NCT06800534 Perineal and Abdominal Reconstruction: a Comparison of Reconstructive Methodologies
| NCT ID | NCT06800534 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna |
| Condition | Surgery |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2023-06-21 |
| Primary Completion | 2025-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2023-06-21 with a primary completion date of 2025-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Marco Pignatti, MD
PRINCIPAL INVESTIGATOR
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Frequently Asked Questions
Who can join the NCT06800534 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Surgery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06800534 currently recruiting?
Yes, NCT06800534 is actively recruiting participants. Contact the research team at marco.pignatti@unibo.it for enrollment information.
Where is the NCT06800534 trial being conducted?
This trial is being conducted at Bologna, Italy.
Who is sponsoring the NCT06800534 clinical trial?
NCT06800534 is sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. The principal investigator is Marco Pignatti, MD at IRCCS Azienda Ospedaliero-Universitaria di Bologna. The trial plans to enroll 50 participants.