Gastroesophageal RefluxNCT05704348
Sleeve-pex: A Randomized Trial to Reduce Reflux After Sleeve Gastrectomy
A study testing Sleeve gastrectomy with gastropexy and Sleeve gastrectomy without gastropexy in people with Gastroesophageal Reflux, run by Helse Forde at 4 sites in Norway.
Trial summary
The goal of this clinical trial is to test gastropexy as a measure to reduce reflux in morbidly obese patients being submitted to sleeve gastrectomy. The main questions it aims to answer are: Does gastropexy reduce reflux symptoms? Does gastropexy reduce objective evidence of reflux? Participants will be randomized to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroesophageal Reflux
- What is being tested?
- Sleeve gastrectomy with gastropexy and Sleeve gastrectomy without gastropexy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 550 participants
- Where
- 4 sitesNorway
- Study dates
- 4 Sep 2023to Dec 2030
- 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
- Patients planned for bariatric surgery with primary LSG
Who cannot join
- Age below 18 yrs
- Use of ARM for other reasons than reflux
- Previous antireflux surgery
- Inability to comprehend and respon to patient related outcome (PRO) questionnaire
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Norway4 sites, 4 recruiting
- Not yet recruiting
Helse Forde
Førde
Villy Våge, PhD, 47 90863744, villy.vage@helse-bergen.no
John Roger Andersen, PhD, 47 48278186, john.roger.andersen@helse-forde.no
- Recruiting
Aleris Oslo
Oslo
Bent Johnny Nergård, MD
- Recruiting
Volda sjukehus
Volda
Therese Saunes, MD
- Recruiting
Voss sjukehus
Voss
Jonas Nedkvitne, MD
About this study
Official title: A Clinical Intervention Study Exploring Gastropexy as a Measure to Reduce Gastro-oesophageal Reflux Disease After Laparoscopic Sleeve Gastrectomy
The goal of this clinical trial is to test gastropexy as a measure to reduce reflux in morbidly obese patients being submitted to sleeve gastrectomy. The main questions it aims to answer are:
Does gastropexy reduce reflux symptoms? Does gastropexy reduce objective evidence of reflux? Participants will be randomized to gastropexy or no gastropexy, and researchers will compare these groups to see if reflux (symptoms / objective evidence of) is different in the two groups.
Read the detailed description
Laparoscopic sleeve gastrectomy (LSG) has become the most commonly performed bariatric procedure worldwide. LSG consists of a longitudinal resection of the stomach leaving the intestines intact, thereby lowering the risk for side-effects due to rerouting of the small bowel. However, gastro-esopageal reflux disease (GERD) has been reported to increase after LSG. Our hypothesis is that GERD is mainly due to intrathoracic migration of the gastric remnant. The aim of this study is to explore if suturing the gastric remnant to the gastrocolic ligament (gastropexy) will prevent intrathoracic migration and thereby reduce the development of reflux.
Patients planned for a sleeve gastrectomy will be invited to participate, and participating patients will be randomized to pexi or no pexi. According to power calculations a total of 550 patients will be randomized in the study. Follow-up will be at six weeks, one-, two- and five years.
- Conditions
- Gastroesophageal Reflux
- Being tested
- Sleeve gastrectomy with gastropexy, Sleeve gastrectomy without gastropexy
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleeve gastrectomy with gastropexyProcedure or surgery
Gastropexy in this project means suturing the gastric remnant to the gastrocolic ligament.
Sleeve gastrectomy without gastropexyProcedure or surgery
Sleeve gastrectomy without suturing the gastric remnant to the gastrocolic ligament.
| Study group | Role | What they receive |
|---|---|---|
| No gastropexy | Active comparator | Sleeve gastrectomy without gastropexy. Receives: Procedure: Sleeve gastrectomy without gastropexy |
| Gastropexy | Experimental | Sleeve gastrectomy with gastropexy Receives: Procedure: Sleeve gastrectomy with gastropexy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants using acid-reducing medication (ARM) or having had reoperations due to GERD
ARM: Daily use of ARM for the last month
Measured: Two years
Secondary outcomes (3)
Endoscopic findings
Visible oesophagitis according to the LA classification
Measured: Two years
Patient related outcome
GerdQ questionnaire
Measured: Two years
pH-metry
pH measurement by Bravo capsule
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2023
- Study start4 Sep 2023
- Primary completionDec 2027 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal RefluxStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helse Forde
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Villy Våge, Helse Forde
- Investigators
- Villy Vage, MD PhD, Study chair, Helse Forde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05704348
- Sponsor's protocol ID
- 421917
- Status last verified
- Oct 2024
- First submitted
- 10 Jan 2023
- Last updated
- 30 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Information about Sleeve-pex will be found at the SOReg-N webpage.
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Intervention Study Exploring Gastropexy as a Measure to Reduce Gastro-oesophageal Reflux Disease After Laparoscopic Sleeve Gastrectomy
- ClinicalTrials.gov ID
- NCT05704348
- Acronym / sponsor ID
- 421917
- Conditions
- Gastroesophageal Reflux
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- Helse FordeUniversity, hospital or other
- Study start
- 4 Sep 2023 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 30 Jan 2023 (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 goal of this clinical trial is to test gastropexy as a measure to reduce reflux in morbidly obese patients being submitted to sleeve gastrectomy. The main questions it aims to answer are:
Does gastropexy reduce reflux symptoms? Does gastropexy reduce objective evidence of reflux? Participants will be randomized to gastropexy or no gastropexy, and researchers will compare these groups to see if reflux (symptoms / objective evidence of) is different in the two groups.
Detailed description
Laparoscopic sleeve gastrectomy (LSG) has become the most commonly performed bariatric procedure worldwide. LSG consists of a longitudinal resection of the stomach leaving the intestines intact, thereby lowering the risk for side-effects due to rerouting of the small bowel. However, gastro-esopageal reflux disease (GERD) has been reported to increase after LSG. Our hypothesis is that GERD is mainly due to intrathoracic migration of the gastric remnant. The aim of this study is to explore if suturing the gastric remnant to the gastrocolic ligament (gastropexy) will prevent intrathoracic migration and thereby reduce the development of reflux.
Patients planned for a sleeve gastrectomy will be invited to participate, and participating patients will be randomized to pexi or no pexi. According to power calculations a total of 550 patients will be randomized in the study. Follow-up will be at six weeks, one-, two- and five years.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No gastropexy | Active comparator | Procedure: Sleeve gastrectomy without gastropexySleeve gastrectomy without gastropexy. |
| Gastropexy | Experimental | Procedure: Sleeve gastrectomy with gastropexySleeve gastrectomy with gastropexy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients planned for bariatric surgery with primary LSG
Key exclusion criteria (4 listed)
- Age below 18 yrs
- Use of ARM for other reasons than reflux
- Previous antireflux surgery
- Inability to comprehend and respon to patient related outcome (PRO) questionnaire
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 |
|---|---|---|
| Sleeve gastrectomy with gastropexyGastropexy in this project means suturing the gastric remnant to the gastrocolic ligament. | Procedure or surgery | Gastropexy |
| Sleeve gastrectomy without gastropexySleeve gastrectomy without suturing the gastric remnant to the gastrocolic ligament. | Procedure or surgery | No gastropexy |
Primary outcome
Number of participants using acid-reducing medication (ARM) or having had reoperations due to GERD
Time frame: Two years
ARM: Daily use of ARM for the last month
3 secondary outcomes
Endoscopic findings
Time frame: Two years
Patient related outcome
Time frame: Two years
pH-metry
Time frame: Two years
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 30 Oct 2024.
- Individual participant dataSharing planned: Yes. Information about Sleeve-pex will be found at the SOReg-N webpage.
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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.
Villy Vage, MD PhD study chair
Helse Forde
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleeve gastrectomy with gastropexy and Sleeve gastrectomy without gastropexy in people with Gastroesophageal Reflux, run by Helse Forde at 4 sites in Norway.
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 1 inclusion and 4 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 30 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Norway. 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 Villy Vage, MD PhD (47 90863744, villy.vage@helse-bergen.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants using acid-reducing medication (ARM) or having had reoperations due to GERD (time frame: Two years). 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 Oct 2024.