Mastectomy in Ambulatory Breast Surgery

NCT03003169 | Completed

• 1 other identifier: ICL OBS 01
• Study Type: observational
• Target: 419
• Locations: 1 country
• Sites: 1

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.

Conditions

Mastectomy

Keywords

surgery; breast cancer; quality of life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

• Patient satisfaction by type of hospitalization (ambulatory / conventional) for each type of surgery (total / partial mastectomy)

  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)

  15 jours

• Estimate the conversion rate from ambulatory surgical to conventional surgery

  15 jours

Study Arms (1)

ambulatory surgery description

Other: Medical questionnaire

Interventions

Medical questionnaire OTHER

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

ambulatory surgery description

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The population includes all the patients managed for total or partial mastectomy at the institute.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut de Cancérologie de Lorraine: lead

Study Sites (1)

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, 54519, France

Location

Related 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.

  PMID: 32407900 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• MARCHAL FREDERIC, MD, PU-PH

  Institut de Cancérologie de Lorraine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2016
• First Posted: December 26, 2016
• Study Start: April 8, 2016
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: April 7, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)