NCT07347093

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
199

participants targeted

Target at P50-P75 for all trials

Timeline
1mo left

Started Nov 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress89%
Nov 2025May 2026

Study Start

First participant enrolled

November 1, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 16, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2026

Expected
Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

5 months

First QC Date

December 16, 2025

Last Update Submit

January 15, 2026

Conditions

Keywords

Roux-en-Y gastric bypassAnatomical reversalIndicationsComplicationsOutcomes

Outcome Measures

Primary Outcomes (1)

  • Symptom relief

    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.

    Through study completion, an average of 2 years.

Secondary Outcomes (5)

  • Indications for surgery

    Through study completion, an average of 2 years.

  • Weight outcome after surgery

    Through study completion, an average of 2 years.

  • Complications

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

  • Height

    Through study completion, an average of 2 years

  • BMI

    Through study completion, an average of 2 years.

Other Outcomes (1)

  • Surgical technique

    Perioperative/periprocedural

Study Arms (1)

Adults (≥ 18years) who underwent reversal of RYGB

Included patients were adults (≥ 18years) who underwent reversal of RYGB between 2007 and 2023. Exclusion criteria included emergency reversal due to bowel ischemia, reversal following other bariatric procedures (e.g. gastric banding), or partial/functional reversals (e.g., gastro-gastric fistula or anastomosis between the Roux-limb and gastric remnant, without full reversal of RYGB)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

National registry-based cohort

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vrinnevi Hospital

Norrköping, 60182, Sweden

Location

Study Officials

  • Ellen A Andersson, MD

    Department of Surgery, Vrinnevi Hospital, Norrköping, and Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor, senior consultant

Study Record Dates

First Submitted

December 16, 2025

First Posted

January 16, 2026

Study Start

November 1, 2025

Primary Completion

March 31, 2026

Study Completion (Estimated)

May 31, 2026

Last Updated

January 20, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Since reversal of RYGB is a rare procedure the risk of identifying individual patients is considerable even if data are pseudonymized.

Locations