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

Obes Surg. 2018 Mar;28(3):606-614. doi: 10.1007/s11695-017-2891-3.

Abstract

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.

Keywords: Bariatric surgery; Health-related quality of life; Lifestyle modification; Outcome; Quality of life.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Double-Blind Method
  • Female
  • Follow-Up Studies
  • Gastric Bypass / methods*
  • Gastric Bypass / rehabilitation*
  • Gastric Bypass / standards
  • Humans
  • Life Style
  • Male
  • Middle Aged
  • Obesity, Morbid / surgery*
  • Patient Reported Outcome Measures
  • Quality of Life*
  • Self Report
  • Surveys and Questionnaires
  • Treatment Outcome
  • Weight Loss

Associated data

  • ClinicalTrials.gov/NCT00821197