Comparing two types of tube feeding in patients with severe swallowing difficulties

Not Applicable

Completed

• Conditions: Severe dysphagia; Signs and Symptoms; Dysphagia

• Registration Number: ISRCTN17642761
• Lead Sponsor: ppsala University Hospital

Brief Summary

2023 Results article in https://pubmed.ncbi.nlm.nih.gov/36852550/ results (added 01/03/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-01-04
• Study Completion: 2022-12-31
• Last Update Posted: 13 March 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

Patients referred to the department for a feeding gastrostomy due to severe dysphagia, and eligible for both methods (PEG/RIG)

Exclusion Criteria

Inability to perform an endoscopy due to pharyngo-esophageal obstruction, total or subtotal gastrectomy, other major upper-abdominal surgery, peritoneal carcinosis or ascites

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall complication rate and major and minor complications occurring early (within 10 days) or late (11-30 days) after gastrostomy placement. Major complications are defined as conditions in potential need of reoperation or cardiovascular support, e.g., gastrointestinal perforations, intrabdominal bleeding, aspiration pneumonia or myocardial infarction, while local and self-limiting problems are to be classified as minor.

Secondary Outcome Measures

Name	Time	Method
Patient-scored health status measured by EQ-5D (EuroQol Research Foundation) at baseline and at 10 and 30 days postoperatively