Skip to main content
Clinical Trials/NCT01476241
NCT01476241
Completed
Not Applicable

Percutaneous Endoscopic Gastrostomy Tube Placement by Otorhinolaryngologist: a Single Institution Experience

University of Helsinki1 site in 1 country292 target enrollmentSeptember 2005
ConditionsDysphagia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dysphagia
Sponsor
University of Helsinki
Enrollment
292
Locations
1
Primary Endpoint
Complications and mortality
Status
Completed
Last Updated
14 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
September 2005
End Date
October 2011
Last Updated
14 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Leif Back

Dr

University of Helsinki

Eligibility 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

Outcomes

Primary Outcomes

Complications and mortality

Time Frame: 12 months follow-up time

Complication * Minor * Major Mortality * Procedure related * \< 7 days * 7-30 days * 30 days * Overall

Study Sites (1)

Loading locations...

Similar Trials