Long-term Follow-up After OAGB

NCT ID: NCT07125638

Last Updated: 2025-08-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2368 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2023-03-01

Brief Summary

This study follows patients who have undergone one-anastomosis gastric bypass (OAGB), a type of weight-loss surgery, to check for changes in the stomach and esophagus over time. All patients have an upper endoscopy before surgery and then again 1, 3, and 5 years later, even if they have no symptoms. The main goal is to see how often problems like bile reflux or ulcers at the surgical join (marginal ulcers) occur. The study also looks at whether patients' symptoms match what is seen during endoscopy.

Detailed Description

This study is designed to learn more about changes in the digestive system after one-anastomosis gastric bypass (OAGB), a widely used weight-loss operation. While this surgery is effective for reducing excess weight and improving obesity-related health problems, some people may develop changes in the stomach or esophagus over time, such as bile reflux (backflow of bile into the stomach or esophagus) or marginal ulcers (sores at the site where the stomach is joined to the small intestine).

To better understand how often these problems occur, and whether they cause symptoms, the study follows patients for at least 5 years after surgery. All participants have an upper endoscopy (a camera test that looks at the esophagus, stomach, and the join with the small intestine) before surgery, and then again 1, 3, and 5 years afterwards. These check-ups are done even if the patient feels well, to detect any hidden changes early.

The study also compares what patients report in symptom questionnaires-covering issues like heartburn, regurgitation, or stomach discomfort-with what is actually seen during endoscopy. This will help doctors understand how well symptoms match the real condition of the digestive tract.

By using the same protocol across several specialized bariatric centers, and including all eligible patients, the study aims to provide reliable, long-term data to guide follow-up care after OAGB. The findings could help refine patient monitoring, improve early detection of problems, and identify risk factors that can be addressed to prevent complications.

Conditions

Obesity, Morbid; Obesity, Abdominal; Ona Anastomosis Gastric Bypass; GERD; Bile Reflux Gastritis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• • Age ≥ 18 years.

• Meets IFSO indications for bariatric surgery (BMI > 40 kg/m², or BMI > 35 kg/m² with obesity-related comorbidities).
• Candidate for primary one-anastomosis gastric bypass (OAGB).
• Preoperative upper endoscopy completed as part of standardized work-up.
• Helicobacter pylori screened preoperatively and (if positive) eradication therapy completed before surgery.
• Able and willing to attend scheduled postoperative upper endoscopies (at approximately 1, 3, and 5 years) regardless of symptoms.
• Able to complete patient-reported outcome instruments (GERD-HRQL and abbreviated GSRS).
• Provided written informed consent.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 67 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Sanitaria Locale Napoli 2 Nord

OTHER

Sponsor Role: lead

Responsible Party

Francesco Pizza

MD,PhD, Responsible for the Bariatric and Metabolic Surgery unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

francesco pizza, PhD

Role: PRINCIPAL_INVESTIGATOR

Azienda Sanitaria Locale Napoli 2 Nord

Locations

Azienda Sanitaria Locale Napoli 2 Nord - U.O.C. Chirurgia Generale, P.O. "Anna Rizzoli", Lacco Ameno, Naples, Italy

Naples, naples, Italy

Countries

Italy

Other Identifiers

0923

Identifier Type: -

Identifier Source: org_study_id