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Completed

NCT Number: NCT03003169

Mastectomy in Ambulatory Breast Surgery

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, 54519, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Medical questionnaire

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

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.

    Time frame: 15 days

    Quality of life is assessed by the EORTC QLQ-C30 questionnaire BR23

Secondary outcomes

  1. 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

  2. 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).

  3. 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

  4. Estimate the conversion rate from ambulatory surgical to conventional surgery

    Time frame: 15 jours

Sponsors and collaborators

Lead sponsor

Institut de Cancérologie de Lorraine

Other

Registry information

Acronym: MASTAMBU

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 26, 2016
Registry last updated
Apr 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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