Pain, PostoperativeNCT04130373
Multicentric Risk Evaluation of Autologous Fat Grafting Procedure
An observational study of Pain, Postoperative, run by Humanitas Clinical and Research Center at 1 site in Italy.
Trial summary
Autologous fat grafting, also known as lipofilling, is a surgical technique consisting in the processing and transfer of adipose tissue from one area in our organism (hips, thighs) to region which in need of reconstructive and aesthetic correction. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Autologous fat grafting procedure and Breast reconstruction
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 6,510 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2019to Jun 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Female patients with breast carcinoma (any histological type, carcinoma in situ included) and treated with radical or conservative surgery and lipofilling. Patients received a minimum of two year follow up.
Who may be able to join
- female
- breast carcinoma (any histological type, carcinoma in situ included) treated with radical or conservative surgery
- group treated with lipofilling and group which didnt receive lipofilling
- timing: retrospective evaluation of cases form 2006 to 2016, with a minimum of two year follow up
Who cannot join
- neoplasie different from infiltrating and in sutu breast carcinoma
- in situ lobular carcinoma
- patients with breast carcinoma and metastasis
- lipofilling procedure used before the oncological treatment for breast carcinoma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicentic Retrospective Evaluation of Risks in Mammary Carcinoma Relapse in Patients With Mammary Reconstruction and Autologous Fat Grafting
Autologous fat grafting, also known as lipofilling, is a surgical technique consisting in the processing and transfer of adipose tissue from one area in our organism (hips, thighs) to region which in need of reconstructive and aesthetic correction. The technique is frequently used after radical or conservative mammary surgery, aiming to achieve better aesthetic results, reduce pain induced by both surgery and radiotherapy. The scientific community was widely involved in the debate regarding the use of mesenchymal/stem cells in a patient with high risk of tumor progression due to their elevated proliferative profile. This study aims to retrospectively evaluate the oncological safety in the use of lipofilling in patients who underwent oncological and reconstructive treatment in our Institute.
- Conditions
- Pain, Postoperative
- Being tested
- Autologous fat grafting procedure, Breast reconstruction
- Keywords
- Autologous fat grafting, Lipofilling, Breast cancer, Breast reconstruction
- Medical subject headings
- Pain, Postoperative, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous fat grafting procedureProcedure or surgery
Surgical intervention based on the injection of autologous fat grafting after radical or conservative breast surgery and breast reconstruction.
Breast reconstructionProcedure or surgery
Breast reconstructive procedures after oncological radical or conservative breast surgery
| Study group | Role | What they receive |
|---|---|---|
| Women receiving autologous fat grafting | Women who received breast reconstruction and autologous fat grafting. Receives: Procedure: Autologous fat grafting procedure; Procedure: Breast reconstruction | |
| Control | Women who received breast reconstruction only. Receives: Procedure: Breast reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oncological safety of autologous fat grafting
Percentage of disease relapse in loco
Measured: Two years
Secondary outcomes (3)
Establishment of timing in disease relapse
Measured: Two years
Establish the distribution in disease relapses
Establish the distribution in disease relapse in thre different histological subtypes of breast carcinoma
Measured: Two years
Establish overall survival rate in experimental and control groups
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2019
- Study start1 Jun 2019
- Primary completionJan 2020 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 6,510 participants (actual)
Sponsor and investigators
- Lead sponsor
- Humanitas Clinical and Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Lisa, Humanitas Clinical and Research Center
- Investigators
- Marco Klinger, MD, Study chair, Istituto Clinico Humanitas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04130373
- Sponsor's protocol ID
- 1955K
- Status last verified
- Oct 2019
- First submitted
- 15 Oct 2019
- Last updated
- 30 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentic Retrospective Evaluation of Risks in Mammary Carcinoma Relapse in Patients With Mammary Reconstruction and Autologous Fat Grafting
- ClinicalTrials.gov ID
- NCT04130373
- Acronym / sponsor ID
- 1955K
- Conditions
- Pain, Postoperative
- Keywords
- Autologous fat grafting, Lipofilling, Breast cancer, Breast reconstruction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 6,510 participants (actual)
- Lead sponsor
- Humanitas Clinical and Research CenterUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 17 Oct 2019 (actual)
- 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.
Autologous fat grafting, also known as lipofilling, is a surgical technique consisting in the processing and transfer of adipose tissue from one area in our organism (hips, thighs) to region which in need of reconstructive and aesthetic correction. The technique is frequently used after radical or conservative mammary surgery, aiming to achieve better aesthetic results, reduce pain induced by both surgery and radiotherapy. The scientific community was widely involved in the debate regarding the use of mesenchymal/stem cells in a patient with high risk of tumor progression due to their elevated proliferative profile. This study aims to retrospectively evaluate the oncological safety in the use of lipofilling in patients who underwent oncological and reconstructive treatment in our Institute.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women receiving autologous fat grafting | – | Procedure: Autologous fat grafting procedure, Procedure: Breast reconstructionWomen who received breast reconstruction and autologous fat grafting. |
| Control | – | Procedure: Breast reconstructionWomen who received breast reconstruction only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Female patients with breast carcinoma (any histological type, carcinoma in situ included) and treated with radical or conservative surgery and lipofilling. Patients received a minimum of two year follow up.
Key inclusion criteria (4 listed)
- female
- breast carcinoma (any histological type, carcinoma in situ included) treated with radical or conservative surgery
- group treated with lipofilling and group which didnt receive lipofilling
- timing: retrospective evaluation of cases form 2006 to 2016, with a minimum of two year follow up
Key exclusion criteria (4 listed)
- neoplasie different from infiltrating and in sutu breast carcinoma
- in situ lobular carcinoma
- patients with breast carcinoma and metastasis
- lipofilling procedure used before the oncological treatment for breast carcinoma
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 |
|---|---|---|
| Autologous fat grafting procedureSurgical intervention based on the injection of autologous fat grafting after radical or conservative breast surgery and breast reconstruction. | Procedure or surgery | Women receiving autologous fat grafting |
| Breast reconstructionBreast reconstructive procedures after oncological radical or conservative breast surgery | Procedure or surgery | Control, Women receiving autologous fat grafting |
Primary outcome
Oncological safety of autologous fat grafting
Time frame: Two years
Percentage of disease relapse in loco
3 secondary outcomes
Establishment of timing in disease relapse
Time frame: Two years
Establish the distribution in disease relapses
Time frame: Two years
Establish overall survival rate in experimental and control groups
Time frame: Two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2019.
- Individual participant dataSharing planned: No
Related trials for Pain, Postoperative
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
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.
Marco Klinger, MD study chair
Istituto Clinico Humanitas
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 Pain, Postoperative, run by Humanitas Clinical and Research Center at 1 site in Italy.
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 4 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: status not confirmed, as of the sponsor's last update on 30 Oct 2019. 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 Italy. 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?
Results are not available in the source record.
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?
Oncological safety of autologous fat grafting (time frame: Two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Oct 2019.