NCT02563977

Brief Summary

The purpose of this study was to perform an evaluation of the structural changes in the abdominal wall after harvesting a DIEP flap in breast reconstruction. 14 women undergoing secondary, unilateral breast reconstruction were recruited to the study and underwent a 2 year postoperative CT scan of the abdomen (without contrast). Structural changes were assessed by comparing the abdominal CT scans performed prior to surgery with the 2 year postoperative CT scans.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2015

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

July 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 30, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

February 6, 2020

Status Verified

February 1, 2020

Enrollment Period

9 months

First QC Date

September 29, 2015

Last Update Submit

February 4, 2020

Conditions

Breast ReconstructionAbdominal Wall Morbidity

Keywords

Breast reconstructionDeep inferior epigastric perforator flapAbdominal wall morbidityPlastic and reconstructive surgery

Outcome Measures

Primary Outcomes (1)

  • Structural measurements of the abdominal wall evaluated on CT scans

    2 year postoperative after performed DIEP flap breast reconstruction

Study Arms (1)

DIEP flap breast reconstruction

14 patients who have had DIEP flap breast reconstruction and preoperative CT scan of the abdomen

Device: 2 year postop CT scan of the abdomen

Interventions

2 year postop CT scan of the abdomenDEVICE

CT scan of the abdomen (from the xiphoid process to the symphysis) performed approximately two years after performed DIEP flap breast reconstruction. No contrast used. Low dose of radiation.

DIEP flap breast reconstruction

Eligibility Criteria

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

14 women consecutively undergoing secondary, unilateral breast reconstruction with a DIEP flap were identified and recruited to participate in the study. The patients were informed about of risks and benefits and gave written consent prior to participation. All smokers stopped smoking 4 weeks prior to surgery

You may qualify if:

  • Secondary, unilateral breast reconstruction with a DIEP flap
  • All smokers stopped smoking 4 weeks prior to surgery

You may not qualify if:

  • Metastatic disease
  • Bilateral breast reconstruction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Plastic and Reconstructive Surgery

Oslo, 0424, Norway

Location

Study Officials

  • Kim A Tønseth, MD PhD

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Department

Study Record Dates

First Submitted

September 29, 2015

First Posted

September 30, 2015

Study Start

July 1, 2015

Primary Completion

April 1, 2016

Study Completion

May 1, 2016

Last Updated

February 6, 2020

Record last verified: 2020-02

Locations

NO(1)