- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03003169
Mastectomy in Ambulatory Breast Surgery (MASTAMBU)
March 29, 2022 updated by: Institut de Cancérologie de Lorraine
This is a prospective observational study, involving 550 mastectomies in Lorraine Institute of Oncology, to assess care patients management of ambulatory surgical compared to standard surgery procedure.
Study Overview
Study Type
Observational
Enrollment (Actual)
419
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Vandœuvre-lès-Nancy, France, 54519
- Institut de Cancérologie de Lorraine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
The population includes all the patients managed for total or partial mastectomy at the institute.
Description
Inclusion Criteria:
- patient managed for breast cancer surgery
- age >18 years old
- understand and comply with the requirements of the study
- patient must be affiliated to a social security system
Exclusion Criteria:
- patient managed for a concomitant reconstructive surgery
- bilateral breast surgery
- patient already included in another clinical trial with an experimental molecule
- men
- patient deprived of liberty or under supervision
- neoadjuvant therapy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
ambulatory surgery description
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Impact of the type of hospitalization (ambulatory / conventional) according to the type of surgery (total / partial mastectomy) on quality of life 15 days after Intervention.
Time Frame: 15 days
|
Quality of life is assessed by the EORTC QLQ-C30 questionnaire BR23
|
15 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Impact of type of hospitalization (ambulatory / conventional) depending on the type of surgery (total / partial mastectomy) on anxiety / depression of the patient 15 days after surgery.
Time Frame: 15 days
|
Anxiety / depressions are assessed by the Hospital Anxiety and Depression scale
|
15 days
|
Patient satisfaction by type of hospitalization (ambulatory / conventional) for each type of surgery (total / partial mastectomy)
Time Frame: 15 days
|
Patient satisfaction is assessed by a satisfaction care questionnaire (PATSAT 32).
|
15 days
|
Complication rate within 15 days the intervention according to the type of hospitalization (ambulatory / conventional) for each type of surgery (total / partial mastectomy)
Time Frame: 15 jours
|
Postoperative complications will be classified according to Dindo- Clavien
|
15 jours
|
Estimate the conversion rate from ambulatory surgical to conventional surgery
Time Frame: 15 jours
|
15 jours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: MARCHAL FREDERIC, MD, PU-PH, Institut de Cancérologie de Lorraine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 8, 2016
Primary Completion (Actual)
December 31, 2017
Study Completion (Actual)
December 31, 2017
Study Registration Dates
First Submitted
December 21, 2016
First Submitted That Met QC Criteria
December 21, 2016
First Posted (Estimate)
December 26, 2016
Study Record Updates
Last Update Posted (Actual)
April 7, 2022
Last Update Submitted That Met QC Criteria
March 29, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ICL OBS 01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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