Clinical trial NCT02563977: Changes To The Abdominal Wall After DIEP Flap Breast Reconstruction
Official title: Structural Changes In The Abdominal Wall After Deep Inferior Epigastric Perforator Flap Breast Reconstruction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Reconstruction
Abdominal Wall Morbidity
Keywords: Breast reconstruction
Deep inferior epigastric perforator flap
Abdominal wall morbidity
Plastic and reconstructive surgery
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2015-09-30
Enrollment: 14
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Structural measurements of the abdominal wall evaluated on CT scans
timeFrame: 2 year postoperative after performed DIEP flap breast reconstruction
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Department of Plastic and Reconstructive Surgery
Study officials:
affiliation: Oslo University Hospital
name: Kim A Tønseth, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: