Clinical trial · Observational
Mastectomy in Ambulatory Breast Surgery
NCT03003169CI-TRIAL-00057654MASTAMBUcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mastectomy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Medical questionnaire | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- ambulatory surgery description
- interventionNames
- Other: Medical questionnaire
Primary outcomes (1)
- measure
- 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.
- timeFrame
- 15 days
- description
- Quality of life is assessed by the EORTC QLQ-C30 questionnaire BR23
Secondary outcomes (4)
- measure
- 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.
- timeFrame
- 15 days
- description
- Anxiety / depressions are assessed by the Hospital Anxiety and Depression scale
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- BACKGROUNDHejl L, Raft J, Leufflen L, Rauch P, Buhler J, Abel-Decollogne F, Routiot T, Hotton J, Salleron J, Marchal F. Quality of life, anxiety, and postoperative complications of patients undergoing breast cancer surgery as ambulatory surgery compared to non-ambulatory surgery: A prospective non-randomized study. J Gynecol Obstet Hum Reprod. 2021 Feb;50(2):101779. doi: 10.1016/j.jogoh.2020.101779. Epub 2020 May 11. PMID 32407900