Perineal and Abdominal Reconstruction: a Comparison of Reconstructive Methodologies

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-21

Study Completion Date

2025-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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