Intraabdominal HypertensionNCT05764577
DIEP Flap Surgery and Intraabdominal Pressure
An observational study of Intraabdominal Hypertension and Breast Neoplasms, run by Aalborg University Hospital at 1 site in Denmark.
Trial summary
Aim: The primary aim of this study is to test if closure of the abdominal donor site increases the Intraabdominal Pressure (IAP) in women undergoing secondary Deep Inferior epigastric perforator (DIEP) flap breast reconstruction. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Intraabdominal Hypertension, Breast Neoplasms
- What is being tested?
- DIEP flap surgery
- Type of treatment
- Surgery or procedure
- How many people
- 13 participants
- Where
- 1 siteDenmark
- Study dates
- 19 Apr 2021to 25 Jan 2022
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Females undergoing secondary DIEP flap breast reconstruction. Performance status ASA 1-2
Who may be able to join
- Females undergoing secondary DIEP flap breast reconstruction.
- Performance status 1-2
Who cannot join
- Performance status above 2.
- Untreated hypertension or atrial fibrillation
- Performance status evalutated using American Society of Anaesthesiologists' (ASA) classification of Physical Health.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intraabdominal Pressure Increases Peri-operatively in Patients Undergoing DIEP Flap Reconstruction: A Prospective Study Linking High IAP to Non-fatal Lung Embolism in One Patient
Aim: The primary aim of this study is to test if closure of the abdominal donor site increases the Intraabdominal Pressure (IAP) in women undergoing secondary Deep Inferior epigastric perforator (DIEP) flap breast reconstruction.
Materials and method: By an Unometer, attached to a standard catheter in the bladder, we measured the intravesical pressure as a surrogate marker for the IAP, at baseline, immediate after- and 24 hours after abdominal skin closure, for 13 patients.
- Conditions
- Intraabdominal Hypertension, Breast Neoplasms
- Being tested
- DIEP flap surgery
- Medical subject headings
- Intra-Abdominal Hypertension, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DIEP flap surgeryProcedure or surgery
Removal off the DIEP flap followed by closure of the rectus sheath and abdominal skin.
| Study group | Role | What they receive |
|---|---|---|
| Surgical intervention | Participants who underwent secondary DIEP flap breast reconstruction Receives: Procedure: DIEP flap surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from Baseline in intraabdominal pressure at timepoint immediate after- and 24 hours after abdominal skin closure.
: By an Unometer, attached to a standard catheter in the bladder, we measured the intravesical pressure as a surrogate marker for the IAP, at baseline, immediate after- and 24 hours after abdominal skin closure
Measured: Baseline, immediate after- and 24 hours after abdominal skin closure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start19 Apr 2021
- Primary completion29 Nov 2021
- Study completion25 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraabdominal HypertensionStudies of the same condition, open and under way.
- More trials run by Aalborg University HospitalThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nikolaj Warming, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05764577
- Sponsor's protocol ID
- 2021-082
- Status last verified
- Mar 2023
- First submitted
- 23 Feb 2023
- Last updated
- 10 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraabdominal Pressure Increases Peri-operatively in Patients Undergoing DIEP Flap Reconstruction: A Prospective Study Linking High IAP to Non-fatal Lung Embolism in One Patient
- ClinicalTrials.gov ID
- NCT05764577
- Acronym / sponsor ID
- 2021-082
- Conditions
- Intraabdominal Hypertension, Breast Neoplasms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Study start
- 19 Apr 2021 (actual)
- Primary completion
- 29 Nov 2021 (actual)
- Study completion
- 25 Jan 2022 (actual)
- First posted
- 10 Mar 2023 (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.
Aim: The primary aim of this study is to test if closure of the abdominal donor site increases the Intraabdominal Pressure (IAP) in women undergoing secondary Deep Inferior epigastric perforator (DIEP) flap breast reconstruction.
Materials and method: By an Unometer, attached to a standard catheter in the bladder, we measured the intravesical pressure as a surrogate marker for the IAP, at baseline, immediate after- and 24 hours after abdominal skin closure, for 13 patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical intervention | – | Procedure: DIEP flap surgeryParticipants who underwent secondary DIEP flap breast reconstruction |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Females undergoing secondary DIEP flap breast reconstruction. Performance status ASA 1-2
Key inclusion criteria (2 listed)
- Females undergoing secondary DIEP flap breast reconstruction.
- Performance status 1-2
Key exclusion criteria (3 listed)
- Performance status above 2.
- Untreated hypertension or atrial fibrillation
- Performance status evalutated using American Society of Anaesthesiologists' (ASA) classification of Physical Health.
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 |
|---|---|---|
| DIEP flap surgeryRemoval off the DIEP flap followed by closure of the rectus sheath and abdominal skin. | Procedure or surgery | Surgical intervention |
Primary outcome
Changes from Baseline in intraabdominal pressure at timepoint immediate after- and 24 hours after abdominal skin closure.
Time frame: Baseline, immediate after- and 24 hours after abdominal skin closure
: By an Unometer, attached to a standard catheter in the bladder, we measured the intravesical pressure as a surrogate marker for the IAP, at baseline, immediate after- and 24 hours after abdominal skin closure
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 10 Mar 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Intraabdominal Hypertension and Breast Neoplasms, run by Aalborg 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 2 inclusion and 3 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 10 Mar 2023. 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?
Changes from Baseline in intraabdominal pressure at timepoint immediate after- and 24 hours after abdominal skin closure. (time frame: Baseline, immediate after- and 24 hours after abdominal skin closure). 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 10 Mar 2023.