Dataset Information

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

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.

SUBMITTER: Svanevik M

PROVIDER: S-EPMC5803278 | biostudies-literature | 2018 Mar

REPOSITORIES: biostudies-literature

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Publications

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

Svanevik Marius M Risstad Hilde H Karlsen Tor-Ivar TI Kristinsson Jon A JA Småstuen Milada Cvancarova MC Kolotkin Ronette L RL Søvik Torgeir T TT Sandbu Rune R Mala Tom T Hjelmesæth Jøran J

Obesity surgery 20180301 3

<h4>Background</h4>The preferred surgical procedure for treating morbid obesity is debated. Patient-reported outcome measures (PROMs) are relevant for evaluation of the optimal bariatric procedure.<h4>Methods</h4>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 ...[more]

PMID: 28865057

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Project description:BackgroundFew long-term or controlled studies of bariatric surgery have been conducted to date. We report the 12-year follow-up results of an observational, prospective study of Roux-en-Y gastric bypass that was conducted in the United States.MethodsA total of 1156 patients with severe obesity comprised three groups: 418 patients who sought and underwent Roux-en-Y gastric bypass (surgery group), 417 patients who sought but did not undergo surgery (primarily for insurance reasons) (nonsurgery group 1), and 321 patients who did not seek surgery (nonsurgery group 2). We performed clinical examinations at baseline and at 2 years, 6 years, and 12 years to ascertain the presence of type 2 diabetes, hypertension, and dyslipidemia.ResultsThe follow-up rate exceeded 90% at 12 years. The adjusted mean change from baseline in body weight in the surgery group was -45.0 kg (95% confidence interval [CI], -47.2 to -42.9; mean percent change, -35.0) at 2 years, -36.3 kg (95% CI, -39.0 to -33.5; mean percent change, -28.0) at 6 years, and -35.0 kg (95% CI, -38.4 to -31.7; mean percent change, -26.9) at 12 years; the mean change at 12 years in nonsurgery group 1 was -2.9 kg (95% CI, -6.9 to 1.0; mean percent change, -2.0), and the mean change at 12 years in nonsurgery group 2 was 0 kg (95% CI, -3.5 to 3.5; mean percent change, -0.9). Among the patients in the surgery group who had type 2 diabetes at baseline, type 2 diabetes remitted in 66 of 88 patients (75%) at 2 years, in 54 of 87 patients (62%) at 6 years, and in 43 of 84 patients (51%) at 12 years. The odds ratio for the incidence of type 2 diabetes at 12 years was 0.08 (95% CI, 0.03 to 0.24) for the surgery group versus nonsurgery group 1 and 0.09 (95% CI, 0.03 to 0.29) for the surgery group versus nonsurgery group 2 (P<0.001 for both comparisons). The surgery group had higher remission rates and lower incidence rates of hypertension and dyslipidemia than did nonsurgery group 1 (P<0.05 for all comparisons).ConclusionsThis study showed long-term durability of weight loss and effective remission and prevention of type 2 diabetes, hypertension, and dyslipidemia after Roux-en-Y gastric bypass. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and others.).

Project description:ContextExtreme obesity is associated with health and cardiovascular disease risks. Although gastric bypass surgery induces rapid weight loss and ameliorates many of these risks in the short term, long-term outcomes are uncertain.ObjectiveTo examine the association of Roux-en-Y gastric bypass (RYGB) surgery with weight loss, diabetes mellitus, and other health risks 6 years after surgery.Design, setting, and participantsA prospective Utah-based study conducted between July 2000 and June 2011 of 1156 severely obese (body mass index [BMI] ≥ 35) participants aged 18 to 72 years (82% women; mean BMI, 45.9; 95% CI, 31.2-60.6) who sought and received RYGB surgery (n = 418), sought but did not have surgery (n = 417; control group 1), or who were randomly selected from a population-based sample not seeking weight loss surgery (n = 321; control group 2).Main outcome measuresWeight loss, diabetes, hypertension, dyslipidemia, and health-related quality of life were compared between participants having RYGB surgery and control participants using propensity score adjustment.ResultsSix years after surgery, patients who received RYGB surgery (with 92.6% follow-up) lost 27.7% (95% CI, 26.6%-28.9%) of their initial body weight compared with 0.2% (95% CI, -1.1% to 1.4%) gain in control group 1 and 0% (95% CI, -1.2% to 1.2%) in control group 2. Weight loss maintenance was superior in patients who received RYGB surgery, with 94% (95% CI, 92%-96%) and 76% (95% CI, 72%-81%) of patients receiving RYGB surgery maintaining at least 20% weight loss 2 and 6 years after surgery, respectively. Diabetes remission rates 6 years after surgery were 62% (95% CI, 49%-75%) in the RYGB surgery group, 8% (95% CI, 0%-16%) in control group 1, and 6% (95% CI, 0%-13%) in control group 2, with remission odds ratios (ORs) of 16.5 (95% CI, 4.7-57.6; P < .001) vs control group 1 and 21.5 (95% CI, 5.4-85.6; P < .001) vs control group 2. The incidence of diabetes throughout the course of the study was reduced after RYGB surgery (2%; 95% CI, 0%-4%; vs 17%; 95% CI, 10%-24%; OR, 0.11; 95% CI, 0.04-0.34 compared with control group 1 and 15%; 95% CI, 9%-21%; OR, 0.21; 95% CI, 0.06-0.67 compared with control group 2; both P < .001). The numbers of participants with bariatric surgery-related hospitalizations were 33 (7.9%), 13 (3.9%), and 6 (2.0%) for the RYGB surgery group and 2 control groups, respectively.ConclusionAmong severely obese patients, compared with nonsurgical control patients, the use of RYGB surgery was associated with higher rates of diabetes remission and lower risk of cardiovascular and other health outcomes over 6 years.

Project description:ObjectiveThe aim of this retrospective study was to evaluate the oral health-related quality of life (oHRQoL) and patient-reported outcome measures (PROMs) after 10 years of supportive periodontal care (SPC).Material and methodsPatients were re-examined 120±12 months after active periodontal therapy. Dental and periodontal status and oHRQoL by completing Oral Health Impact Profile-G49 (OHIP-G49) and PROMs by marking a visual analogue scale (VAS) for self-perceived esthetics (VASe), chewing function (VASc), and hygiene ability (VASh) were assessed. Patient- and tooth-related factors (age, insurance status, number of SPC, compliance, change of therapist, smoking, tooth loss, need for surgery or antibiotic intake, bleeding on probing (BOP), periodontal inflamed surface area) influencing oHRQoL and PROMs were evaluated.ResultsOne hundred eight periodontally compromised patients (59 female, mean age 65.4±10.7 years) lost 135 teeth during 10 years of SPC. At re-examination, 1.8% of all sites showed PPD ≥6mm. The mean OHIP-G49 sum score was 17.6±18.5, and VAS resulted in 76.0±22.5 (VASe), 86.3±16.3 (VASc), and 79.8±15.8 (VASh). Linear regression analyses identified a positive correlation with oHRQoL and/or PROMs for private insurance status (OHIP-G49, p=0.015, R2=0.204; VASc, p=0.005, R2=0.084; VASh, p=0.012, R2=0.222) and compliance to SPC (VASe, p=0.032; R2=0.204), as well as a negative correlation for active smoking (VASc, p=0.012, R2=0.084), increased BOP (VASh, p=0.029, R2=0.222) at the start of SPC, and number of lost molars (VASh, p=0.008, R2=0.222).ConclusionIt is realistic to obtain satisfactory oHRQoL and PROM values in most of the patients after 10 years of SPC. The identified factors may help to predict patient satisfaction in the long-term course of therapy.Clinical relevanceSystematic therapy of periodontally compromised patients provides values for oHRQoL and PROMs in a favorable range 10 years after therapy. This should encourage dentists to implement SPC in their daily routine.Clinical trial numberNCT03048045.

Dataset Information

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

Background

Methods

Results

Conclusions

Trial registration

Publications

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

Similar Datasets

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