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临床试验/NCT03227939
NCT03227939Unknown不适用

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

Bing Wang0 个研究点目标入组 100 人开始时间: 2017年7月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
100
主要终点
The mean change in Apnoea-Hypopnoea Index (AHI)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
16 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Chinese Han population aged 16 to 65 years
  • BMI more than 32.5Kg/㎡ with AHI more than ≥30/hour
  • First diagnosed with PSG without any corresponding treatment;
  • Adenoid tonsil hypertrophy (Friedman stage II-III).

排除标准

  • Drug abuse, alcohol addiction and mental diseases
  • Over-high expectation
  • Risk-averse patient;
  • Poor tolerance to surgery
  • Patient suffering from gastroesophageal reflux and hiatal hernia
  • Central or mixed sleep apnea diagnosed by PSG
  • PO2<60mmHg when the patient is awake
  • Suffering from maligent tumor, neural system injury and respiratory insufficiency
  • Hypothyroidism
  • Other special issue decided by specialist.

研究组 & 干预措施

Combined Surgery Group

Experimental

LSG + UPPP&Adenoidectomy/Tonsillectomy

干预措施: Laparoscopic sleeve gastrectomy(LSG) (Procedure)

Combined Surgery Group

Experimental

LSG + UPPP&Adenoidectomy/Tonsillectomy

干预措施: Uvulopalatopharyngoplasty(UPPP) and Adenoidectomy/Tonsillectomy (Procedure)

LSG Group

Active Comparator

LSG only

干预措施: Laparoscopic sleeve gastrectomy(LSG) (Procedure)

结局指标

主要结局

The mean change in Apnoea-Hypopnoea Index (AHI)

时间窗: At the 6 month after surgery

The mean change in AHI

次要结局

  • Time to response(during 6 months after surgery)
  • Weight, BMI(At the 6 month after surgery)
  • Changes in the CT scan of upper airway and head radiography(At the 6 month after surgery)
  • Epworth Sleepiness Scale (ESS) scores(At the 6 month after surgery)
  • Other PSG measures: average and lowest blood oxygen saturation at night(At the 6 month after surgery)
  • neck,chest,waist hip and biceps circumference(At the 6 month after surgery)

研究者

发起方
Bing Wang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Bing Wang

Professor of Surgery

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

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