Long-term Follow-up After OAGB

Completed

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

• Registration Number: NCT07125638
• Lead Sponsor: Azienda Sanitaria Locale Napoli 2 Nord

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.

Study Timeline

• Study Start: 2018-01-01
• Primary Completion: 2023-01-01
• Study Completion: 2023-03-01
• Status Verified: 2025-08
• Study First Submitted: 2025-08-10
• Study First Submitted QC: 2025-08-10
• Last Update Submitted: 2025-08-10
• Study First Posted: 2025-08-15
• Last Update Posted: 2025-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2368

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of Bile Reflux and Marginal Ulcers Assessed by Standardized Endoscopic Follow-up After OAGB	5 years follow-up	The primary outcome is the proportion of patients presenting with bile reflux following one-anastomosis gastric bypass (OAGB). Findings are determined through standardized upper gastrointestinal endoscopy performed at 1, 3, and 5 years postoperatively.; Bile reflux is defined as the presence of visible bile in the gastric pouch or esophagus during endoscopy, with or without associated mucosal changes.; .
Incidence of Marginal Ulcers After One-Anastomosis Gastric Bypass	5 years follow-up	The primary outcome is the proportion of patients developing marginal ulcers following one-anastomosis gastric bypass (OAGB). Marginal ulcers are defined as mucosal ulcerations located at the gastrojejunal anastomosis, confirmed by direct visualization during standardized upper gastrointestinal endoscopy.; Endoscopy is performed at 1, 3, and 5 years postoperatively, regardless of the presence or absence of symptoms. Lesions are classified according to established endoscopic morphological criteria, and their size, depth, and location are systematically recorded.

Secondary Outcome Measures

Name	Time	Method
Correlation Between Gastroesophageal Symptoms and Endoscopic Findings After OAGB	5 year follow-up	The secondary outcome is the level of agreement between patient-reported gastroesophageal symptoms, assessed using the GERD-Health Related Quality of Life (GERD-HRQL) questionnaire, and objective findings on standardized upper gastrointestinal endoscopy at 1, 3, and 5 years after one-anastomosis gastric bypass (OAGB). Concordance is measured using the Cohen's kappa statistic, with symptoms recorded as present/absent and endoscopic lesions classified according to the Los Angeles grading system for esophagitis and established criteria for gastritis and ulcer disease.

Trial Locations

Locations (1)

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