Percutaneous Endoscopic Gastrostomy in Hands of ORL-HN Surgeon

Head and Neck Cancer Clinical Trial

Official title:

Prospective Experience of Percutaneous Endoscopic Gastrostomy Tubes in an Otolaryngologist Service - Safety and Benefits

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02937610
• Other study ID #: JR/Helsinki/ORL/3
• Status: Completed
• Phase: N/A
• First received: October 17, 2016
• Last updated: October 17, 2016
• Start date: October 2011
• Est. completion date: October 2013

Study information

• Verified date: October 2016
• Source: Helsinki University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Observational

Clinical Trial Summary

PEG tubes are commonly used to provide nutritional support to patients with head and neck cancer. PEG insertions are typically carried out by gastroenterologists, but also otorhinolaryngologist - head and neck surgeons perform the procedure in some countries. Prospective studies on PEG tube placements in an ORL - HNS service are lacking. The investigators aim was to prospectively evaluate the preformance of ORL - HN surgeons in PEG tube insertions, and analyze the time gains and cost effectiveness achieved of the independency from other specialities.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: October 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 31 Years to 89 Years

Eligibility

Inclusion Criteria:

• head and neck cancer as a underlying disease

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Complication
• Head and Neck Cancer
• Head and Neck Neoplasms
• Percutaneous Endoscopic Gastrostomy

Intervention

Procedure:
• percutaneous endoscopic gastrostomy
PEG tube inserted with pull technique

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	costs	cost of the procedure	1 year	No
Primary	complications		1 year	Yes
Primary	mortality		1 year	Yes
Secondary	delay	delay from the decision to insert PEG to the procedure	1 year	Yes