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

Gynecologic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01974193
• Other study ID #: BFL01
• Status: Recruiting
• Phase: Phase 3
• First received: October 28, 2013
• Last updated: February 10, 2015
• Start date: December 2013
• Est. completion date: December 2016

Study information

• Verified date: February 2015
• Source: Ewha Womans University Mokdong Hospital
• Contact: Yun Hwan Kim, Dr
• Phone: +82-10-9096-7875
• Email: medok74[@]gmail.com
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Gynecologic Cancer
• Lymphocele

Intervention

Drug:
• Floseal
application of floseal on intervention arm

Locations

Country	Name	City	State
Korea, Republic of	Ewha Womans University Mokdong Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Ewha Womans University Mokdong Hospital	Baxter Healthcare Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of pelvic lymphocele	Frequency of ipsilateral pelvic lymphocele at post-operative 6th month.	6 month	No
Secondary	Post-operative drainage	left and right post-operative drainage	post-operative 3 days	No
Secondary	lymphedema	lymphedema symptoms and sign at post-operative 3 and 6 month	post-operative 3 and 6 month	No