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Search / Trial NCT05452980

Sleeve Gastrectomy With Reestablishment of the Acute Angle of His (SG-REACH) in Obese Patients

Launched by ZHEN JUN WANG · Jul 6, 2022

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Gastroesophageal Reflux Disease Sleeve Gastrectomy Angle Of His Weight Loss

ClinConnect Summary

This clinical trial, called SG-REACH, is looking at a new approach to help prevent gastroesophageal reflux disease (GERD) in patients who are undergoing sleeve gastrectomy (SG) for obesity. GERD is a common condition where stomach acid flows back into the esophagus, causing discomfort and affecting quality of life. While sleeve gastrectomy is a popular weight-loss surgery, many patients experience GERD afterward. The researchers believe that by carefully restoring a specific angle in the stomach (called the angle of His) during the surgery, they can reduce the chances of GERD developing.

To participate in this study, individuals need to be between 16 and 65 years old and have a body mass index (BMI) of at least 32.5, or a lower BMI if they also have type 2 diabetes and other health issues. However, those who have GERD before the surgery or certain other health conditions will not be eligible. Participants can expect to undergo the sleeve gastrectomy procedure with the added step of reestablishing the angle of His, and they will be monitored to see if this helps prevent GERD. This study aims to improve outcomes for patients seeking weight loss surgery and enhance their overall health after the procedure.

Gender

ALL

Eligibility 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

About Zhen Jun Wang

Zhen Jun Wang is a distinguished clinical trial sponsor dedicated to advancing medical research and innovation. With a focus on enhancing patient care, the organization specializes in designing and conducting clinical trials across various therapeutic areas. Zhen Jun Wang leverages a robust network of experienced professionals and cutting-edge methodologies to ensure rigorous study protocols and regulatory compliance. Committed to ethical practices and transparency, the sponsor aims to contribute valuable insights to the medical community, ultimately facilitating the development of effective treatments and improving health outcomes for patients worldwide.

Locations

Beijing, Beijing, China

Patients applied

0 patients applied

Trial Officials

Zhen Jun Wang

Study Chair

Beijing Chao Yang Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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