Mastectomy in Ambulatory Breast Surgery

Completed

• Conditions: Mastectomy
• Interventions: Other: Medical questionnaire

• Registration Number: NCT03003169
• Lead Sponsor: Institut de Cancérologie de Lorraine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04-08
• Study First Submitted: 2016-12-21
• Study First Submitted QC: 2016-12-21
• Study First Posted: 2016-12-26
• Primary Completion: 2017-12-31
• Study Completion: 2017-12-31
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-29
• Last Update Posted: 2022-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 419

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ambulatory surgery description	Medical questionnaire	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Estimate the conversion rate from ambulatory surgical to conventional surgery	15 jours
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
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).

Trial Locations

Locations (1)

Institut de Cancérologie de Lorraine; 🇫🇷 Vandœuvre-lès-Nancy, France