Percutaneous Endoscopic Gastrostomy Tube Placement by Otorhinolaryngologist

Completed

• Conditions: Dysphagia
• Interventions: Procedure: PEG tube placement

• Registration Number: NCT01476241
• Lead Sponsor: University of Helsinki

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.

Study Timeline

• Study Start: 2005-09
• Primary Completion: 2010-10
• Study Completion: 2011-10
• Status Verified: 2011-11
• Study First Submitted: 2011-11-15
• Study First Submitted QC: 2011-11-17
• Last Update Submitted: 2011-11-17
• Study First Posted: 2011-11-22
• Last Update Posted: 2011-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 292

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
EarNoseThroatGroup	PEG tube placement	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
SurgeryGroup	PEG tube placement	a historic cohort group of patients with the PEG tube placed in the Department of Surgery from September 2005 until September 2009

Primary Outcome Measures

Name	Time	Method
Complications and mortality	12 months follow-up time	Complication; * Minor; * Major; Mortality; * Procedure related; * \< 7 days; * 7-30 days; * 30 days; * Overall

Trial Locations

Locations (1)

Dept of Otorhinolaryngology - Head and Neck Surgery; 🇫🇮 Helsinki, Finland