Severe ObesityN'SLEEVENCT04626232
Comparison of the Sleeve Gastrectomy Technique With a Nissen Fundoplication Added to the Conventional Sleeve Gastrectomy Technique in Morbidly Obese Patients
A study testing N-SLEEVE technique and SLEEVE in people with Severe Obesity and GERD, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The purpose of this study is to evaluate the impact of the procedure (sleeve gastrectomy technique with a Nissen fundoplication (N-Sleeve) vs conventional sleeve gastrectomy technique Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Severe Obesity, GERD, Bariatric Surgery Candidate
- What is being tested?
- N-SLEEVE technique and SLEEVE
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteFrance
- Study dates
- 12 Sep 2022to 30 Nov 2022
- 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
- Signed informed consent form
- Subjects must be able to attend all scheduled visits and to comply with all trial procedures
- Subjects must be covered by public health insurance
- Contraception efficacy
- Subjects eligible for sleeve gastrectomy after multidisciplinary evaluation according to HAS 2009 criteria: BMI ≥ 40 kg / m² with failure of the dietary treatment for at least 1 year, or a BMI ≥ 35kg / m² with at least one co-morbidity that could be improved after surgery (hypertension, obstructive sleep apnea hypopnea syndrome (OSAHS) and other severe respiratory disorders, severe metabolic disorders (especially type 2 diabetes), debilitating musculoskeletal diseases, non-alcoholic steato-hepatitis (NASH))
Who cannot join
- Subject unable to read or/and write
- Planned longer stay outside the region that prevents compliance with the visit plan
- Current pregnancy
- Previous bariatric surgery (ring, vertical banded gastroplasty, sleeve gastrectomy or Gastric Bypass).
- BMI > 50 kg / m² for women and > 45kg / m² for men (dissecting the hiatus region can be a technical challenge in these cases).
- Barrett oesophagus and esophagitis stage III and IV.
Show all 12Show fewer
- Funditis
- Long-term NSAIDs and/or corticosteroid therapy
- No affiliation at the French social security scheme.
- Major protected by law.
- Deprivation of liberty by judicial or administrative decision.
- Participation to another clinical research program.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Monocentric Prospective Randomized Controlled Study Comparing the Sleeve Gastrectomy Technique With a Nissen Fundoplication Added to the Conventional Sleeve Gastrectomy Technique (N-Sleeve) in Morbidly Obese Patients
The purpose of this study is to evaluate the impact of the procedure (sleeve gastrectomy technique with a Nissen fundoplication (N-Sleeve) vs conventional sleeve gastrectomy technique
Read the detailed description
Bariatric surgery is recognized as the only effective therapeutic weapon for morbidly obese patients. Gastro-Oesophageal Reflux Disease is very common (30-45% of cases) with serious consequences on the oesophageal mucosa. It could be an exacerbation of preoperative GERD symptoms or a "de novo" postoperative GERD. Medical treatment is usually effective but reoperation may be required to treat refractory GERD.GERD can lead to serious consequences on the oesophageal mucosa (esophagitis, Barrett's oesophagus, cancer). The conventional surgical treatment of GERD is fundoplication, which can be partial or total. The gastric fundus is wrapped around the oesophagus to strengthen the tone of the oesophageal sphincter. We hypothesize that the creation of a total anti-reflux fundoplication before performing LSG (Nissen + Sleeve = N-sleeve) could significantly reduce the postoperative GERD complication as compared with the standard LSG.
To evaluate the impact of the procedure N-Sleeve vs conventional sleeve gastrectomy technique on the rate of patient with GERD at 1, 6 and 12 months postoperatively. To evaluate the impact of the procedure (sleeve gastrectomy technique with a Nissen fundoplication (N-Sleeve) vs conventional sleeve gastrectomy technique during all the follow-up on the gastric fistula on the staple line, on the postoperative morbidity and mortality , on the evolution of weight loss, the excess weight loss, the BMI and the excess BMI loss during the follow-up. Evaluate the impact of these procedures on the quality of life of patients at baseline and 1, 6 and 12 months postoperatively. Evaluate the safety during all the follow-up.
•Methods: Monocentric, randomized, single-blind controlled trial, with 2 parallel arms. 144 patients. The target population is all adult patients with severe or morbid obesity, who underwent multidisciplinary care and having the criteria of 2009 HAS recommendations for bariatric surgery.
Presence of gastro-oesophageal reflux will be assessed by a composite criteria: consumption of Proton Pump Inhibitor and gastroscopy at baseline and 12-month.
The N-SLEEVE technique consists of creating a gastric total fundoplication before to perform the removal of 2/3 of the stomach.
This study may really lead to a change in terms of choice of first intention bariatric procedures.
- Conditions
- Severe Obesity, GERD, Bariatric Surgery Candidate, Morbid Obesity
- Being tested
- N-SLEEVE technique, SLEEVE
- Keywords
- Obesity, GERD, Surgery
- Medical subject headings
- Obesity, Morbid, Gastroesophageal Reflux, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-SLEEVE techniqueProcedure or surgery
The N-SLEEVE technique (figure 2) consists of creating a gastric total fundoplication (Nissen technique) before to perform the removal of 2/3 of the stomach (SLEEVE technique).
SLEEVEProcedure or surgery
SLEEVE Technique : Removal of 2/3 of the stomach
| Study group | Role | What they receive |
|---|---|---|
| N SLEEVE | Experimental | Monocentric, randomized, single-blind controlled trial, with 2 parallel arms (experimental technique versus surgical reference technique). Receives: Procedure: N-SLEEVE technique |
| SLEEVE | Other | The conventional sleeve gastrectomy technique consists of reducing the gastric capacity by removing 2/3 of the stomach by a vertical transection. Receives: Procedure: SLEEVE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of gastroesophageal reflux disease
Gastroscopy is a standard endoscopic examination that examines the lining of the oesophagus and stomach. It can detect Helicobacter pylori and highlight the presence of:
- Gastro-Oesophageal Reflux Disease
- Gastritis
- Esophagitis
- Barrett's oesophagus
- Hiatal hernia
- Gastric tumor
- Bile reflux
- Incompetent cardia
Measured: 12 months
Consumption of Proton Pump Inhibitor
The consumption of PPI, revealing the presence of GERD symptoms, will be recorded at each visit thanks a diary card.
Measured: 12 months
Secondary outcomes (21)
type of fistula Month 1
The diagnosis is confirmed by conducting a CT with contrast medium opacification. 4 stages are defined I, II, III and IV. TDM will be realized only in case of suspicion of fistulas (fever, pain in the left shoulder, vomiting).
The type, the severity and the time between the date of occurrence of fistula and the date of the surgery will be recorded at each visit.
Measured: Month 1
severity of fistula Month 1
The severity of fistula is classified depending on the classification of Montpellier 2013 (Nedelcu)
Measured: Month 1
type of fistula Month 6
The diagnosis is confirmed by conducting a CT with contrast medium opacification. 4 stages are defined I, II, III and IV. TDM will be realized only in case of suspicion of fistulas (fever, pain in the left shoulder, vomiting).
The type, the severity and the time between the date of occurrence of fistula and the date of the surgery will be recorded at each visit.
Measured: Month 6
severity of fistula Month 6
The severity of fistula is classified depending on the classification of Montpellier 2013 (Nedelcu)
Measured: Month 6
type of fistula Month 12
The diagnosis is confirmed by conducting a CT with contrast medium opacification. 4 stages are defined I, II, III and IV. TDM will be realized only in case of suspicion of fistulas (fever, pain in the left shoulder, vomiting).
The type, the severity and the time between the date of occurrence of fistula and the date of the surgery will be recorded at each visit.
Measured: Month 12
severity of fistula Month 12
The severity of fistula is classified depending on the classification of Montpellier 2013 (Nedelcu)
Measured: Month 12
Postoperative morbidity Month 1
Assessed by the type of postoperative complication
Measured: Month 1
Postoperative morbidity Month 6
Assessed by the frequency of each type of postoperative complication
Measured: Month 6
Postoperative morbidity Month 12
Assessed by the severity of each type of postoperative complication
Measured: Month 12
Weight loss Month 1
The evolution of the weight of the patients will be assessed by measuring their weight in kilograms on the same scale at each visit in the digestive surgery service. The height (in meter) will be assessed at baseline in the digestive surgery service. The BMI will be calculated at each visit.
Measured: Month 1
Weight loss Month 6
The evolution of the weight of the patients will be assessed by measuring their weight in kilograms on the same scale at each visit in the digestive surgery service. The height (in meter) will be assessed at baseline in the digestive surgery service. The BMI will be calculated at each visit.
Measured: Month 6
Weight loss Month 12
The evolution of the weight of the patients will be assessed by measuring their weight in kilograms on the same scale at each visit in the digestive surgery service. The height (in meter) will be assessed at baseline in the digestive surgery service. The BMI will be calculated at each visit.
Measured: Month 12
mortality Month 1
number of death
Measured: Month 1
mortality Month 6
number of death
Measured: Month 6
mortality Month 12
number of death
Measured: Month 12
Quality of Life Month 1 : SF 12
Quality of life will be assessed by the self-questionnaire SF12
Measured: Month 1
Quality of Life Month 6 : SF 12
Quality of life will be assessed by the self-questionnaire SF12
Measured: Month 6
Quality of Life Month 12 : SF 12
Quality of life will be assessed by the self-questionnaire SF12
Measured: Month 12
Serious adverse event Month 1
number and type of adverse events
Measured: Month 1
safety Month 6: number and type of adverse events
number and type of adverse events
Measured: Month 6
safety Month 12: number and type of adverse events
number and type of adverse events
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2020
- Study start12 Sep 2022
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Why it stopped: no inclusions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe ObesityStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04626232
- Sponsor's protocol ID
- RECHMPL20_0013
- Acronym
- N'SLEEVE
- Status last verified
- Sep 2025
- First submitted
- 8 Oct 2020
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monocentric Prospective Randomized Controlled Study Comparing the Sleeve Gastrectomy Technique With a Nissen Fundoplication Added to the Conventional Sleeve Gastrectomy Technique (N-Sleeve) in Morbidly Obese Patients
- ClinicalTrials.gov ID
- NCT04626232
- Acronym / sponsor ID
- N'SLEEVE / RECHMPL20_0013
- Conditions
- Severe Obesity, GERD, Bariatric Surgery Candidate, Morbid Obesity
- Keywords
- Obesity, GERD, Surgery
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: no inclusions
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 12 Sep 2022 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 12 Nov 2020 (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.
The purpose of this study is to evaluate the impact of the procedure (sleeve gastrectomy technique with a Nissen fundoplication (N-Sleeve) vs conventional sleeve gastrectomy technique
Detailed description
Bariatric surgery is recognized as the only effective therapeutic weapon for morbidly obese patients. Gastro-Oesophageal Reflux Disease is very common (30-45% of cases) with serious consequences on the oesophageal mucosa. It could be an exacerbation of preoperative GERD symptoms or a "de novo" postoperative GERD. Medical treatment is usually effective but reoperation may be required to treat refractory GERD.GERD can lead to serious consequences on the oesophageal mucosa (esophagitis, Barrett's oesophagus, cancer). The conventional surgical treatment of GERD is fundoplication, which can be partial or total. The gastric fundus is wrapped around the oesophagus to strengthen the tone of the oesophageal sphincter. We hypothesize that the creation of a total anti-reflux fundoplication before performing LSG (Nissen + Sleeve = N-sleeve) could significantly reduce the postoperative GERD complication as compared with the standard LSG.
To evaluate the impact of the procedure N-Sleeve vs conventional sleeve gastrectomy technique on the rate of patient with GERD at 1, 6 and 12 months postoperatively. To evaluate the impact of the procedure (sleeve gastrectomy technique with a Nissen fundoplication (N-Sleeve) vs conventional sleeve gastrectomy technique during all the follow-up on the gastric fistula on the staple line, on the postoperative morbidity and mortality , on the evolution of weight loss, the excess weight loss, the BMI and the excess BMI loss during the follow-up. Evaluate the impact of these procedures on the quality of life of patients at baseline and 1, 6 and 12 months postoperatively. Evaluate the safety during all the follow-up.
•Methods: Monocentric, randomized, single-blind controlled trial, with 2 parallel arms. 144 patients. The target population is all adult patients with severe or morbid obesity, who underwent multidisciplinary care and having the criteria of 2009 HAS recommendations for bariatric surgery.
Presence of gastro-oesophageal reflux will be assessed by a composite criteria: consumption of Proton Pump Inhibitor and gastroscopy at baseline and 12-month.
The N-SLEEVE technique consists of creating a gastric total fundoplication before to perform the removal of 2/3 of the stomach.
This study may really lead to a change in terms of choice of first intention bariatric procedures.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| N SLEEVE | Experimental | Procedure: N-SLEEVE techniqueMonocentric, randomized, single-blind controlled trial, with 2 parallel arms (experimental technique versus surgical reference technique). |
| SLEEVE | Other | Procedure: SLEEVEThe conventional sleeve gastrectomy technique consists of reducing the gastric capacity by removing 2/3 of the stomach by a vertical transection. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signed informed consent form
- Subjects must be able to attend all scheduled visits and to comply with all trial procedures
- Subjects must be covered by public health insurance
- Contraception efficacy
- Subjects eligible for sleeve gastrectomy after multidisciplinary evaluation according to HAS 2009 criteria: BMI ≥ 40 kg / m² with failure of the dietary treatment for at least 1 year, or a BMI ≥ 35kg / m² with at least one co-morbidity that could be improved after surgery (hypertension, obstructive sleep apnea hypopnea syndrome (OSAHS) and other severe respiratory disorders, severe metabolic disorders (especially type 2 diabetes), debilitating musculoskeletal diseases, non-alcoholic steato-hepatitis (NASH))
Key exclusion criteria (12 listed)
- Subject unable to read or/and write
- Planned longer stay outside the region that prevents compliance with the visit plan
- Current pregnancy
- Previous bariatric surgery (ring, vertical banded gastroplasty, sleeve gastrectomy or Gastric Bypass).
- BMI > 50 kg / m² for women and > 45kg / m² for men (dissecting the hiatus region can be a technical challenge in these cases).
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 |
|---|---|---|
| N-SLEEVE techniqueThe N-SLEEVE technique (figure 2) consists of creating a gastric total fundoplication (Nissen technique) before to perform the removal of 2/3 of the stomach (SLEEVE technique). | Procedure or surgery | N SLEEVE |
| SLEEVESLEEVE Technique : Removal of 2/3 of the stomach | Procedure or surgery | SLEEVE |
Primary outcome
Presence of gastroesophageal reflux disease
Time frame: 12 months
Gastroscopy is a standard endoscopic examination that examines the lining of the oesophagus and stomach. It can detect Helicobacter pylori and highlight the presence of: * Gastro-Oesophageal Reflux Disease * Gastritis * Esophagitis * Barrett's oesophagus * Hiatal hernia * Gastric tumor * Bile reflux * Incompetent cardia
Consumption of Proton Pump Inhibitor
Time frame: 12 months
The consumption of PPI, revealing the presence of GERD symptoms, will be recorded at each visit thanks a diary card.
21 secondary outcomes
type of fistula Month 1
Time frame: Month 1
severity of fistula Month 1
Time frame: Month 1
type of fistula Month 6
Time frame: Month 6
severity of fistula Month 6
Time frame: Month 6
type of fistula Month 12
Time frame: Month 12
severity of fistula Month 12
Time frame: Month 12
Postoperative morbidity Month 1
Time frame: Month 1
Postoperative morbidity Month 6
Time frame: Month 6
Postoperative morbidity Month 12
Time frame: Month 12
Weight loss Month 1
Time frame: Month 1
Weight loss Month 6
Time frame: Month 6
Weight loss Month 12
Time frame: Month 12
mortality Month 1
Time frame: Month 1
mortality Month 6
Time frame: Month 6
mortality Month 12
Time frame: Month 12
Quality of Life Month 1 : SF 12
Time frame: Month 1
Quality of Life Month 6 : SF 12
Time frame: Month 6
Quality of Life Month 12 : SF 12
Time frame: Month 12
Serious adverse event Month 1
Time frame: Month 1
safety Month 6: number and type of adverse events
Time frame: Month 6
safety Month 12: number and type of adverse events
Time frame: Month 12
Results and safety
The study was stopped early (reason given: no inclusions). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing N-SLEEVE technique and SLEEVE in people with Severe Obesity and GERD, 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 5 inclusion and 12 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: stopped early, as of the sponsor's last update on 3 Oct 2025. 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 was stopped early (reason given: no inclusions). 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?
Presence of gastroesophageal reflux disease (time frame: 12 months). 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 3 Oct 2025.