NCT05764577

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 19, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 29, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2022

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 23, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 10, 2023

Completed
Last Updated

March 10, 2023

Status Verified

March 1, 2023

Enrollment Period

7 months

First QC Date

February 23, 2023

Last Update Submit

March 9, 2023

Conditions

Intraabdominal HypertensionBreast Neoplasms

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Surgical intervention

Participants who underwent secondary DIEP flap breast reconstruction

Procedure: DIEP flap surgery

Interventions

DIEP flap surgeryPROCEDURE

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

Surgical intervention

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Females undergoing secondary DIEP flap breast reconstruction. Performance status ASA 1-2

You may qualify if:

  • Females undergoing secondary DIEP flap breast reconstruction.
  • Performance status 1-2

You may not qualify if:

  • Performance status above 2.
  • Untreated hypertension or atrial fibrillation
  • Performance status evalutated using American Society of Anaesthesiologists' (ASA) classification of Physical Health.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospital Aalborg

Aalborg, North Jutland, 9000, Denmark

Location

MeSH Terms

Conditions

Intra-Abdominal HypertensionBreast Neoplasms

Condition Hierarchy (Ancestors)

Compartment SyndromesMuscular DiseasesMusculoskeletal DiseasesVascular DiseasesCardiovascular DiseasesNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 23, 2023

First Posted

March 10, 2023

Study Start

April 19, 2021

Primary Completion

November 29, 2021

Study Completion

January 25, 2022

Last Updated

March 10, 2023

Record last verified: 2023-03

Locations

DK(1)