Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Indications for surgery | Indications are categorized as abdominal pain, malnutrition, gastrointestinal symptoms, post-bariatric hypoglycemia, and psychological distress, and reported as number (frequencies). | Through study completion, an average of 2 years. |
| Weight outcome after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical technique |
| Perioperative/periprocedural |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
National registry-based cohort
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ellen A Andersson, MD | Department of Surgery, Vrinnevi Hospital, Norrköping, and Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vrinnevi Hospital | Norrköping | 60182 | Sweden |
Since reversal of RYGB is a rare procedure the risk of identifying individual patients is considerable even if data are pseudonymized.
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 1, 2025 | Dec 16, 2025 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
Not provided
Weigth [in kilograms] will be reported at baseline (before surgery), at one year follow-up, and two-year follow-up. |
| Through study completion, an average of 2 years. |
| Complications | Complications after surgery are registered as any complication and major complication (defined as Clavien-Dindo classification >=3b), presented as number (frequencies). | At 30-day follow-up and one-year follow-up after surgery. |
| Height | Height (in meters) will be used to report BMI (in kg/m2). | Through study completion, an average of 2 years |
| BMI | 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. | Through study completion, an average of 2 years. |