Percutaneous Endoscopic Gastrostomy Tube Placement by Otorhinolaryngologist
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| First Received Date ICMJE | November 15, 2011 | ||||
| Last Updated Date | November 17, 2011 | ||||
| Start Date ICMJE | September 2005 | ||||
| Primary Completion Date | October 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Complications and mortality [ Time Frame: 12 months follow-up time ] [ Designated as safety issue: Yes ] Complication
Mortality
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01476241 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Percutaneous Endoscopic Gastrostomy Tube Placement by Otorhinolaryngologist | ||||
| Official Title ICMJE | Percutaneous Endoscopic Gastrostomy Tube Placement by Otorhinolaryngologist: a Single Institution Experience | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients that had undergone PEG tube placement in a tertiary care center. |
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| Condition ICMJE | Dysphagia | ||||
| Intervention ICMJE | Procedure: PEG tube placement
Percutaneous endoscopic gastrostomy
Other Names:
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| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 292 | ||||
| Completion Date | October 2011 | ||||
| Primary Completion Date | October 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Finland | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01476241 | ||||
| Other Study ID Numbers ICMJE | PEG and ENT | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Leif Back, Helsinki University | ||||
| Study Sponsor ICMJE | Helsinki University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Helsinki University | ||||
| Verification Date | November 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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