Comparing different methods for reconstructive surgery after pelvic-perineal amputations
Official title: Perineal and Abdominal Reconstruction: a Comparison of Reconstructive Methodologies
Run by IRCCS Azienda Ospedaliero-Universitaria di Bologna · NCT06800534 · Data updated 2026-11-12
This study is testing different surgical methods for rebuilding the body after pelvic-perineal amputations to see which one leads to fewer complications for patients.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 1 site (Bologna) |
| Status | Recruiting |
| Started | June 21, 2023 |
| Main results expected | June 30, 2025 |
| Study ends | June 30, 2025 |
| Registry record updated | January 30, 2025 |
| Trial ID | NCT06800534 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 and older undergoing pelvic-perineal amputations for oncological or chronic inflammatory diseases requiring reconstructive surgery.
✕Probably not a fit
Patients with incomplete or missing data will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to compare various reconstructive methodologies, including V-Y flap, lotus flap, gracilis muscle flap, and TRAM flap, in patients undergoing pelvic-perineal amputations due to oncological or chronic inflammatory diseases. By analyzing patient data collected from medical records and outpatient reports, the study seeks to identify which reconstructive methods result in fewer complications. The research focuses on understanding the outcomes associated with each technique in different patient categories, providing insights into optimal surgical practices.
Why it matters
Potential benefit: If successful, this study could help identify the safest and most effective reconstructive methods, leading to improved patient outcomes and reduced complications.
How similar studies have gone: While this study employs established reconstructive techniques, the comparative analysis of their outcomes in this specific patient population is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
IRCCS AOU di Bologna Policlinico di Sant'Orsola
Bologna, Italy Recruiting
Study contacts
- Principal investigator: Marco Pignatti, MD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Study coordinator: Marco Pignatti, MD
- Email: marco.pignatti@unibo.it
- Phone: +390512143614
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.