Prevention of Pelvic Lymphocele by Floseal During Pelvic... | NCT01974193

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

NCT01974193

Sponsor

Ewha Womans University Mokdong Hospital

Status

Unknown status

Last Update Posted

Feb 11, 2015Estimated

Enrollment

40Estimated

Phase

Phase 3

Conditions

Gynecologic Cancer

Interventions

Floseal

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2013

Primary Completion Date

Dec 2015Estimated

Completion Date

Dec 2016Estimated

First Submitted Date

Oct 28, 2013

First Submission Date that Met QC Criteria

Oct 31, 2013

First Posted Date

Nov 1, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 10, 2015

Last Update Posted Date

Feb 11, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yun Hwan KIM, Assistant Professor, Ewha Womans University Mokdong HospitalPrincipal Investigator

Lead Sponsor

Ewha Womans University Mokdong HospitalOTHER

Collaborators

Name	Class
Baxter Healthcare Corporation	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Floseal	Drug	application of floseal on intervention arm	Floseal

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Gynecologic cancer patients who need laparotomic bilateral PLND

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yun Hwan Kim, Dr	Contact	+82-10-9096-7875		medok74@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ewha Womans University Mokdong Hospital	Recruiting	Seoul		158-710	South Korea

Type	Date	Date Unknown
Release	Jul 26, 2022
Reset	Jun 29, 2023

Submission Tracking

Estimated Results First Submitted Date

Jul 26, 2022

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jul 26, 2022			Jun 29, 2023

Intervention Browse Module

MeSH Terms

ID	Term
C411004	FloSeal Matrix

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided