Perineal and Abdominal Reconstruction: a Comparison of Reconstructive Methodologies

NCT06800534 | Recruiting

• 1 other identifier: PLAST-GEN-1
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The different reconstructive methods (V-Y flap, lotus flap, gracilis muscle flap, TRAM flap) will be compared with the complications that occurred following the surgery, so as to define which reconstructive methods have led to fewer complications and in which categories of patients.

Conditions

Surgery

Outcome Measures

Primary Outcomes (1)

• Technical Success

  Technical success is assessed by the number of reinterventions after 1 year from the treatment and the number of major complications.

  From the first patient enrolled to the 50th patient, 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

The patient population consists of subjects affected by rectal or vulvar neoplasia or chronic inflammatory bowel disease and subjected to demolition surgery at the General Surgery Unit of the IRCCS Azienda Ospedaliero-Universitaria di Bologna and related reconstruction (performed by the Plastic Surgery Unit of the IRCCS Azienda Ospedaliero-Universitaria di Bologna) in the period between 01/01/2011 and 31/12/2021.

You may qualify if:

• Patients undergoing pelvic-perineal amputations for oncological disease or chronic inflammatory diseases whose surgical treatment required the collaboration of the plastic surgeon
• Patients with complications in the abdominal or pelvic-perineal region of surgical relevance and requiring reconstruction (enteric fistulas, abdominal wall defects)
• Age greater than or equal to 18 years
• Acquisition of written informed consent

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)