DIEP Flap Surgery and Intraabdominal Pressure

Completed

• Conditions: Intraabdominal Hypertension; Breast Neoplasms
• Interventions: Procedure: DIEP flap surgery

• Registration Number: NCT05764577
• Lead Sponsor: Aalborg University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-19
• Primary Completion: 2021-11-29
• Study Completion: 2022-01-25
• Study First Submitted: 2023-02-23
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-09
• Last Update Submitted: 2023-03-09
• Study First Posted: 2023-03-10
• Last Update Posted: 2023-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 13

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Surgical intervention	DIEP flap surgery	Participants who underwent secondary DIEP flap breast reconstruction

Primary Outcome Measures

Name	Time	Method
Changes from Baseline in intraabdominal pressure at timepoint immediate after- and 24 hours after abdominal skin closure.	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

Trial Locations

Locations (1)

University hospital Aalborg; 🇩🇰 Aalborg, North Jutland, Denmark