Sekundær Brystrekonstruktion Med Hudlap Fra Ryggen

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Vejle Hospital
Sponsor:
Collaborators:
University of Southern Denmark
Region Southern Denmark
Sygehus Lillebaelt
Information provided by (Responsible Party):
Mikkel Børsen-Koch, Vejle Hospital
ClinicalTrials.gov Identifier:
NCT02169011
First received: June 18, 2014
Last updated: June 19, 2014
Last verified: June 2014
  Purpose

The purpose of this study is to examine the different outcomes of breast reconstruction in women who are treated for breast cancer with mastectomy and subsequently have delayed breast reconstruction by one of two different surgical techniques both of which are based on the use of a tissue flap from the patient's back. These techniques are either a latissimus dorsi flap (LD-flap) or a thoracodorsal artery perforator flap (TAP-flap)

The main objective of the study is to establish whether one of these techniques may result in a superior outcome and thus should be recommended as first choice treatment rather than the other. Hence we wish to evaluate several different outcomes that are all related to reconstructive surgery and may influence the patient. These outcomes include quality of life, complications, morbidity, socio-economic aspects and aesthetic outcome.


Condition Intervention
Breast Reconstruction
Procedure: Latissimus Dorsi Flap Reconstruction
Procedure: TAP Flap Reconstruction

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Delayed Breast Reconstruction With Skin Flap From the Back

Resource links provided by NLM:


Further study details as provided by Vejle Hospital:

Primary Outcome Measures:
  • Shoulder Function [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    All participating patients will have the function of their shoulder and upper arm examined to establish whether one of the two techniques will affect this area more than the other.

    For this purpose the investigators have chosen the validated Constant Shoulder Score-test (CCS). This test allows a quantified evaluation of the following four parameters:

    Level of pain, Level of function in everyday-life, Range of movement and Strength

    For all patients in both the retrospective and prospective clinical trials the shoulder function is evaluated bilaterally. A mean of the overall score is calculated for the different groups of patients and compared.

    In the retrospective trial the shoulder evaluation is carried out during the clinical examination in the outpatient clinic. In the prospective trial the shoulder function will be examined preoperatively and again 3, 6 and 12 months after surgery.



Secondary Outcome Measures:
  • Quality of Life [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    Several papers describe the quality of life to improve in women after breast reconstruction, including delayed reconstruction using the LD-flap.

    This particular part of the trial aims to evaluate the patients' life quality before and after reconstruction by one of the two techniques. The investigators use the international validated questionnaire developed by The European Organisation for Research and Treatment of Cancer (EORTC) including the general questionnaire QLQ-30 in combination with the additional questionnaire QLQ-BR23 that has been specifically developed for patients with breast-related diseases.

    In the retrospective trial the questionnaires will be completed during the interview in the outpatient clinic. In the prospective trial the participants will be asked to complete the questionnaires before surgery and once again during the final visit in the outpatient clinic, when the course of the reconstruction is at an end.


  • Complication Rates [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    Complications following the surgery are recorded including:

    Delayed healing, Infection, Seromas, Hematoma, Flap-necrosis and Explantation

    Complications will be classified as either major or minor depending on the need for surgical revision. Complication rates will be calculated and compared between the two groups of patients.

    In the retrospective trial the data are collected by reviewing of charts with information supplemented through interviews. In the prospective trial complications are continuously recorded during the patients' admission to the hospital and after their discharge in the outpatient clinic.


  • Socio-Economic Aspects [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    In order to evaluate the socio-economic aspects and cost-benefit associated with the use of each surgical technique the investigators record the following parameters for all patients:

    Duration of operation, Duration of hospitalization, Duration of entire course of the breast reconstruction, Duration of sick leave, Need for revisional/correctional procedures, Need for physiotherapy and/or other kinds of rehabilitation

    Based on the data collected the investigators will perform an evaluation of the total expenditure associated with the two different types of delayed reconstruction. This evaluation will comprise an estimate of the costs associated with the procedures including expenses for utensils, implants and ADM as well as an estimate of the expenses related to hospitalization, sick leave and rehabilitation. A mean value of the total costs will be calculated and compared.


  • Aesthetics [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    The investigators wish to conduct an evaluation of the aesthetic result including a professional assessment from a specialist's point of view and an assessment from the patients.

    Hence all patients will be asked to evaluate the appearance of their bosom on a scale from 1 to 10 indicating their satisfaction with the reconstruction. The women in the prospective trial will be asked to evaluate before surgery and once again at the final consultation in the outpatient clinic.

    Furthermore the patients will be subjected to a professional evaluation as all women will have their bosom photographed by a professional photographer, who is experienced with these kinds of clinical assignment. The photographs will be evaluated by two unbiased Medical Specialist in plastic surgery who are not associated with neither the department nor the project.



Estimated Enrollment: 50
Study Start Date: September 2013
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Latissimus Dorsi Flap Reconstruction

Patients are randomized to reconstruction with a tissue flap from the back based on the latissimus dorsi muscle.

This arm affects both the retrospective study and the prospective, randomized study.

Procedure: Latissimus Dorsi Flap Reconstruction
Investigation of delayed breast reconstruction using the latissimus dorsi flap. Covers both the retrospective study and the prospective randomized study. For each of the two studies the outcome measures primary and secondary are the same.
Active Comparator: TAP Flap Reconstruction

Patients are randomized to reconstruction with a tissue flap from the back based on the thoracodorsal artery perforator.

This arm affects both the retrospective study and the prospective, randomized study.

Procedure: TAP Flap Reconstruction
Investigation of delayed breast reconstruction using the TAP flap. Covers both the retrospective study and the prospective randomized study. For each of the two studies the outcome measures primary and secondary are the same.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Retrospective Study:

Inclusion Criteria:

  1. Women over 18 years of age who have had mastectomy and subsequent delayed breast reconstruction using the LD-flap at Vejle Hospital in the time period between 1st of January 2009 and 30th of June 2011.
  2. Women over 18 years of age who have had mastectomy and subsequent delayed breast reconstruction at Vejle Hospital using the TAP-flap in the time period between 1st of July 2011 and 31rd of August 2013.

Exclusion Criteria:

  1. Dementia that makes it impossible to obtain informed consent
  2. Non-Danish speaking patients from whom informed consent cannot be obtained by interpreter

Prospective Randomized Study:

Inclusion Criteria:

Women over 18 years of age who are referred to the participating departments of plastic surgery in the period between 1st of September 2013 and 31st of August 2015 for the purpose of delayed breast reconstruction, and who are eligible for delayed breast reconstruction using a skin flap from the back.

Exclusion criteria:

  1. Dementia that makes it impossible to obtain informed consent
  2. Non-Danish speaking patients from whom informed consent cannot be obtained by interpreter
  3. Lack of suitable perforator from the thoracodorsal artery
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02169011

Contacts
Contact: Mikkel Børsen-Koch, MD +45 79405643 mikkel.borseb-koch@rsyd.dk
Contact: Jørn B Thomsen, MD, PhD +45 79405411 joern.thomsen@rsyd.dk

Locations
Denmark
Odense University Hospital Recruiting
Odense, Denmark, 5000
Contact: Ann Udesen, MD    + 4566113333    ann.udesen@rsyd.dk   
Contact: Jørn B Thomsen, MD    +45 79405411    joern.thomsen@rsyd.dk   
Principal Investigator: Ann Udesen, MD         
Sub-Investigator: Mikkel Børsen-Koch, MD         
Vejle Hospital Recruiting
Vejle, Denmark, 7100
Contact: Mikkel Børsen-Koch, MD    +45 79405643    mikkel.borsen-koch@rsyd.dk   
Contact: Jørn B Thomsen, MD, PhD    +79405411    joern.thomsen@rsyd.dk   
Principal Investigator: Mikkel Børsen-Koch, MD         
Norway
Telemark Hospital Recruiting
Skien, Telemark, Norway, 3710
Contact: Gudjon L Gunnarsson, MD    +4635003500    gudjon.leifur@yahoo.com   
Principal Investigator: Gudjon L Gunnarsson, MD         
Sub-Investigator: Mikkel Børsen-Koch, MD         
Sponsors and Collaborators
Vejle Hospital
University of Southern Denmark
Region Southern Denmark
Sygehus Lillebaelt
Investigators
Study Chair: Jørn B Thomsen, MD, PhD Center Hospital Lillebaelt, Institute of Regional Health Research, University of Southern Denmark
  More Information

Publications:

Responsible Party: Mikkel Børsen-Koch, MD, Vejle Hospital
ClinicalTrials.gov Identifier: NCT02169011     History of Changes
Other Study ID Numbers: S-20120207
Study First Received: June 18, 2014
Last Updated: June 19, 2014
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
Norway: Ethics Committee

Keywords provided by Vejle Hospital:
Breast reconstruction
Breast cancer

ClinicalTrials.gov processed this record on August 20, 2014