se of TachoSil® for the prevention of postoperative complications afterremoval of lymphnodes in groin in vulva cancer patients

Phase 1

Conditions: Vulva cancer
MedDRA version: 19.1Level: HLTClassification code 10047750Term: Vulval neoplasms malignantSystem Organ Class: 100000004864
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Equipment and Supplies [E07]

Registration Number: EUCTR2016-001191-30-DK

Lead Sponsor: Department of Obstetrics & Gynecology, Copenhagen University Hospital, Rigshospitalet

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Female

Target Recruitment: 70

Inclusion Criteria

Women undergoing uni- or bilateral ILND for vulva cancer at Rigshospitalet, Denmark
Age > 18
Understand and speak Danish fluently
Written and oral informed consent
Written informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 55

Exclusion Criteria

Women with previously diagnosed lymphedema of the legs
Known disease of the lymphatic system
Women who previously had a pelvic or paraaortic lymphadenectomy performed
Age < 18
Women who do not speak or read Danish
Active cancer at another cancer site

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate and compare the incidence of symptomatic lymphocele (defined by CTCAE 4.03 grade =2) within 4 weeks after surgery in women undergoing ILND for vulva cancer with or without the application of TachoSil® during surgery;Secondary Objective: -To compare the incidence of sonographically detected asymptomatic lymphocele of at least 4 cm at the largest diameter 4 weeks after surgery in women undergoing ILND for vulva cancer with and without the application of TachoSil® during surgery<br>-To compare rate of medical interventions for clinically symptomatic lymphocele such as puncture among women with and without application of TachoSil®<br>-To evaluate the incidence of LLL<br>-To evaluate and compare different aspects of quality of life in women after ILND with and without TachoSil® application during surgery<br><br>;Primary end point(s): Incidence of symptomatic lymphocele (defined by CTCAE 4.03 grade =2) ;Timepoint(s) of evaluation of this end point: Within 4 weeks after surgery

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Incidence of LLL<br>Several aspects of Quality of life;Timepoint(s) of evaluation of this end point: 3, 6, 12 months after surgery