Morbid Obesity Clinical Trial
Official title:
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).
Status | Recruiting |
Enrollment | 70 |
Est. completion date | December 17, 2024 |
Est. primary completion date | November 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 65 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Taiwan | National Taiwan University Hospital | Taipei |
Lead Sponsor | Collaborator |
---|---|
National Taiwan University Hospital |
Taiwan,
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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. — View Citation
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* Note: There are 17 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Impedance reflux | Impedance reflux after single swallow by high resolution impedance manometry | 12 months after the surgery | |
Secondary | Esophagogastric junction (EGJ) resting pressure | Measured by high resolution impedance manometry | 12 months after the surgery | |
Secondary | Lower esophageal sphincter (LES) length | Measured by high resolution impedance manometry | 12 months after the surgery | |
Secondary | 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 ) | |
Secondary | 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. | |
Secondary | Post-operative complication | Defined as complication ? grade III Clavien-Dindo classification | Within 30 days of surgery | |
Secondary | 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 |
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