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

Prevention of Pelvic Lymphocele by Floseal During Pelvic Lymphadenectomy for Gynecologic Cancer: a Pilot Study

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.

Study Overview

• Status: Unknown
• Conditions: Gynecologic Cancer
• Intervention / Treatment: Drug: Floseal

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Yun Hwan Kim, Dr; Phone Number: +82-10-9096-7875; Email: medok74@gmail.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 158-710
    • Recruiting
    • Ewha Womans University Mokdong Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Gynecologic cancer patients who need laparotomic bilateral PLND

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Floseal; application of floseal to one side of pelvis after pelvic lymphadenectomy	Drug: Floseal; application of floseal on intervention arm
No Intervention: Control; counter-site of pelvis; no intervention after pelvic lymphadenectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of pelvic lymphocele	Frequency of ipsilateral pelvic lymphocele at post-operative 6th month.	6 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative drainage	left and right post-operative drainage	post-operative 3 days
lymphedema	lymphedema symptoms and sign at post-operative 3 and 6 month	post-operative 3 and 6 month

Collaborators and Investigators

• Sponsor: Ewha Womans University Mokdong Hospital
• Collaborators: Baxter Healthcare Corporation

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: October 28, 2013
• First Submitted That Met QC Criteria: October 31, 2013
• First Posted (Estimate): November 1, 2013

Study Record Updates

• Last Update Posted (Estimate): February 11, 2015
• Last Update Submitted That Met QC Criteria: February 10, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Lymphatic Diseases; Cysts; Lymphocele
• Other Study ID Numbers: BFL01