DIEP Flap Surgery and Intraabdominal Pressure

Breast Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05764577
• Other study ID #: 2021-082
• Status: Completed
• Start date: April 19, 2021
• Est. completion date: January 25, 2022

Study information

• Verified date: March 2023
• Source: Aalborg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: January 25, 2022
• Est. primary completion date: November 29, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Intra-Abdominal Hypertension
• Intraabdominal Hypertension

Intervention

Procedure:
• DIEP flap surgery
Removal off the DIEP flap followed by closure of the rectus sheath and abdominal skin.

Locations

Country	Name	City	State
Denmark	University hospital Aalborg	Aalborg	North Jutland

Sponsors (1)

Lead Sponsor	Collaborator
Aalborg University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline, immediate after- and 24 hours after abdominal skin closure