Surgery to improve weight loss and reduce reflux in obese patients
Sleeve Gastrectomy With Reestablishment of the Acute Angle of His (SG-REACH) in Obese Patients, a Prospective Randomized Controlled Study
This study tests if a special type of weight loss surgery can help obese patients lose weight while also reducing their heartburn symptoms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 66 (estimated) |
| Ages | 16 Years to 65 Years |
| Sex | All |
| Sponsor | Beijing Chao Yang Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT05452980 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of sleeve gastrectomy combined with the reestablishment of the acute angle of His in obese patients. The study aims to address gastroesophageal reflux disease (GERD), which can occur after traditional sleeve gastrectomy. By preserving the anatomical structures around the angle of His during surgery, the trial seeks to improve outcomes related to weight loss and GERD symptoms. Participants will undergo laparoscopic surgery with specific techniques to maintain the integrity of the lower esophageal sphincter.
Who should consider this trial
Good fit: Ideal candidates include obese individuals aged 16 to 65 with a BMI of 32.5 or higher, or those with a BMI between 27.5 and 32.5 who have type 2 diabetes and other metabolic conditions.
Not a fit: Patients with pre-existing GERD, hiatus hernia, or those who are pregnant or have certain mental or neurological conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved weight loss outcomes and reduced incidence of GERD in obese patients undergoing surgery.
How similar studies have performed: While there have been studies on sleeve gastrectomy and GERD, the specific approach of reestablishing the acute angle of His is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Beijing, Beijing
- Beijing Chaoyang Hospital — Beijing, Beijing, China (Recruiting)
Study contacts
- Study coordinator: Jia Gang Han
- Email: hanjiagang@ccmu.edu.cn
- Phone: +861085231604
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.