Direct to Implant Breast Reconstruction Based Pre- or Retropectoral

NCT03143335 | Unknown DMC

• 1 other identifier: S-2016060
• Study Type: interventional
• Target: 70
• Locations: 2 countries
• Sites: 3

Brief Summary

The purpose of this study is to examine different outcomes of breast reconstruction in women who are treated for breast cancer with skin sparing mastectomy and subsequently a primary implant based reconstruction by one of two different techniques with either a pre- or retropectoral placement of the implant. 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.

Conditions

Breast Reconstruction

Keywords

Breast; Reconstruction; BAD; Implant; ADM

Outcome Measures

Primary Outcomes (1)

• Breast animation deformity

  Breast animation deformity (BAD) is one of the more unpleasant cosmetic results that can be seen after breast reconstruction with a retropectoral placed implant. The degree of breast distortion will be evaluated by two experienced plastic surgeons and classified according to the published classification by Spear S. Because the degree of breast distortion will be the primary outcome measure of this randomised trial, the sample size will be based on assumptions regarding the grade of distortion between groups. For this purpose, the distortion will be divided into two groups: 1) Severe distortion containing degree 3 and 4 and 2) Moderate distortion containing degree 1 and 2. In bilateral cases the most severe side will be the one used for comparison

  12 months

Secondary Outcomes (1)

• Shoulder function

  3 and 12 months

Other Outcomes (8)

• Quality of Life

  12 months

• Postoperative pain

  3 months

• Postoperative complications

  3 months

Study Arms (2)

Retropectoral immediate breast reconstruction

ACTIVE COMPARATOR

Participants are randomized to immediate breast reconstruction with the implant placed retropectoral.

Procedure: Retropectoral immediate breast reconstruction

Prepectoral immediate breast reconstruction

ACTIVE COMPARATOR

Participants are randomized to direct to immediate breast reconstruction with the implant placed prepectoral using acellular dermal matrix for support.

Procedure: Prepectoral immediate breast reconstruction

Interventions

Retropectoral immediate breast reconstruction PROCEDURE

Immediate reconstruction with the implant placed in a standard fashion, i.e. retropectoral in combination with an acellular dermal matrix.

Retropectoral immediate breast reconstruction

Prepectoral immediate breast reconstruction PROCEDURE

Immediate breast reconstruction with the implant placed prepectoral supported by acellular dermal matrix alone.

Prepectoral immediate breast reconstruction

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women over 18 years referred to the Department of plastic surgery, Odense University Hospital, Lillebaelt Hospital Vejle, Denmark or Telemark Hospital, Skien, Norway between January 2017 and July 2018, who are found eligible for immediate breast reconstruction.

You may not qualify if:

• Dementia that makes it impossible to obtain informed consent
• Non-Danish speaking patients from whom informed consent cannot be obtained by interpreter
• Tobacco users
• Women with known hypertension treated with more than one drug
• Women who had pre-surgical radiation therapy.
• Women planned to have postsurgical radiation therapy.
• BMI above 32 or below 22
• However, the final decision relies on sufficient thickness of the skin flaps after mastectomy prior to immediate reconstruction.
• Invited patient will receive both oral and written participant information after which there will be as many days for reflection as the treatment guaranty for cancer allows.
• Patients considering participation will be invited for a second consultation where written informed consent will be obtained from all who accept the invitation. Randomization will be performed during surgery, prior to reconstruction. Patients who do not wish to participate will be reconstruction with the implant placed retropectoral.

Sponsors & Collaborators

• Odense University Hospital: lead
• Sygehus Lillebaelt: collaborator
• Sykehuset Telemark: collaborator

Study Sites (3)

Odense University Hospital

Odense, 5000, Denmark

Location

Lillebaelt Hospital Vejle

Vejle, 7100, Denmark

Location

Telemark Hospital

Skien, 3710, Norway

Location

Related Publications (1)

• Dyrberg DL, Gunnarsson GL, Bille C, Sorensen JA, Thomsen JB. Direct-to-Implant Extracellular Matrix Hammock-based Breast Reconstruction; Prepectoral or Subpectoral? Trials. 2020 Feb 10;21(1):160. doi: 10.1186/s13063-020-4125-6.

  PMID: 32041661 DERIVED

Study Officials

• Jørn Bo JB Thomsen, MD, PhD

  Center Hospital Vejle, Institute of Regional Health Research, University of Southern Denmark

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: May 1, 2017
• First Posted: May 8, 2017
• Study Start: May 1, 2017
• Primary Completion: April 1, 2020
• Study Completion: May 1, 2020
• Last Updated: August 29, 2019

Record last verified: 2019-08

Locations

DK (2); NO (1)