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

Phase 3

• Conditions: Gynecologic Cancer
• Interventions: Drug: Floseal

• Registration Number: NCT01974193
• Lead Sponsor: Ewha Womans University Mokdong Hospital

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 available

Study Timeline

• Study First Submitted: 2013-10-28
• Study First Submitted QC: 2013-10-31
• Study First Posted: 2013-11-01
• Study Start: 2013-12
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-10
• Last Update Posted: 2015-02-11
• Primary Completion: 2015-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• Gynecologic cancer patients who need laparotomic bilateral PLND

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Floseal	Floseal	application of floseal to one side of pelvis after pelvic lymphadenectomy

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Post-operative drainage	post-operative 3 days	left and right post-operative drainage
lymphedema	post-operative 3 and 6 month	lymphedema symptoms and sign at post-operative 3 and 6 month

Trial Locations

Locations (1)

Ewha Womans University Mokdong Hospital; 🇰🇷 Seoul, Korea, Republic of