Endoscopic Complications After Gastric Bypass
April 27, 2024 updated by: Christine Stier, Sana Klinikum Offenbach
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
1000
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Remscheid, Germany, 42859
- Sana obesity center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- all patients who underwent RYGB or MGB/OAGB as a primary surgery and were readmitted to tho hospital undergoing upper endoscopy are included
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: group 1: RYGB
All patients who underwent RYGB and were readmitted to upper endoscopy are getting observed
|
endoscopy of the gastrointestinal tract
|
|
Other: group 2:MGB/OAGB
All patients who underwent MGB/OAGB and were readmitted to upper endoscopy are getting observed
|
endoscopy of the gastrointestinal tract
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Complication
Time Frame: Up to 15 years post surgery
|
Pathological finding during upper endoscopy
|
Up to 15 years post surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Weight Loss since Surgery
Time Frame: Up to 15 years post surgery
|
Weight Loss since Surgery: Total Weight Loss in %
|
Up to 15 years post surgery
|
|
toxic status
Time Frame: Up to 15 years post surgery
|
toxic status (NSAID)
|
Up to 15 years post surgery
|
|
toxic status II
Time Frame: Up to 15 years post surgery
|
toxic status (nicotin)
|
Up to 15 years post surgery
|
|
Revisional Surgery
Time Frame: Up to 15 years post surgery
|
Revisional Surgery due to complication
|
Up to 15 years post surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Christine Stier, MD, Sana Klinikum Offenbach/Sana Klinikum Remscheid
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Abd 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2014
Primary Completion (Actual)
March 1, 2019
Study Completion (Actual)
March 1, 2019
Study Registration Dates
First Submitted
April 24, 2018
First Submitted That Met QC Criteria
May 9, 2018
First Posted (Actual)
May 22, 2018
Study Record Updates
Last Update Posted (Actual)
April 30, 2024
Last Update Submitted That Met QC Criteria
April 27, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FF 111/2016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Data will be published anonymous in a peer review journal
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.