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

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ClinicalTrials.gov Identifier: NCT03227939
Recruitment Status : Not yet recruiting
First Posted : July 24, 2017
Last Update Posted : July 24, 2017
Sponsor:
Information provided by (Responsible Party):
Bing Wang, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
To Compare the Difference of AHI Variation Between LSG and Combined Surgery Procedure: Laparoscopic sleeve gastrectomy(LSG) Procedure: Uvulopalatopharyngoplasty(UPPP) and Adenoidectomy/Tonsillectomy Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : July 25, 2017
Estimated Primary Completion Date : February 1, 2020
Estimated Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. The mean change in Apnoea-Hypopnoea Index (AHI) [ Time Frame: At the 6 month after surgery ]
    The mean change in AHI


Secondary Outcome Measures :
  1. Time to response [ Time Frame: during 6 months after surgery ]
    AHI reduse to 50% of the base line

  2. Other PSG measures: average and lowest blood oxygen saturation at night [ Time Frame: At the 6 month after surgery ]
    in psg report

  3. Weight, BMI [ Time Frame: At the 6 month after surgery ]
  4. neck,chest,waist hip and biceps circumference [ Time Frame: At the 6 month after surgery ]
  5. Epworth Sleepiness Scale (ESS) scores [ Time Frame: At the 6 month after surgery ]
  6. Changes in the CT scan of upper airway and head radiography [ Time Frame: At the 6 month after surgery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03227939


Contacts
Contact: Bing Wang, M.D. +86-15821423382 wingping01@126.com

Sponsors and Collaborators
Bing Wang

Responsible Party: Bing Wang, Professor of Surgery, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
ClinicalTrials.gov Identifier: NCT03227939     History of Changes
Other Study ID Numbers: JYLJ013
First Posted: July 24, 2017    Key Record Dates
Last Update Posted: July 24, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases