DysphagiaNCT01476241
Percutaneous Endoscopic Gastrostomy Tube Placement by Otorhinolaryngologist
An observational study of Dysphagia, run by University of Helsinki at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dysphagia
- What is being tested?
- PEG tube placement
- Type of treatment
- Surgery or procedure
- How many people
- 292 participants
- Where
- 1 siteFinland
- Study dates
- Sep 2005to Oct 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients that had undergone PEG tube placement in a tertiary care center.
Who may be able to join
- ENT patient with PEG tube placement
Who cannot join
- electrolyte imbalance
- coagulation imbalance
- morbid obesity (BMI > 40 kg/m2)
- large volume ascites
- previous gastrectomy
- sepsis
Trial locations and contacts
1 site in 1 country.
Finland1 site
Dept of Otorhinolaryngology - Head and Neck Surgery
Helsinki, 00029
About this study
Official title: Percutaneous Endoscopic Gastrostomy Tube Placement by Otorhinolaryngologist: a Single Institution Experience
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.
Read the 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.
- Conditions
- Dysphagia
- Being tested
- PEG tube placement
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEG tube placementProcedure or surgery
Also called A) = EarNoseThroatGroup, B) = SurgeryGroup
Percutaneous endoscopic gastrostomy
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: PEG tube placement | |
| SurgeryGroup | a historic cohort group of patients with the PEG tube placed in the Department of Surgery from September 2005 until September 2009 Receives: Procedure: PEG tube placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications and mortality
Complication
- Minor
- Major
Mortality
- Procedure related
- < 7 days
- 7-30 days
- 30 days
- Overall
Measured: 12 months follow-up time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2011 (estimated)
- Study startSep 2005
- Primary completionOct 2010
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 292 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Helsinki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leif Back, University of Helsinki
- Investigators
- Leif JJ Bäck, MD PhD, Principal investigator, Dept of Otorhinolaryngology - Head and Neck Surgery, Helsinki University Central Hospital and University of Helsinki, Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01476241
- Sponsor's protocol ID
- PEG and ENT
- Status last verified
- Nov 2011
- First submitted
- 15 Nov 2011
- Last updated
- 22 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Endoscopic Gastrostomy Tube Placement by Otorhinolaryngologist: a Single Institution Experience
- ClinicalTrials.gov ID
- NCT01476241
- Acronym / sponsor ID
- PEG and ENT
- Conditions
- Dysphagia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 292 participants (actual)
- Lead sponsor
- University of HelsinkiUniversity, hospital or other
- Study start
- Sep 2005
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 22 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EarNoseThroatGroup | – | Procedure: PEG tube placementa 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 | – | Procedure: PEG tube placementa historic cohort group of patients with the PEG tube placed in the Department of Surgery from September 2005 until September 2009 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients that had undergone PEG tube placement in a tertiary care center.
Key inclusion criteria (1 listed)
- ENT patient with PEG tube placement
Key exclusion criteria (6 listed)
- electrolyte imbalance
- coagulation imbalance
- morbid obesity (BMI > 40 kg/m2)
- large volume ascites
- previous gastrectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEG tube placementAlso: A) = EarNoseThroatGroup, B) = SurgeryGroupPercutaneous endoscopic gastrostomy | Procedure or surgery | EarNoseThroatGroup, SurgeryGroup |
Primary outcome
Complications and mortality
Time frame: 12 months follow-up time
Complication * Minor * Major Mortality * Procedure related * < 7 days * 7-30 days * 30 days * Overall
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2011.
- Dept of Otorhinolaryngology - Head and Neck SurgeryLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leif JJ Bäck, MD PhD principal investigator
Dept of Otorhinolaryngology - Head and Neck Surgery, Helsinki University Central Hospital and University of Helsinki, Finland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dysphagia, run by University of Helsinki at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complications and mortality (time frame: 12 months follow-up time). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2011.