Prospective randomized multicenter trial of prevention of groin complications by insertion of internal inguino-peritoneal drains after radical inguinofemoral lymphonodectomy for advanced vulvar cancer.
Not Applicable
- Conditions
- C51Malignant neoplasm of vulva
- Registration Number
- DRKS00027334
- Lead Sponsor
- niversitätsklinikum Augsburg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Female
- Target Recruitment
- 100
Inclusion Criteria
Age over 18 years
- Inguinal-nodal positive vulvar carcinoma confirmed by sentinel lymphonodectomy (also after pos. frozen section) or by punch biopsy with indication for radical inguinofemoral lymphonodectomy unilaterally or bilaterally
- Primary vulvar carcinoma with a stage T2(>4cm) Nx
- Karnofsky index >80% and/or ECOG 0-1
- No history of invasive vulvar malignancy
- Consent to adjuvant radiation if indicated postoperatively
Exclusion Criteria
- History of other malignancy with need for systematic therapy or radiotherapy in the vulva or groin area
- Lack of compliance for groin compression (e.g., dementia)
- Adipositas permagna from BMI 35 kg/m2
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction in the incidence of at least one postoperative complication such as seromas, lymphoceles, wound healing disorders, infections, or complications from drainage of severity greater than or equal to Clavien Dindo grade IIIa within 3 months after primary surgery. between patients with inguino-peritoneal drainage and volume-controlled drainage.
- Secondary Outcome Measures
Name Time Method - Improvement in quality of life<br>- Shortening of time to start of adjuvant radiotherapy indicated by nodal status.<br>- Shortening the length of hospital stay<br>- Reduction in the need for physician visits<br>- well tolerated pain<br>- no change in progression free survival.