About this trial
Background:Lipomas are the most common benign soft tissue tumors, traditionally treated by open surgical excision. However, open surgery is associated with relatively large incisions, prolonged recovery, and visible scarring. While liposuction offers a less invasive alternative, it often achieves unsatisfactory clearance rates for lipomas with significant fibrotic components, leading to higher recurrence rates.
Study Objective:This study aims to investigate the safety and efficacy of CUSA in the minimally invasive treatment of lipomas.
Study Methods:this is a single-center, prospective clinical study. A total of 30 eligible patients with clinically diagnosed lipomas scheduled for surgical treatment will be enrolled. All participants will undergo minimally invasive tumor resection using the CUSA system. The primary outcome measure is tumor clearance rate .Secondary outcome measures include operation time, intraoperative blood loss, postoperative pain score, complication rate, recurrence rate, cosmetic outcome, and patient satisfaction. Patients will be followed up for 6 months after treatment.
Study Significance:The results of this study will provide evidence-based clinical support for the application of CUSA in the minimally invasive treatment of lipomas, particularly for lesions with abundant fibrotic components, and may help optimize treatment strategies and improve patient outcomes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Coagulation dysfunction or currently receiving anticoagulant therapy;
Lipoma located in the head and face or within the muscle layer;
Atypical lipoma or liposarcoma indicated by needle biopsy pathology;
Ulceration, redness, swelling, or infection of the skin overlying the lipoma;
Trial design
Single group
Treatments tested in this trial
CUSA Minimally Invasive Resection
DeviceCUSA Minimally Invasive Resection
Treatment groups
Trial outcomes
Primary outcomes
Complete resection rate of lipoma
Proportion of patients with complete resection of lipoma confirmed by postoperative ultrasound or pathological examination.
Locations
Sponsors and contacts
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