Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:14 PM
Ignite Modification Date:
2025-12-24 @ 10:14 PM
NCT ID:
NCT03143335
Eligibility Criteria:
Inclusion Criteria:
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.
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. Tobacco users
4. Women with known hypertension treated with more than one drug
5. Women who had pre-surgical radiation therapy.
6. Women planned to have postsurgical radiation therapy.
7. 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.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT03143335
Study Brief:
Protocol Section:
NCT03143335