This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Laparoscopic Sleeve Gastrectomy With or Without Hiatal Hernia Repair in Morbidly Obese Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03776669
Recruitment Status : Recruiting
First Posted : December 17, 2018
Last Update Posted : January 21, 2022
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

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).


Condition or disease Intervention/treatment Phase
Morbid Obesity Hiatal Hernia Gastroesophageal Reflux Disease Sleeve Gastrectomy Procedure: Laparoscopic sleeve gastrectomy + Hiatal hernia repair Procedure: Laparoscopic sleeve gastrectomy alone Not Applicable

Detailed Description:

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.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Laparoscopic Sleeve Gastrectomy With or Without Hiatal Hernia Repair in Morbidly Obese Patients: a Single-center Randomized Controlled Trial
Actual Study Start Date : January 9, 2019
Estimated Primary Completion Date : November 1, 2023
Estimated Study Completion Date : December 17, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: LSG alone

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.

 Procedure: Laparoscopic sleeve gastrectomy alone
Current mainstay and standard surgical treatment for morbidly obese patients.
Experimental: LSG + HHR

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.

 Procedure: Laparoscopic sleeve gastrectomy + Hiatal hernia repair
To evaluate the role of concomitant hiatal hernia repair in laparoscopic sleeve gastrectomy for morbidly obese patients.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. De novo reflux esophagitis [ Time Frame: Within 12 months after surgery if symptomatic or at 12 months if asymptomatic. ]
    Los angles classification grade B/C/D reflux esophagitis diagnosed by esophagogastroduodenoscopy.


Secondary Outcome Measures :
  1. Impedance reflux [ Time Frame: 12 months after the surgery ]
    Impedance reflux after single swallow by high resolution impedance manometry

  2. Esophagogastric junction (EGJ) resting pressure [ Time Frame: 12 months after the surgery ]
    Measured by high resolution impedance manometry

  3. Lower esophageal sphincter (LES) length [ Time Frame: 12 months after the surgery ]
    Measured by high resolution impedance manometry

  4. De novo or aggravating hiatal hernia [ Time Frame: 12 months after the surgery (or within 12 months after surgery if symptomatic ) ]
    Diagnosed by high resolution impedance manometry or esophagogastroduodenoscopy.

  5. 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. ]
    Questionnaire for gastroesophageal reflux symptoms

  6. Post-operative complication [ Time Frame: Within 30 days of surgery ]
    Defined as complication ≧ grade III Clavien-Dindo classification

  7. Mesh-related complication [ Time Frame: Within 12 months after surgery ]
    infection, allergic reaction, intestinal complication, fistula formation, seroma formation, hematoma, recurrence of tissue defect, dysphagia, esophageal erosion or perforation.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with:

    1. Body mass index (BMI) ≧ 35, or
    2. 30 ≦ BMI < 35, with inadequately controlled type 2 diabetes mellitus (T2DM) or metabolic syndrome, or
    3. T2DM with BMI ≧ 32.5, or
    4. T2DM with BMI between 27.5 and 32.5 not well controlled by medication, especially for those with major cardiovascular risk.
  • Age: 20 to 65 years old.

  • Hiatal hernia diagnosed by either:

    1. HRIM: defined as the distance between low esophageal sphincter (LES) and crural diaphragm (CD) equal to or greater than 2 cm. (LES-CD ≧ 2 cm)
    2. EGD: defined as the apparent separation between the squamocolumnar junction and the diaphragmatic impression is greater than 2 cm.

Exclusion Criteria:

  • Prior major gastrointestinal (GI) tract surgery.
  • Bleeding tendency.
  • American Society of Anesthesiologists physical status (ASA) ≧ class III.
  • Pregnancy or lactating women.
  • Allergy to contrast medium for CT scan.
  • Concomitantly untreated or uncontrolled endocrine disease.
  • Alcohol or drug abuse.

  • Mental, behavioral, and neurodevelopmental disorders.

    1. Patients who possess "National Health Insurance (NHI) Major Illness/Injury Certificate" for ICD-10-CM codes F01-F99. (ICD: International Classification of Diseases; CM: Clinical Modification)
    2. Patients who have been hospitalized in psychiatric ward in the recent one year.
  • Type IV hiatal hernia.
  • Moderate to severe reflux esophagitis (LA classification grade B/C/D) refractory to medical treatment.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT03776669


Contacts
Layout table for location contacts
Contact: PoChu Lee, MD 886972651953 pochu.leepochu@gmail.com

Locations
Layout table for location information
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: PoChu Lee, MD    886972651953    pochu.leepochu@gmail.com   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Layout table for investigator information
Principal Investigator: PoChu Lee, MD National Taiwan University Hospital
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT03776669    
Other Study ID Numbers: 201810017RINB
First Posted: December 17, 2018    Key Record Dates
Last Update Posted: January 21, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no individual patient data (IPD) sharing plan now.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Taiwan University Hospital:
Morbid obesity
Hiatal hernia
Gastroesophageal reflux disease
High resolution impedance manometry
Additional relevant MeSH terms:
Layout table for MeSH terms
Gastroesophageal Reflux
Obesity, Morbid
Hernia
Hernia, Hiatal
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
 Pathological Conditions, Anatomical
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Hernia, Diaphragmatic
Internal Hernia