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Percutaneous Endoscopic Gastrostomy Tube Placement by Otorhinolaryngologist

NCT ID: NCT01476241

Last Updated: 2011-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

292 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-09-30

Study Completion Date

2011-10-31

Brief Summary

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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

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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.

Conditions

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Dysphagia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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SurgeryGroup

a historic cohort group of patients with the PEG tube placed in the Department of Surgery from September 2005 until September 2009

PEG tube placement

Intervention Type PROCEDURE

Percutaneous endoscopic gastrostomy

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

PEG tube placement

Intervention Type PROCEDURE

Percutaneous endoscopic gastrostomy

Interventions

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PEG tube placement

Percutaneous endoscopic gastrostomy

Intervention Type PROCEDURE

Other Intervention Names

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A) = EarNoseThroatGroup B) = SurgeryGroup

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Helsinki

OTHER

Sponsor Role lead

Responsible Party

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Leif Back

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Leif JJ Bäck, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Dept of Otorhinolaryngology - Head and Neck Surgery, Helsinki University Central Hospital and University of Helsinki, Finland

Locations

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Dept of Otorhinolaryngology - Head and Neck Surgery

Helsinki, , Finland

Site Status

Countries

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Finland

Related Links

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http://www.hus.fi

Dept of Otorhinolaryngology - Head and Neck Surgery

Other Identifiers

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PEG and ENT

Identifier Type: -

Identifier Source: org_study_id