Type 2 diabetes mellitus (T2DM) is a chronic progressive illness affecting a substantial percentage of the general population. While pharmacotherapy remains the mainstay of treatment, around 60% of patients cannot achieve the recommended goals for diabetic control. Weight control is a well-known essential component in normalizing blood glucose level in T2DM. The term metabolic surgery is recently introduced and it is now increasingly accepted as a valid option for obese T2DM patients with poor glycemic control despite optimal medical therapy. While laparoscopic roux-en-Y gastric bypass (RYGBP) is the gold-standard bariatric/metabolic procedure in many countries, it is not widely accepted in Asia. Recently, a novel bypass technique called single loop duodenojejunal bypass with sleeve gastrectomy (SLDJB-SG) has been developed trying to tackle most drawbacks of RYGBP. Realizing there is a knowledge gap in applying the new duodenojejunal bypass procedure to obese T2DM patients, we propose to investigate and compare the efficacy of glycemic control and functional outcomes of SLDJB-SG with conventional RYGBP.
Aim of study: To investigate and compare the safety profile, functional outcomes, efficacy in diabetic control and changes of hormonal profile of laparoscopic single loop duodenojejunal bypass plus sleeve gastrectomy (SLDJB-SG) versus the conventional standard roux-en-Y gastric bypass (RYGBP). Hypothesis: The efficacy of glycemic control and functional outcomes of SLDJB-SG is better than conventional RYGBP, and is a more suitable option for obese Chinese diabetic patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
80
Chinese University of Hong Kong
Hong Kong, China
RECRUITING% of patient achieve HbA1c<6%
Time frame: 1 year
operation time
Time frame: during operation
Total blood loss
Total blood loss data from operation record
Time frame: during operation
Perioperative complications
Time frame: 30 days
mortality
Time frame: 30 days
Postoperative hospital stay
Time frame: during index operation
Excessive body weight loss (kg)
Time frame: 6 months & 1 year
BMI change (kg/m^2)
Time frame: 6 months & 1 year
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