Bowel PerforatedDANAKIRNCT05442164
Effect of Implementation of the Danish Emergency Surgery (DANAKIR) Support Network on Post-discharge Outcomes After Major Emergency Abdominal Surgery
An observational study of Bowel Perforated and Bowel Obstruction, run by Herlev Hospital.
Trial summary
Effect of implementation of the Danish Emergency Surgery (DANAKIR) support Network on post-discharge outcomes after major emergency abdominal surgery: a prospective before and-after study Background Major emergency abdominal surgery is performed in more than 5000 patients yearly in Denmark. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bowel Perforated, Bowel Obstruction
- What is being tested?
- DANAKIR support network
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2022to 31 Aug 2023
- How long will I take part?
- 6 Months
- 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 at the department of Surgery, Herlev Hospital. A large University Hospital in the Capital Region of Denmark
Who may be able to join
- Emergency open, laparoscopic or laparoscopically assisted procedures involving: stomach, small bowel, large bowel, or rectum for conditions such as perforation, ischemia, abdominal abscess, bleeding, haematoma, or obstruction
- Bowel resection due to incarcerated incisional, umbilical, inguinal, and femoral hernias (but not hernia repair without bowel resection/repair)
- Laparoscopic/open adhesiolysis
- Fascial dehiscence
- Emergency surgery after elective surgery if criteria above is met
Who cannot join
- Elective procedures
- Appendectomy +/- drainage of localized abscess
- Cholecystectomy +/- drainage of localized abscess
- Emergency hernia repair without bowel resection
- Large-bowel endoscopic stent procedures
- Superficial wound dehiscence above the fascia
- Ruptured ectopic pregnancy or pelvic abscess due to inflammatory disease
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Implementation of the Danish Emergency Surgery (DANAKIR) Support Network on Post-discharge Outcomes After Major Emergency Abdominal Surgery: a Prospective Before And-after Study
Effect of implementation of the Danish Emergency Surgery (DANAKIR) support Network on post-discharge outcomes after major emergency abdominal surgery: a prospective before and-after study
Background Major emergency abdominal surgery is performed in more than 5000 patients yearly in Denmark. In general, little is known about the period after the discharge of these patients besides that chronic pain, physical dysfunction, and quality of life are severely affected in up to 50% of patients at long-term follow-up. A recent study investigating unplanned readmission after major emergency abdominal surgery found that up to 50% undergo unplanned readmission within the first 180 days after discharge.
Read more
Purpose The purpose of this study is to evaluate the effects of inviting patients undergoing major emergency surgery and their relatives to join a support network after discharge (the DANAKIR network).
Methods This study is designed as a before- and after study. Prior to establishing the DANAKIR (Danish Emergency Surgery Network) support network, the investigators will consecutively during a one year inclusion period prospectively include all patients undergoing emergency abdominal surgery with a midline laparotomy. The inclusion period starts 1st August 2021.
The investigators will register the following in the pre-implementation phase:
- Postoperative day (POD) 30: Quality of life (EQ-5D-5L) (by telephone)
- POD90: Quality of life (EQ-5D-5L) (by telephone), readmissions (by hospital file)
- POD 180: Quality of life (EQ-5D-5L) (by telephone), readmissions (by hospital file)
- Number of days at home with 90 days (by hospital file)
- Number of participants with at least one readmission (by hospital file) Hereafter the investigators will establish the DANAKIR support network. The investigators plan for a six-month inclusion period with DANAKIR starting 1th of September 2022
Intervention
The DANAKIR intervention will consist of:
- Structured written discharge information for the participanats and relatives about expectations and precautions
- Invitation to the DANAKIR monthly information meeting All patients undergoing emergency abdominal surgery and members of their family are invited to participate in at least one DANAKIR meeting. Patients and their relatives can participate in as many meetings as they wish; however, we encourage all patients to participate at least once.
DANAKIR meetings The monthly meetings are a core component of the support network. One time each month, a meeting will be held at Herlev Hospital with the participation of an emergency surgeon, an emergency surgery dedicated nurse, a dietician, and a physiotherapist. Furthermore, there will be research personnel present. Each professional (surgeon, nurse, dietician, physiotherapist) will host an informative 15 minute session regarding the postoperative course after major emergency surgery. Following the presentations time for questions in plenum and private with the different experts will be held. Furthermore, there will be an opportunity for networking at the DANAKIR meeting. Each meeting is planned to last 2 hours. At the end of each meeting the patients will be asked to evaluate the meeting and content.
Outcome measures The primary outcome of this study is the number of days at home within 90 days of surgery. The secondary outcomes are quality of life at 30 days, 90 days, and 180 days after surgery and the number of patients with at least one emergency readmission 90 days and 180 days from surgery.
Trial size The investigators expect to include 200 patients in the before group and 200 patients in the after group.
Perspectives The DANAKIR support network examines if a structure with physical network meetings is effective in regard to quality of life and preventing readmissions after major emergency surgery. The investigators hypothesize that the days at home will increase within 90 days from surgery and that quality of life will increase for both participants and their relatives by implementing a simple and obvious solution. If the DANAKIR network proves efficient it is an easily implemented solution to increase quality of life and days at home after major emergency surgery.
- Conditions
- Bowel Perforated, Bowel Obstruction
- Being tested
- DANAKIR support network
- Medical subject headings
- Intestinal Perforation, Intestinal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DANAKIR support networkBehavioural
The DANAKIR intervention will consist of:
- Structured written discharge information
- Invitation to the DANAKIR monthly information meeting DANAKIR meetings The monthly meetings are a core component of the support network. One time each month, a meeting will be held at Herlev Hospital with the participation of an emergency surgeon, an emergency surgery dedicated nurse, a dietician, and a physiotherapist. Each professional (surgeon, nurse, dietician, physiotherapist) will host an informative 15 minute session regarding the postoperative course after major emergency surgery. Following the presentations time for questions in plenum and private with the different experts will be held. Furthermore, there will be an opportunity for networking at the DANAKIR meeting. Each meeting is planned to last 2 hours. At the end of each meeting the patients will be asked to evaluate the meeting and content.
| Study group | Role | What they receive |
|---|---|---|
| Before-group | Patients undergoing major emergency surgery before a supportive network is established | |
| After-group | Patients undergoing major emergency surgery after a supportive network is established Receives: Behavioral: DANAKIR support network |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days at home within 90 days
Number of days at home within 90 days of surgery
Measured: 90 day
Secondary outcomes (2)
Quality of life
EQ-5D-5L
Measured: Day 30, day 90, day 180
Readmission
number of patients with at least one emergency readmission
Measured: Day 90 and day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2022
- Study start1 Sep 2022 (estimated)
- Primary completion28 Feb 2023 (estimated)
- Study completion31 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bowel PerforatedStudies 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
- 400 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dunja Kokotovic, Herlev Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05442164
- Sponsor's protocol ID
- DANAKIR
- Acronym
- DANAKIR
- Status last verified
- Jul 2022
- First submitted
- 28 Jun 2022
- Last updated
- 7 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Implementation of the Danish Emergency Surgery (DANAKIR) Support Network on Post-discharge Outcomes After Major Emergency Abdominal Surgery: a Prospective Before And-after Study
- ClinicalTrials.gov ID
- NCT05442164
- Acronym / sponsor ID
- DANAKIR / DANAKIR
- Conditions
- Bowel Perforated, Bowel Obstruction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 28 Feb 2023 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 1 Jul 2022 (actual)
- 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.
Effect of implementation of the Danish Emergency Surgery (DANAKIR) support Network on post-discharge outcomes after major emergency abdominal surgery: a prospective before and-after study
Background Major emergency abdominal surgery is performed in more than 5000 patients yearly in Denmark. In general, little is known about the period after the discharge of these patients besides that chronic pain, physical dysfunction, and quality of life are severely affected in up to 50% of patients at long-term follow-up. A recent study investigating unplanned readmission after major emergency abdominal surgery found that up to 50% undergo unplanned readmission within the first 180 days after discharge.
Purpose The purpose of this study is to evaluate the effects of inviting patients undergoing major emergency surgery and their relatives to join a support network after discharge (the DANAKIR network).
Methods This study is designed as a before- and after study. Prior to establishing the DANAKIR (Danish Emergency Surgery Network) support network, the investigators will consecutively during a one year inclusion period prospectively include all patients undergoing emergency abdominal surgery with a midline laparotomy. The inclusion period starts 1st August 2021.
The investigators will register the following in the pre-implementation phase:
- Postoperative day (POD) 30: Quality of life (EQ-5D-5L) (by telephone)
- POD90: Quality of life (EQ-5D-5L) (by telephone), readmissions (by hospital file)
- POD 180: Quality of life (EQ-5D-5L) (by telephone), readmissions (by hospital file)
- Number of days at home with 90 days (by hospital file)
- Number of participants with at least one readmission (by hospital file) Hereafter the investigators will establish the DANAKIR support network. The investigators plan for a six-month inclusion period with DANAKIR starting 1th of September 2022
Intervention
The DANAKIR intervention will consist of:
- Structured written discharge information for the participanats and relatives about expectations and precautions
- Invitation to the DANAKIR monthly information meeting All patients undergoing emergency abdominal surgery and members of their family are invited to participate in at least one DANAKIR meeting. Patients and their relatives can participate in as many meetings as they wish; however, we encourage all patients to participate at least once.
DANAKIR meetings The monthly meetings are a core component of the support network. One time each month, a meeting will be held at Herlev Hospital with the participation of an emergency surgeon, an emergency surgery dedicated nurse, a dietician, and a physiotherapist. Furthermore, there will be research personnel present. Each professional (surgeon, nurse, dietician, physiotherapist) will host an informative 15 minute session regarding the postoperative course after major emergency surgery. Following the presentations time for questions in plenum and private with the different experts will be held. Furthermore, there will be an opportunity for networking at the DANAKIR meeting. Each meeting is planned to last 2 hours. At the end of each meeting the patients will be asked to evaluate the meeting and content.
Outcome measures The primary outcome of this study is the number of days at home within 90 days of surgery. The secondary outcomes are quality of life at 30 days, 90 days, and 180 days after surgery and the number of patients with at least one emergency readmission 90 days and 180 days from surgery.
Trial size The investigators expect to include 200 patients in the before group and 200 patients in the after group.
Perspectives The DANAKIR support network examines if a structure with physical network meetings is effective in regard to quality of life and preventing readmissions after major emergency surgery. The investigators hypothesize that the days at home will increase within 90 days from surgery and that quality of life will increase for both participants and their relatives by implementing a simple and obvious solution. If the DANAKIR network proves efficient it is an easily implemented solution to increase quality of life and days at home after major emergency surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Before-group | – | –Patients undergoing major emergency surgery before a supportive network is established |
| After-group | – | Behavioral: DANAKIR support networkPatients undergoing major emergency surgery after a supportive network is established |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients at the department of Surgery, Herlev Hospital. A large University Hospital in the Capital Region of Denmark
Key inclusion criteria (5 listed)
- Emergency open, laparoscopic or laparoscopically assisted procedures involving: stomach, small bowel, large bowel, or rectum for conditions such as perforation, ischemia, abdominal abscess, bleeding, haematoma, or obstruction
- Bowel resection due to incarcerated incisional, umbilical, inguinal, and femoral hernias (but not hernia repair without bowel resection/repair)
- Laparoscopic/open adhesiolysis
- Fascial dehiscence
- Emergency surgery after elective surgery if criteria above is met
Key exclusion criteria (7 listed)
- Elective procedures
- Appendectomy +/- drainage of localized abscess
- Cholecystectomy +/- drainage of localized abscess
- Emergency hernia repair without bowel resection
- Large-bowel endoscopic stent procedures
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 |
|---|---|---|
| DANAKIR support networkThe DANAKIR intervention will consist of: * Structured written discharge information * Invitation to the DANAKIR monthly information meeting DANAKIR meetings The monthly meetings are a core component of the support network. One time each month, a meeting will be held at Herlev Hospital with the participation of an emergency surgeon, an emergency surgery dedicated nurse, a dietician, and a physiotherapist. Each professional (surgeon, nurse, dietician, physiotherapist) will host an informative 15 minute session regarding the postoperative course after major emergency surgery. Following the presentations time for questions in plenum and private with the different experts will be held. Furthermore, there will be an opportunity for networking at the DANAKIR meeting. Each meeting is planned to last 2 hours. At the end of each meeting the patients will be asked to evaluate the meeting and content. | Behavioural | After-group |
Primary outcome
Days at home within 90 days
Time frame: 90 day
Number of days at home within 90 days of surgery
2 secondary outcomes
Quality of life
Time frame: Day 30, day 90, day 180
Readmission
Time frame: Day 90 and day 180
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2022.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Bowel Perforated and Bowel Obstruction, run by Herlev Hospital.
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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 7 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dunja K Gellert-Kristensen, MD, PhD (28776364, dunja.kokotovic.gellert-kristensen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Days at home within 90 days (time frame: 90 day). 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 7 Jul 2022.