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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

November 15, 2011
November 17, 2011
September 2005
October 2010   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01476241 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Percutaneous Endoscopic Gastrostomy Tube Placement by Otorhinolaryngologist
Percutaneous Endoscopic Gastrostomy Tube Placement by Otorhinolaryngologist: a Single Institution Experience

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

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

Dysphagia
Procedure: PEG tube placement
Percutaneous endoscopic gastrostomy
Other Names:
  • A) = EarNoseThroatGroup
  • B) = SurgeryGroup
  • 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
    Intervention: Procedure: PEG tube placement
  • SurgeryGroup
    a historic cohort group of patients with the PEG tube placed in the Department of Surgery from September 2005 until September 2009
    Intervention: Procedure: PEG tube placement
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
292
October 2011
October 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT01476241
PEG and ENT
No
Leif Back, Helsinki University
Helsinki University
Not Provided
Principal Investigator: Leif JJ Bäck, MD PhD Dept of Otorhinolaryngology - Head and Neck Surgery, Helsinki University Central Hospital and University of Helsinki, Finland
Helsinki University
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP