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Page 4 of 12 Yang et al. Mini-invasive Surg 2021;5:11 I http://dx.doi.org/10.20517/2574-1225.2021.06

Table 1. Demographics and baseline characteristics
Overall (n = 130) T2DM (n = 103)
Characteristic
n Mean ± SD/n (%) n Mean ± SD/n (%)
Age (years) 130 43.4 ± 11.3 103 46.2 ± 10.1
Sex
Female 130 45 (34.6) 103 33 (32.0)
Male 130 85 (65.4) 103 70 (68.0)
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BMI (kg/m ) 127 33.1 ± 9.0 101 31.2 ± 7.9
Weight (kg) 130 94.7 ± 29.6 103 87.9 ± 24.2
Waist circumference (cm) 102 108.0 ± 21.4 86 104.2 ± 18.7
Female 35 108.2 ± 18.4 27 105.5 ± 19.3
Male 67 107.9 ± 22.9 59 103.6 ± 18.6
Waist-to-hip ratio 76 0.96 ± 0.10 75 0.96 ± 0.10
Female 24 0.93 ± 0.14 24 0.93 ± 0.14
Male 52 0.97 ± 0.06 51 0.97 ± 0.06
Duration of T2DM (years) NA NA 102 6.6 ± 4.7

BMI: Body mass index; NA: not applicable; SD: standard deviation; T2DM: type 2 diabetes mellitus.

T2DM remission. Logistic regression analyses with T2DM remission as the dependent variable were also
performed using backward selection to determine what variables were independently associated with
T2DM remission when considering all predictors simultaneously. All statistical analyses were performed
with SAS®, Cary, NC.

RESULTS
Patient characteristics
In total, 130 Han Chinese patients met the eligibility criteria, of whom 103 patients (79.2%) had a diagnosis
of T2DM. Demographics and baseline characteristics are presented in Table 1.

Surgical interventions and outcomes
RYGB procedures and postoperative care were performed per the standard of care at each hospital. The
mean length of the biliopancreatic limb was 74.9 ± 37.0 cm, and the Roux limb was 97.5 ± 36.6 cm. All 130
procedures were successfully completed laparoscopically across a broad BMI range of 20.8-65.3 kg/m (2.4%
2
2
2
2
for BMI 18.5 to < 23.0 kg/m ; 29.9% for BMI 23.0 to < 27.5 kg/m ; 27.6% for BMI 27.5 to < 32.5 kg/m ; and
2
40.2% for BMI > 32.5 kg/m ). The mean operative time was 179 ± 59 min. The mean length of stay (surgery-
to-discharge) was 8.8 ± 5.7 nights.
For the total population, weight pre-surgery and at 12 months was available for 90 patients and was
2
reduced by 16.5 ± 12.8%. Meaningful reductions in BMI were also observed (-6.2 ± 5.6 kg/m ) at 12 months
2
with LOCF. Excessive weight loss was not observed as the lowest postoperative BMI reported was 18.1 kg/m .
Meaningful improvements were also observed in the total population through 12 months for glycemic
control, vital signs, blood lipids, and liver function [Table 2]. Among 53 procedure-related AEs, 24 (45.3%)
were recorded as Clavien-Dindo Grade 1, 20 (37.7%) were Grade 2, and 9 (17.0%) were Grade 3. The more
serious events (all Grade 3, no Grade 4) included ileus (n = 2), anastomotic leak (n = 1), anastomotic
stenosis (n = 1), gastric fistula (n = 1), gastric ulcer (n = 1), intestinal obstruction (n = 1), post-procedural
edema (n = 1), and small intestinal obstruction (n = 1). Six patients (4.6%) reported nine AEs within 30
days after the procedure, including five patients (six AEs) with GI disorders. Five patients experienced AEs
requiring reoperation, and these AEs included small bowel obstruction, anastomotic leakage, anastomotic
stenosis, ileus, gastric fistula, and anastomotic edema. Every AE requiring reoperation was resolved.

PATIENTS WITH T2DM AND RISK ANALYSIS
Following RYGB surgery in patients with T2DM, statistically significant and clinically meaningful
improvements in anthropometric characteristics and laboratory values were observed 12 months after