Latissimus Dorsi Flap Reconstructions: Retrospective Study (PLAST-LD)

January 28, 2025 updated by: IRCCS Azienda Ospedaliero-Universitaria di Bologna
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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

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

Study Contact

Study Locations

  • Italy
      • Bologna, Italy, 40138
        • Recruiting
        • IRCCS AOU di Bologna Policlinico di Sant'Orsola
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Incomplete or missing data

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From the first enrollment, up to the 200th, an average of 2 years

Collaborators and Investigators

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

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Investigators

  • Principal Investigator: Marco Pignatti, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

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)

June 21, 2023

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

January 9, 2025

First Submitted That Met QC Criteria

January 28, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 28, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • PLAST-LD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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