Laparoscopic Sleeve Gastrectomy With or Without Hiatal Hernia Repair in Morbidly Obese Patients
Morbid Obesity, Hiatal Hernia, Gastroesophageal Reflux Disease
About this trial
This is an interventional treatment trial for Morbid Obesity focused on measuring Morbid obesity, Hiatal hernia, Gastroesophageal reflux disease, High resolution impedance manometry
Eligibility Criteria
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.
Sites / Locations
- National Taiwan University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
LSG alone
LSG + HHR
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.
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.