Early Feeding Following Percutaneous Gastrostomy Tube Placement

NCT03319576 | Completed

• 1 other identifier: 16-1074
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This study plans to learn more about the safety of early feeding following placement of a feeding tube. Doctors in other specialties feed patients 4 hours after patients receive a feeding tube. However, Interventional Radiologists typically wait to feed patients for 24 hours following feeding tube placement. The investigator would like to demonstrate that feeding after 4 hours does not increase complications and can actually reduce the burden to patients who receive a feeding tube.

Conditions

Gastrostomy

Keywords

Gastrostomy; Feeding; G-tube

Outcome Measures

Primary Outcomes (2)

• Inability to feed

  Inability to feed due to high pre-feeding gastric residual volume

  4 hours after gastrostomy tube placement

• Changes in any major or minor complications

  Any change(s) noted in any major and/or minor complications arising post gastrostomy tube placement will be evaluated.

  24 hours after gastrostomy tube placement

Secondary Outcomes (2)

• Positive predictive value of computed tomography (CT) prior to gastrostomy tube placement will be measured at the end of the study.

  At Study Completion, approximately 2 years

• Procedural experience from the patients' perspective

  2 weeks after gastrostomy tube placement

Study Arms (2)

Early feeding

EXPERIMENTAL

Patients randomized to early feeding will be fed 4 hours following gastrostomy tube placement

Other: Feeding at 4 hours

Standard feeding

NO INTERVENTION

Patients randomized to standard feeding will be fed 24 hours following gastrostomy tube placement

Interventions

Feeding at 4 hours OTHER

Patients will be fed 4 hours after their gastrostomy tube placement procedure.

Early feeding

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients between the ages of 18-80 years
• Outpatients receiving a gastrostomy tube at University of Colorado that do not require post-pyloric feeding
• Patients that have no contraindication for intragastric feeding immediately following tube placement
• INR (international normalized ratio) \<1.5
• Platelet count \> 50,000/µL
• WBC (white blood cell count) 4.0-11.1 x 109/L

You may not qualify if:

• Patients \< 18 years or \> 80 years of age
• Patients admitted to the hospital at the time of screening (i.e., inpatients)
• Women who are pregnant (confirmed by urine pregnancy screen)
• Patients requiring post-pyloric feeding
• Patients receiving venting gastrostomy tubes
• Patients receiving primary Gastro-Jejunal (GJ) Tube tube placement
• Patients with an interposed bowel on CT after stomach insufflation
• INR \> 1.5
• Platelet count \< 50,000/µL
• WBC \> 11.1 x 109/L
• Known active infection
• Need for post-gastric feeding
• History of gastric bypass surgery or Roux-En-Y
• Mechanical obstruction of the GI tract
• Active peritonitis

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado

Aurora, Colorado, 80045, United States

Location

Study Officials

• Premal Trivedi, MD, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2017
• First Posted: October 24, 2017
• Study Start: October 30, 2017
• Primary Completion: October 16, 2019
• Study Completion: October 16, 2019
• Last Updated: October 23, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)