Clinical Trials Directory

Trials / Unknown

UnknownNCT01974193

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

Status
Unknown
Phase
Phase 3
Study type
Interventional
Enrollment
40 (estimated)
Sponsor
Ewha Womans University Mokdong Hospital · Academic / Other
Sex
Female
Age
20 Years – 80 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGFlosealapplication of floseal on intervention arm

Timeline

Start date
2013-12-01
Primary completion
2015-12-01
Completion
2016-12-01
First posted
2013-11-01
Last updated
2015-02-11

Locations

1 site across 1 country: South Korea

Source: ClinicalTrials.gov record NCT01974193. Inclusion in this directory is not an endorsement.