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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

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

Conditions
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Morbid Obesity, Hiatal Hernia, Gastroesophageal Reflux Disease, Sleeve Gastrectomy

Intervention / Treatment
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* Procedure: Laparoscopic sleeve gastrectomy + Hiatal hernia repair
* Procedure: Laparoscopic sleeve gastrectomy alone


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: LSG alone<br>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<br>* Current mainstay and standard surgical treatment for morbidly obese patients.<br>|
| Experimental: LSG + HHR<br>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<br>* To evaluate the role of concomitant hiatal hernia repair in laparoscopic sleeve gastrectomy for morbidly obese patients.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| De novo reflux esophagitis | 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 | Impedance reflux after single swallow by high resolution impedance manometry | 12 months after the surgery | 
| Esophagogastric junction (EGJ) resting pressure | Measured by high resolution impedance manometry | 12 months after the surgery | 
| Lower esophageal sphincter (LES) length | Measured by high resolution impedance manometry | 12 months after the surgery | 
| De novo or aggravating hiatal hernia | Diagnosed by high resolution impedance manometry or esophagogastroduodenoscopy. | 12 months after the surgery (or within 12 months after surgery if symptomatic ) | 
| GerdQ score | 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 | Defined as complication ≧ grade III Clavien-Dindo classification | Within 30 days of surgery | 
| Mesh-related complication | infection, allergic reaction, intestinal complication, fistula formation, seroma formation, hematoma, recurrence of tissue defect, dysphagia, esophageal erosion or perforation. | Within 12 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Morbid obesity, Hiatal hernia, Gastroesophageal reflux disease, High resolution impedance manometry