How Does Bariatric Surgery Affect Social Experiences and Well-being - The BaSES-study

Study acronym: BaSES
StatusCompleted
PhaseNot applicable
Started

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Record History

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  1. Trial status changed: Enrolling by Invitation → Completed Show 5 more changesShow less
    • Final enrollment: 134 participants (planned 113)
    • Study completion date changed from estimate of Jun 2026 to Nov 5, 2025
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints: details revised at 16 of 22 entries
    • Publications: details revised at 8 of 8 entries
  2. Secondary endpoints: 21 to 22v6
  3. Primary completion date: Dec 2024 to Dec 2025v5
  4. Primary completion date: Aug 2024 to Dec 2024
    • Study completion date: Jun 2025 to Jun 2026
    v4
  5. Re-verified, no change to tracked fieldsv3
  6. Trial status: Not Yet Recruiting to Enrolling by Invitationv2 Show 7 more changesShow less
    • Start date changed from estimate of Jan 2022 to May 12, 2022
    • Primary endpoint revised
    • Enrollment target: 140 to 113
    • Study sites: 0 to 1
    • Interventions: Gastric bypass (Procedure), Sleeve gastrectomy (Procedure) to Gastric bypass (Procedure), Single anastomosis sleeve ileal (SASI) bypass (Procedure), Sleeve gastrectomy (Procedure)
    • Secondary endpoints: 20 to 21
    • Study arms: 2 to 3
  7. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Nonrandomized controlled trial to assess whether or not sleeve gastrectomy (SG) or Roux-en-Y gastric bypass (RYGB) affect social experiences and biomarkers of well-being 6 weeks and 1 year after surgery. The decision whether SG or RYGB will be performed is determined by medical decision making. Hypotheses: Bariatric surgery influences social experiences and well-being through changes in body image, reward responsivity and gut hormones. These changes may differ between gastric bypass (RYGB) and sleeve gastrectomy (SG).
Trial Details
NCT Number NCT05207917
Lead Sponsor The Hospital of Vestfold
Collaborators: University of Oslo
Conditions
(from sponsor)		 Obesity
Related terms Obesity
Enrollment 134 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov