Obesity, MorbidNCT03532646
Endoscopic Complications After Gastric Bypass
A study testing upper endoscopy in people with Obesity, Morbid and Bariatric Surgery Candidate, run by Sana Klinikum Offenbach at 1 site in Germany.
Trial summary
Endoscopic complications such as gastro-esophageal reflux disease, ulcera, gastritis, bile reflux, anastomotic stricture and so on are described after gastric bypass surgery. The incidence of these complications after RYGB versus MGB/OAGB are getting observed. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obesity, Morbid, Bariatric Surgery Candidate
- What is being tested?
- upper endoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2014to Mar 2019
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all patients who underwent RYGB or MGB/OAGB as a primary surgery and were readmitted to tho hospital undergoing upper endoscopy are included
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Endoscopic Complications After Roux-en Y Gastric Bypass Versus Mini/One Anastomosis Gastric Bypass
Endoscopic complications such as gastro-esophageal reflux disease, ulcera, gastritis, bile reflux, anastomotic stricture and so on are described after gastric bypass surgery. The incidence of these complications after RYGB versus MGB/OAGB are getting observed.
Read the detailed description
All patients who were readmitted to our centre of excellence for obesity and metabolic surgery (October 2014 - March 2018) are observed regarding endoscopic complications in s.a. RYGB and MGB/OAGB.
- Conditions
- Obesity, Morbid, Bariatric Surgery Candidate
- Being tested
- upper endoscopy
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
upper endoscopyProcedure or surgery
endoscopy of the gastrointestinal tract
| Study group | Role | What they receive |
|---|---|---|
| group 1: RYGB | Other | All patients who underwent RYGB and were readmitted to upper endoscopy are getting observed Receives: Procedure: upper endoscopy |
| group 2:MGB/OAGB | Other | All patients who underwent MGB/OAGB and were readmitted to upper endoscopy are getting observed Receives: Procedure: upper endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complication
Pathological finding during upper endoscopy
Measured: Up to 15 years post surgery
Secondary outcomes (4)
Weight Loss since Surgery
Weight Loss since Surgery: Total Weight Loss in %
Measured: Up to 15 years post surgery
toxic status
toxic status (NSAID)
Measured: Up to 15 years post surgery
toxic status II
toxic status (nicotin)
Measured: Up to 15 years post surgery
Revisional Surgery
Revisional Surgery due to complication
Measured: Up to 15 years post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2018
- Study startOct 2014
- Primary completionMar 2019
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- All patients who underwent RYGB and MGB/OAGB readmitted for complications in our centre of excellence are getting observed
- Masking
- None (open label)
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sana Klinikum Offenbach
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christine Stier, Sana Klinikum Offenbach
- Investigators
- Christine Stier, MD, Principal investigator, Sana Klinikum Offenbach/Sana Klinikum Remscheid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03532646
- Sponsor's protocol ID
- FF 111/2016
- Status last verified
- Apr 2024
- First submitted
- 24 Apr 2018
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be published anonymous in a peer review journal
Publications
De Palma GD, Forestieri P. Role of endoscopy in the bariatric surgery of patients. World J Gastroenterol. 2014 Jun 28;20(24):7777-84. doi: 10.3748/wjg.v20.i24.7777.
PubMed 24976715Abd Ellatif ME, Alfalah H, Asker WA, El Nakeeb AE, Magdy A, Thabet W, Ghaith MA, Abdallah E, Shahin R, Shoma A, Dawoud IE, Abbas A, Salama AF, Ali Gamal M. Place of upper endoscopy before and after bariatric surgery: A multicenter experience with 3219 patients. World J Gastrointest Endosc. 2016 May 25;8(10):409-17. doi: 10.4253/wjge.v8.i10.409.
PubMed 27247708
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Complications After Roux-en Y Gastric Bypass Versus Mini/One Anastomosis Gastric Bypass
- ClinicalTrials.gov ID
- NCT03532646
- Acronym / sponsor ID
- FF 111/2016
- Conditions
- Obesity, Morbid, Bariatric Surgery Candidate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Sana Klinikum OffenbachUniversity, hospital or other
- Study start
- Oct 2014 (actual)
- Primary completion
- Mar 2019 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 22 May 2018 (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.
Endoscopic complications such as gastro-esophageal reflux disease, ulcera, gastritis, bile reflux, anastomotic stricture and so on are described after gastric bypass surgery. The incidence of these complications after RYGB versus MGB/OAGB are getting observed.
Detailed description
All patients who were readmitted to our centre of excellence for obesity and metabolic surgery (October 2014 - March 2018) are observed regarding endoscopic complications in s.a. RYGB and MGB/OAGB.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All patients who underwent RYGB and MGB/OAGB readmitted for complications in our centre of excellence are getting observed
| Arm | Type | Receives |
|---|---|---|
| group 1: RYGB | Other | Procedure: upper endoscopyAll patients who underwent RYGB and were readmitted to upper endoscopy are getting observed |
| group 2:MGB/OAGB | Other | Procedure: upper endoscopyAll patients who underwent MGB/OAGB and were readmitted to upper endoscopy are getting observed |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all patients who underwent RYGB or MGB/OAGB as a primary surgery and were readmitted to tho hospital undergoing upper endoscopy are included
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| upper endoscopyendoscopy of the gastrointestinal tract | Procedure or surgery | group 1: RYGB, group 2:MGB/OAGB |
Primary outcome
Complication
Time frame: Up to 15 years post surgery
Pathological finding during upper endoscopy
4 secondary outcomes
Weight Loss since Surgery
Time frame: Up to 15 years post surgery
toxic status
Time frame: Up to 15 years post surgery
toxic status II
Time frame: Up to 15 years post surgery
Revisional Surgery
Time frame: Up to 15 years post surgery
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 30 Apr 2024.
- Results publication: PubMed 24976715De Palma GD, Forestieri P. Role of endoscopy in the bariatric surgery of patients. World J Gastroenterol. 2014 Jun 28;20(24):7777-84. doi: 10.3748/wjg.v20.i24.7777.
- Results publication: PubMed 27247708Abd Ellatif ME, Alfalah H, Asker WA, El Nakeeb AE, Magdy A, Thabet W, Ghaith MA, Abdallah E, Shahin R, Shoma A, Dawoud IE, Abbas A, Salama AF, Ali Gamal M. Place of upper endoscopy before and after bariatric surgery: A multicenter experience with 3219 patients. World J Gastrointest Endosc. 2016 May 25;8(10):409-17. doi: 10.4253/wjge.v8.i10.409.
- Individual participant dataSharing planned: No. Data will be published anonymous in a peer review journal
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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.
Christine Stier, MD principal investigator
Sana Klinikum Offenbach/Sana Klinikum Remscheid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing upper endoscopy in people with Obesity, Morbid and Bariatric Surgery Candidate, run by Sana Klinikum Offenbach at 1 site in Germany.
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 1 inclusion and 1 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 30 Apr 2024. 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 Germany. 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?
Complication (time frame: Up to 15 years post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03532646, which also lists 2 linked publications.
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 30 Apr 2024.