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

  • STATUS
    Recruiting
  • End date
    Dec 17, 2024
  • participants needed
    70
  • sponsor
    National Taiwan University Hospital
Updated on 25 March 2022

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).

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.

Details
Condition Morbid Obesity, Hiatal Hernia, Gastroesophageal Reflux Disease, Sleeve Gastrectomy
Treatment Laparoscopic sleeve gastrectomy + Hiatal hernia repair, Laparoscopic sleeve gastrectomy alone
Clinical Study IdentifierNCT03776669
SponsorNational Taiwan University Hospital
Last Modified on25 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients with
Body mass index (BMI) ≧ 35, or
30 ≦ BMI < 35, with inadequately controlled type 2 diabetes mellitus (T2DM) or metabolic syndrome, or
T2DM with BMI ≧ 32.5, or
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
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)
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
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)
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
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