Perineal and Abdominal Reconstruction: a Comparison of Reconstructive Methodologies
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Surgery. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Technical Success [Time frame: From the first patient enrolled to the 50th patient, an average of 2 years]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- IRCCS AOU di Bologna Policlinico di Sant'Orsola — Bologna
Identifiers
NCT: NCT06800534 · PLAST-GEN-1