SurgeryPLAST-LDNCT06800547
Latissimus Dorsi Flap Reconstructions: Retrospective Study
An observational study of Surgery, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
Various options for reconstruction alternatives to LD are described, as are the possible early and late side effects of LD harvesting. Currently, the choice of whether or not to resort to LD harvesting to repair the defect is based on the experience and preference of the specific working group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 21 Jun 2023to 30 Jun 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have already undergone reconstruction surgery with a LD flap at the following U.O. Maxillofacial Surgery, Thoracic Surgery, Cardiac Surgery, Orthopedics, Urology, General Surgery, with involvement of the U.O. Plastic Surgery, from 1 January 2010 to 31 January 2023.
Who may be able to join
- Duration of surgery, expressed in minutes;
- Hospitalization time, expressed in days;
- Need for reoperation within 30 days of the first operation;
- Survival and recurrences, based on the last available follow-up
Who cannot join
- Incomplete or missing data
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS AOU di Bologna Policlinico di Sant'Orsola
Bologna, 40138
Marco Pignatti, MD, +390512143614, marco.pignatti@unibo.it
About this study
Various options for reconstruction alternatives to LD are described, as are the possible early and late side effects of LD harvesting. Currently, the choice of whether or not to resort to LD harvesting to repair the defect is based on the experience and preference of the specific working group. The importance of the study lies in the attempt to analyze the choices made in the diagnostic and therapeutic phase (demolitive and reconstructive) on patients in order to correlate the outcomes obtained in terms of healing, quality of life and complications in the recipient site and in the donor site.
Read the detailed description
Currently, there are no universally accepted guidelines regarding when it is advisable to resort to a LD flap for the repair of a large defect and when it is considered contraindicated. Various options for reconstruction alternatives to LD are described, as are the possible early and late side effects of LD harvesting. Currently, the choice of whether or not to resort to LD harvesting to repair the defect is based on the experience and preference of the specific working group. The importance of the study lies in the attempt to analyze the choices made in the diagnostic and therapeutic phase (demolitive and reconstructive) on patients treated at IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola in past years, in order to correlate the outcomes obtained in terms of healing, quality of life and complications in the recipient site and in the donor site with the baseline conditions of the patients, the site and the extension of the defect.
- Conditions
- Surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical Success
Technical success is assessed by: the duration of surgery; days of Hospitalization; need for reoperation within 30 days of the first operation; survival and recurrences, based on the last available follow-up.
Measured: From the first enrollment, up to the 200th, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2025
- Study start21 Jun 2023
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies 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
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marco Pignatti, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06800547
- Sponsor's protocol ID
- PLAST-LD
- Acronym
- PLAST-LD
- Status last verified
- Dec 2024
- First submitted
- 9 Jan 2025
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Latissimus Dorsi Flap Reconstructions: Retrospective Study
- ClinicalTrials.gov ID
- NCT06800547
- Acronym / sponsor ID
- PLAST-LD / PLAST-LD
- Conditions
- Surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 21 Jun 2023 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 30 Jan 2025 (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.
Various options for reconstruction alternatives to LD are described, as are the possible early and late side effects of LD harvesting. Currently, the choice of whether or not to resort to LD harvesting to repair the defect is based on the experience and preference of the specific working group. The importance of the study lies in the attempt to analyze the choices made in the diagnostic and therapeutic phase (demolitive and reconstructive) on patients in order to correlate the outcomes obtained in terms of healing, quality of life and complications in the recipient site and in the donor site.
Detailed description
Currently, there are no universally accepted guidelines regarding when it is advisable to resort to a LD flap for the repair of a large defect and when it is considered contraindicated. Various options for reconstruction alternatives to LD are described, as are the possible early and late side effects of LD harvesting. Currently, the choice of whether or not to resort to LD harvesting to repair the defect is based on the experience and preference of the specific working group. The importance of the study lies in the attempt to analyze the choices made in the diagnostic and therapeutic phase (demolitive and reconstructive) on patients treated at IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola in past years, in order to correlate the outcomes obtained in terms of healing, quality of life and complications in the recipient site and in the donor site with the baseline conditions of the patients, the site and the extension of the defect.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have already undergone reconstruction surgery with a LD flap at the following U.O. Maxillofacial Surgery, Thoracic Surgery, Cardiac Surgery, Orthopedics, Urology, General Surgery, with involvement of the U.O. Plastic Surgery, from 1 January 2010 to 31 January 2023.
Key inclusion criteria (4 listed)
- Duration of surgery, expressed in minutes;
- Hospitalization time, expressed in days;
- Need for reoperation within 30 days of the first operation;
- Survival and recurrences, based on the last available follow-up
Key exclusion criteria (1 listed)
- Incomplete or missing data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Technical Success
Time frame: From the first enrollment, up to the 200th, an average of 2 years
Technical success is assessed by: the duration of surgery; days of Hospitalization; need for reoperation within 30 days of the first operation; survival and recurrences, based on the last available follow-up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
Related trials for Surgery
Not yet recruiting
The Contribution of Accelerated Recovery (mERAS) Approach to Postoperative Recovery in Pediatric Laparoscopic Surgery Cases
mERAS Intervention, The ASA (American Society of Anesthesiologists) Score
RecruitingObservational study
Label-free Femtosecond Laser Imaging Combined With the Fast Lung Artificial Intelligence Model for Rapid Intraoperative Diagnosis of Lung Surgical Specimens: A Multicentre, Prospective, Parallel-workflow, Non-inferiority Study.
Lung Cancer
RecruitingPhase 3
Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma
Ganglioneuroblastoma, Nodular, Neuroblastoma
Not yet recruiting
The Effect of Compound Chamomile and Lidocaine Hydronchloride Gel as an Endotracheal Tube Lubricant on Postoperative Pharyngeal and Laryngeal Complications in Thoracic Surgery Patients
Postoperative Sore Throat
Active, not recruitingObservational study
Nerve Transfer Surgery to Restore Upper-limb Function After Cervical Spinal Cord Injury
Spinal Cord Injury, Spinal Cord Injury at C5-C7 Level
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.
Marco Pignatti, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
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 Surgery, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna 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 1 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: looking for participants now, as of the sponsor's last update on 30 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marco Pignatti, MD (+390512143614, marco.pignatti@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical Success (time frame: From the first enrollment, up to the 200th, an average of 2 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 Jan 2025.