Ignite Creation Date:
2025-12-25 @ 1:17 AM
Ignite Modification Date:
2025-12-27 @ 1:44 AM
Study NCT ID:
NCT01974193
Status:
UNKNOWN
Last Update Posted:
2015-02-11
First Post:
2013-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevention of Pelvic Lymphocele by Floseal During Pelvic Lymphadenectomy for Gynecologic Cancer
Sponsor:
Ewha Womans University Mokdong Hospital
Organization:
Study Overview
Official Title:
Prevention of Pelvic Lymphocele by Floseal During Pelvic Lymphadenectomy for Gynecologic Cancer: a Pilot Study
Status:
UNKNOWN
Status Verified Date:
2015-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: