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Completed

NCT Number: NCT07125638

Long-term Follow-up After OAGB

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.

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Key information

Conditions

Obesity, Morbid Bile Reflux Gastritis Body Weight Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders GERD Gastroesophageal Reflux Gastrointestinal Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Abdominal Ona Anastomosis Gastric Bypass Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–67 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Naples, naples, 80131, Italy

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Incidence of Bile Reflux and Marginal Ulcers Assessed by Standardized Endoscopic Follow-up After OAGB

    Time frame: 1 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.

    .

  2. Incidence of Bile Reflux and Marginal Ulcers Assessed by Standardized Endoscopic Follow-up After OAGB

    Time frame: 3 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.

    .

  3. Incidence of Bile Reflux and Marginal Ulcers Assessed by Standardized Endoscopic Follow-up After OAGB

    Time frame: 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.

    .

  4. Incidence of Marginal Ulcers After One-Anastomosis Gastric Bypass

    Time frame: 1 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.

  5. Incidence of Marginal Ulcers After One-Anastomosis Gastric Bypass

    Time frame: 3 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.

  6. Incidence of Marginal Ulcers After One-Anastomosis Gastric Bypass

    Time frame: 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 outcomes

  1. Correlation Between Gastroesophageal Symptoms and Endoscopic Findings After OAGB

    Time frame: 1 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.

  2. Correlation Between Gastroesophageal Symptoms and Endoscopic Findings After OAGB

    Time frame: 3 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.

  3. Correlation Between Gastroesophageal Symptoms and Endoscopic Findings After OAGB

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Azienda Sanitaria Locale Napoli 2 Nord

Other

Registry information

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Aug 15, 2025
Registry last updated
Aug 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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