Percutaneous Endoscopic Gastrostomy Tube Placement by Otorhinolaryngologist

Dysphagia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01476241
• Other study ID #: PEG and ENT
• Status: Completed
• Phase: N/A
• First received: November 15, 2011
• Last updated: November 17, 2011
• Start date: September 2005
• Est. completion date: October 2011

Study information

• Verified date: November 2011
• Source: Helsinki University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Data Protection Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 292
• Est. completion date: October 2011
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Dysphagia

Intervention

Procedure:
• PEG tube placement
Percutaneous endoscopic gastrostomy

Locations

Country	Name	City	State
Finland	Dept of Otorhinolaryngology - Head and Neck Surgery	Helsinki

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complications and mortality	Complication; Minor; Major; Mortality; Procedure related; < 7 days; 7-30 days; 30 days; Overall	12 months follow-up time	Yes

External Links

•   Dept of Otorhinolaryngology - Head and Neck Surgery