Clinical Trials Directory

Trials / Completed

CompletedNCT02563977

Changes To The Abdominal Wall After DIEP Flap Breast Reconstruction

Structural Changes In The Abdominal Wall After Deep Inferior Epigastric Perforator Flap Breast Reconstruction

Status
Completed
Phase
Study type
Observational
Enrollment
14 (actual)
Sponsor
Oslo University Hospital · Academic / Other
Sex
Female
Age
Healthy volunteers
Not accepted

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.

Detailed description

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. The following structural changes were evaluated at four specific levels of the abdomen by two radiologists (among the authors): 1) rectus diastasis, 2) thickness and width of the rectus muscles, 3) thickness of the adipose tissue, 4) hernias (in the zone between the xiphoid process and the symphysis). The measurement levels chosen were: 1) 7 cm below the xiphoid process, 2) umbilicus level, 3) "central zone" (between level 2 and 4), 4) 5 cm above the symphysis Statistical analysis were performed to see if the structural measurements were significantly different comparing preoperative CT versus 2 year postoperative CT.

Conditions

Interventions

TypeNameDescription
DEVICE2 year postop CT scan of the abdomenCT 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.

Timeline

Start date
2015-07-01
Primary completion
2016-04-01
Completion
2016-05-01
First posted
2015-09-30
Last updated
2020-02-06

Locations

1 site across 1 country: Norway

Source: ClinicalTrials.gov record NCT02563977. Inclusion in this directory is not an endorsement.