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Tachosil for the Prevention of Symptomatic Lymph Cysts

NCT01470677 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2022-07-08

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Ruhr University of Bochum

    lead OTHER

Principal Investigators

  • Clemens Tempfer, MD · Ruhr University Bochum, Germany

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2016-01-31
Completion
2016-01-31

Countries

  • Austria
  • Germany

Study Locations

More Related Trials

Entities

Diseases

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 NCT01470677 on ClinicalTrials.gov