Patient-Reported Outcome Measures 2 Years After Standard and Distal Gastric Bypass—a Double-Blind Randomized Controlled Trial

• Published in: Obesity surgery 2018-03, Vol.28 (3), p.606-614
• Main Authors: Svanevik, Marius, Risstad, Hilde, Karlsen, Tor-Ivar, Kristinsson, Jon A., Småstuen, Milada Cvancarova, Kolotkin, Ronette L, Søvik, Torgeir T, Sandbu, Rune, Mala, Tom, Hjelmesæth, Jøran
• Format: Article
• Language: English
• Subjects: Adult; Clinical outcomes; Double-Blind Method; Double-blind studies; Female; Follow-Up Studies; Gastric Bypass - methods; Gastric Bypass - rehabilitation; Gastric Bypass - standards; Gastrointestinal surgery; Humans; Life Style; Male; Medicine; Medicine & Public Health; Middle Aged; Obesity; Obesity, Morbid - surgery; Original Contributions; Patient Reported Outcome Measures; Quality of Life; Self Report; Surgery; Surgical outcomes; Surgical techniques; Surveys and Questionnaires; Treatment Outcome; Weight control; Weight Loss
• ISSN: 0960-8923; 1708-0428
• DOI: 10.1007/s11695-017-2891-3

Background The preferred surgical procedure for treating morbid obesity is debated. Patient-reported outcome measures (PROMs) are relevant for evaluation of the optimal bariatric procedure. Methods A total of 113 patients with BMI from 50 to 60 were randomly assigned to standard ( n  = 57) or distal ( n  = 56) Roux-en-Y gastric bypass (RYGB). Validated PROMS questionnaires were completed at baseline and 2 years after surgery. Data were analyzed using mixed models for repeated measures and the results are expressed as estimated means and mean changes. Results Obesity-related quality of life improved significantly after both procedures, without significant between-group differences (− 0.4 (95% CI = − 8.4, 7.2) points, p  = 0.88, ES = 0.06). Both groups had significant reductions in the number of weight-related symptoms and symptom distress score, with a mean group difference (95% CI) of 1.4 (− 0.3, 3.3) symptoms and 5.0 (2.9. 12.8) symptom distress score points. There were no between-group differences for uncontrolled eating (22.0 (17.2–26.7) vs. 28.9 (23.3–34.5) points), cognitive restraint (57.4 (52.0–62.7) vs. 62.1 (57.9–66.2) points), and emotional eating (26.8 (20.5–33.1) vs. 32.6 (25.5–39.7) points). The prevalence of anxiety was 33% after standard and 25% after distal RYGB ( p  = 0.53), and for depression 12 and 9%, respectively ( p  = 0.76). Conclusions There were no statistically significant differences between standard and distal RYGB 2 years post surgery regarding weight loss, obesity-related quality of life, weight-related symptoms, anxiety, depression, or eating behavior. Trial Registration Clinical Trials.gov number NCT00821197