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Application of Tachosil During Lymphadenectomy

NCT03752606 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2018-11-26

No results posted yet for this study

Summary

The prevention of lymphoceles was assessed using collagen patch coated with the human coagulation factors (TachoSil, Nycomed International Management GmbH, Zurich, Switzerland; NCT Number ICMJE NCT01192022; Other Study ID Numbers ICMJE TC-2402-040-SP; U1111-1130-9121 Registry Identifier: WHO) on 50 consecutive patients with endometrial and cervical cancer stages IB to II who had undergone open hysterectomy and pelvic lymphadenectomy (PL).

Methods:

Each patient was simultaneously randomized in two groups: as a control (side without Tachosil applied) and study group (side with Tachosil applied). All surgical parameters were collected and patients underwent ultrasound examination on postoperative days 1, 6, and 30, and at the end of treatment.

Conditions

Interventions

BIOLOGICAL

TACHOSIL GROUP

Sponsors & Collaborators

  • Takeda

    collaborator INDUSTRY

  • Medical University of Lublin

    lead OTHER

Principal Investigators

  • Tomasz Rechberger, Prof · IInd Department of Gynecology, Medical University of Lublin, Poland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-29
Primary Completion
2014-12-31
Completion
2017-12-31

Countries

  • Poland

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03752606 on ClinicalTrials.gov