<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/NCT03776669</url>
  </required_header>
  <id_info>
    <org_study_id>201810017RINB</org_study_id>
    <nct_id>NCT03776669</nct_id>
  </id_info>
  <brief_title>Laparoscopic Sleeve Gastrectomy With or Without Hiatal Hernia Repair in Morbidly Obese Patients</brief_title>
  <official_title>Laparoscopic Sleeve Gastrectomy With or Without Hiatal Hernia Repair in Morbidly Obese Patients: a Single-center Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background:&#xD;
&#xD;
      Obesity and hiatal hernia are both risk factors of gastroesophageal reflux disease (GERD),&#xD;
      and the incidence of hiatal hernia is much higher in morbidly obese patients. Many believe&#xD;
      that higher intra-abdominal pressure with higher esophagogastric junction (EGJ) pressure&#xD;
      gradient in morbidly obese patients is the main mechanism accounting for the occurrence of&#xD;
      GERD. Hiatal hernia, on the other hand, is associated with structure abnormality of EGJ.&#xD;
      Sleeve gastrectomy (SG) has been becoming a standalone bariatric surgery for decades, and it&#xD;
      has been proved to effectively induce long-term weight loss in morbidly obese patients. Some&#xD;
      studies found morbidly obese patients benefited from resolution of GERD after SG, however,&#xD;
      other studies had the opposite findings. Some morbidly obese patients had aggravating GERD or&#xD;
      de novo GERD after SG. The mechanism is still unclear now. It might result from removal of&#xD;
      fundus and sling muscular fibers of EGJ, increased intra-gastric pressure (IIGP), and hiatal&#xD;
      hernia after surgery. High resolution impedance manometry (HRIM) is used to access esophageal&#xD;
      and EGJ function objectively. Impedance reflux was more frequently observed in patients&#xD;
      having gastroesophageal reflux (GER) symptoms after SG. In addition, previous studies also&#xD;
      found decreased EGJ resting pressure, decreased length of lower esophageal sphincter (LES),&#xD;
      and presence of hiatal hernia were associated with more GERD after SG.&#xD;
&#xD;
      Objective:&#xD;
&#xD;
      To evaluate the long-term EGJ function and GERD in morbidly obese patients with hiatal hernia&#xD;
      receiving laparoscopic sleeve gastrectomy (LSG) with or without hiatal hernia repair (HHR).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients and methods:&#xD;
&#xD;
      A total of 70 patients will be recruited and randomized to two groups with a 1:1 allocation&#xD;
      ratio. Patients in the control group receive LSG alone and in the experimental group receive&#xD;
      LSG with HHR. All subjects should provide basic clinical and demographic information, be&#xD;
      evaluated for GER symptoms using GerdQ score, sign informed consent, and complete&#xD;
      preoperative abdominal computed tomography (CT) scan, esophagogastroduodenoscopy (EGD), and&#xD;
      HRIM. Outpatient follow-up would be arranged 1 weeks after discharge, then 1 month, 3 months,&#xD;
      6 months, and 12 months after surgery. Weight change and GER symptoms will be evaluated at&#xD;
      every outpatient visit. Abdominal CT scan, EGD, and HRIM will be performed 12 months after&#xD;
      surgery.&#xD;
&#xD;
      Expected results:&#xD;
&#xD;
      Less reflux esophagitis, less impedance reflux episodes, lower incidence of hiatal hernia,&#xD;
      higher EGJ resting pressure, and longer LES length should be observed in morbidly obese&#xD;
      patients receiving LSG with HHR at 12-month follow-up, using EGD and HRIM as evaluation&#xD;
      tools. Furthermore, lower GerdQ score should be observed in these patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 9, 2019</start_date>
  <completion_date type="Anticipated">December 17, 2024</completion_date>
  <primary_completion_date type="Anticipated">November 1, 2023</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>De novo reflux esophagitis</measure>
    <time_frame>Within 12 months after surgery if symptomatic or at 12 months if asymptomatic.</time_frame>
    <description>Los angles classification grade B/C/D reflux esophagitis diagnosed by esophagogastroduodenoscopy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Impedance reflux</measure>
    <time_frame>12 months after the surgery</time_frame>
    <description>Impedance reflux after single swallow by high resolution impedance manometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Esophagogastric junction (EGJ) resting pressure</measure>
    <time_frame>12 months after the surgery</time_frame>
    <description>Measured by high resolution impedance manometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lower esophageal sphincter (LES) length</measure>
    <time_frame>12 months after the surgery</time_frame>
    <description>Measured by high resolution impedance manometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>De novo or aggravating hiatal hernia</measure>
    <time_frame>12 months after the surgery (or within 12 months after surgery if symptomatic )</time_frame>
    <description>Diagnosed by high resolution impedance manometry or esophagogastroduodenoscopy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>GerdQ score</measure>
    <time_frame>At 1 week (± 1 week) after discharge, then 1 month (± 2 weeks), 3 months (± 1 month), 6 months (± 1 month), and 12 months (± 1 month) after surgery.</time_frame>
    <description>Questionnaire for gastroesophageal reflux symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operative complication</measure>
    <time_frame>Within 30 days of surgery</time_frame>
    <description>Defined as complication ≧ grade III Clavien-Dindo classification</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mesh-related complication</measure>
    <time_frame>Within 12 months after surgery</time_frame>
    <description>infection, allergic reaction, intestinal complication, fistula formation, seroma formation, hematoma, recurrence of tissue defect, dysphagia, esophageal erosion or perforation.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">70</enrollment>
  <condition>Morbid Obesity</condition>
  <condition>Hiatal Hernia</condition>
  <condition>Gastroesophageal Reflux Disease</condition>
  <condition>Sleeve Gastrectomy</condition>
  <arm_group>
    <arm_group_label>LSG alone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intervention: laparoscopic sleeve gastrectomy alone.&#xD;
LSG will be performed laparoscopically via a 5-port technique. The greater omentum is dissected by using the 5-mm laparoscopic LigaSure or Harmonic from 4 cm proximal to the pyloric ring to the angle of His. Sleeve calibration is done by a 36-French bougie inserted along the lesser curvature. Then the stomach is transected with sequential firings of linear green, gold, and blue 60 mm staplers starting about 4 cm proximal to the pylorus and ending approximately 2 cm distal to the left of the esophagus. The staple-line of the remnant gastric tube is oversewn with 3-0 V-Loc to prevent leakage and hemorrhage.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LSG + HHR</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention: concomitant laparoscopic sleeve gastrectomy + hiatal hernia repair.&#xD;
The surgical detail of LSG is the same as described in &quot;LSG alone&quot; arm, and the surgical detail of HHR is described as below.&#xD;
The hiatus is approached from the right side of the EGJ, through the lesser omentum. The hiatal defect is repaired by 1-0 Surgilon interruptedly, and then a commercialized &quot;U-shaped&quot; Biodesign Hiatal Hernia Graft is placed to the EGJ to cover the posterior side but spare the anterior side of the hiatus. Care must be taken to avoid direct contact of mesh to the esophagus to avoid any unnecessary complication. After the mesh is appropriately placed and oriented, 2 ml of TISSEEL solution for sealant is applied all over the mesh for fixation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Laparoscopic sleeve gastrectomy + Hiatal hernia repair</intervention_name>
    <description>To evaluate the role of concomitant hiatal hernia repair in laparoscopic sleeve gastrectomy for morbidly obese patients.</description>
    <arm_group_label>LSG + HHR</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Laparoscopic sleeve gastrectomy alone</intervention_name>
    <description>Current mainstay and standard surgical treatment for morbidly obese patients.</description>
    <arm_group_label>LSG alone</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with:&#xD;
&#xD;
               1. Body mass index (BMI) ≧ 35, or&#xD;
&#xD;
               2. 30 ≦ BMI &lt; 35, with inadequately controlled type 2 diabetes mellitus (T2DM) or&#xD;
                  metabolic syndrome, or&#xD;
&#xD;
               3. T2DM with BMI ≧ 32.5, or&#xD;
&#xD;
               4. T2DM with BMI between 27.5 and 32.5 not well controlled by medication, especially&#xD;
                  for those with major cardiovascular risk.&#xD;
&#xD;
          -  Age: 20 to 65 years old.&#xD;
&#xD;
          -  Hiatal hernia diagnosed by either:&#xD;
&#xD;
               1. HRIM: defined as the distance between low esophageal sphincter (LES) and crural&#xD;
                  diaphragm (CD) equal to or greater than 2 cm. (LES-CD ≧ 2 cm)&#xD;
&#xD;
               2. EGD: defined as the apparent separation between the squamocolumnar junction and&#xD;
                  the diaphragmatic impression is greater than 2 cm.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior major gastrointestinal (GI) tract surgery.&#xD;
&#xD;
          -  Bleeding tendency.&#xD;
&#xD;
          -  American Society of Anesthesiologists physical status (ASA) ≧ class III.&#xD;
&#xD;
          -  Pregnancy or lactating women.&#xD;
&#xD;
          -  Allergy to contrast medium for CT scan.&#xD;
&#xD;
          -  Concomitantly untreated or uncontrolled endocrine disease.&#xD;
&#xD;
          -  Alcohol or drug abuse.&#xD;
&#xD;
          -  Mental, behavioral, and neurodevelopmental disorders.&#xD;
&#xD;
               1. Patients who possess &quot;National Health Insurance (NHI) Major Illness/Injury&#xD;
                  Certificate&quot; for ICD-10-CM codes F01-F99. (ICD: International Classification of&#xD;
                  Diseases; CM: Clinical Modification)&#xD;
&#xD;
               2. Patients who have been hospitalized in psychiatric ward in the recent one year.&#xD;
&#xD;
          -  Type IV hiatal hernia.&#xD;
&#xD;
          -  Moderate to severe reflux esophagitis (LA classification grade B/C/D) refractory to&#xD;
             medical treatment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>PoChu Lee, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Taiwan University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>PoChu Lee, MD</last_name>
    <phone>886972651953</phone>
    <email>pochu.leepochu@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>100</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>PoChu Lee, MD</last_name>
      <phone>886972651953</phone>
      <email>pochu.leepochu@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <reference>
    <citation>Che F, Nguyen B, Cohen A, Nguyen NT. Prevalence of hiatal hernia in the morbidly obese. Surg Obes Relat Dis. 2013 Nov-Dec;9(6):920-4. doi: 10.1016/j.soard.2013.03.013. Epub 2013 Apr 19.</citation>
    <PMID>23810611</PMID>
  </reference>
  <reference>
    <citation>Santonicola A, Angrisani L, Cutolo P, Formisano G, Iovino P. The effect of laparoscopic sleeve gastrectomy with or without hiatal hernia repair on gastroesophageal reflux disease in obese patients. Surg Obes Relat Dis. 2014 Mar-Apr;10(2):250-5. doi: 10.1016/j.soard.2013.09.006. Epub 2013 Sep 20.</citation>
    <PMID>24355324</PMID>
  </reference>
  <reference>
    <citation>Soricelli E, Iossa A, Casella G, Abbatini F, Cali B, Basso N. Sleeve gastrectomy and crural repair in obese patients with gastroesophageal reflux disease and/or hiatal hernia. Surg Obes Relat Dis. 2013 May-Jun;9(3):356-61. doi: 10.1016/j.soard.2012.06.003. Epub 2012 Jun 19.</citation>
    <PMID>22867558</PMID>
  </reference>
  <reference>
    <citation>Mahawar KK, Carr WR, Jennings N, Balupuri S, Small PK. Simultaneous sleeve gastrectomy and hiatus hernia repair: a systematic review. Obes Surg. 2015 Jan;25(1):159-66. doi: 10.1007/s11695-014-1470-0.</citation>
    <PMID>25348434</PMID>
  </reference>
  <reference>
    <citation>Crawford C, Gibbens K, Lomelin D, Krause C, Simorov A, Oleynikov D. Sleeve gastrectomy and anti-reflux procedures. Surg Endosc. 2017 Mar;31(3):1012-1021. doi: 10.1007/s00464-016-5092-6. Epub 2016 Jul 20.</citation>
    <PMID>27440196</PMID>
  </reference>
  <reference>
    <citation>Braghetto I, Lanzarini E, Korn O, Valladares H, Molina JC, Henriquez A. Manometric changes of the lower esophageal sphincter after sleeve gastrectomy in obese patients. Obes Surg. 2010 Mar;20(3):357-62. doi: 10.1007/s11695-009-0040-3. Epub 2009 Dec 15.</citation>
    <PMID>20013071</PMID>
  </reference>
  <reference>
    <citation>DuPree CE, Blair K, Steele SR, Martin MJ. Laparoscopic sleeve gastrectomy in patients with preexisting gastroesophageal reflux disease : a national analysis. JAMA Surg. 2014 Apr;149(4):328-34. doi: 10.1001/jamasurg.2013.4323.</citation>
    <PMID>24500799</PMID>
  </reference>
  <reference>
    <citation>Oor JE, Roks DJ, Unlu C, Hazebroek EJ. Laparoscopic sleeve gastrectomy and gastroesophageal reflux disease: a systematic review and meta-analysis. Am J Surg. 2016 Jan;211(1):250-67. doi: 10.1016/j.amjsurg.2015.05.031. Epub 2015 Aug 14.</citation>
    <PMID>26341463</PMID>
  </reference>
  <reference>
    <citation>Soricelli E, Casella G, Rizzello M, Cali B, Alessandri G, Basso N. Initial experience with laparoscopic crural closure in the management of hiatal hernia in obese patients undergoing sleeve gastrectomy. Obes Surg. 2010 Aug;20(8):1149-53. doi: 10.1007/s11695-009-0056-8. Epub 2010 Jan 5.</citation>
    <PMID>20049652</PMID>
  </reference>
  <reference>
    <citation>Ruscio S, Abdelgawad M, Badiali D, Iorio O, Rizzello M, Cavallaro G, Severi C, Silecchia G. Simple versus reinforced cruroplasty in patients submitted to concomitant laparoscopic sleeve gastrectomy: prospective evaluation in a bariatric center of excellence. Surg Endosc. 2016 Jun;30(6):2374-81. doi: 10.1007/s00464-015-4487-0. Epub 2015 Oct 1.</citation>
    <PMID>26428202</PMID>
  </reference>
  <reference>
    <citation>Samakar K, McKenzie TJ, Tavakkoli A, Vernon AH, Robinson MK, Shikora SA. The Effect of Laparoscopic Sleeve Gastrectomy with Concomitant Hiatal Hernia Repair on Gastroesophageal Reflux Disease in the Morbidly Obese. Obes Surg. 2016 Jan;26(1):61-6. doi: 10.1007/s11695-015-1737-0. Erratum In: Obes Surg. 2016 Jan;26(1):67.</citation>
    <PMID>25990380</PMID>
  </reference>
  <reference>
    <citation>Tutuian R, Vela MF, Shay SS, Castell DO. Multichannel intraluminal impedance in esophageal function testing and gastroesophageal reflux monitoring. J Clin Gastroenterol. 2003 Sep;37(3):206-15. doi: 10.1097/00004836-200309000-00004.</citation>
    <PMID>12960718</PMID>
  </reference>
  <reference>
    <citation>Kahrilas PJ, Bredenoord AJ, Fox M, Gyawali CP, Roman S, Smout AJ, Pandolfino JE; International High Resolution Manometry Working Group. The Chicago Classification of esophageal motility disorders, v3.0. Neurogastroenterol Motil. 2015 Feb;27(2):160-74. doi: 10.1111/nmo.12477. Epub 2014 Dec 3.</citation>
    <PMID>25469569</PMID>
  </reference>
  <reference>
    <citation>Suter M, Dorta G, Giusti V, Calmes JM. Gastro-esophageal reflux and esophageal motility disorders in morbidly obese patients. Obes Surg. 2004 Aug;14(7):959-66. doi: 10.1381/0960892041719581.</citation>
    <PMID>15329186</PMID>
  </reference>
  <reference>
    <citation>Mion F, Tolone S, Garros A, Savarino E, Pelascini E, Robert M, Poncet G, Valette PJ, Marjoux S, Docimo L, Roman S. High-resolution Impedance Manometry after Sleeve Gastrectomy: Increased Intragastric Pressure and Reflux are Frequent Events. Obes Surg. 2016 Oct;26(10):2449-56. doi: 10.1007/s11695-016-2127-y.</citation>
    <PMID>26956879</PMID>
  </reference>
  <reference>
    <citation>Jones R, Junghard O, Dent J, Vakil N, Halling K, Wernersson B, Lind T. Development of the GerdQ, a tool for the diagnosis and management of gastro-oesophageal reflux disease in primary care. Aliment Pharmacol Ther. 2009 Nov 15;30(10):1030-8. doi: 10.1111/j.1365-2036.2009.04142.x. Epub 2009 Sep 8.</citation>
    <PMID>19737151</PMID>
  </reference>
  <reference>
    <citation>Bredenoord AJ, Fox M, Kahrilas PJ, Pandolfino JE, Schwizer W, Smout AJ; International High Resolution Manometry Working Group. Chicago classification criteria of esophageal motility disorders defined in high resolution esophageal pressure topography. Neurogastroenterol Motil. 2012 Mar;24 Suppl 1(Suppl 1):57-65. doi: 10.1111/j.1365-2982.2011.01834.x.</citation>
    <PMID>22248109</PMID>
  </reference>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>December 13, 2018</study_first_submitted>
  <study_first_submitted_qc>December 13, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 17, 2018</study_first_posted>
  <last_update_submitted>January 19, 2022</last_update_submitted>
  <last_update_submitted_qc>January 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Morbid obesity</keyword>
  <keyword>Hiatal hernia</keyword>
  <keyword>Gastroesophageal reflux disease</keyword>
  <keyword>High resolution impedance manometry</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastroesophageal Reflux</mesh_term>
    <mesh_term>Obesity, Morbid</mesh_term>
    <mesh_term>Hernia</mesh_term>
    <mesh_term>Hernia, Hiatal</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>There is no individual patient data (IPD) sharing plan now.</ipd_description>
  </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/NCT03776669
org study id: 201810017RINB
nct id: NCT03776669
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Background:

      Obesity and hiatal hernia are both risk factors of gastroesophageal reflux disease (GERD),
      and the incidence of hiatal hernia is much higher in morbidly obese patients. Many believe
      that higher intra-abdominal pressure with higher esophagogastric junction (EGJ) pressure
      gradient in morbidly obese patients is the main mechanism accounting for the occurrence of
      GERD. Hiatal hernia, on the other hand, is associated with structure abnormality of EGJ.
      Sleeve gastrectomy (SG) has been becoming a standalone bariatric surgery for decades, and it
      has been proved to effectively induce long-term weight loss in morbidly obese patients. Some
      studies found morbidly obese patients benefited from resolution of GERD after SG, however,
      other studies had the opposite findings. Some morbidly obese patients had aggravating GERD or
      de novo GERD after SG. The mechanism is still unclear now. It might result from removal of
      fundus and sling muscular fibers of EGJ, increased intra-gastric pressure (IIGP), and hiatal
      hernia after surgery. High resolution impedance manometry (HRIM) is used to access esophageal
      and EGJ function objectively. Impedance reflux was more frequently observed in patients
      having gastroesophageal reflux (GER) symptoms after SG. In addition, previous studies also
      found decreased EGJ resting pressure, decreased length of lower esophageal sphincter (LES),
      and presence of hiatal hernia were associated with more GERD after SG.

      Objective:

      To evaluate the long-term EGJ function and GERD in morbidly obese patients with hiatal hernia
      receiving laparoscopic sleeve gastrectomy (LSG) with or without hiatal hernia repair (HHR).
Patients and methods:

      A total of 70 patients will be recruited and randomized to two groups with a 1:1 allocation
      ratio. Patients in the control group receive LSG alone and in the experimental group receive
      LSG with HHR. All subjects should provide basic clinical and demographic information, be
      evaluated for GER symptoms using GerdQ score, sign informed consent, and complete
      preoperative abdominal computed tomography (CT) scan, esophagogastroduodenoscopy (EGD), and
      HRIM. Outpatient follow-up would be arranged 1 weeks after discharge, then 1 month, 3 months,
      6 months, and 12 months after surgery. Weight change and GER symptoms will be evaluated at
      every outpatient visit. Abdominal CT scan, EGD, and HRIM will be performed 12 months after
      surgery.

      Expected results:

      Less reflux esophagitis, less impedance reflux episodes, lower incidence of hiatal hernia,
      higher EGJ resting pressure, and longer LES length should be observed in morbidly obese
      patients receiving LSG with HHR at 12-month follow-up, using EGD and HRIM as evaluation
      tools. Furthermore, lower GerdQ score should be observed in these patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: De novo reflux esophagitis
time frame: Within 12 months after surgery if symptomatic or at 12 months if asymptomatic.
description: Los angles classification grade B/C/D reflux esophagitis diagnosed by esophagogastroduodenoscopy.
measure: Impedance reflux
time frame: 12 months after the surgery
description: Impedance reflux after single swallow by high resolution impedance manometry
measure: Esophagogastric junction (EGJ) resting pressure
time frame: 12 months after the surgery
description: Measured by high resolution impedance manometry
measure: Lower esophageal sphincter (LES) length
time frame: 12 months after the surgery
description: Measured by high resolution impedance manometry
measure: De novo or aggravating hiatal hernia
time frame: 12 months after the surgery (or within 12 months after surgery if symptomatic )
description: Diagnosed by high resolution impedance manometry or esophagogastroduodenoscopy.
measure: GerdQ score
time frame: At 1 week (± 1 week) after discharge, then 1 month (± 2 weeks), 3 months (± 1 month), 6 months (± 1 month), and 12 months (± 1 month) after surgery.
description: Questionnaire for gastroesophageal reflux symptoms
measure: Post-operative complication
time frame: Within 30 days of surgery
description: Defined as complication ≧ grade III Clavien-Dindo classification
measure: Mesh-related complication
time frame: Within 12 months after surgery
description: infection, allergic reaction, intestinal complication, fistula formation, seroma formation, hematoma, recurrence of tissue defect, dysphagia, esophageal erosion or perforation.
arm group label: LSG alone
arm group type: Active Comparator
description: Intervention: laparoscopic sleeve gastrectomy alone.
LSG will be performed laparoscopically via a 5-port technique. The greater omentum is dissected by using the 5-mm laparoscopic LigaSure or Harmonic from 4 cm proximal to the pyloric ring to the angle of His. Sleeve calibration is done by a 36-French bougie inserted along the lesser curvature. Then the stomach is transected with sequential firings of linear green, gold, and blue 60 mm staplers starting about 4 cm proximal to the pylorus and ending approximately 2 cm distal to the left of the esophagus. The staple-line of the remnant gastric tube is oversewn with 3-0 V-Loc to prevent leakage and hemorrhage.
arm group label: LSG + HHR
arm group type: Experimental
description: Intervention: concomitant laparoscopic sleeve gastrectomy + hiatal hernia repair.
The surgical detail of LSG is the same as described in "LSG alone" arm, and the surgical detail of HHR is described as below.
The hiatus is approached from the right side of the EGJ, through the lesser omentum. The hiatal defect is repaired by 1-0 Surgilon interruptedly, and then a commercialized "U-shaped" Biodesign Hiatal Hernia Graft is placed to the EGJ to cover the posterior side but spare the anterior side of the hiatus. Care must be taken to avoid direct contact of mesh to the esophagus to avoid any unnecessary complication. After the mesh is appropriately placed and oriented, 2 ml of TISSEEL solution for sealant is applied all over the mesh for fixation.
intervention type: Procedure
intervention name: Laparoscopic sleeve gastrectomy + Hiatal hernia repair
description: To evaluate the role of concomitant hiatal hernia repair in laparoscopic sleeve gastrectomy for morbidly obese patients.
arm group label: LSG + HHR
intervention type: Procedure
intervention name: Laparoscopic sleeve gastrectomy alone
description: Current mainstay and standard surgical treatment for morbidly obese patients.
arm group label: LSG alone
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: No
last name: PoChu Lee, MD
role: Principal Investigator
affiliation: National Taiwan University Hospital
last name: PoChu Lee, MD
phone: 886972651953
email: pochu.leepochu@gmail.com
facility: 
status: Recruiting
contact: 
country: Taiwan
citation: Che F, Nguyen B, Cohen A, Nguyen NT. Prevalence of hiatal hernia in the morbidly obese. Surg Obes Relat Dis. 2013 Nov-Dec;9(6):920-4. doi: 10.1016/j.soard.2013.03.013. Epub 2013 Apr 19.
PMID: 23810611
citation: Santonicola A, Angrisani L, Cutolo P, Formisano G, Iovino P. The effect of laparoscopic sleeve gastrectomy with or without hiatal hernia repair on gastroesophageal reflux disease in obese patients. Surg Obes Relat Dis. 2014 Mar-Apr;10(2):250-5. doi: 10.1016/j.soard.2013.09.006. Epub 2013 Sep 20.
PMID: 24355324
citation: Soricelli E, Iossa A, Casella G, Abbatini F, Cali B, Basso N. Sleeve gastrectomy and crural repair in obese patients with gastroesophageal reflux disease and/or hiatal hernia. Surg Obes Relat Dis. 2013 May-Jun;9(3):356-61. doi: 10.1016/j.soard.2012.06.003. Epub 2012 Jun 19.
PMID: 22867558
citation: Mahawar KK, Carr WR, Jennings N, Balupuri S, Small PK. Simultaneous sleeve gastrectomy and hiatus hernia repair: a systematic review. Obes Surg. 2015 Jan;25(1):159-66. doi: 10.1007/s11695-014-1470-0.
PMID: 25348434
citation: Crawford C, Gibbens K, Lomelin D, Krause C, Simorov A, Oleynikov D. Sleeve gastrectomy and anti-reflux procedures. Surg Endosc. 2017 Mar;31(3):1012-1021. doi: 10.1007/s00464-016-5092-6. Epub 2016 Jul 20.
PMID: 27440196
citation: Braghetto I, Lanzarini E, Korn O, Valladares H, Molina JC, Henriquez A. Manometric changes of the lower esophageal sphincter after sleeve gastrectomy in obese patients. Obes Surg. 2010 Mar;20(3):357-62. doi: 10.1007/s11695-009-0040-3. Epub 2009 Dec 15.
PMID: 20013071
citation: DuPree CE, Blair K, Steele SR, Martin MJ. Laparoscopic sleeve gastrectomy in patients with preexisting gastroesophageal reflux disease : a national analysis. JAMA Surg. 2014 Apr;149(4):328-34. doi: 10.1001/jamasurg.2013.4323.
PMID: 24500799
citation: Oor JE, Roks DJ, Unlu C, Hazebroek EJ. Laparoscopic sleeve gastrectomy and gastroesophageal reflux disease: a systematic review and meta-analysis. Am J Surg. 2016 Jan;211(1):250-67. doi: 10.1016/j.amjsurg.2015.05.031. Epub 2015 Aug 14.
PMID: 26341463
citation: Soricelli E, Casella G, Rizzello M, Cali B, Alessandri G, Basso N. Initial experience with laparoscopic crural closure in the management of hiatal hernia in obese patients undergoing sleeve gastrectomy. Obes Surg. 2010 Aug;20(8):1149-53. doi: 10.1007/s11695-009-0056-8. Epub 2010 Jan 5.
PMID: 20049652
citation: Ruscio S, Abdelgawad M, Badiali D, Iorio O, Rizzello M, Cavallaro G, Severi C, Silecchia G. Simple versus reinforced cruroplasty in patients submitted to concomitant laparoscopic sleeve gastrectomy: prospective evaluation in a bariatric center of excellence. Surg Endosc. 2016 Jun;30(6):2374-81. doi: 10.1007/s00464-015-4487-0. Epub 2015 Oct 1.
PMID: 26428202
citation: Samakar K, McKenzie TJ, Tavakkoli A, Vernon AH, Robinson MK, Shikora SA. The Effect of Laparoscopic Sleeve Gastrectomy with Concomitant Hiatal Hernia Repair on Gastroesophageal Reflux Disease in the Morbidly Obese. Obes Surg. 2016 Jan;26(1):61-6. doi: 10.1007/s11695-015-1737-0. Erratum In: Obes Surg. 2016 Jan;26(1):67.
PMID: 25990380
citation: Tutuian R, Vela MF, Shay SS, Castell DO. Multichannel intraluminal impedance in esophageal function testing and gastroesophageal reflux monitoring. J Clin Gastroenterol. 2003 Sep;37(3):206-15. doi: 10.1097/00004836-200309000-00004.
PMID: 12960718
citation: Kahrilas PJ, Bredenoord AJ, Fox M, Gyawali CP, Roman S, Smout AJ, Pandolfino JE; International High Resolution Manometry Working Group. The Chicago Classification of esophageal motility disorders, v3.0. Neurogastroenterol Motil. 2015 Feb;27(2):160-74. doi: 10.1111/nmo.12477. Epub 2014 Dec 3.
PMID: 25469569
citation: Suter M, Dorta G, Giusti V, Calmes JM. Gastro-esophageal reflux and esophageal motility disorders in morbidly obese patients. Obes Surg. 2004 Aug;14(7):959-66. doi: 10.1381/0960892041719581.
PMID: 15329186
citation: Mion F, Tolone S, Garros A, Savarino E, Pelascini E, Robert M, Poncet G, Valette PJ, Marjoux S, Docimo L, Roman S. High-resolution Impedance Manometry after Sleeve Gastrectomy: Increased Intragastric Pressure and Reflux are Frequent Events. Obes Surg. 2016 Oct;26(10):2449-56. doi: 10.1007/s11695-016-2127-y.
PMID: 26956879
citation: Jones R, Junghard O, Dent J, Vakil N, Halling K, Wernersson B, Lind T. Development of the GerdQ, a tool for the diagnosis and management of gastro-oesophageal reflux disease in primary care. Aliment Pharmacol Ther. 2009 Nov 15;30(10):1030-8. doi: 10.1111/j.1365-2036.2009.04142.x. Epub 2009 Sep 8.
PMID: 19737151
citation: Bredenoord AJ, Fox M, Kahrilas PJ, Pandolfino JE, Schwizer W, Smout AJ; International High Resolution Manometry Working Group. Chicago classification criteria of esophageal motility disorders defined in high resolution esophageal pressure topography. Neurogastroenterol Motil. 2012 Mar;24 Suppl 1(Suppl 1):57-65. doi: 10.1111/j.1365-2982.2011.01834.x.
PMID: 22248109
responsible party type: Sponsor
mesh term: Gastroesophageal Reflux
mesh term: Obesity, Morbid
mesh term: Hernia
mesh term: Hernia, Hiatal
sharing ipd: No
ipd description: There is no individual patient data (IPD) sharing plan now.