An observational study in Emergency and Surgery, sponsored by Hvidovre University Hospital. Completed at 1 site in Denmark. Open to participants aged 75 Years and older. Per ClinicalTrials.gov, last updated 2016-02-24.
Sponsored by Hvidovre University Hospital · Observational
To study the impact of emergency high risk GI surgery on HRQOL in elderly patients, seventy-five years or above and to explore the patients' experience with the informed consent process and the status 6 months after surgery.
We will identify all patients aged ≥ 75 having an emergency GI laparotomy or laparoscopy between the 1st of November 2014 and the 30st of April 2015.
The first part of the study will take place in the first postoperative week, while the patient is in hospital. After consent we will ask both patient and relatives/caregivers questions concerning the preoperative course and the informed consent. We will ask for permission to call the patients for a followup (the second part of the study) 5-7 months after discharge and permission to contact their closest relative. The closest relative is chosen by the patient and will after consent be asked the same questions in the first postoperative week and after 6 months.
The second part of the study will be initiated with a letter with SF-36 and an additional questionnaire . The SF-36 will be returned by letter. We will contact the patients by telephone 2 weeks after sending the letter ask them the questions from the additional questinaire.
We will compare the results from the SF-36 with age-matched controls (Data from the Danish SF-36 Manual).
If the patient is not capable of answering the questionnaires, the primary reason is noted (e.g. suffering from dementia or didn't speak Danish, dead).
We will aim at a 6 month follow-up period after discharge allowing a range from 5-7 months. Data acquisition will be done in the fall 2014 until late 2015.
1,721 studies on the registry are indexed under Emergencies; 335 are open to participants now.
This study's enrollment of 52 is below the median of 351 across 726 observational studies indexed under Emergencies.
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We will identify all patients aged ≥ 75 having an emergency GI laparotomy or laparoscopy between the 1st of November 2014 and the 30st of April 2015. We will also include reoperations after elective surgery (major bleeding, anastomotic leakage etc.) and endoscopic procedures converted during the intervention (upper GI-bleeding, unsuccessful stenting of obstructing colorectal cancer etc.).
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Exclusion Criteria:
all patients aged ≥ 75 having an emergency GI laparotomy or laparoscopy
Other: observational study
HRQoL
Time frame: 6 months after surgery
Functional status
Time frame: 6 months after surgery
Plan to share: No
No publications or documents are linked to this record.
The record gives a start of Nov 2014, a primary completion of Nov 2015 and a completion of Nov 2015. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
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