Changes To The Abdominal Wall After DIEP Flap Breast Reconstruction

Completed

• Conditions: Breast Reconstruction; Abdominal Wall Morbidity
• Interventions: Device: 2 year postop CT scan of the abdomen

• Registration Number: NCT02563977
• Lead Sponsor: Oslo University Hospital

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.

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.

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-09-29
• Study First Submitted QC: 2015-09-29
• Study First Posted: 2015-09-30
• Primary Completion: 2016-04
• Study Completion: 2016-05
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-04
• Last Update Posted: 2020-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 14

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
DIEP flap breast reconstruction	2 year postop CT scan of the abdomen	14 patients who have had DIEP flap breast reconstruction and preoperative CT scan of the abdomen

Primary Outcome Measures

Name	Time	Method
Structural measurements of the abdominal wall evaluated on CT scans	2 year postoperative after performed DIEP flap breast reconstruction

Trial Locations

Locations (1)

Department of Plastic and Reconstructive Surgery; 🇳🇴 Oslo, Norway