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

• Published in: Obesity surgery Vol. 28; no. 2; pp. 293 - 302
• Main Authors: Murphy, Rinki, Clarke, Michael G., Evennett, Nicholas J., John Robinson, S., Lee Humphreys, M., Hammodat, Hisham, Jones, Bronwen, Kim, David D., Cutfield, Richard, Johnson, Malcolm H., Plank, Lindsay D., Booth, Michael W. C.
• Format: Journal Article
• Language: English
• Published: New York Springer US 01-02-2018; Springer Nature B.V
• Subjects: Clinical trials; Comparative studies; Diabetes; Double-blind studies; Gastrointestinal surgery; Laparoscopy; Medicine; Medicine & Public Health; Obesity; Original Contributions; Quality of life; Surgery; Surgical outcomes; Surgical techniques; Weight control; New Zealand; Type 2 diabetes; Obesity; Banded bypass; Randomised trial; Gastric bypass; Bariatric surgery; Remission; Sleeve gastrectomy; Quality of life
• ISSN: 0960-8923; 1708-0428
• DOI: 10.1007/s11695-017-2872-6

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/m
2
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/m
2
, 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).