Percutaneous Endoscopic Gastrostomy in Hands of ORL-HN Surgeon
October 17, 2016 updated by: Leif Back, University of Helsinki
Prospective Experience of Percutaneous Endoscopic Gastrostomy Tubes in an Otolaryngologist Service - Safety and Benefits
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
127
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
31 years to 89 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
127 consecutive head and neck cancer patients, who underwent PEG placement at the Department of ORL - HNS, Helsinki University Hospital, between October 2011 and May 2013.
Description
Inclusion Criteria:
- head and neck cancer as a underlying disease
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
mortality
Time Frame: 1 year
|
1 year
|
|
complications
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
delay
Time Frame: 1 year
|
delay from the decision to insert PEG to the procedure
|
1 year
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
costs
Time Frame: 1 year
|
cost of the procedure
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Johanna Ruohoalho, MD, Otorhinolaryngology - Head and Neck Surgery
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2011
Primary Completion (Actual)
May 1, 2013
Study Completion (Actual)
October 1, 2013
Study Registration Dates
First Submitted
October 17, 2016
First Submitted That Met QC Criteria
October 17, 2016
First Posted (Estimate)
October 18, 2016
Study Record Updates
Last Update Posted (Estimate)
October 18, 2016
Last Update Submitted That Met QC Criteria
October 17, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- JR/Helsinki/ORL/3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.