Efficacy Study of FloSeal for Prevention of Lymphocele After Lymphadenectomy for Gynecologic Cancer

NCT01679483 | Completed

• 1 other identifier: FloSeal-LND
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the incidence of lymphocele and lymphatic ascites between patient who use versus who do not use FloSeal during lymph node dissection

Conditions

Gynecologic Cancer; Cervical Cancer; Endometrial Cancer; Ovarian Cancer; Fallopian Tubal Cancer

Outcome Measures

Primary Outcomes (1)

• Incidence of lymphocele an lymphatic ascites

  within 1 year after surgery

Secondary Outcomes (7)

• Time interval from surgery to removal of closed drain system

  with 2 weeks after surgery

• Postoperative drain amount

  with 2 weeks after surgery

• Postoperative hospital stay

  within 2 weeks after surgery

• Postoperative bleeding incidence

  within 2 weeks after surgery

• Postoperative complication incidence

  within 1 month after surgery

Study Arms (2)

FloSeal group

EXPERIMENTAL

This group will undergo appropriate cancer surgery for each patient with pelvic lymph node dissection +/- para-aortic lymph node dissection. At the completion of lymph node dissection, 2 vials of Floseal will be applied to each lymph node area.

Drug: FloSeal application

No FloSeal group

NO INTERVENTION

All surgical procedures of control group is the same with study group except that Floseal is not applicated in control group.

Interventions

FloSeal application DRUG

At the completion of lymph node dissection, 2 vials of Floseal will be applied to each lymph node area.

FloSeal group

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed primary cancer of the uterine cervix, uterine corpus, ovary, and fallopian tube
• FIGO stage Cervical cancer: FIOG stage IA2-IIA2 Uterine cancer: FIGO stage I-III Ovarian and fallopian tubal cancer: FIGO stage I-IIIB
• Patients who undergoing surgery including pelvic and/or para-aortic lymph node dissection
• Patients with adequate bone marrow, renal and hepatic function:
• WBC \> 3,000 cells/mcl Platelets \>100,000/mcl Creatinine \<2.0 mg/dL Bilirubin \<1.5 x normal and SGOT or SGPT \<3 x normal
• American Society of Anesthesiology Physical Status 0-1
• Performance status of ECOG 0-2
• Patient must be suitable candidates for surgery
• Patients who have signed an approved Informed Consent

You may not qualify if:

• Patients with a history of pelvic or abdominal radiotherapy;
• Patients who are pregnant
• Patients with contraindications to surgery;
• Patients who are unfit for Surgery: serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator);
• Patient's compliance and geographic proximity that do not allow adequate follow-up.
• Patients who undergo only lymph node sampling

Sponsors & Collaborators

• Asan Medical Center: lead
• Baxter Healthcare Corporation: collaborator

Study Sites (1)

Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center

Seoul, 138-736, South Korea

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Endometrial Neoplasms; Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Joo-Hyun Nam, M.D., Ph.D.

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 3, 2012
• First Posted: September 6, 2012
• Study Start: September 1, 2012
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: May 31, 2017

Record last verified: 2017-05

Locations

KR (1)