- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05764577
DIEP Flap Surgery and Intraabdominal Pressure
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
North Jutland
-
Aalborg, North Jutland, Denmark, 9000
- University Hospital Aalborg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Females undergoing secondary DIEP flap breast reconstruction.
- Performance status 1-2
Exclusion Criteria:
- Performance status above 2.
- Untreated hypertension or atrial fibrillation
Performance status evalutated using American Society of Anaesthesiologists' (ASA) classification of Physical Health.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Surgical intervention
Participants who underwent secondary DIEP flap breast reconstruction
|
Removal off the DIEP flap followed by closure of the rectus sheath and abdominal skin.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Baseline, immediate after- and 24 hours after abdominal skin closure
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-082
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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