deltatrials
Active Not Recruiting INTERVENTIONAL NCT00923819

4XL Study - Obesity Surgery in Adolescence (4XL)

4XL-Study - Obesity Surgery in Adolescence

Sponsor: Sykehuset i Vestfold HF

Updated 10 times since 2017 Last updated: Apr 21, 2026 Started: Jun 1, 2009 Primary completion: Aug 1, 2033 Completion: Dec 1, 2035
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT00923819, this observational or N/A phase trial focuses on Obesity, Morbid and remains ongoing. Sponsored by Sykehuset i Vestfold HF, it has been updated 10 times since 2009, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Study Description(click to expand)

The study has two intervention arms: Experimental: Group A Surgery; laparoscopic gastric bypass Active comparator: Group B Patients from Child Obesity Registry of Vestfold who get standard conservative treatment in a multidisiplinary team at Morbid Obesity Center. All patients are referred to Morbid Obesity Center from other hospitals or general practionairs in Norway. The procedure will take place at the Vestfold Hospital Trust The participants are included for 2 years follow-up with visits to a multidisciplinary team every 3rd month at the Morbid Obesity Center. Total follow-up time is ten years.

The study has two intervention arms:

Experimental: Group A Surgery; laparoscopic gastric bypass

Active comparator: Group B Patients from Child Obesity Registry of Vestfold who get standard conservative treatment in a multidisiplinary team at Morbid Obesity Center.

All patients are referred to Morbid Obesity Center from other hospitals or general practionairs in Norway. The procedure will take place at the Vestfold Hospital Trust The participants are included for 2 years follow-up with visits to a multidisciplinary team every 3rd month at the Morbid Obesity Center. Total follow-up time is ten years.

Status Flow

~Jan 2017 – ~Jun 2018 · 17 months · monthly snapshotRecruiting~Jun 2018 – ~Jan 2019 · 7 months · monthly snapshotRecruiting~Jan 2019 – ~Apr 2020 · 15 months · monthly snapshotRecruiting~Apr 2020 – ~Jan 2021 · 9 months · monthly snapshotRecruiting~Jan 2021 – ~Sep 2023 · 32 months · monthly snapshotRecruiting~Sep 2023 – ~May 2024 · 8 months · monthly snapshotActive Not Recruiting~May 2024 – ~Jul 2024 · 2 months · monthly snapshotActive Not Recruiting~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotActive Not Recruiting~Sep 2024 – ~Apr 2026 · 20 months · monthly snapshotActive Not RecruitingApr 28, 2026 – present · 2 months · daily APIActive Not Recruiting

Change History

10 versions recorded
  1. Apr 28, 2026 — Present [daily]

    Active Not Recruiting

    Phase: NANone

  2. Sep 2024 — Apr 2026 [monthly]

    Active Not Recruiting NA

  3. Jul 2024 — Sep 2024 [monthly]

    Active Not Recruiting NA

  4. May 2024 — Jul 2024 [monthly]

    Active Not Recruiting NA

  5. Sep 2023 — May 2024 [monthly]

    Active Not Recruiting NA

    Status: RecruitingActive Not Recruiting

Show 5 earlier versions
  1. Jan 2021 — Sep 2023 [monthly]

    Recruiting NA

  2. Apr 2020 — Jan 2021 [monthly]

    Recruiting NA

  3. Jan 2019 — Apr 2020 [monthly]

    Recruiting NA

  4. Jun 2018 — Jan 2019 [monthly]

    Recruiting NA

  5. Jan 2017 — Jun 2018 [monthly]

    Recruiting NA

    First recorded

Jun 2009

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

The purpose of this study on adolescents between 13 and 18 years of age with morbid obesity is to determine whether surgical treatment gives more health benefits than standard conservative treatment, and if laparoscopic gastric bypass is a method with high safety and a low complication rate.

Contact Information

Sponsor contact:
  • Sykehuset i Vestfold HF
  • The Hospital of Vestfold
Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations