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Completed

NCT Number: NCT02563977

Changes To The Abdominal Wall After DIEP Flap Breast Reconstruction

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.

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Key information

Sex eligibility

Female

Study type

Observational

Primary location

Department of Plastic and Reconstructive Surgery

Oslo, 0424, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

2 year postop CT scan of the abdomen

Device

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.

Primary outcomes

  1. Structural measurements of the abdominal wall evaluated on CT scans

    Time frame: 2 year postoperative after performed DIEP flap breast reconstruction

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 30, 2015
Registry last updated
Feb 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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