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

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.

Study Overview

• Status: Unknown
• Conditions: To Compare the Difference of AHI Variation Between LSG and Combined Surgery
• Intervention / Treatment: Procedure: Laparoscopic sleeve gastrectomy（LSG）; Procedure: Uvulopalatopharyngoplasty(UPPP) and Adenoidectomy/Tonsillectomy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Combined Surgery Group; LSG + UPPP＆Adenoidectomy/Tonsillectomy	Procedure: Laparoscopic sleeve gastrectomy（LSG）; 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.; Procedure: Uvulopalatopharyngoplasty(UPPP) and Adenoidectomy/Tonsillectomy; 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.
Active Comparator: LSG Group; LSG only	Procedure: Laparoscopic sleeve gastrectomy（LSG）; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Bing Wang

Study record dates

Study Major Dates

• Study Start (Anticipated): July 25, 2017
• Primary Completion (Anticipated): February 1, 2020
• Study Completion (Anticipated): May 1, 2020

Study Registration Dates

• First Submitted: July 20, 2017
• First Submitted That Met QC Criteria: July 21, 2017
• First Posted (Actual): July 24, 2017

Study Record Updates

• Last Update Posted (Actual): July 24, 2017
• Last Update Submitted That Met QC Criteria: July 21, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: JYLJ013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No