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Perineal and Abdominal Reconstruction: a Comparison of Reconstructive Methodologies

Perineal and Abdominal Reconstruction: a Comparison of Reconstructive Methodologies

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06800534
Acronym
PLAST-GEN-1
Enrollment
50
Registered
2025-01-30
Start date
2023-06-21
Completion date
2025-06-30
Last updated
2025-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgery

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.

Detailed description

he study is of a non-interventional observational nature. It involves the collection of patient data in pseudonymous form from preoperative and postoperative assessments in accordance with daily clinical practice and normally performed for proper patient management. The data recorded in the study are obtained from the medical records of patients who are normally accessed by the doctors of the operating unit during daily practice. After having performed a meticulous collection of the basic data of the patients (gender, age, remote pathological history, recent pathological history, type of demolitive and reconstructive surgery performed), 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. The complications are assessed through the retrospective analysis of the outpatient reports that are normally drawn up during the usual follow-up outpatient visits.

Interventions

None listed

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Incomplete or missing data.

Design outcomes

Primary

MeasureTime frameDescription
Technical SuccessFrom the first patient enrolled to the 50th patient, an average of 2 yearsTechnical success is assessed by the number of reinterventions after 1 year from the treatment and the number of major complications.

Countries

Italy

Contacts

Primary ContactMarco Pignatti, MD
marco.pignatti@unibo.it+390512143614

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026