Table 1.
Outcome parameters
| Outcome | Measurement | Time point | |
|---|---|---|---|
| Primary | Percent total weight loss | %TWL | 5 years |
| Secondary | Percent total weight loss | %TWL | Other follow-up moments |
| Weight loss |
• %EWL • %EBMIL • 22 ≤ BMI ≤ 30 kg/m2 |
Each follow-up moment | |
| Defecation |
• Mean daily bowel movements • Number of days with daily bowel movements > 3 in the last 2 weeks |
Each follow-up moment | |
| Remission of T2D, hypertension, and OSA |
• Current use of medication • HbA1c • Blood pressure • Use of CPAP or other devices |
Each follow-up moment | |
| Nutritional deficiencies | Vitamins A, B1, B6, B12, and D; iron; folic acid; calcium; phosphate; albumin; and zinc | 6 months and 1, 2, 3, 4, and 5 years | |
| Copper and selenium | 1, 3, and 5 years | ||
| Quality of life | OBESI-Q [15] | Preoperative, 6 months, 12, 18, 30, 42, 54, and 60 months | |
| Symptoms of dumping syndrome | DSS [16] | Preoperative, 6 months, 12, 18, 30, 42, 54, and 60 months |
TWL total weight loss, EWL excess weight loss, EBMIL excess BMI loss, BMI body mass index, T2D diabetes mellitus type 2, OSA obstructive sleep apnea
Follow-up moments: 6, 12, 18, 24, 30, 36, 42, 48, 54, and 60 months