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

January 19, 2022 updated by: National Taiwan University Hospital

Laparoscopic Sleeve Gastrectomy With or Without Hiatal Hernia Repair in Morbidly Obese Patients: a Single-center Randomized Controlled Trial

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taipei, Taiwan, 100
        • Recruiting
        • National Taiwan University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Within 12 months after surgery if symptomatic or at 12 months if asymptomatic.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impedance reflux
Time Frame: 12 months after the surgery
Impedance reflux after single swallow by high resolution impedance manometry
12 months after the surgery
Esophagogastric junction (EGJ) resting pressure
Time Frame: 12 months after the surgery
Measured by high resolution impedance manometry
12 months after the surgery
Lower esophageal sphincter (LES) length
Time Frame: 12 months after the surgery
Measured by high resolution impedance manometry
12 months after the surgery
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.
12 months after the surgery (or within 12 months after surgery if symptomatic )
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
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.
Post-operative complication
Time Frame: Within 30 days of surgery
Defined as complication ≧ grade III Clavien-Dindo classification
Within 30 days of surgery
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.
Within 12 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Principal Investigator: PoChu Lee, MD, National Taiwan University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 9, 2019

Primary Completion (Anticipated)

November 1, 2023

Study Completion (Anticipated)

December 17, 2024

Study Registration Dates

First Submitted

December 13, 2018

First Submitted That Met QC Criteria

December 13, 2018

First Posted (Actual)

December 17, 2018

Study Record Updates

Last Update Posted (Actual)

January 21, 2022

Last Update Submitted That Met QC Criteria

January 19, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201810017RINB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

There is no individual patient data (IPD) sharing plan now.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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