Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-28 @ 12:07 AM
Study NCT ID:
NCT06800534
Status:
RECRUITING
Last Update Posted:
2025-01-30
First Post:
2025-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Perineal and Abdominal Reconstruction: a Comparison of Reconstructive Methodologies
Sponsor:
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Organization:
Study Overview
Official Title:
Perineal and Abdominal Reconstruction: a Comparison of Reconstructive Methodologies
Status:
RECRUITING
Status Verified Date:
2024-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PLAST-GEN-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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: