DIEP Flap Surgery and Intraabdominal Pressure

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.

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Key information

Conditions

Intraabdominal Hypertension Breast Diseases Breast Neoplasms Cardiovascular Diseases Compartment Syndromes Intra-Abdominal Hypertension Muscular Diseases Musculoskeletal Diseases Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases Vascular Diseases

Sex eligibility

Female

Study type

Observational

Primary location

University hospital Aalborg

Aalborg, North Jutland, 9000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DIEP flap surgery

Procedure

Removal off the DIEP flap followed by closure of the rectus sheath and abdominal skin.

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Aalborg University Hospital

Other

Registry information

Official study 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

Important dates

Study start: 2021
Primary completion: 2021
Study completion: 2022
First posted: Mar 10, 2023
Registry last updated: Mar 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed