MastectomyMASTAMBUNCT03003169
Mastectomy in Ambulatory Breast Surgery
An observational study of Mastectomy, run by Institut de Cancérologie de Lorraine at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Mastectomy
- What is being tested?
- Medical questionnaire
- How many people
- 419 participants
- Where
- 1 siteFrance
- Study dates
- 8 Apr 2016to 31 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The population includes all the patients managed for total or partial mastectomy at the institute.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Medical questionnaire
- Keywords
- surgery, breast cancer, quality of life
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical questionnaireOther
- quality of life questionnaire (EORTC QLQ-C30 and QLQ-BR23)
- Hospital Anxiety and Depression scale
- satisfaction care questionnaire (IN-PATSAT32)
| Study group | Role | What they receive |
|---|---|---|
| ambulatory surgery description | Not described Receives: Other: Medical questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Anxiety / depressions are assessed by the Hospital Anxiety and Depression scale
Measured: 15 days
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).
Measured: 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)
Postoperative complications will be classified according to Dindo- Clavien
Measured: 15 jours
Estimate the conversion rate from ambulatory surgical to conventional surgery
Measured: 15 jours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2016 (estimated)
- Study start8 Apr 2016
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MastectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 419 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Cancérologie de Lorraine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- MARCHAL FREDERIC, MD, PU-PH, Principal investigator, Institut de Cancérologie de Lorraine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03003169
- Sponsor's protocol ID
- ICL OBS 01
- Acronym
- MASTAMBU
- Status last verified
- Mar 2022
- First submitted
- 21 Dec 2016
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 32407900
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mastectomy in Ambulatory Breast Surgery
- ClinicalTrials.gov ID
- NCT03003169
- Acronym / sponsor ID
- MASTAMBU / ICL OBS 01
- Conditions
- Mastectomy
- Keywords
- surgery, breast cancer, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 419 participants (actual)
- Lead sponsor
- Institut de Cancérologie de LorraineUniversity, hospital or other
- Study start
- 8 Apr 2016 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 26 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ambulatory surgery description | – | Other: Medical questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population includes all the patients managed for total or partial mastectomy at the institute.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical questionnaire* quality of life questionnaire (EORTC QLQ-C30 and QLQ-BR23) * Hospital Anxiety and Depression scale * satisfaction care questionnaire (IN-PATSAT32) | Other | ambulatory surgery description |
Primary outcome
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
4 secondary outcomes
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
Patient satisfaction by type of hospitalization (ambulatory / conventional) for each type of surgery (total / partial mastectomy)
Time frame: 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
Estimate the conversion rate from ambulatory surgical to conventional surgery
Time frame: 15 jours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
- Background: PubMed 32407900Hejl 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.
- Individual participant dataSharing planned: No
Related trials for Mastectomy
Not yet recruiting
Regenerative Peripheral Nerve Interface for Prophylaxis Against Post-Breast Surgery Pain Syndrome
Post-mastectomy Pain Syndrome
Recruiting
Comparison of Mastectomy Expander Trial
Mastectomy and Breast Reconstruction, Tissue Expander Based Breast Reconstruction
Not yet recruiting
Impact of Intraoperative Neurotization on Sensory Recovery of the Nipple and Breast Skin in Patients Undergoing Nipple Sparing Mastectomy With Immediate Implant-Based Reconstruction: NERSENSE, Prospective Randomized Control Study
Breast Cancer
Recruiting
Comparison of Postoperative Analgesic Efficacy of Two Different Blocks in Modified Radical Mastectomy Surgery
Breast Cancer, Postoperative Pain
Active, not recruitingObservational study
Autologous Nerve Graft Breast Reconstruction Neurotization
Breast Reconstruction, Breast Cancer Patients
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MARCHAL FREDERIC, MD, PU-PH principal investigator
Institut de Cancérologie de Lorraine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mastectomy, run by Institut de Cancérologie de Lorraine at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03003169, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2022.