Latissimus Dorsi Flap Reconstructions: Retrospective Study

NCT06800547 | Recruiting

• 1 other identifier: PLAST-LD
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Surgery

Outcome Measures

Primary Outcomes (1)

• 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.

  From the first enrollment, up to the 200th, an average of 2 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Incomplete or missing data

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS AOU di Bologna Policlinico di Sant'Orsola

Bologna, 40138, Italy

RECRUITING

Study Officials

• Marco Pignatti, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marco Pignatti, MD

CONTACT

+390512143614; marco.pignatti@unibo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: January 30, 2025
• Study Start: June 21, 2023
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: January 30, 2025

Record last verified: 2024-12

Locations

IT (1)