Prevention of Pelvic Lymphocele by Floseal During Pelvic Lymphadenectomy for Gynecologic Cancer

Ewha Womans University

Status and phase: Unknown; Phase 3

Conditions: Gynecologic Cancer

Treatments: Drug: Floseal

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01974193

BFL01

Details and patient eligibility

About

Pelvic lymph node dissection (PLND) is an important step in the surgical staging and treatment of gynecologic malignancies.

Sometimes, complicated lymphoceles after PLND often delay adjuvant treatment including chemotherapy and radiation therapy, which potentially affects the success of cancer treatment.

A number of surgical techniques have developed, but failed to reduce the incidence of pelvic lymphoceles after PLND.

The investigators hypothesized that floseal can prevent lymphoceles in patients with gynecologic cancer who has undergone PLND.

The investigators designed prospective randomized controlled study as a pilot study.

The investigators will randomly apply floseal to one side of pelvis after bilateral PLND, and observe the occurence of pelvic lymphoceles after 6 months later.

Enrollment: 40 estimated patients

Sex: Female

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Gynecologic cancer patients who need laparotomic bilateral PLND

Exclusion criteria

• Incomplete PLND which can influence the occurrence of lymphocele (surgeon's decision)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Floseal

Experimental group

Description:

application of floseal to one side of pelvis after pelvic lymphadenectomy

Treatment:

Drug: Floseal

Control

No Intervention group

Description:

counter-site of pelvis; no intervention after pelvic lymphadenectomy