DIEP Flap Surgery and Intraabdominal Pressure

Sponsor

Aalborg University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT05764577

Collaborator

(none)

Enrollment

Location

9.2

Actual Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intraabdominal Hypertension Breast Neoplasms	Procedure: DIEP flap surgery

Study Design

Study Type:

Observational

Actual Enrollment :

13 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

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

Actual Study Start Date :

Apr 19, 2021

Actual Primary Completion Date :

Nov 29, 2021

Actual Study Completion Date :

Jan 25, 2022

Arms and Interventions

Arm	Intervention/Treatment
Surgical intervention Participants who underwent secondary DIEP flap breast reconstruction	Procedure: DIEP flap surgery Removal off the DIEP flap followed by closure of the rectus sheath and abdominal skin.

Arm

Intervention/Treatment

Surgical intervention

Participants who underwent secondary DIEP flap breast reconstruction

Procedure: DIEP flap surgery

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University hospital Aalborg	Aalborg	North Jutland	Denmark	9000

Sponsors and Collaborators

Aalborg University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nikolaj Warming, Principal investigator, Aalborg University Hospital

ClinicalTrials.gov Identifier:

NCT05764577

Other Study ID Numbers:

2021-082

First Posted:

Mar 10, 2023

Last Update Posted:

Mar 10, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Breast Neoplasms

Intra-Abdominal Hypertension

Study Results

No Results Posted as of Mar 10, 2023