Use of TachoSil® for the prevention of postoperative complications after removal of lymphnodes in groin in vulva cancer patients

Use of TachoSil® for the prevention of postoperative complications after groin dissection in vulva cancer patients -

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-001191-30-DK

Enrollment

Registered

2017-03-03

Start date

2017-04-25

Completion date

Unknown

Last updated

2017-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vulva cancer MedDRA version: 19.1 Level: HLT Classification code 10047750 Term: Vulval neoplasms malignant System Organ Class: 100000004864

Interventions

Trade Name: Tachosil Pharmaceutical Form: Sealant INN or Proposed INN: Human Thrombin active susbtans Other descriptive name: THROMBIN, BOVINE Concentration unit: U unit(s) Concentration type: equal C

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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 - To compare rate of medical interventions for clinically symptomatic lymphocele such as puncture among women with and without application of TachoSil® - To evaluate the incidence of LLL - To evaluate and compare different aspects of quality of life in women after ILND with and without TachoSil® application during surgery ;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	—

Measure

Time frame

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 - To compare rate of medical interventions for clinically symptomatic lymphocele such as puncture among women with and without application of TachoSil® - To evaluate the incidence of LLL - To evaluate and compare different aspects of quality of life in women after ILND with and without TachoSil® application during surgery ;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

Measure	Time frame
Secondary end point(s): Incidence of LLL Several aspects of Quality of life;Timepoint(s) of evaluation of this end point: 3, 6, 12 months after surgery	—

Countries

Denmark

Contacts

Public ContactLigita Paskeviciute Frøding

Department of Obstetrics & Gynecology, Copenhagen University Hospital, Rigshospitalet

ligitapask@dadlnet.dk004535459719

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026