Early versus Delayed enteral feeding after Percutaneous endoscopic gastrostomy (PEG) placement in adult patients, A randomized controlled trial

Phase 2

Completed

• Conditions: Appropriate time for feeding after PEG; Percutaneous endoscopic gastrostomy; PEG; Early feeding

• Registration Number: TCTR20220105003
• Lead Sponsor: Faculty of Medicine Siriraj hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-05
• Study Completion: 2023-08-03
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

18-85 years old
- Underlying conditions
Non-cancer ex. Neurological diseases
Cancer ex. CA esophagus, CA head and neck
- Underwent push-PEG in Siriraj hospital

Exclusion Criteria

- Life expectancy less than 30 days
- ASA 4,5 and ECOG PS 4
- BMI < 18 or > 30 kg/m2
- Serum albumin <2.5 g/dL

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Maximum gastric residual volume about 16 months measured as ml

Secondary Outcome Measures

Name	Time	Method
umber of symptoms and complications occurred about 16 months number of occurrences,Number of patients with large gastric residual volume about 16 months number of occurrences,Mean time to initiate the feeding, to complete the protocol and to be discharged about 16 months measured as hours,Pain score and opioid requirements about 16 months pain score/ volume as mg of opioid given,Microbiological profile at the wound site about 16 months Reported as culture positive with identification or culture negative,Quality of life about 24 months Euro QOL-5D-5