DIEP Flap Surgery and Intraabdominal Pressure

NCT ID: NCT05764577

Last Updated: 2023-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

13 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-19

Study Completion Date

2022-01-25

Brief Summary

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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

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Conditions

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Intraabdominal Hypertension Breast Neoplasms

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Surgical intervention

Participants who underwent secondary DIEP flap breast reconstruction

DIEP flap surgery

Intervention Type PROCEDURE

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

Interventions

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DIEP flap surgery

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Aalborg University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Nikolaj Warming

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University hospital Aalborg

Aalborg, North Jutland, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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2021-082

Identifier Type: -

Identifier Source: org_study_id

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