Is Life Worth Living After Major Emergency GI Surgery? Patient Reported Outcome in Elderly Emergency Surgery Patients
|ClinicalTrials.gov Identifier: NCT02377687|
Recruitment Status : Completed
First Posted : March 3, 2015
Last Update Posted : February 24, 2016
|Condition or disease||Intervention/treatment|
|Emergency Surgery||Other: observational study|
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.
|Study Type :||Observational|
|Actual Enrollment :||52 participants|
|Official Title:||Is Life Worth Living After Major Emergency GI Surgery? Patient Reported Outcome in Elderly Emergency Surgery Patients|
|Study Start Date :||November 2014|
|Actual Primary Completion Date :||November 2015|
|Actual Study Completion Date :||November 2015|
elderly >75 years
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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02377687
|Hvidovre University Hospital|
|Hvidovre, Denmark, 2650|
|Study Chair:||Morten Bay-Nielsen, DMSc||Hvidovre University Hospital|