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Changes To The Abdominal Wall After DIEP Flap Breast Reconstruction

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ClinicalTrials.gov Identifier: NCT02563977
Recruitment Status : Completed
First Posted : September 30, 2015
Last Update Posted : February 6, 2020
Sponsor:
Information provided by (Responsible Party):
Kim Alexander Tønseth, 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.


Condition or disease Intervention/treatment
Breast Reconstruction Abdominal Wall Morbidity Device: 2 year postop CT scan of the abdomen

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.

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Study Type : Observational
Actual Enrollment : 14 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Structural Changes In The Abdominal Wall After Deep Inferior Epigastric Perforator Flap Breast Reconstruction
Actual Study Start Date : July 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
DIEP flap breast reconstruction
14 patients who have had DIEP flap breast reconstruction and preoperative CT scan of the abdomen
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.




Primary Outcome Measures :
  1. Structural measurements of the abdominal wall evaluated on CT scans [ Time Frame: 2 year postoperative after performed DIEP flap breast reconstruction ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02563977


Locations
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Norway
Department of Plastic and Reconstructive Surgery
Oslo, Norway, 0424
Sponsors and Collaborators
Oslo University Hospital
Investigators
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Principal Investigator: Kim A Tønseth, MD PhD Oslo University Hospital
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Responsible Party: Kim Alexander Tønseth, Head of Department, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT02563977    
Other Study ID Numbers: KATønseth
First Posted: September 30, 2015    Key Record Dates
Last Update Posted: February 6, 2020
Last Verified: February 2020
Keywords provided by Kim Alexander Tønseth, Oslo University Hospital:
Breast reconstruction
Deep inferior epigastric perforator flap
Abdominal wall morbidity
Plastic and reconstructive surgery