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Completed

NCT Number: NCT01476241

Percutaneous Endoscopic Gastrostomy Tube Placement by Otorhinolaryngologist

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.

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Key information

Conditions

Dysphagia Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dept of Otorhinolaryngology - Head and Neck Surgery

Helsinki, 00029, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PEG tube placement

Procedure

Percutaneous endoscopic gastrostomy

Other names: A) = EarNoseThroatGroup, B) = SurgeryGroup

Primary outcomes

  1. Complications and mortality

    Time frame: 12 months follow-up time

    Complication

    • Minor
    • Major

    Mortality

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

Sponsors and collaborators

Lead sponsor

University of Helsinki

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2010
Study completion
2011
First posted
Nov 22, 2011
Registry last updated
Nov 22, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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