Back to resultsEndoscopic Complications After Gastric Bypass
Primary Purpose
Obesity, Morbid, Bariatric Surgery Candidate
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
upper endoscopy
Sponsored by
About this trial
This is an interventional diagnostic trial for Obesity, Morbid
Eligibility Criteria
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:
-
Sites / Locations
- Sana obesity centerRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
group 1: RYGB
group 2:MGB/OAGB
Arm Description
All patients who underwent RYGB and were readmitted to upper endoscopy are getting observed
All patients who underwent MGB/OAGB and were readmitted to upper endoscopy are getting observed
Outcomes
Primary Outcome Measures
Complication
Pathological finding during upper endoscopy
Secondary Outcome Measures
Weight Loss since Surgery
Weight Loss since Surgery: Total Weight Loss in %
toxic status
toxic status (NSAID)
toxic status II
toxic status (nicotin)
Revisional Surgery
Revisional Surgery due to complication
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03532646
Brief Title
Endoscopic Complications After Gastric Bypass
Official Title
Endoscopic Complications After Roux-en Y Gastric Bypass Versus Mini/One Anastomosis Gastric Bypass
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (Actual)
Primary Completion Date
March 2021 (Actual)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sana Klinikum Offenbach
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Morbid, Bariatric Surgery Candidate
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
Non-Randomized
Enrollment
1000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
group 1: RYGB
Arm Type
Other
Arm Description
All patients who underwent RYGB and were readmitted to upper endoscopy are getting observed
Arm Title
group 2:MGB/OAGB
Arm Type
Other
Arm Description
All patients who underwent MGB/OAGB and were readmitted to upper endoscopy are getting observed
Intervention Type
Procedure
Intervention Name(s)
upper endoscopy
Intervention Description
endoscopy of the gastrointestinal tract
Primary Outcome Measure Information:
Title
Complication
Description
Pathological finding during upper endoscopy
Time Frame
Up to 15 years post surgery
Secondary Outcome Measure Information:
Title
Weight Loss since Surgery
Description
Weight Loss since Surgery: Total Weight Loss in %
Time Frame
Up to 15 years post surgery
Title
toxic status
Description
toxic status (NSAID)
Time Frame
Up to 15 years post surgery
Title
toxic status II
Description
toxic status (nicotin)
Time Frame
Up to 15 years post surgery
Title
Revisional Surgery
Description
Revisional Surgery due to complication
Time Frame
Up to 15 years post surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sonja Chiappetta, MD
Email
sonja.chiappetta@sana.de
First Name & Middle Initial & Last Name or Official Title & Degree
Christine Stier, MD
Email
christinestier@googlemail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine Stier, MD
Organizational Affiliation
Sana Klinikum Offenbach/Sana Klinikum Remscheid
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sana obesity center
City
Remscheid
ZIP/Postal Code
42859
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine Stier, MD
Phone
+492233594538
Email
christine.stier@sana.de
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Data will be published anonymous in a peer review journal
Citations:
PubMed Identifier
24976715
Citation
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.
Results Reference
result
PubMed Identifier
27247708
Citation
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.
Results Reference
result
Learn more about this trial
Endoscopic Complications After Gastric Bypass
We'll reach out to this number within 24 hrs