NCT01974193

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2013

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 1, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

February 11, 2015

Status Verified

February 1, 2015

Enrollment Period

2 years

First QC Date

October 28, 2013

Last Update Submit

February 10, 2015

Conditions

Gynecologic Cancer

Outcome Measures

Primary Outcomes (1)

  • Frequency of pelvic lymphocele

    Frequency of ipsilateral pelvic lymphocele at post-operative 6th month.

    6 month

Secondary Outcomes (2)

  • Post-operative drainage

    post-operative 3 days

  • lymphedema

    post-operative 3 and 6 month

Study Arms (2)

Floseal

EXPERIMENTAL

application of floseal to one side of pelvis after pelvic lymphadenectomy

Drug: Floseal

Control

NO INTERVENTION

counter-site of pelvis; no intervention after pelvic lymphadenectomy

Interventions

FlosealDRUG

application of floseal on intervention arm

Floseal

Eligibility Criteria

Age20 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Gynecologic cancer patients who need laparotomic bilateral PLND

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ewha Womans University Mokdong Hospital

Seoul, 158-710, South Korea

RECRUITING

MeSH Terms

Interventions

FloSeal Matrix

Central Study Contacts

Yun Hwan Kim, Dr

CONTACT

+82-10-9096-7875medok74@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 28, 2013

First Posted

November 1, 2013

Study Start

December 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2016

Last Updated

February 11, 2015

Record last verified: 2015-02

Locations

KR(1)