Management of Symptomatic Post-operative Lymphocele

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-30

Study Completion Date

2021-03-31

Brief Summary

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Symptomatic lymphocele (LC) can be a complication after pelvic and para-aortic lymphadenectomy performed for treatment or staging purposes in the management of some cancers. Management procedures are: single or repeated puncture, prolonged drainage with drains or catheters, mostly followed by sclerotherapy, or surgery. A decision, which management option is most optimal, should be guided by two principles: first to control patient's symptoms, second to apply the least invasive but effective way to treat LC, taking into account that the patient has undergone major surgery recently, and often needs adjuvant treatment at the moment when symptomatic LC is diagnosed.

The aim of this study is to validate feasibility, safety and efficacy of a minimally invasive management of a symptomatic LC - drainage with the usage of vascular catheter followed by sclerotherapy, as well as to evaluate patient's experience on the treatment.

Patients with symptomatic LC are evaluated with ultrasound. Data about diameters, estimated volume of LC and other organs failure if appear is recorded. Management options are discussed with patient, and if the method with catheter insertion and drainage is chosen than the patient is eligible for the study. After vascular catheter insertion into LC and fluid evacuation, patient is followed with active drainage. Patients with drainage only are observed for a short period of time (up to 7 days), and if not efficient a sclerotherapy is considered. In case a patient does not agree to sclerotherapy, or there are contraindications, or it is doctor's decision that drainage alone is sufficient, than the prolonged drainage without sclerotherapy is the only procedure. The choice about the regimen used for sclerotherapy, it's volume, time intervals between repeated infusion depend on institution practice.

Data concerning feasibility, safety and efficacy are noted in designated templates. Patients' experience on the treatment is evaluated with formal questionnaire FACIT-TS-G.

The study is observational. Primary outcome measure is to establish efficacy of the method. Secondary outcome measures are safety and patient's experience on the treatment.

Investigators hope to establish step-by-step guidelines for optimal, minimally invasive management of symptomatic lymphocele.

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Detailed Description

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Conditions

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Lymphocele

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Drainage and sclerotherapy.

Patients with symptomatic lymphocele who are managed with percutaneous drainage and sclerotherapy.

Drainage and sclerotherapy.

Intervention Type PROCEDURE

Lymphocele percutaneous / transvaginal drainage with a use of a vascular catheter followed by sclerotherapy.

Drainage alone.

Patients with symptomatic lymphocele who are managed with percutaneous drainage alone.

Drainage alone.

Intervention Type PROCEDURE

Lymphocele percutaneous / transvaginal drainage with a vascular catheter alone (without sclerotherapy).

Interventions

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Drainage and sclerotherapy.

Lymphocele percutaneous / transvaginal drainage with a use of a vascular catheter followed by sclerotherapy.

Intervention Type PROCEDURE

Drainage alone.

Lymphocele percutaneous / transvaginal drainage with a vascular catheter alone (without sclerotherapy).

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* symptomatic lymphocele after abdominal lymphadenectomy for cancer,
* age \> 18 years old,
* informed consent signed,

Exclusion Criteria

* asymptomatic lymphocele,
* apparent infection of the skin or subcutaneus tissue over the lymphocele (in the place of potential catheter insertion),
* significant coagulopathy

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No