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NCT Number: NCT07347093

Reversal of Roux-en-Y Gastric Bypass: A Swedish National Cohort Study

Objective:

To investigates incidence, indications, symptom relief, complications, and weight outcomes after Roux-en-Y gastric bypass (RYGB) reversal.

Background:

RYGB is an effective treatment for obesity, but in rare cases may be associated with severe long-term complications requiring RYGB reversal. Evidence on incidence and outcomes is limited.

Methods:

This nationwide, multi-center, retrospective cohort study included all patients undergoing RYGB reversal in Sweden between 2007 and 2023. Data were obtained from the Scandinavian Obesity Surgery Registry (SOReg) and medical records.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Gastric Bypass Surgery Complications After Bariatric Surgery Revisional Bariatric Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vrinnevi Hospital

Norrköping, 60182, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients (≥ 18years) who underwent reversal of RYGB between 2007 and 2023.

Exclusion criteria

  • Emergency reversal due to bowel ischemia
  • Reversal following other bariatric procedures (e.g. gastric banding)
  • Partial/functional reversals (e.g., gastro-gastric fistula or anastomosis between the Roux-limb and gastric remnant, without full reversal of RYGB)

Treatment and study plan

Primary outcomes

  1. Symptom relief

    Time frame: Through study completion, an average of 2 years.

    Symptom relief is classified as no, partial, or complete improvement.

    Complete improvement was defined as full resolution of the index symptom (e.g., cessation of hypoglycemia, pain-free status without analgesics).

    Partial improvement denoted a clinically meaningful reduction in symptom severity or frequency that did not meet criteria for complete resolution.

    No improvement indicated persistent symptoms.

Secondary outcomes

  1. Indications for surgery

    Time frame: Through study completion, an average of 2 years.

    Indications are categorized as abdominal pain, malnutrition, gastrointestinal symptoms, post-bariatric hypoglycemia, and psychological distress, and reported as number (frequencies).

  2. Weight outcome after surgery

    Time frame: Through study completion, an average of 2 years.

    Weigth [in kilograms] will be reported at baseline (before surgery), at one year follow-up, and two-year follow-up.

  3. Complications

    Time frame: At 30-day follow-up and one-year follow-up after surgery.

    Complications after surgery are registered as any complication and major complication (defined as Clavien-Dindo classification >=3b), presented as number (frequencies).

  4. Height

    Time frame: Through study completion, an average of 2 years

    Height (in meters) will be used to report BMI (in kg/m2).

  5. BMI

    Time frame: Through study completion, an average of 2 years.

    Weight (in kilograms) and height (in meters) will be combined to report BMI (in kg/m2) at baseline (before surgery), at one year follow-up, andat two-year follow-up.

Other outcomes

  1. Surgical technique

    Time frame: Perioperative/periprocedural

    • Surgical approach (laparoscopic or open procedure)
    • Handling of the Roux limb (resection or reconnection)
    • Jejuno-jejunostomy technique (stapled/handsewn)
    • Pyloroplasty/pyloromyotomy (yes/no)
    • Gastro-gastrostomy technique (stapled/handsewn)
    • Blood loss during surgery (ml)
    • Operation time (minutes) -all data presented as number (frequencies)

Sponsors and collaborators

Lead sponsor

Vrinnevi Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 16, 2026
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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