Long-term Follow-up After OAGB

NCT07125638 | Completed

• 1 other identifier: 0923
• Study Type: observational
• Target: 2,368
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (6)

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

  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. .

  1 years follow-up

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

  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 years follow-up

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

  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. .

  5 years follow-up

• Incidence of Marginal Ulcers After One-Anastomosis Gastric Bypass

  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.

  1 years follow-up

• Incidence of Marginal Ulcers After One-Anastomosis Gastric Bypass

  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.

  3 years follow-up

• Incidence of Marginal Ulcers After One-Anastomosis Gastric Bypass

  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 years follow-up

Secondary Outcomes (3)

• Correlation Between Gastroesophageal Symptoms and Endoscopic Findings After OAGB

  1 year follow-up

• Correlation Between Gastroesophageal Symptoms and Endoscopic Findings After OAGB

  3 year follow-up

• Correlation Between Gastroesophageal Symptoms and Endoscopic Findings After OAGB

  5 year follow-up

Eligibility Criteria

• Age: 18 Years - 67 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

* Major postoperative complication within 30 days after OAGB (Clavien-Dindo grade III or IV). * Any subsequent abdominal surgery after OAGB (e.g., cholecystectomy, incisional hernia repair) prior to planned endoscopic follow-up. * Prior or concomitant revisional bariatric procedure that could impair esophageal motility. * Total clinical follow-up shorter than 12 months. * Chronic corticosteroid use. * Chronic nonsteroidal anti-inflammatory drug (NSAID) use. * Preoperative upper endoscopy showing Los Angeles grade ≥ B esophagitis. * Preoperative hiatal hernia \> 5 cm. * Severe, proton-pump-inhibitor-resistant GERD symptoms or advanced lower esophageal sphincter (LES) incompetence preoperatively. * Inability or unwillingness to provide informed consent or comply with follow-up.

You may qualify if:

• 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.

Sponsors & Collaborators

• Azienda Sanitaria Locale Napoli 2 Nord: lead

Study Sites (1)

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

Naples, naples, 80131, Italy

Location

MeSH Terms

Conditions

Obesity, Morbid; Obesity, Abdominal; Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• francesco pizza, PhD

  Azienda Sanitaria Locale Napoli 2 Nord

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD,PhD, Responsible for the Bariatric and Metabolic Surgery unit

Study Record Dates

• First Submitted: August 10, 2025
• First Posted: August 15, 2025
• Study Start: January 1, 2018
• Primary Completion: January 1, 2023
• Study Completion: March 1, 2023
• Last Updated: August 15, 2025

Record last verified: 2025-08

Locations

IT (1)