in France.
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 8 inclusion and 13 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 10 Jan 2020. 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 France. 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?
Comparison of the frequency appearance of RGO after surgery intervention (between two techniques longitudinal gastrectomy) in patients of morbid obesity (time frame: 12 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 10 Jan 2020.