To Compare the Difference of AHI Variation Between LSG and Combined SurgeryNCT03227939
Effects of Combined Surgery on Obstructive Sleep Apnea in Obese Patients: an Open-label Randomized Controlled Clinical Trial
A study testing Laparoscopic sleeve gastrectomy（LSG） and Uvulopalatopharyngoplasty(UPPP) and Adenoidectomy/Tonsillectomy in people with To Compare the Difference of AHI Variation Between LSG and Combined Surgery, run by Bing Wang.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- To Compare the Difference of AHI Variation Between LSG and Combined Surgery
- What is being tested?
- Laparoscopic sleeve gastrectomy（LSG） and Uvulopalatopharyngoplasty(UPPP) and Adenoidectomy/Tonsillectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 25 Jul 2017to 1 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Being tested
- Laparoscopic sleeve gastrectomy（LSG）, Uvulopalatopharyngoplasty(UPPP) and Adenoidectomy/Tonsillectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic sleeve gastrectomy（LSG）Procedure or surgery
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.
Uvulopalatopharyngoplasty(UPPP) and Adenoidectomy/TonsillectomyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Combined Surgery Group | Experimental | LSG + UPPP＆Adenoidectomy/Tonsillectomy Receives: Procedure: Laparoscopic sleeve gastrectomy（LSG）; Procedure: Uvulopalatopharyngoplasty(UPPP) and Adenoidectomy/Tonsillectomy |
| LSG Group | Active comparator | LSG only Receives: Procedure: Laparoscopic sleeve gastrectomy（LSG） |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean change in Apnoea-Hypopnoea Index (AHI)
The mean change in AHI
Measured: At the 6 month after surgery
Secondary outcomes (6)
Time to response
AHI reduse to 50% of the base line
Measured: during 6 months after surgery
Other PSG measures: average and lowest blood oxygen saturation at night
in psg report
Measured: At the 6 month after surgery
Weight, BMI
Measured: At the 6 month after surgery
neck,chest,waist hip and biceps circumference
Measured: At the 6 month after surgery
Epworth Sleepiness Scale (ESS) scores
Measured: At the 6 month after surgery
Changes in the CT scan of upper airway and head radiography
Measured: At the 6 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2017
- Study start25 Jul 2017 (estimated)
- Primary completion1 Feb 2020 (estimated)
- Study completion1 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for To Compare the Difference of AHI Variation Between LSG and Combined SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bing Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bing Wang, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03227939
- Sponsor's protocol ID
- JYLJ013
- Status last verified
- Jul 2017
- First submitted
- 20 Jul 2017
- Last updated
- 24 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03227939
- Acronym / sponsor ID
- JYLJ013
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Bing WangUniversity, hospital or other
- Study start
- 25 Jul 2017 (estimated)
- Primary completion
- 1 Feb 2020 (estimated)
- Study completion
- 1 May 2020 (estimated)
- First posted
- 24 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined Surgery Group | Experimental | Procedure: Laparoscopic sleeve gastrectomy（LSG）, Procedure: Uvulopalatopharyngoplasty(UPPP) and Adenoidectomy/TonsillectomyLSG + UPPP＆Adenoidectomy/Tonsillectomy |
| LSG Group | Active comparator | Procedure: Laparoscopic sleeve gastrectomy（LSG）LSG only |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (11 listed)
- Drug abuse, alcohol addiction and mental diseases
- Dysgnosia
- Over-high expectation
- Risk-averse patient;
- Poor tolerance to surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 or surgery | Combined Surgery Group, LSG Group |
| Uvulopalatopharyngoplasty(UPPP) and Adenoidectomy/TonsillectomyUPPP：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. | Procedure or surgery | Combined Surgery Group |
Primary outcome
The mean change in Apnoea-Hypopnoea Index (AHI)
Time frame: At the 6 month after surgery
The mean change in AHI
6 secondary outcomes
Time to response
Time frame: during 6 months after surgery
Other PSG measures: average and lowest blood oxygen saturation at night
Time frame: At the 6 month after surgery
Weight, BMI
Time frame: At the 6 month after surgery
neck,chest,waist hip and biceps circumference
Time frame: At the 6 month after surgery
Epworth Sleepiness Scale (ESS) scores
Time frame: At the 6 month after surgery
Changes in the CT scan of upper airway and head radiography
Time frame: At the 6 month after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2017.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic sleeve gastrectomy（LSG） and Uvulopalatopharyngoplasty(UPPP) and Adenoidectomy/Tonsillectomy in people with To Compare the Difference of AHI Variation Between LSG and Combined Surgery, run by Bing Wang.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bing Wang, M.D. (+86-15821423382, wingping01@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The mean change in Apnoea-Hypopnoea Index (AHI) (time frame: At the 6 month after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2017.