NCT02937610

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
127

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2011

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

October 17, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 18, 2016

Completed
Last Updated

October 18, 2016

Status Verified

October 1, 2016

Enrollment Period

1.6 years

First QC Date

October 17, 2016

Last Update Submit

October 17, 2016

Conditions

Head and Neck CancerPercutaneous Endoscopic GastrostomyComplication

Outcome Measures

Primary Outcomes (2)

  • complications

    1 year

  • mortality

    1 year

Secondary Outcomes (1)

  • delay

    1 year

Other Outcomes (1)

  • costs

    1 year

Interventions

percutaneous endoscopic gastrostomyPROCEDURE

PEG tube inserted with pull technique

Also known as: PEG

Eligibility Criteria

Age31 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • head and neck cancer as a underlying disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Study Officials

  • Johanna Ruohoalho, MD

    Otorhinolaryngology - Head and Neck Surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

October 17, 2016

First Posted

October 18, 2016

Study Start

October 1, 2011

Primary Completion

May 1, 2013

Study Completion

October 1, 2013

Last Updated

October 18, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share