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Randomized Controlled Trial
. 2018 Mar;28(3):606-614.
doi: 10.1007/s11695-017-2891-3.

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

Marius Svanevik  1   2   3 , Hilde Risstad  4   5 , Tor-Ivar Karlsen  6 , Jon A Kristinsson  5 , Milada Cvancarova Småstuen  6   7 , Ronette L Kolotkin  6   8 , Torgeir T Søvik  5   9 , Rune Sandbu  6   10 , Tom Mala  5   9 , Jøran Hjelmesæth  6   4
Affiliations
Randomized Controlled Trial

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

Marius Svanevik et al. Obes Surg. 2018 Mar.

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.

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Conflict of interest statement

Conflict of Interest

Dr. Marius Svanevik reports grants from Southern and Eastern Norway Health Authority, during the conduct of the study.

Dr. Hilde Risstad has nothing to disclose.

Dr. Tor-Ivar Karlsen has nothing to disclose.

Dr. Jon A. Kristinsson has nothing to disclose.

Dr. Milada Cvancarova Småstuen has nothing to disclose.

Dr. Ronette L Kolotkin reports personal fees from Morbid Obesity Centre, Vestfold Hospital Trust, Tønsberg, Norway, during the conduct of the study.

Dr. Torgeir T Søvik has nothing to disclose.

Dr. Rune Sandbu has nothing to disclose.

Dr. Tom Mala reports grants from Health Region South East, Norway, during the conduct of the study; other from Medtronic, travel support to congress as invited lecturer outside the submitted work.

Dr. Jøran Hjelmesæth has nothing to disclose.

Informed Consent

Informed consent was obtained from all individual participants included in the study.

Human and Animal Rights

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Registration

www.clinicaltrials.gov no: NCT00821197

Figures

Fig. 1
Fig. 1
Modeled changes in obesity-specific quality of life and weight-related symptoms after standard and distal RYGB
See this image and copyright information in PMC

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