Obesity, MorbidNCT07125638
Long-term Follow-up After OAGB
An observational study of Obesity, Morbid and Obesity, Abdominal, run by Azienda Sanitaria Locale Napoli 2 Nord at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 67 years
- Conditions the study is for
- Obesity, Morbid, Obesity, Abdominal, Ona Anastomosis Gastric Bypass
- How many people
- 2,368 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2018to 1 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 67 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- • 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Azienda Sanitaria Locale Napoli 2 Nord - U.O.C. Chirurgia Generale, P.O. "Anna Rizzoli", Lacco Ameno, Naples, Italy
Naples, naples, 80131
About this study
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.
Read the 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
- Medical subject headings
- Obesity, Morbid, Obesity, Abdominal, Gastroesophageal Reflux
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
.
Measured: 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.
.
Measured: 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.
.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 5 years follow-up
Secondary outcomes (3)
Correlation Between Gastroesophageal Symptoms and Endoscopic Findings After OAGB
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.
Measured: 1 year follow-up
Correlation Between Gastroesophageal Symptoms and Endoscopic Findings After OAGB
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.
Measured: 3 year follow-up
Correlation Between Gastroesophageal Symptoms and Endoscopic Findings After OAGB
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.
Measured: 5 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study start1 Jan 2018
- Primary completion1 Jan 2023
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, MorbidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 2,368 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Sanitaria Locale Napoli 2 Nord
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Pizza, Azienda Sanitaria Locale Napoli 2 Nord
- Investigators
- francesco pizza, PhD, Principal investigator, Azienda Sanitaria Locale Napoli 2 Nord
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07125638
- Sponsor's protocol ID
- 0923
- Status last verified
- Aug 2025
- First submitted
- 10 Aug 2025
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Follow-up After OAGB
- ClinicalTrials.gov ID
- NCT07125638
- Acronym / sponsor ID
- 0923
- Conditions
- Obesity, Morbid, Obesity, Abdominal, Ona Anastomosis Gastric Bypass, GERD, Bile Reflux Gastritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,368 participants (actual)
- Lead sponsor
- Azienda Sanitaria Locale Napoli 2 NordUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 15 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- • Age ≥ 18 years.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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. .
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. .
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. .
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.
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.
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.
3 secondary outcomes
Correlation Between Gastroesophageal Symptoms and Endoscopic Findings After OAGB
Time frame: 1 year follow-up
Correlation Between Gastroesophageal Symptoms and Endoscopic Findings After OAGB
Time frame: 3 year follow-up
Correlation Between Gastroesophageal Symptoms and Endoscopic Findings After OAGB
Time frame: 5 year follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
francesco pizza, PhD principal investigator
Azienda Sanitaria Locale Napoli 2 Nord
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, Morbid and Obesity, Abdominal, run by Azienda Sanitaria Locale Napoli 2 Nord at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Bile Reflux and Marginal Ulcers Assessed by Standardized Endoscopic Follow-up After OAGB (time frame: 1 years follow-up). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2025.