Mastectomy in Ambulatory Breast Surgery (MASTAMBU)

March 29, 2022 updated by: Institut de Cancérologie de Lorraine
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

419

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Vandœuvre-lès-Nancy, France, 54519
        • Institut de Cancérologie de Lorraine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ambulatory surgery description
  • quality of life questionnaire (EORTC QLQ-C30 and QLQ-BR23)
  • Hospital Anxiety and Depression scale
  • satisfaction care questionnaire (IN-PATSAT32)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 15 days
Quality of life is assessed by the EORTC QLQ-C30 questionnaire BR23
15 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 15 days
Anxiety / depressions are assessed by the Hospital Anxiety and Depression scale
15 days
Patient satisfaction by type of hospitalization (ambulatory / conventional) for each type of surgery (total / partial mastectomy)
Time Frame: 15 days
Patient satisfaction is assessed by a satisfaction care questionnaire (PATSAT 32).
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)
Time Frame: 15 jours
Postoperative complications will be classified according to Dindo- Clavien
15 jours
Estimate the conversion rate from ambulatory surgical to conventional surgery
Time Frame: 15 jours
15 jours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: MARCHAL FREDERIC, MD, PU-PH, Institut de Cancérologie de Lorraine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 8, 2016

Primary Completion (Actual)

December 31, 2017

Study Completion (Actual)

December 31, 2017

Study Registration Dates

First Submitted

December 21, 2016

First Submitted That Met QC Criteria

December 21, 2016

First Posted (Estimate)

December 26, 2016

Study Record Updates

Last Update Posted (Actual)

April 7, 2022

Last Update Submitted That Met QC Criteria

March 29, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • ICL OBS 01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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