ObesityNCT06271317
Evaluation of Possible Postoperative Complications After Nissen Sleeve Gastrectomy. French Multicenter Study
An observational study of Obesity, run by Nantes University Hospital at 1 site in France.
Trial summary
The purpose of this study is to evaluate the impact about complications between the procedure (sleeve gastrectomy technique with a Nissen fundoplication (N-Sleeve)) and conventional sleeve gastrectomy technique Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2024to Mar 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 years and older
- All sexes
- Adult, Older adult
Study population: 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 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).
- Previous reflux surgery
- BMI > 50 kg / m² for women and > 45kg / m² for men (dissecting the hiatus region can be a technical challenge in these cases).
Show all 11Show fewer
- Barrett oesophagus and esophagitis stage III and IV.
- Funditis
- 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. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Nantes
Nantes, Nantes, 44000
Claire Blanchard, MD; PhD
Alexandra Poinas, 0603197295, alexandra.poinas@chu-nantes.fr
About this study
The purpose of this study is to evaluate the impact about complications between the procedure (sleeve gastrectomy technique with a Nissen fundoplication (N-Sleeve)) and conventional sleeve gastrectomy technique
Read the detailed description
Obesity is currently a major health problem. 2% of the French adult population is morbidly obese (BMI>40kg/m²). In this case, the only effective treatment is bariatric surgery. More than 50,000 acts of bariatric surgery were performed in 2018 in France. Three main operations are considered: Sleeve Gastrectomy (SG), Roux en Y Gastric Bypass (RYGB) and Gastric Banding.
SG was validated by the Haute Autorité de Santé (HAS) in 2008 and is the most widely used procedure in France (35,580 operations in 2018). It consists of a 2/3 partial gastrectomy. Long-term weight loss of 61 ± 23% is expected, with significant improvement in obesity-related comorbidities.
However, this technique is associated with postoperative complications. Gastric fistula (2%), most often located at the upper end of the stapling line, bleeding from the gastric section (2%) and gastric stenosis (1%) are the most frequent early postoperative complications that may require reoperation. In addition, gastroesophageal reflux disease (GERD) is very common (30-57%), and can have serious consequences for the esophageal mucosa (esophagitis, Barrett's esophagus, cancer). Alarmingly high rates of Barrett's esophagus (17-18%) after SG have recently been described in the long term, causing concern in the medical community. This may be an exacerbation of preoperative GERD symptoms or "de novo" postoperative GERD. Medical treatment is generally effective (proton pump inhibitors (PPIs)). However, the long-term safety of PPIs has not been demonstrated. What's more, these patients' quality of life may be considerably reduced, and re-intervention (gastric Y-bypass) may be necessary to treat refractory GERD.
The classic surgical treatment for GERD, independently of bariatric surgery, is fundoplication, which can be partial (180°: Toupet technique) or total (360°: Nissen technique). The gastric fundus is wrapped around the esophagus to reinforce the esophageal sphincter.
Nissen-Sleeve Gastrectomy (Nissen-SG) is an innovative technique performed in expert centers in France. It consists in creating a total anti-reflux fundoplicature (Nissen) before performing a SG.
A prospective non-comparative pilot study of 25 patients who underwent Nissen-SG in 2014 at Montpellier University Hospital, showed that while 92% of patients had symptoms of GERD preoperatively, 24% were symptomatic at 3 months after Nissen and SG, only 12% had clinical GERD at 6 months and 1 year postoperatively. Excess weight loss at 1 year was 59%, similar to the efficacy of conventional SG, although a larger gastric residual volume was left after Nissen-SG but used as plication. The 5-year results were presented at the SOFFCO 2020 congress and at the International Federation of Obesity Surgery (IFSO) congress. Excess weight loss (EWL) was 70.87% (112 patients) and 58.32% (31 patients) at 2 and 5 years follow-up. Less than 7% of patients had GERD symptoms at 5 years.
Our hypothesis is that the creation of a total anti-reflux fundoplicature prior to performing SLEEVE could significantly reduce the rate of postoperative GERD observed with standard SLEEVE.
What's more, the creation of a Nissen fundoplicature means that a gastric section is made away from the HIS angle (the area most at risk of fistula (90%)), which could reduce this complication almost definitively (no gastric fistula on the staple line in this pilot study).
Quality of life and socio-economic impact could be significant if such hypotheses are confirmed. However, complications specific to the Nissen sleeve, such as dilatation and perforation of the envelope, were also reported in this prospective trial. A 3.9% rate of perioperative complications after Nissen Sleeve was described after the learning curve of the procedure on 301 patients (2018-2020).
Our aim in this study is to highlight that there are no more complications when performing Nissen-SG than SG (taking published PMSI data) and to show a decrease in post-operative GERD after Nissen-SG. To achieve this, data will be collected on patients undergoing Nissen-SG surgery in 2022 until 2024 in 18 French hospitals. For these patients, any post-operative complications and the presence/evolution of GERD will be collected and compared with SG data available in the literature.
- Conditions
- Obesity
- Keywords
- Nissen sleeve gastrectomy, Morbidity-Fistula-Bariatric surgery, Sleeve gastrectomy
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Nissen sleeve gastrectomy | Nissen sleeve gastrectomy patients | |
| Sleeve gastrectomy with the data of PMSI | Sleeve gastrectomy with the data of PMSI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study postoperative morbidity after nissen sleeve gastrectomy in Nantes
Collection of complications at 30 days post-op (aphagia, valve necrosis, fistula, etc.) and classification according to Dindo-Clavien.
Measured: 30 days post operation
postoperative morbidity of nissen sleeve gastrectomy with sleeve gastrectomy in France
Comparison of Nissen Sleeve Gastrectomy data at 30d post-op (aphagia, valve necrosis, fistula...) with published PMSI sleeve gastrectomy data.
Measured: 30 days post operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start1 Mar 2024
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (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.
- More trials run by Nantes University HospitalThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06271317
- Sponsor's protocol ID
- AP_CL_001
- Status last verified
- Jun 2026
- First submitted
- 14 Feb 2024
- Last updated
- 24 Jun 2026
- 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 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Possible Postoperative Complications After Nissen Sleeve Gastrectomy. French Multicenter Study
- ClinicalTrials.gov ID
- NCT06271317
- Acronym / sponsor ID
- AP_CL_001
- Conditions
- Obesity
- Keywords
- Nissen sleeve gastrectomy, Morbidity-Fistula-Bariatric surgery, Sleeve gastrectomy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 21 Feb 2024 (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 about complications between the procedure (sleeve gastrectomy technique with a Nissen fundoplication (N-Sleeve)) and conventional sleeve gastrectomy technique
Detailed description
Obesity is currently a major health problem. 2% of the French adult population is morbidly obese (BMI>40kg/m²). In this case, the only effective treatment is bariatric surgery. More than 50,000 acts of bariatric surgery were performed in 2018 in France. Three main operations are considered: Sleeve Gastrectomy (SG), Roux en Y Gastric Bypass (RYGB) and Gastric Banding.
SG was validated by the Haute Autorité de Santé (HAS) in 2008 and is the most widely used procedure in France (35,580 operations in 2018). It consists of a 2/3 partial gastrectomy. Long-term weight loss of 61 ± 23% is expected, with significant improvement in obesity-related comorbidities.
However, this technique is associated with postoperative complications. Gastric fistula (2%), most often located at the upper end of the stapling line, bleeding from the gastric section (2%) and gastric stenosis (1%) are the most frequent early postoperative complications that may require reoperation. In addition, gastroesophageal reflux disease (GERD) is very common (30-57%), and can have serious consequences for the esophageal mucosa (esophagitis, Barrett's esophagus, cancer). Alarmingly high rates of Barrett's esophagus (17-18%) after SG have recently been described in the long term, causing concern in the medical community. This may be an exacerbation of preoperative GERD symptoms or "de novo" postoperative GERD. Medical treatment is generally effective (proton pump inhibitors (PPIs)). However, the long-term safety of PPIs has not been demonstrated. What's more, these patients' quality of life may be considerably reduced, and re-intervention (gastric Y-bypass) may be necessary to treat refractory GERD.
The classic surgical treatment for GERD, independently of bariatric surgery, is fundoplication, which can be partial (180°: Toupet technique) or total (360°: Nissen technique). The gastric fundus is wrapped around the esophagus to reinforce the esophageal sphincter.
Nissen-Sleeve Gastrectomy (Nissen-SG) is an innovative technique performed in expert centers in France. It consists in creating a total anti-reflux fundoplicature (Nissen) before performing a SG.
A prospective non-comparative pilot study of 25 patients who underwent Nissen-SG in 2014 at Montpellier University Hospital, showed that while 92% of patients had symptoms of GERD preoperatively, 24% were symptomatic at 3 months after Nissen and SG, only 12% had clinical GERD at 6 months and 1 year postoperatively. Excess weight loss at 1 year was 59%, similar to the efficacy of conventional SG, although a larger gastric residual volume was left after Nissen-SG but used as plication. The 5-year results were presented at the SOFFCO 2020 congress and at the International Federation of Obesity Surgery (IFSO) congress. Excess weight loss (EWL) was 70.87% (112 patients) and 58.32% (31 patients) at 2 and 5 years follow-up. Less than 7% of patients had GERD symptoms at 5 years.
Our hypothesis is that the creation of a total anti-reflux fundoplicature prior to performing SLEEVE could significantly reduce the rate of postoperative GERD observed with standard SLEEVE.
What's more, the creation of a Nissen fundoplicature means that a gastric section is made away from the HIS angle (the area most at risk of fistula (90%)), which could reduce this complication almost definitively (no gastric fistula on the staple line in this pilot study).
Quality of life and socio-economic impact could be significant if such hypotheses are confirmed. However, complications specific to the Nissen sleeve, such as dilatation and perforation of the envelope, were also reported in this prospective trial. A 3.9% rate of perioperative complications after Nissen Sleeve was described after the learning curve of the procedure on 301 patients (2018-2020).
Our aim in this study is to highlight that there are no more complications when performing Nissen-SG than SG (taking published PMSI data) and to show a decrease in post-operative GERD after Nissen-SG. To achieve this, data will be collected on patients undergoing Nissen-SG surgery in 2022 until 2024 in 18 French hospitals. For these patients, any post-operative complications and the presence/evolution of GERD will be collected and compared with SG data available in the literature.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nissen sleeve gastrectomy | – | –Nissen sleeve gastrectomy patients |
| Sleeve gastrectomy with the data of PMSI | – | –Sleeve gastrectomy with the data of PMSI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 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 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 (11 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).
- Previous reflux surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Study postoperative morbidity after nissen sleeve gastrectomy in Nantes
Time frame: 30 days post operation
Collection of complications at 30 days post-op (aphagia, valve necrosis, fistula, etc.) and classification according to Dindo-Clavien.
postoperative morbidity of nissen sleeve gastrectomy with sleeve gastrectomy in France
Time frame: 30 days post operation
Comparison of Nissen Sleeve Gastrectomy data at 30d post-op (aphagia, valve necrosis, fistula...) with published PMSI sleeve gastrectomy data.
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 24 Jun 2026.
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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.
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 Obesity, run by Nantes University Hospital 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 11 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 24 Jun 2026. 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?
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 Claire Louis, M.D (0240083022, Claire.BLANCHARD@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study postoperative morbidity after nissen sleeve gastrectomy in Nantes (time frame: 30 days post operation). 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 24 Jun 2026.