EmergencyNCT02377687
Is Life Worth Living After Major Emergency GI Surgery? Patient Reported Outcome in Elderly Emergency Surgery Patients
An observational study of Emergency and Surgery, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 75 years and older
- What is being tested?
- observational study
- How many people
- 52 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2014to Nov 2015
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: 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.).
Who may be able to join
- 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.).
Who cannot join
- appendectomies, negative laparoscopy/laparotomy, laparoscopic cholecystectomy, acute hernias without strangulation, sub-acute internal hernia after Roux-en-Y gastric bypass surgery, sub-acute IBD-surgery and sub-acute Colorectal Cancer-surgery. Sub-acute is defined as planned in less than 48 hours.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Being tested
- observational study
- Keywords
- Emergency surgery, HRQoL, Elderly
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observational studyOther
| Study group | Role | What they receive |
|---|---|---|
| elderly >75 years | all patients aged ≥ 75 having an emergency GI laparotomy or laparoscopy Receives: Other: observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
HRQoL
Measured: 6 months after surgery
Secondary outcomes (1)
Functional status
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2015 (estimated)
- Study startNov 2014
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmergencyStudies 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
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Line Toft Tengberg, Hvidovre University Hospital
- Investigators
- Morten Bay-Nielsen, DMSc, Study chair, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02377687
- Sponsor's protocol ID
- 2012-58-0004
- Status last verified
- Feb 2016
- First submitted
- 25 Feb 2015
- Last updated
- 24 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Life Worth Living After Major Emergency GI Surgery? Patient Reported Outcome in Elderly Emergency Surgery Patients
- ClinicalTrials.gov ID
- NCT02377687
- Acronym / sponsor ID
- 2012-58-0004
- Keywords
- Emergency surgery, HRQoL, Elderly
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 3 Mar 2015 (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.
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.
Detailed description
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| elderly >75 years | – | Other: observational studyall patients aged ≥ 75 having an emergency GI laparotomy or laparoscopy |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- 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.).
Key inclusion criteria (1 listed)
- 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.).
Key exclusion criteria (1 listed)
- appendectomies, negative laparoscopy/laparotomy, laparoscopic cholecystectomy, acute hernias without strangulation, sub-acute internal hernia after Roux-en-Y gastric bypass surgery, sub-acute IBD-surgery and sub-acute Colorectal Cancer-surgery. Sub-acute is defined as planned in less than 48 hours.
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 |
|---|---|---|
| observational study | Other | elderly >75 years |
Primary outcome
HRQoL
Time frame: 6 months after surgery
1 secondary outcome
Functional status
Time frame: 6 months after surgery
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 24 Feb 2016.
- Individual participant dataSharing planned: No
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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.
Morten Bay-Nielsen, DMSc study chair
Hvidovre University Hospital
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 Emergency and Surgery, run by Hvidovre University Hospital at 1 site in Denmark.
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 1 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 24 Feb 2016. 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 Denmark. 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?
HRQoL (time frame: 6 months after surgery). 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 24 Feb 2016.