ObesityHH-N SleeveNCT06835790
Comparative 3-year Study of Nissen-sleeve vs. Sleeve Plus Cruroplasty in Obese Patients With Hiatal Hernia
A study testing Ph-measurement, Questionnaires and gastroduodenal transit in people with Obesity and Hiatal Hernia, run by Elsan at 1 site in France.
Trial summary
The success of laparoscopic sleeve gastrectomy (LSG) is not only due to its proven efficacy in the treatment of obesity and associated to comorbidities in the short and long term, but also because it is considered as less technically complicated compared to other malabsorptive procedures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Hiatal Hernia
- What is being tested?
- Ph-measurement, Questionnaires and gastroduodenal transit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 2 Mar 2025to 2 Nov 2031
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patient,
- Patient with severe obesity (BMI >35) with comorbidity or morbidity (BMI >40),
- Patient awaiting a sleeve gastrectomy,
- Patient with a hiatal hernia <or= 4 cm,
- Patient having undergone a gastroscopy,
- Patient having undergone an esophagogastroduodenal transit (OGDT),
- Patient having been informed and having given their free, informed and written consent,
- Patient affiliated with or beneficiary of a social security scheme.
Who cannot join
- Patient with poorly controlled diabetes,
- Patient with major esophageal motility disorders,
- Patient with a Hiatal Hernia > 4cm,
- History of bariatric surgery, history of ring,
- Patient refusing pH-metry examination,
- Refusal to participate in the study,
Show all 9Show fewer
- Patient under legal protection,
- Patient not benefiting from health protection,
- Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision.
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
Clinique Saint Michel
Toulon, 83100
Sergio Dr Carandina, 04 94 03 96 20, sergio.carandina@gmail.com
About this study
The success of laparoscopic sleeve gastrectomy (LSG) is not only due to its proven efficacy in the treatment of obesity and associated to comorbidities in the short and long term, but also because it is considered as less technically complicated compared to other malabsorptive procedures. Unfortunately, the main long-term side effect of LSG appears to be the development of severe gastroesophageal reflux (GERD). This problem is aggravated by the concomitant presence of a hiatal hernia at the time of surgery. Indeed, by causing laxity of the lower esophageal sphincter (LES), the hiatal hernia reduces the barrier functions of the esophageal-gastric junction against the reflux of gastric contents.
The classic combination of sleeve and hiatal hernia treatment by cruroplasty gives contradictory results and several surgeons prefer to perform only the sleeve without addressing the hiatal hernia especially if it is small (<4 cm). For this reason a modification of the usual surgical technique of LSG has been proposed by adding a Nissen fundoplication-Nissen Sleeve (NS). The intentions of this technique were to minimize the rate of postoperative GERD especially for patients with hiatal hernia, to protect the staple line of the angle of His, and finally to provide a safe and effective alternative for patients with a contraindication to LRYGB due to GERD. Although the first results of the technique are encouraging, the realization of the Nissen valve remains a sensitive technical point that can transform a relatively simple procedure like LSG into a more complex procedure like NS. The only test able to directly identify and classify gastric reflux is pH-metry with or without esophageal manometry. Unfortunately, especially due to the difficulty of access to the examination, there are no studies with solid scientific bases that identify the correct conduct to adopt in the case of an obese patient with a hiatal hernia (with or without preoperative reflux).
The main objective of this study is to evaluate the occurence or worsening of GERD at 3 years following a Nissen-sleeve vs. sleeve plus cruroplasty intervention in patients with obesity and hiatal hernia.
- Conditions
- Obesity, Hiatal Hernia
- Being tested
- Ph-measurement, Questionnaires, gastroduodenal transit
- Medical subject headings
- Obesity, Hernia, Hiatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ph-measurementDiagnostic test
Ph measurement before and after the surgery
QuestionnairesOther
GERD-HRQL Reflux symptom index scale before and after surgery
gastroduodenal transitDiagnostic test
Imaging test that uses the properties of X-rays - after the administration of a radiopaque contrast agent (usually barium) - to visualize the upper digestive tract: the esophagus, stomach, and duodenum (the upper segment of the small intestine).
| Study group | Role | What they receive |
|---|---|---|
| Nissen sleeve surgery | Experimental | Not described Receives: Diagnostic Test: Ph-measurement; Other: Questionnaires; Diagnostic Test: gastroduodenal transit |
| Sleeve plus cruroplasty | Active comparator | Not described Receives: Diagnostic Test: Ph-measurement; Other: Questionnaires; Diagnostic Test: gastroduodenal transit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appearance of GERD 3 years after surgery.
Occurrence if DeMeester score at 3 years is ≥ 14.72 (<14.72 before surgery) and/or treatment with proton pump inhibitors (PPIs) and/or Reflux Disease Questionnaire score > 10 (≤10 before surgery) and/or GERD-HRQL score > 16 (≤16 before surgery).
Measured: 3 years
Worsening of GERD 3 years after surgery.
Worsening if increase in DeMeester score at 3 years compared to that before the intervention and/or introduction or increase in the dose of PPI compared to that before the intervention and/or increase in the Reflux Disease Questionnaire score at 3 years compared to that before the intervention and/or increase in the GERD-HRQL score at 3 years compared to that before the intervention.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start2 Mar 2025 (estimated)
- Primary completion2 Nov 2028 (estimated)
- Study completion2 Nov 2031 (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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elsan
- Sponsor type
- University, hospital or other
- Collaborators
- Clinique saint-Michel de Toulon
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06835790
- Sponsor's protocol ID
- 2024-A00367-40
- Acronym
- HH-N Sleeve
- Status last verified
- Feb 2025
- First submitted
- 18 Feb 2025
- Last updated
- 19 Feb 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 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative 3-year Study of Nissen-sleeve vs. Sleeve Plus Cruroplasty in Obese Patients With Hiatal Hernia
- ClinicalTrials.gov ID
- NCT06835790
- Acronym / sponsor ID
- HH-N Sleeve / 2024-A00367-40
- Conditions
- Obesity, Hiatal Hernia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- ElsanUniversity, hospital or other
- Collaborators
- Clinique saint-Michel de Toulon
- Study start
- 2 Mar 2025 (estimated)
- Primary completion
- 2 Nov 2028 (estimated)
- Study completion
- 2 Nov 2031 (estimated)
- First posted
- 19 Feb 2025 (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 success of laparoscopic sleeve gastrectomy (LSG) is not only due to its proven efficacy in the treatment of obesity and associated to comorbidities in the short and long term, but also because it is considered as less technically complicated compared to other malabsorptive procedures. Unfortunately, the main long-term side effect of LSG appears to be the development of severe gastroesophageal reflux (GERD). This problem is aggravated by the concomitant presence of a hiatal hernia at the time of surgery. Indeed, by causing laxity of the lower esophageal sphincter (LES), the hiatal hernia reduces the barrier functions of the esophageal-gastric junction against the reflux of gastric contents.
The classic combination of sleeve and hiatal hernia treatment by cruroplasty gives contradictory results and several surgeons prefer to perform only the sleeve without addressing the hiatal hernia especially if it is small (<4 cm). For this reason a modification of the usual surgical technique of LSG has been proposed by adding a Nissen fundoplication-Nissen Sleeve (NS). The intentions of this technique were to minimize the rate of postoperative GERD especially for patients with hiatal hernia, to protect the staple line of the angle of His, and finally to provide a safe and effective alternative for patients with a contraindication to LRYGB due to GERD. Although the first results of the technique are encouraging, the realization of the Nissen valve remains a sensitive technical point that can transform a relatively simple procedure like LSG into a more complex procedure like NS. The only test able to directly identify and classify gastric reflux is pH-metry with or without esophageal manometry. Unfortunately, especially due to the difficulty of access to the examination, there are no studies with solid scientific bases that identify the correct conduct to adopt in the case of an obese patient with a hiatal hernia (with or without preoperative reflux).
The main objective of this study is to evaluate the occurence or worsening of GERD at 3 years following a Nissen-sleeve vs. sleeve plus cruroplasty intervention in patients with obesity and hiatal hernia.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nissen sleeve surgery | Experimental | Diagnostic Test: Ph-measurement, Other: Questionnaires, Diagnostic Test: gastroduodenal transit |
| Sleeve plus cruroplasty | Active comparator | Diagnostic Test: Ph-measurement, Other: Questionnaires, Diagnostic Test: gastroduodenal transit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adult patient,
- Patient with severe obesity (BMI >35) with comorbidity or morbidity (BMI >40),
- Patient awaiting a sleeve gastrectomy,
- Patient with a hiatal hernia <or= 4 cm,
- Patient having undergone a gastroscopy,
Key exclusion criteria (9 listed)
- Patient with poorly controlled diabetes,
- Patient with major esophageal motility disorders,
- Patient with a Hiatal Hernia > 4cm,
- History of bariatric surgery, history of ring,
- Patient refusing pH-metry examination,
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 |
|---|---|---|
| Ph-measurementPh measurement before and after the surgery | Diagnostic test | Nissen sleeve surgery, Sleeve plus cruroplasty |
| QuestionnairesGERD-HRQL Reflux symptom index scale before and after surgery | Other | Nissen sleeve surgery, Sleeve plus cruroplasty |
| gastroduodenal transitImaging test that uses the properties of X-rays - after the administration of a radiopaque contrast agent (usually barium) - to visualize the upper digestive tract: the esophagus, stomach, and duodenum (the upper segment of the small intestine). | Diagnostic test | Nissen sleeve surgery, Sleeve plus cruroplasty |
Primary outcome
Appearance of GERD 3 years after surgery.
Time frame: 3 years
Occurrence if DeMeester score at 3 years is ≥ 14.72 (<14.72 before surgery) and/or treatment with proton pump inhibitors (PPIs) and/or Reflux Disease Questionnaire score > 10 (≤10 before surgery) and/or GERD-HRQL score > 16 (≤16 before surgery).
Worsening of GERD 3 years after surgery.
Time frame: 3 years
Worsening if increase in DeMeester score at 3 years compared to that before the intervention and/or introduction or increase in the dose of PPI compared to that before the intervention and/or increase in the Reflux Disease Questionnaire score at 3 years compared to that before the intervention and/or increase in the GERD-HRQL score at 3 years compared to that before the intervention.
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 19 Feb 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ph-measurement, Questionnaires and gastroduodenal transit in people with Obesity and Hiatal Hernia, run by Elsan 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 9 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: opening soon, as of the sponsor's last update on 19 Feb 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?
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 Sergio D Carandina (00334 94 03 96 20, sergio.carandina@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Appearance of GERD 3 years after surgery. (time frame: 3 years). 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 19 Feb 2025.