Endoscopic Complications After Gastric Bypass

Bariatric Surgery Candidate Clinical Trial

Official title:

Endoscopic Complications After Roux-en Y Gastric Bypass Versus Mini/One Anastomosis Gastric Bypass

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03532646
• Other study ID #: FF 111/2016
• Status: Completed
• Phase: N/A
• Start date: October 2014
• Est. completion date: March 2019

Study information

• Verified date: April 2024
• Source: Sana Klinikum Offenbach
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: March 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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: -

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Obesity, Morbid

Intervention

Procedure:
• upper endoscopy
endoscopy of the gastrointestinal tract

Locations

Country	Name	City	State
Germany	Sana obesity center	Remscheid

Sponsors (1)

Lead Sponsor	Collaborator
Sana Klinikum Offenbach

Country where clinical trial is conducted

Germany, 

References & Publications (2)

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 pat — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complication	Pathological finding during upper endoscopy	Up to 15 years post surgery
Secondary	Weight Loss since Surgery	Weight Loss since Surgery: Total Weight Loss in %	Up to 15 years post surgery
Secondary	toxic status	toxic status (NSAID)	Up to 15 years post surgery
Secondary	toxic status II	toxic status (nicotin)	Up to 15 years post surgery
Secondary	Revisional Surgery	Revisional Surgery due to complication	Up to 15 years post surgery