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Tachosil for the Prevention of Symptomatic Lymph Cysts

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01470677
Recruitment Status : Completed
First Posted : November 11, 2011
Last Update Posted : January 20, 2016
Sponsor:
Information provided by (Responsible Party):
Clemens Tempfer, Ruhr University of Bochum

Brief Summary:
This is a randomized trial of 140 women with endometrial or cervical cancer undergoing removal of lymph tissue (lymphadenectomy). The application of 4 tachosil fibrin patches to the pelvic side wall after tissue removal is tested against no such intervention after tissue removal. The primary endpoint is 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. The study's hypothesis is that the application of tachosil fibrin patches will significantly reduce the rate of symptomatic lymph cysts.

Condition or disease Intervention/treatment Phase
Endometrial Cancer Cervical Cancer Drug: Tachosil fibrin patch Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Collagen-Fibrin Patch (Tachosil®) for the Prevention of Symptomatic Lymphoceles After Pelvic Lymphadenectomy in Women With Gynecologic Malignancies: a Randomized Clinical Trial
Study Start Date : November 2011
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

Drug Information available for: TachoSil

Arm Intervention/treatment
Experimental: application of Tachosil fibrin patches
A Tachosil® patch of 4.8x4.8cm will be attached to the obturator fossa and a Tachosil® patch of 4.8x4.8cm will be attached to the femoral canal of each side of surgery in the intervention group.
Drug: Tachosil fibrin patch
A Tachosil® patch of 4.8x4.8cm will be attached to the obturator fossa and a Tachosil® patch of 4.8x4.8cm will be attached to the femoral canal of each side of surgery in the intervention group. In the control group, no Tachosil® patch will be used. No specific drainage of the retroperitoneum will be performed.
Other Name: EU registration number: EU/1/04/277/002

No Intervention: Control group
In the control group, no Tachosil® patch will be used. No specific drainage of the retroperitoneum will be performed.



Primary Outcome Measures :
  1. symptomatic lymph cysts [ Time Frame: 4 weeks ]

    Primary outcome variable:

    2.1. 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.



Secondary Outcome Measures :
  1. asymptomatic lymph cysts, intervention rate due to symptomatic lymph cysts [ Time Frame: 4 weeks ]

    Secondary outcome variables:

    2.2. 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.

    2.3. To evaluate the rate and type of medical interventions for clinically symptomatic pelvic lymphoceles such as analgesics and/or lymphocele puncture and drainage.




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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women undergoing open or laparoscopic surgery for cervical or endometrial cancer
  • Age between 18 and 70 yrs
  • Informed consent

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01470677


Locations
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Austria
Medical University of Vienna
Vienna, Austria, A-1090
Germany
Ruhr University Bochum
Bochum, Germany, D-44625
Sponsors and Collaborators
Ruhr University of Bochum
Investigators
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Principal Investigator: Clemens Tempfer, MD Ruhr University Bochum, Germany

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Clemens Tempfer, Prof. Dr. med. Clemens Tempfer, Ruhr University of Bochum
ClinicalTrials.gov Identifier: NCT01470677    
Other Study ID Numbers: TACH-01
First Posted: November 11, 2011    Key Record Dates
Last Update Posted: January 20, 2016
Last Verified: January 2016
Keywords provided by Clemens Tempfer, Ruhr University of Bochum:
lymph cyst
lymphocele
fibrin
collagen
prevention
cancer
Additional relevant MeSH terms:
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Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female