Gastroesophageal Reflux Disease Clinical Trial
— SG-REACHOfficial title:
Sleeve Gastrectomy With Reestablishment of the Acute Angle of His (SG-REACH) in Obese Patients, a Prospective Randomized Controlled Study
Gastroesophageal reflux disease (GERD) is one of the most common chronic conditions that can affect one's quality of life. Laparoscopic sleeve gastrectomy (LSG) has become a popular technique and currently is the most frequently practiced surgical operation to treat obesity today. However, the prevalence of GERD following SG can be fairly high. Several studies have noted an incidence between 6% and 47%. To preserve this natural barrier during SG, a careful dissection at the angle of His must be maintained in order to spare the sling fibers and avoid blunting the angle of His. During creation of the sleeve, the gastric sling fibers are frequently transected near the angle of His, particularly if the transection line is very close to this anatomic landmark. These sling fibers contribute significantly to the function of the LES. The investigators suggest that after the finishing of SG, the anatomical structure of His horn was destroyed or partly destroyed, and the acute angle of His become obtuse angle. The investigators propose to perform a prospective randomized controlled study to reestablish the acute angle of His in obese patients followig sleeve gastrectomy to prevent GERD.
Status | Recruiting |
Enrollment | 66 |
Est. completion date | December 30, 2025 |
Est. primary completion date | December 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years to 65 Years |
Eligibility | Inclusion Criteria: - BMI = 32.5 kg/m2 with or without T2DM; - 27.5 kg/ m2 < BMI < 32.5 kg/m2 with T2DM but failed conservative treatment and combined with at least two metabolic diseases or comorbidities; - Duration of T2DM =15 years with fasting Cpeptide = 50% of normal lower limit - Waist circumference: male = 90 cm, female = 85 cm - Age within 16~65 years old Exclusion Criteria: - GERD preoperatively - Hiatus hernia approved by gastroscopy preoperatively - Pregnancy; - A history of mental illness and neurological disease; - The patient refuses surgery; - Combined with pituitary tumor; - Long-term use of antidepressant drugs; - Long-term use of immunosuppressants; - Situations in which the investigator or other examiner considers from the enrolled study that there are good reasons for nonconformity: if there are potential inconsistencies with the clinical protocol |
Country | Name | City | State |
---|---|---|---|
China | Beijing Chaoyang Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Zhen Jun Wang |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of gastroesophageal reflux disease | The rate of gastroesophageal reflux disease following sleeve gastrectomy at 1 year | 1 year | |
Secondary | Complications | Complications within 30 days postoperatively | 30 days postoperatively] | |
Secondary | Operating time | Time from opeing of the operation to the end of the operation | During the operation | |
Secondary | excessive weight loss | Percentage of excess weight loss (EWL) at any time postoperative was calculated as the amount of weight loss divided by the amount of excess weight times 100%. | 3 months, 6 months, 1 year, 3 years and 5 years postoperatively | |
Secondary | total weight loss | total weight loss compared with preoperative weight | 3 months, 6 months, 1 year, 3 years and 5 years postoperatively |
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