DIEP Flap Surgery and Intraabdominal Pressure | NCT05764577

Studies
DIEP Flap Surgery and Intraabdominal Pressure

NCT05764577

Sponsor

Aalborg University Hospital

Status

Completed

Last Update Posted

Mar 10, 2023Actual

Enrollment

13Actual

Phase

Not provided

Conditions

Intraabdominal Hypertension
Breast Neoplasms

Interventions

DIEP flap surgery

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 19, 2021Actual

Primary Completion Date

Nov 29, 2021Actual

Completion Date

Jan 25, 2022Actual

First Submitted Date

Feb 23, 2023

First Submission Date that Met QC Criteria

Mar 9, 2023

First Posted Date

Mar 10, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 9, 2023

Last Update Posted Date

Mar 10, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

13Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Surgical intervention		Participants who underwent secondary DIEP flap breast reconstruction	Procedure: DIEP flap surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DIEP flap surgery	Procedure	Removal off the DIEP flap followed by closure of the rectus sheath and abdominal skin.	Surgical intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University hospital Aalborg		Aalborg	North Jutland	9000	Denmark

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D059325	Intra-Abdominal Hypertension
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D003161	Compartment Syndromes
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided