To Compare the Difference of AHI Variation Between LSG and Combined Surgery Clinical Trial
Official title:
Effect of Laparoscopic Sleeve Gastrectomy (LSG) Plus Uvulopalatopharyngoplasty and Adenoidectomy/Tonsillectomy on Severe Obstructive Sleep Apnea & Hyponea Syndromes in Moderate-to-severe Obese Patients: an Open-label Randomized Controlled Clinical Trial
This research is created for compare the difference of AHI variation between LSG and combined surgery on obstructive sleep apnea in obese patients , evaluate the risk of combined surgery and explore the correlative factor of the curative effect.
Obesity is one of the new health challenges in China and all over the world，Morbidly obesity
(MO) is an important risk factor for metabolic diseases and obstructive sleep apnea(OSA),
which can be effectively and lastingly reduced by bariatric surgery.
OSA is the most common type of sleep apnea and is caused by complete or partial obstructions
of the upper airway. It is characterized by repetitive episodes of shallow or paused
breathing during sleep, and is a potentially fatal disease. OSA has complex pathogenesis and
numerous pathogeny, while morbidly obesity is one of the important risk factors of OSA.
Previous research has shown that the incidence of OSA will rise by 1.14 % while body mass
index(BMI) rise by 1%.Therefor, loseing weight is highly recommend for morbidly obese
patients with OSA in clinical guideline for OSA both in USA and China, and bariatric surgery
is effective for morbidly obese patients with OSA. Most yellow race morbidly obesity patients
have abdominal obesity which is different from the white race，while Abdominal obesity is
associated with greater incidence and more severely of OSA. There are maybe twenty million
patients with OSA and 80% of them haven't been diagnosed.
At present,. Laparoscopic sleeve gastrectomy(LSG) and laparoscopic Roux-en-Y gastric
bypass(LRYGB) are two of the main bariatric surgical procedures performed in China. They can
performed as one stage each or multiple sessions(LSG-LRYGB) which is depend on the severity
of obesity and its complications.
UPPP was first performed in 1981 by doctor Fujita and modified these years, it has been a
standardized treatment for OSA. The effective rate of UPPP is less than 65% and is associated
with the BMI and age of patients , younger and lower BMI means better effect. Consideration
of the discontented outcome in obese patients, Simple UPPP is not recommended for OSA
patients with morbidly obesity in clinical guidelines for OSA.
Although simple LSG has a sure prostecdtive efficacy for both OSA and morbidly obesity,
patients still need CPAP during several months after surgery. So we chosed patients who
conformed the surgical indications of both morbidly obesity and OSA，and performed an combined
surgery (LSG+UPPP+adenoidectomy/tonsillectomy). We found that combined surgery has a better
short-term efficacy than simple LSG, so the randomized clinical trial(RCT) was designed to
explore the efficacy of combined surgery in the treatment of severe OSA in moderate-to-severe
obese patients.
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