Mastectomy
Conditions
Keywords
surgery, breast cancer, quality of life
Brief summary
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.
Interventions
* quality of life questionnaire (EORTC QLQ-C30 and QLQ-BR23) * Hospital Anxiety and Depression scale * satisfaction care questionnaire (IN-PATSAT32)
Sponsors
Institut de Cancérologie de Lorraine
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 15 days | Quality of life is assessed by the EORTC QLQ-C30 questionnaire BR23 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 15 days | Anxiety / depressions are assessed by the Hospital Anxiety and Depression scale |
| Patient satisfaction by type of hospitalization (ambulatory / conventional) for each type of surgery (total / partial mastectomy) | 15 days | Patient satisfaction is assessed by a satisfaction care questionnaire (PATSAT 32). |
| Complication rate within 15 days the intervention according to the type of hospitalization (ambulatory / conventional) for each type of surgery (total / partial mastectomy) | 15 jours | Postoperative complications will be classified according to Dindo- Clavien |
| Estimate the conversion rate from ambulatory surgical to conventional surgery | 15 jours | — |
Countries
France
Outcome results
None listed