A Collagen-Fibrin Patch (Tachosil®) for the Prevention of Symptomatic Lymphatic Cysts after Removal of Lymph Nodes in the Pelvis in Women with Gynecologic Cancer: a Randomized Clinical Trial

A Collagen-Fibrin Patch (Tachosil®) for the Prevention of Symptomatic Lymphoceles after Pelvic Lymphadenectomy in Women with Gynecologic Malignancies: a Randomized Clinical Trial - Tachosil for Prevention of Symptomatic Lymphoceles after pelvic lymphadenectomy

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-003115-34-AT

Enrollment

140

Registered

2012-05-22

Start date

2012-06-06

Completion date

Unknown

Last updated

2018-09-10

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

Conditions

endometrial cancer, cervical cancer

Interventions

Trade Name: Tachosil Product Name: Tachosil Pharmaceutical Form: Medicated sponge CAS Number: 9001-32-5 Other descriptive name: HUMAN FIBRINOGEN Concentration unit: mg milligram(s) Concentration type:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Women undergoing open or laparoscopic surgery for cervical or endometrial cancer -Age between 18 and 70 yrs -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 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60

Exclusion criteria

Exclusion criteria: -Women with previously diagnosed lymph edema -Known disease of the lymphatic system -Immunocompromised women such as those with an immunosuppressive medication or a known disease of the immune system

Design outcomes

Primary

Measure	Time frame
Main Objective: We intend to assess whether or not the intraoperative application of two collagen-fibrin patches (Tachosil®) to the obturator fossa and the femoral canal will reduce the number of symptomatic pelvic lymphoceles by at least 50% (primary study end point) in women with endometrial or cervical cancer undergoing pelvic lymphadenectomy.;Secondary Objective: To evaluate the incidence of sonographically detected pelvic lymphoceles of at least 2cm in the largest diameter 4 weeks after surgery in women undergoing open or laparoscopic pelvic lymphadenectomy for cervical and endometrial cancer with and without the application of Tachosil® during surgery. To evaluate the rate and type of medical interventions for clinically symptomatic pelvic lymphoceles such as analgesics and/or lymphocele puncture and drainage. ;Primary end point(s): Primary outcome variable: To evaluate the incidence of symptomatic pelvic lymphoceles defined by CTCAE 4.03 grade >2 within 4 weeks after surgery in women undergoing open or laparoscopic pelvic lymphadenectomy for cervical and endometrial cancer with and without the application of Tachosil® during surgery. ;Timepoint(s) of evaluation of this end point: 4 weeks after surgery	—

Measure

Time frame

Main Objective: We intend to assess whether or not the intraoperative application of two collagen-fibrin patches (Tachosil®) to the obturator fossa and the femoral canal will reduce the number of symptomatic pelvic lymphoceles by at least 50% (primary study end point) in women with endometrial or cervical cancer undergoing pelvic lymphadenectomy.;Secondary Objective: To evaluate the incidence of sonographically detected pelvic lymphoceles of at least 2cm in the largest diameter 4 weeks after surgery in women undergoing open or laparoscopic pelvic lymphadenectomy for cervical and endometrial cancer with and without the application of Tachosil® during surgery. To evaluate the rate and type of medical interventions for clinically symptomatic pelvic lymphoceles such as analgesics and/or lymphocele puncture and drainage. ;Primary end point(s): Primary outcome variable: To evaluate the incidence of symptomatic pelvic lymphoceles defined by CTCAE 4.03 grade >2 within 4 weeks after surgery in women undergoing open or laparoscopic pelvic lymphadenectomy for cervical and endometrial cancer with and without the application of Tachosil® during surgery. ;Timepoint(s) of evaluation of this end point: 4 weeks after surgery

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Secondary

Measure	Time frame
Secondary end point(s): Secondary outcome variables: To evaluate the incidence of sonographically detected pelvic lymphoceles of at least 2cm in the largest diameter 4 weeks after surgery in women undergoing open or laparoscopic pelvic lymphadenectomy for cervical and endometrial cancer with and without the application of Tachosil® during surgery. To evaluate the rate and type of medical interventions for clinically symptomatic pelvic lymphoceles such as analgesics and/or lymphocele puncture and drainage. ;Timepoint(s) of evaluation of this end point: 4 weeks after surgery	—

Measure

Time frame

Secondary end point(s): Secondary outcome variables: To evaluate the incidence of sonographically detected pelvic lymphoceles of at least 2cm in the largest diameter 4 weeks after surgery in women undergoing open or laparoscopic pelvic lymphadenectomy for cervical and endometrial cancer with and without the application of Tachosil® during surgery. To evaluate the rate and type of medical interventions for clinically symptomatic pelvic lymphoceles such as analgesics and/or lymphocele puncture and drainage. ;Timepoint(s) of evaluation of this end point: 4 weeks after surgery

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Countries

Austria

Contacts

Public ContactAbtlg f. Gyn. und gyn. Onkologie

Medizinische Universität Wien

alexander.reinthaller@meduniwien.ac.at004301404002915

Outcome results

None listed

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