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Percutaneous Endoscopic Gastrostomy Tube Placement by Otorhinolaryngologist

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Leif Back, Helsinki University
ClinicalTrials.gov Identifier:
NCT01476241
First received: November 15, 2011
Last updated: November 17, 2011
Last verified: November 2011
History of Changes
  Purpose

The investigators main endpoint was focused on the analysis of the type, rate and the impact of different clinical parameters on the complications of the PEG tube placements performed at the Department of Otorhinolaryngology - Head and Neck Surgery since October 2008. In addition, the investigators aimed to compare the results with a historic cohort patient group (September 2005 - October 2008) sent to the Department of Surgery for PEG tube placement in order to evaluate the results of the changed routine.


Condition Intervention
Dysphagia
 Procedure: PEG tube placement

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Percutaneous Endoscopic Gastrostomy Tube Placement by Otorhinolaryngologist: a Single Institution Experience

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Helsinki University:

Primary Outcome Measures:
  • Complications and mortality [ Time Frame: 12 months follow-up time ] [ Designated as safety issue: Yes ]

    Complication

    • Minor
    • Major

    Mortality

    • Procedure related
    • < 7 days
    • 7-30 days
    • 30 days
    • Overall


Enrollment: 292
Study Start Date: September 2005
Study Completion Date: October 2011
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
EarNoseThroatGroup
a cohort of patients that had undergone PEG tube placement from October 2008 until October 2010 at the Department of Otorhinolaryngology - Head and Neck Surgery
 Procedure: PEG tube placement
Percutaneous endoscopic gastrostomy
Other Names:
  • A) = EarNoseThroatGroup
  • B) = SurgeryGroup
SurgeryGroup
a historic cohort group of patients with the PEG tube placed in the Department of Surgery from September 2005 until September 2009
 Procedure: PEG tube placement
Percutaneous endoscopic gastrostomy
Other Names:
  • A) = EarNoseThroatGroup
  • B) = SurgeryGroup

Detailed Description:

We retrospectively reviewed a cohort of patients that had undergone PEG tube placement from October 2008 until October 2010 at the Department of Otorhinolaryngology - Head and Neck Surgery, Helsinki University Central Hospital (HUCH), Helsinki, Finland, with a health care district currently including approximately 1.5 million inhabitants. Hospital surgical and discharge registries were used to identify the patients. Medical records were studied and details collected on the patients' age, sex, preoperative condition, preoperative laboratory parameters, coexisting medical diagnoses (Charlson Comorbidity Index, CCI (Hall 2004)), indication and date for PEG tube placement, complications, the time of PEG use, follow-up time, and clinical status at last follow up. The study period was aimed to run from PEG tube placement to the last clinical evaluation (minimum 12 months) or the time of death. These results were compared with those from a historic cohort group of patients with the PEG tube placed in the Department of Surgery, HUCH, Helsinki, Finland from September 2005 until October 2008.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients that had undergone PEG tube placement in a tertiary care center.

Criteria

Inclusion Criteria:

  • ENT patient with PEG tube placement

Exclusion Criteria:

  • electrolyte imbalance
  • coagulation imbalance
  • morbid obesity (BMI > 40 kg/m2)
  • large volume ascites
  • previous gastrectomy
  • sepsis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01476241

Locations
Finland
Dept of Otorhinolaryngology - Head and Neck Surgery
Helsinki, Finland, 00029
Sponsors and Collaborators
Helsinki University
Investigators
Principal Investigator: Leif JJ Bäck, MD PhD Dept of Otorhinolaryngology - Head and Neck Surgery, Helsinki University Central Hospital and University of Helsinki, Finland
  More Information

Additional Information:
Dept of Otorhinolaryngology - Head and Neck Surgery  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Leif Back, Dr, Helsinki University
ClinicalTrials.gov Identifier: NCT01476241     History of Changes
Other Study ID Numbers: PEG and ENT
Study First Received: November 15, 2011
Last Updated: November 17, 2011
Health Authority: Finland: Data Protection Board

Additional relevant MeSH terms:
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
 Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on May 16, 2013