Dataset Information

Laparoscopic fundoplication versus laparoscopic Roux-en-Y gastric bypass for gastro-oesophageal reflux disease in obese patients: protocol for a randomized clinical trial

ABSTRACT: Abstract

Background

Laparoscopic fundoplication (LF) is the standard surgical procedure for the treatment of gastro-oesophageal reflux disease (GORD). Laparoscopic Roux-en-Y gastric bypass (LRYGB) is commonly performed to achieve weight loss in obese patients, but it also has anti-reflux properties. Hence, in the obese population suffering from GORD, LRYGB could be an alternative to LF. The aim of this trial will be to compare LF and LRYGB in an obese population presenting with GORD and being considered for surgery.

Methods

This will be an investigator-initiated randomized clinical trial. The research population will be obese patients (BMI 30–34.9 with waist circumference more than 88 cm (women) or more than 102 cm (men), or BMI 35–40 with any waist circumference) referred to a public hospital for consideration of anti-reflux surgery. The primary aim of the study will be to determine the efficacy of LF compared with LRYGB on subjective and objective control of GORD. Secondary aims include determining early and late surgical morbidity and the side-effect profile of LF compared with LRYGB and to quantify any non-reflux benefits of LRYGB (including overall quality of life) compared with LF.

Conclusion

This trial will determine whether LRYGB is effective and acceptable as an alternative to LF for the surgical treatment of GORD in obese patients Registration number: Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12622000636752p (https://www.anzctr.org.au/). This is an investigator-initiated randomized clinical trial of laparoscopic fundoplication (LF) versus laparoscopic Roux-en-Y gastric bypass (LRYGB) for the treatment of gastro-oesophageal reflux disease (GORD) in obese patients (BMI 30–34.9 with waist circumference more than 88 cm (women) or more than 102 cm (men), or BMI 35–40 with any waist circumference). The primary outcome will be the difference in treatment success (defined as a reduction of 50 per cent of more in the GERD-HRQL score between the preoperative and 1 year values) after LRYGB compared with LF. Secondary outcomes will include identification of any difference in treatment success at 5 years (decrease of 50 per cent of more in the GERD-HRQL score between the preoperative value and the 5-year value), objective measures of GORD at 1 and 5 years (ambulatory pH study and endoscopy), non-GORD gastrointestinal symptom scores at 1 and 5 years, and subjective and objective metrics of overall health at 1 and 5 years.

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PROVIDER: S-EPMC9703586 | biostudies-literature | 2022 Nov

REPOSITORIES: biostudies-literature

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Project description:IntroductionLaparoscopic sleeve gastrectomy (LSG) and laparoscopic Roux-en-Y gastric bypass (LRYGB) are the most frequently performed procedures in bariatric surgery. In patients with morbid obesity and gastro-oesophageal reflux disease (GORD), LRYGB is the most accepted procedure. For patients with a contraindication for LRYGB or a strong preference for LSG, the Nissen-Sleeve procedure may be a viable new option. The aim of this study is to compare effectiveness of Nissen-Sleeve with LRYGB.Method and analysisThis is a single-centre, phase III, parallel-group randomised controlled trial in a high-volume bariatric centre in the Netherlands. A total of 88 patients with morbid obesity and GORD will be randomised to evaluate non-inferiority of Nissen-Sleeve versus LRYGB (non-inferiority margin 15%, power 80%, one-sided α 0.025, 9% drop out). Patients with morbid obesity aged 18 years and older with GORD according to the Montreal definition will be included after obtaining informed consent. Exclusion criteria are achalasia, neoplastic abnormalities diagnosed during endoscopy, super obesity (body mass index ≥50 kg/m2), Crohn's disease and medical history of major abdominal surgery. After randomisation, all patients will undergo an upper gastrointestinal endoscopy. Patients in the Nissen-Sleeve arm will undergo a timed barium oesophagram to exclude oesophageal motility disorders. Patients will complete six questionnaires at baseline and every year until 5 years of follow-up. At day 1 postoperative, patients in the Nissen-Sleeve arm will undergo a swallow X-ray to confirm passage. At 1 year, all patients will undergo another endoscopy. The primary outcome is GORD status. Absence of GORD is defined as <8 points on the GORD questionnaire. Secondary outcome measures are long-term GORD improvement; failure rate of procedure; health-related quality of live; weight loss; proton pump inhibitor use; postoperative complications <30 days and >30 days; length of hospital stay; duration of primary surgery; effect on comorbidities; presence and grade of oesophagitis (grade A-D) and/or presence of Barrett's oesophagus and cost-effectiveness.Ethics and disseminationThe protocol was approved by the Medical Research Ethics Committees United (MEC-U), Nieuwegein, on 15 September 2021. Written informed consent will be obtained for all participants in the study. The study results will be disseminated through peer-reviewed publications and conference presentations.Trial registration numberNL9789; The Netherlands Trial Registry.

Project description:ImportanceThere is conflicting evidence about how different bariatric procedures impact health care use.ObjectiveTo compare the impact of laparoscopic adjustable gastric banding (AGB) and laparoscopic Roux-en-Y gastric bypass (RYGB) on health care use and costs.Design, setting, and participantsRetrospective interrupted time series with comparison series study using a national claims data set. The data analysis was initiated in September 2011 and completed in January 2015. We identified bariatric surgery patients aged 18 to 64 years who underwent a first AGB or RYGB between 2005 and 2011. We propensity score matched 4935 AGB to 4935 RYGB patients according to baseline age group, sex, race/ethnicity, socioeconomic variables, comorbidities, year of procedure and baseline costs, emergency department (ED) visits, and hospital days. Median postoperative follow-up time was 2.5 years.Main outcomes and measuresQuarterly and yearly total health care costs, ED visits, hospital days, and prescription drug costs. We used segmented regression to compare pre-to-post changes in level and trend of these measures in the AGB vs the RYGB groups and difference-in-differences analysis to estimate the magnitude of difference by year.ResultsBoth AGB and RYGB were associated with downward trends in costs; however, by year 3, AGB patients had total annual costs that were 16% higher than RYGB patients (P < .001; absolute change: $818; 95% CI, $278 to $1357). In postoperative years 1 and 2, AGB was associated with 27% to 29% fewer ED visits than RYGB (P < .001; absolute changes: -0.6; 95% CI, -0.9 to -0.4 and -0.4; 95% CI, -0.6 to -0.1 visits/person, respectively); however, by year 3, there were no detectable differences. Postoperative annual hospital days were not significantly different between the groups. Although both procedures lowered prescription costs, annual postoperative prescription costs were 17% to 32% higher for AGB patients than RYGB patients (P < .001).Conclusions and relevanceBoth laparoscopic AGB and RYGB were associated with flattened total health care cost trajectories but RYGB patients experienced lower total and prescription costs by 3 years postsurgery. On the other hand, RYGB was associated with increased ED visits in the 2 years after surgery. Clinicians and policymakers should weigh such differences in use and costs when making recommendations or shaping regulatory guidance about these procedures.

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