Endoscopic Complications After Gastric Bypass

NCT03532646 | Completed

• 1 other identifier: FF 111/2016
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity, Morbid; Bariatric Surgery Candidate

Outcome Measures

Primary Outcomes (1)

• Complication

  Pathological finding during upper endoscopy

  Up to 15 years post surgery

Secondary Outcomes (4)

• Weight Loss since Surgery

  Up to 15 years post surgery

• toxic status

  Up to 15 years post surgery

• toxic status II

  Up to 15 years post surgery

• Revisional Surgery

  Up to 15 years post surgery

Study Arms (2)

group 1: RYGB

OTHER

All patients who underwent RYGB and were readmitted to upper endoscopy are getting observed

Procedure: upper endoscopy

group 2:MGB/OAGB

OTHER

All patients who underwent MGB/OAGB and were readmitted to upper endoscopy are getting observed

Procedure: upper endoscopy

Interventions

upper endoscopy PROCEDURE

endoscopy of the gastrointestinal tract

group 1: RYGB; group 2:MGB/OAGB

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• all patients who underwent RYGB or MGB/OAGB as a primary surgery and were readmitted to tho hospital undergoing upper endoscopy are included

Sponsors & Collaborators

• Sana Klinikum Offenbach: lead

Study Sites (1)

Sana obesity center

Remscheid, 42859, Germany

Location

Related Publications (2)

• 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.

  PMID: 24976715 RESULT

• 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.

  PMID: 27247708 RESULT

MeSH Terms

Conditions

Obesity, Morbid

Interventions

Gastroscopy

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Christine Stier, MD

  Sana Klinikum Offenbach/Sana Klinikum Remscheid

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med. Sonja Chiappetta, MD, senior consultant, principal investigator

Model Details: All patients who underwent RYGB and MGB/OAGB readmitted for complications in our centre of excellence are getting observed

Study Record Dates

• First Submitted: April 24, 2018
• First Posted: May 22, 2018
• Study Start: October 1, 2014
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: April 30, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)