Sleeve-pex: A Randomized Trial to Reduce Reflux After Sleeve Gastrectomy
NCT ID: NCT05704348
Last Updated: 2024-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
550 participants
INTERVENTIONAL
2023-09-04
2030-12-31
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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No gastropexy
Sleeve gastrectomy without gastropexy.
Sleeve gastrectomy without gastropexy
Sleeve gastrectomy without suturing the gastric remnant to the gastrocolic ligament.
Gastropexy
Sleeve gastrectomy with gastropexy
Sleeve gastrectomy with gastropexy
Gastropexy in this project means suturing the gastric remnant to the gastrocolic ligament.
Interventions
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Sleeve gastrectomy with gastropexy
Gastropexy in this project means suturing the gastric remnant to the gastrocolic ligament.
Sleeve gastrectomy without gastropexy
Sleeve gastrectomy without suturing the gastric remnant to the gastrocolic ligament.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Use of ARM for other reasons than reflux
* Previous antireflux surgery
* Inability to comprehend and respon to patient related outcome (PRO) questionnaire
18 Years
ALL
No
Sponsors
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Helse Forde
OTHER
Responsible Party
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Villy Våge
Project leader
Principal Investigators
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Villy Vage, MD PhD
Role: STUDY_CHAIR
Helse Forde
Locations
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Helse Forde
Førde, , Norway
Aleris Oslo
Oslo, , Norway
Volda sjukehus
Volda, , Norway
Voss sjukehus
Voss, , Norway
Countries
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Central Contacts
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Facility Contacts
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Bent Johnny Nergård, MD
Role: primary
Therese Saunes, MD
Role: primary
Jonas Nedkvitne, MD
Role: primary
Other Identifiers
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421917
Identifier Type: -
Identifier Source: org_study_id
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