Efficacy Study of FloSeal for Prevention of Lymphocele After Lymphadenectomy for Gynecologic Cancer

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

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2015-11-30

Brief Summary

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To compare the incidence of lymphocele and lymphatic ascites between patient who use versus who do not use FloSeal during lymph node dissection

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Detailed Description

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Conditions

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Gynecologic Cancer Cervical Cancer Endometrial Cancer Ovarian Cancer Fallopian Tubal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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FloSeal group

This group will undergo appropriate cancer surgery for each patient with pelvic lymph node dissection +/- para-aortic lymph node dissection. At the completion of lymph node dissection, 2 vials of Floseal will be applied to each lymph node area.

Group Type EXPERIMENTAL

FloSeal application

Intervention Type DRUG

At the completion of lymph node dissection, 2 vials of Floseal will be applied to each lymph node area.

No FloSeal group

All surgical procedures of control group is the same with study group except that Floseal is not applicated in control group.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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FloSeal application

At the completion of lymph node dissection, 2 vials of Floseal will be applied to each lymph node area.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Histologically confirmed primary cancer of the uterine cervix, uterine corpus, ovary, and fallopian tube
* FIGO stage Cervical cancer: FIOG stage IA2-IIA2 Uterine cancer: FIGO stage I-III Ovarian and fallopian tubal cancer: FIGO stage I-IIIB
* Patients who undergoing surgery including pelvic and/or para-aortic lymph node dissection
* Patients with adequate bone marrow, renal and hepatic function:

WBC \> 3,000 cells/mcl Platelets \>100,000/mcl Creatinine \<2.0 mg/dL Bilirubin \<1.5 x normal and SGOT or SGPT \<3 x normal

* American Society of Anesthesiology Physical Status 0-1
* Performance status of ECOG 0-2
* Patient must be suitable candidates for surgery
* Patients who have signed an approved Informed Consent

Exclusion Criteria

* Patients with a history of pelvic or abdominal radiotherapy;
* Patients who are pregnant
* Patients with contraindications to surgery;
* Patients who are unfit for Surgery: serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator);
* Patient's compliance and geographic proximity that do not allow adequate follow-up.
* Patients who undergo only lymph node sampling

Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No