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Laparoscopic Sleeve Gastrectomy Versus Banded Roux-en-Y Gastric Bypass for Diabetes and Obesity: a Prospective Randomised Double-Blind Trial

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Abstract

Background

There are very few randomised, blinded trials comparing laparoscopic sleeve gastrectomy (LSG) versus laparoscopic Roux-en-Y gastric bypass (LRYGB) in achieving remission of type 2 diabetes (T2D), particularly silastic ring (SR)-LRYGB. We compared the effectiveness of (LSG) versus SR-LRYGB among patients with T2D and morbid obesity.

Methods

Prospective, randomised, parallel, 2-arm, blinded clinical trial conducted in a single Auckland (New Zealand) centre. Eligible patients aged 20–55 years, T2D of at least 6 months duration and BMI 35–65 kg/m2 were randomised 1:1 to LSG (n = 58) or SR-LRYGB (n = 56) using random number codes disclosed after anaesthesia induction. Primary outcome was T2D remission defined by different HbA1c thresholds at 1 year. Secondary outcomes included weight loss, quality of life, anxiety and depressive symptoms, post-operative complications and mortality.

Results

Mean ± standard deviation (SD) pre-operative BMI was 42.5 ± 6.2 kg/m2, HbA1c 63 ± 16 mmol/mol (30% insulin-treated, 28% had diabetes duration over 10 years). Proportions achieving HbA1c ≤ 38 mmol/mol, < 42 mmol/mol, < 48 mmol/mol and < 53 mmol/mol without diabetes medication at 1 year in SR-LRYGB vs LSG were 38 vs 43% (p = 0.56), 52 vs 49% (p = 0.85), 75 vs 72% (p = 0.83) and 80 vs 77% (p = 0.82), respectively. Mean ± SD % total weight loss at 1 year was greater after SR-LRYGB than LSG: 32.2 ± 7.7 vs 27.1 ± 7.5%, respectively (p < 0.001). Gastrointestinal complications were more frequent after SR-LRYGB (including 3 ulcers, 1 anastomotic leak, 1 abdominal bleeding). Quality of life and depression symptoms improved significantly in both groups.

Conclusion

Despite significantly greater weight loss after SR-LRYGB, there was similar T2D remission and psychosocial improvement after LSG and SR-LRYGB at 1 year.

Trial Registration

Prospectively registered at Australia and New Zealand Clinical Trials Register (ACTRN 12611000751976) and retrospectively registered at Clinical Trials (NCT1486680).

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Acknowledgements

We thank the staff at North Shore Hospital who assisted with this study and all the patients who took part.

Sources of Support

This investigator-initiated study was funded primarily through Waitemata District Health Board, which provides limited publically funded bariatric surgery (approximately 100 cases annually). Additional funding for blood sample storage and a research nurse salary was provided by Johnson and Johnson (NZ), Covidien (NZ), and Obex (NZ). The study sponsors had no role in the study design, in analysis or interpretation of data, or the manuscript preparation.

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Author notes

  1. Rinki Murphy, Michael G. Clarke and Michael W. C. Booth contributed equally to this paper

Authors and Affiliations

  1. Department of Medicine, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand

    Rinki Murphy

  2. Department of Surgery, North Shore Hospital, Waitemata District Health Board, Auckland, New Zealand

    Michael G. Clarke, Nicholas J. Evennett, S. John Robinson, M. Lee Humphreys, Hisham Hammodat, Bronwen Jones & Michael W. C. Booth

  3. Department of Endocrinology, Waitemata District Health Board, North Shore Hospital, Auckland, New Zealand

    David D. Kim & Richard Cutfield

  4. Department of Psychological Medicine, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand

    Malcolm H. Johnson

  5. Department of Surgery, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand

    Lindsay D. Plank

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  1. Rinki Murphy
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Contributions

MB and RM conceived this study. HH, LP, RC, DK, SG, MC, NE and JC contributed to study design. MB, MC, HH, NE, SR were primarily responsible for the surgical aspects of the study. RC and DK were primarily responsible for the medical assessment of participants. LP and MJ were responsible for the statistical analyses. RM and MC wrote the first draft of this manuscript. All authors read and contributed to the paper.

Corresponding author

Correspondence to Michael W. C. Booth.

Ethics declarations

Informed Consent

Informed consent was obtained from all individual participants included in the study. All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Conflict of Interest

The authors declare that they have no conflict of interest.

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Murphy, R., Clarke, M.G., Evennett, N.J. et al. Laparoscopic Sleeve Gastrectomy Versus Banded Roux-en-Y Gastric Bypass for Diabetes and Obesity: a Prospective Randomised Double-Blind Trial. OBES SURG 28, 293–302 (2018). https://doi.org/10.1007/s11695-017-2872-6

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