Changes To The Abdominal Wall After DIEP Flap Breast Reconstruction

Breast Reconstruction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02563977
• Other study ID #: KATønseth
• Status: Completed
• Start date: July 2015
• Est. completion date: May 2016

Study information

• Verified date: February 2020
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: May 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Secondary, unilateral breast reconstruction with a DIEP flap

• All smokers stopped smoking 4 weeks prior to surgery

Exclusion Criteria:

• Metastatic disease

• Bilateral breast reconstruction

Related Conditions & MeSH terms

• Abdominal Wall Morbidity
• Breast Reconstruction

Intervention

Device:
• 2 year postop CT scan of the abdomen
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.

Locations

Country	Name	City	State
Norway	Department of Plastic and Reconstructive Surgery	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Structural measurements of the abdominal wall evaluated on CT scans		2 year postoperative after performed DIEP flap breast reconstruction