Mastectomy in Ambulatory Breast Surgery

Mastectomy Clinical Trial

— MASTAMBU  

Official title:

Mastectomy in Ambulatory Breast Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03003169
• Other study ID #: ICL OBS 01
• Status: Completed
• Start date: April 8, 2016
• Est. completion date: December 31, 2017

Study information

• Verified date: March 2022
• Source: Institut de Cancérologie de Lorraine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 419
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mastectomy

Intervention

Other:
• Medical questionnaire
quality of life questionnaire (EORTC QLQ-C30 and QLQ-BR23) Hospital Anxiety and Depression scale satisfaction care questionnaire (IN-PATSAT32)

Locations

Country	Name	City	State
France	Institut de Cancérologie de Lorraine	Vandœuvre-lès-Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Institut de Cancérologie de Lorraine

Country where clinical trial is conducted

France, 

References & Publications (1)

Hejl 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Quality of life is assessed by the EORTC QLQ-C30 questionnaire BR23	15 days
Secondary	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.	Anxiety / depressions are assessed by the Hospital Anxiety and Depression scale	15 days
Secondary	Patient satisfaction by type of hospitalization (ambulatory / conventional) for each type of surgery (total / partial mastectomy)	Patient satisfaction is assessed by a satisfaction care questionnaire (PATSAT 32).	15 days
Secondary	Complication rate within 15 days the intervention according to the type of hospitalization (ambulatory / conventional) for each type of surgery (total / partial mastectomy)	Postoperative complications will be classified according to Dindo- Clavien	15 jours
Secondary	Estimate the conversion rate from ambulatory surgical to conventional surgery		15 jours