ClinicalTrials.gg
Status unknownNCT05442164DANAKIRUpdated Jul 7, 2022

Effect of Implementation of the Danish Emergency Surgery (DANAKIR) Support Network on Post-discharge Outcomes After Major Emergency Abdominal Surgery

An observational study in Bowel Perforated and Bowel Obstruction, sponsored by Herlev Hospital. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-07.

Sponsored by Herlev Hospital · Observational

The sponsor has not verified this record recently (last verified Jul 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
400
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Bowel Perforated
  • Bowel Obstruction
03

In context

Intestinal Perforation

39 studies on the registry are indexed under Intestinal Perforation; 4 are open to participants now.

This study's planned enrollment of 400 is above the median of 195 across 24 observational studies indexed under Intestinal Perforation.

Browse Intestinal Perforation studies →

Lead sponsor

Herlev Hospital is the lead sponsor of 201 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients at the department of Surgery, Herlev Hospital. A large University Hospital in the Capital Region of Denmark

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
400 participants (estimated)
Target follow-up
6 Months
Patient registry
Yes

Groups and cohorts

  • 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

    Behavioral: DANAKIR support network

Interventions

  • BehavioralDANAKIR support network

    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.

06

What researchers measure

Primary outcomes

  1. Days at home within 90 days

    Number of days at home within 90 days of surgery

    Time frame: 90 day

Secondary outcomes

  1. Quality of life

    EQ-5D-5L

    Time frame: Day 30, day 90, day 180

  2. Readmission

    number of patients with at least one emergency readmission

    Time frame: Day 90 and day 180

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Sep 2022; primary completion for Feb 2023, 5 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 28, 2022
First posted
Jul 1, 2022
StartEst.
Sep 1, 2022
Primary completionEst.
Feb 28, 2023
CompletionEst.
Aug 31, 2023
Last update
Jul 7, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 7, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05442164
Lead sponsor
Herlev Hospital
Responsible party
Dunja Kokotovic (Doctor, Postdocteral fellow, Herlev Hospital) — Principal investigator
First posted
Jul 1, 2022
Start date
Sep 1, 2022 (estimated)
Primary completion
Feb 28, 2023 (estimated)
Completion
Aug 31, 2023 (estimated)
Last update
Jul 7, 2022

Study contacts

Dunja K Gellert-Kristensen, MD, PhD
Contact
dunja.kokotovic.gellert-kristensen@regionh.dk
28776364

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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