Effects of Combined Surgery on Obstructive Sleep Apnea in Obese Patients: an Open-label Randomized Controlled Clinical Trial

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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To Compare the Difference of AHI Variation Between LSG and Combined Surgery

Intervention / Treatment
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* Procedure: Laparoscopic sleeve gastrectomy（LSG）
* Procedure: Uvulopalatopharyngoplasty(UPPP) and Adenoidectomy/Tonsillectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Exclusion Criteria: Drug abuse, alcohol addiction and mental diseases Dysgnosia 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.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combined Surgery Group<br>LSG + UPPP＆Adenoidectomy/Tonsillectomy | Procedure: Laparoscopic sleeve gastrectomy（LSG）<br>* LSG：All these operations were performed by the same surgeon team. Dissect the greater omentum alongside the greater gastric curvature, make sure that the greater gastric curvature and fundus of stomach were completely made free from pancreas and spleen.Fully Exposed left and right diaphragm angle and taking care not to injure the esophagus. Resection was started 2 to 4 cm from pylorus and alongside a 40Fr tube up to the esophagogastric junction and created a 60 to 80ml gastric lumen, removed the fundus of stomach thoroughly and take care of the esophagus and preventriculus. Repaired the hiatal hernia if it was exsit.<br>Procedure: Uvulopalatopharyngoplasty(UPPP) and Adenoidectomy/Tonsillectomy<br>* UPPP：PPP is typically administered to patients with obstructive sleep apnea in isolation. It is administered as a stand-alone procedure in the hope that the tissue which obstructs the patient's airway is localized in the back of the throat. The rationale is that, by removing the tissue, the patient's airway will be wider and breathing will become easier.<br>|
| Active Comparator: LSG Group<br>LSG only | Procedure: Laparoscopic sleeve gastrectomy（LSG）<br>* LSG：All these operations were performed by the same surgeon team. Dissect the greater omentum alongside the greater gastric curvature, make sure that the greater gastric curvature and fundus of stomach were completely made free from pancreas and spleen.Fully Exposed left and right diaphragm angle and taking care not to injure the esophagus. Resection was started 2 to 4 cm from pylorus and alongside a 40Fr tube up to the esophagogastric junction and created a 60 to 80ml gastric lumen, removed the fundus of stomach thoroughly and take care of the esophagus and preventriculus. Repaired the hiatal hernia if it was exsit.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mean change in Apnoea-Hypopnoea Index (AHI) | The mean change in AHI | At the 6 month after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to response | AHI reduse to 50% of the base line | during 6 months after surgery | 
| Other PSG measures: average and lowest blood oxygen saturation at night | in psg report | At the 6 month after surgery | 
| Weight, BMI |  | At the 6 month after surgery | 
| neck,chest,waist hip and biceps circumference |  | At the 6 month after surgery | 
| Epworth Sleepiness Scale (ESS) scores |  | At the 6 month after surgery | 
| Changes in the CT scan of upper airway and head radiography |  | At the 6 month after surgery |