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

Marius Svanevik, Hilde Risstad, Tor-Ivar Karlsen, Jon A Kristinsson, Milada Cvancarova Småstuen, Ronette L Kolotkin, Torgeir T Søvik, Rune Sandbu, Tom Mala, Jøran Hjelmesæth

Journal: Obesity surgery 2018;28(3):606-614

PMID: 28865057

Free Full Text on PubMed Central View on PubMed

Plain Language Summary

Bariatric surgery may induce weight loss, improvement of weight-associated comorbidities, and improved health and well-being. The aim of the study is to compare the effects of standard and distal Rou-en-Y gastric bypass on obesity-specific health related quality of life, weight-related symptoms, eating behaviour, anxiety and depression. The study is a double-blind, parallel-group randomised controlled trial. The participants’ age ranged from 18 to 60 years of age with a BMI of 50 to 60 kg/m2. Results indicated improvements in most patient-reported outcome measures after both surgeries, but no significant difference between groups after surgery in relation to obesity-specific health related quality of life, weight-related symptoms, anxiety and depression, or eating behaviour. Authors conclude that both surgeries lead to sustained weight loss and improved health related quality of life 2 years after surgery in patients with a BMI 50-60kg/m2.

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.

Address: Morbid Obesity Center, Vestfold Hospital Trust, Tønsberg, Norway. [email protected].; Institute of Clinical Medicine, University of Oslo, Oslo, Norway. [email protected].; Department of Gastrointestinal Surgery, Vestfold Hospital Trust, Tønsberg, Norway. [email protected].; Institute of Clinical Medicine, University of Oslo, Oslo, Norway.; Department of Endocrinology, Morbid Obesity, and Preventive Medicine, Oslo University Hospital, Oslo, Norway.; Morbid Obesity Center, Vestfold Hospital Trust, Tønsberg, Norway.; Department of Endocrinology, Morbid Obesity, and Preventive Medicine, Oslo University Hospital, Oslo, Norway.; Morbid Obesity Center, Vestfold Hospital Trust, Tønsberg, Norway.; Oslo and Akershus University College of Applied Science, Oslo, Norway.; Morbid Obesity Center, Vestfold Hospital Trust, Tønsberg, Norway.; Quality of Life Consulting, Durham, NC, USA.; Department of Endocrinology, Morbid Obesity, and Preventive Medicine, Oslo University Hospital, Oslo, Norway.; Department of Gastrointestinal Surgery, Oslo University Hospital, Oslo, Norway.; Morbid Obesity Center, Vestfold Hospital Trust, Tønsberg, Norway.; Department of Gastrointestinal Surgery, Vestfold Hospital Trust, Tønsberg, Norway.; Morbid Obesity Center, Vestfold Hospital Trust, Tønsberg, Norway.; Institute of Clinical Medicine, University of Oslo, Oslo, Norway.

DOI: 10.1007/s11695-017-2891-3

Patient Centred Factor

Triggers: Bariatric surgery

Physical Environment

Mind and spirit

Clinical Imbalances

Gastro-intestinal Structural Integrity and Musculoskeletal

Modifiable Lifestyle Factors

Diet Psychological

Jadad Score

Allocation Concealment

Yes

Nutrition Evidence Keywords

BMI Obesity Body mass index Weight loss Emotional eating

Link outs

Free resources

Full Text Sources:

Medical:

Other Literature Sources:

https://scite.ai/reports/28865057

Research Materials:

https://antibodies.cancer.gov/detail/CPTC-NT5E-1

Subscription / membership required

Full Text Sources:

https://dx.doi.org/10.1007/s11695-017-2891-3

MeSH Terms: Adult, Double-Blind Method, Female, Follow-Up Studies, Gastric Bypass, Humans, Life Style, Male, Middle Aged, Obesity, Morbid, Patient Reported Outcome Measures, Quality of Life, Self Report, Surveys and Questionnaires, Treatment Outcome, Weight Loss