<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03227939</url>
  </required_header>
  <id_info>
    <org_study_id>JYLJ013</org_study_id>
    <nct_id>NCT03227939</nct_id>
  </id_info>
  <brief_title>Effects of Combined Surgery on Obstructive Sleep Apnea in Obese Patients: an Open-label Randomized Controlled Clinical Trial</brief_title>
  <official_title>Effect of Laparoscopic Sleeve Gastrectomy (LSG) Plus Uvulopalatopharyngoplasty and Adenoidectomy/Tonsillectomy on Severe Obstructive Sleep Apnea &amp; Hyponea Syndromes in Moderate-to-severe Obese Patients: an Open-label Randomized Controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bing Wang</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This research is created for compare the difference of AHI variation between LSG and combined&#xD;
      surgery on obstructive sleep apnea in obese patients , evaluate the risk of combined surgery&#xD;
      and explore the correlative factor of the curative effect.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Obesity is one of the new health challenges in China and all over the world，Morbidly obesity&#xD;
      (MO) is an important risk factor for metabolic diseases and obstructive sleep apnea(OSA),&#xD;
      which can be effectively and lastingly reduced by bariatric surgery.&#xD;
&#xD;
      OSA is the most common type of sleep apnea and is caused by complete or partial obstructions&#xD;
      of the upper airway. It is characterized by repetitive episodes of shallow or paused&#xD;
      breathing during sleep, and is a potentially fatal disease. OSA has complex pathogenesis and&#xD;
      numerous pathogeny, while morbidly obesity is one of the important risk factors of OSA.&#xD;
      Previous research has shown that the incidence of OSA will rise by 1.14 % while body mass&#xD;
      index(BMI) rise by 1%.Therefor, loseing weight is highly recommend for morbidly obese&#xD;
      patients with OSA in clinical guideline for OSA both in USA and China, and bariatric surgery&#xD;
      is effective for morbidly obese patients with OSA. Most yellow race morbidly obesity patients&#xD;
      have abdominal obesity which is different from the white race，while Abdominal obesity is&#xD;
      associated with greater incidence and more severely of OSA. There are maybe twenty million&#xD;
      patients with OSA and 80% of them haven't been diagnosed.&#xD;
&#xD;
      At present,. Laparoscopic sleeve gastrectomy(LSG) and laparoscopic Roux-en-Y gastric&#xD;
      bypass(LRYGB) are two of the main bariatric surgical procedures performed in China. They can&#xD;
      performed as one stage each or multiple sessions(LSG-LRYGB) which is depend on the severity&#xD;
      of obesity and its complications.&#xD;
&#xD;
      UPPP was first performed in 1981 by doctor Fujita and modified these years, it has been a&#xD;
      standardized treatment for OSA. The effective rate of UPPP is less than 65% and is associated&#xD;
      with the BMI and age of patients , younger and lower BMI means better effect. Consideration&#xD;
      of the discontented outcome in obese patients, Simple UPPP is not recommended for OSA&#xD;
      patients with morbidly obesity in clinical guidelines for OSA.&#xD;
&#xD;
      Although simple LSG has a sure prostecdtive efficacy for both OSA and morbidly obesity,&#xD;
      patients still need CPAP during several months after surgery. So we chosed patients who&#xD;
      conformed the surgical indications of both morbidly obesity and OSA，and performed an combined&#xD;
      surgery (LSG+UPPP+adenoidectomy/tonsillectomy). We found that combined surgery has a better&#xD;
      short-term efficacy than simple LSG, so the randomized clinical trial(RCT) was designed to&#xD;
      explore the efficacy of combined surgery in the treatment of severe OSA in moderate-to-severe&#xD;
      obese patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 25, 2017</start_date>
  <completion_date type="Anticipated">May 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">February 1, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The mean change in Apnoea-Hypopnoea Index (AHI)</measure>
    <time_frame>At the 6 month after surgery</time_frame>
    <description>The mean change in AHI</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to response</measure>
    <time_frame>during 6 months after surgery</time_frame>
    <description>AHI reduse to 50% of the base line</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Other PSG measures: average and lowest blood oxygen saturation at night</measure>
    <time_frame>At the 6 month after surgery</time_frame>
    <description>in psg report</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight, BMI</measure>
    <time_frame>At the 6 month after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>neck,chest,waist hip and biceps circumference</measure>
    <time_frame>At the 6 month after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Epworth Sleepiness Scale (ESS) scores</measure>
    <time_frame>At the 6 month after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in the CT scan of upper airway and head radiography</measure>
    <time_frame>At the 6 month after surgery</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>To Compare the Difference of AHI Variation Between LSG and Combined Surgery</condition>
  <arm_group>
    <arm_group_label>Combined Surgery Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>LSG + UPPP＆Adenoidectomy/Tonsillectomy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LSG Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>LSG only</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Laparoscopic sleeve gastrectomy（LSG）</intervention_name>
    <description>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.</description>
    <arm_group_label>Combined Surgery Group</arm_group_label>
    <arm_group_label>LSG Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Uvulopalatopharyngoplasty(UPPP) and Adenoidectomy/Tonsillectomy</intervention_name>
    <description>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.</description>
    <arm_group_label>Combined Surgery Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Chinese Han population aged 16 to 65 years&#xD;
&#xD;
          2. BMI more than 32.5Kg/㎡ with AHI more than ≥30/hour&#xD;
&#xD;
          3. First diagnosed with PSG without any corresponding treatment;&#xD;
&#xD;
          4. Adenoid tonsil hypertrophy (Friedman stage II-III).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Drug abuse, alcohol addiction and mental diseases&#xD;
&#xD;
          2. Dysgnosia&#xD;
&#xD;
          3. Over-high expectation&#xD;
&#xD;
          4. Risk-averse patient;&#xD;
&#xD;
          5. Poor tolerance to surgery&#xD;
&#xD;
          6. Patient suffering from gastroesophageal reflux and hiatal hernia&#xD;
&#xD;
          7. Central or mixed sleep apnea diagnosed by PSG&#xD;
&#xD;
          8. PO2&lt;60mmHg when the patient is awake&#xD;
&#xD;
          9. Suffering from maligent tumor, neural system injury and respiratory insufficiency&#xD;
&#xD;
         10. Hypothyroidism&#xD;
&#xD;
         11. Other special issue decided by specialist.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Bing Wang, M.D.</last_name>
    <phone>+86-15821423382</phone>
    <email>wingping01@126.com</email>
  </overall_contact>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 20, 2017</study_first_submitted>
  <study_first_submitted_qc>July 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2017</study_first_posted>
  <last_update_submitted>July 21, 2017</last_update_submitted>
  <last_update_submitted_qc>July 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University</investigator_affiliation>
    <investigator_full_name>Bing Wang</investigator_full_name>
    <investigator_title>Professor of Surgery</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Apnea, Obstructive</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03227939
org study id: JYLJ013
nct id: NCT03227939
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The mean change in Apnoea-Hypopnoea Index (AHI)
time frame: At the 6 month after surgery
description: The mean change in AHI
measure: Time to response
time frame: during 6 months after surgery
description: AHI reduse to 50% of the base line
measure: Other PSG measures: average and lowest blood oxygen saturation at night
time frame: At the 6 month after surgery
description: in psg report
measure: Weight, BMI
time frame: At the 6 month after surgery
measure: neck,chest,waist hip and biceps circumference
time frame: At the 6 month after surgery
measure: Epworth Sleepiness Scale (ESS) scores
time frame: At the 6 month after surgery
measure: Changes in the CT scan of upper airway and head radiography
time frame: At the 6 month after surgery
arm group label: Combined Surgery Group
arm group type: Experimental
description: LSG + UPPP＆Adenoidectomy/Tonsillectomy
arm group label: LSG Group
arm group type: Active Comparator
description: LSG only
intervention type: Procedure
intervention name: Laparoscopic sleeve gastrectomy（LSG）
description: 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.
arm group label: Combined Surgery Group
arm group label: LSG Group
intervention type: Procedure
intervention name: Uvulopalatopharyngoplasty(UPPP) and Adenoidectomy/Tonsillectomy
description: 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.
arm group label: Combined Surgery Group
criteria: 
gender: All
minimum age: 16 Years
maximum age: 65 Years
healthy volunteers: No
last name: Bing Wang, M.D.
phone: +86-15821423382
email: wingping01@126.com
responsible party type: Sponsor-Investigator
investigator affiliation: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
investigator full name: Bing Wang
investigator title: Professor of Surgery
mesh term: Sleep Apnea, Obstructive
sharing ipd: Undecided