Application of Thrombin Gel Matrix for the Prevention of Lymphocele in Patients With Endometrial Cancer.

NCT04205864 | Completed

• 1 other identifier: KIA 2019/93
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the incidence of lymphocele in Endometrial cancer patients with thrombin gel matrix used and not used during pelvic lymph node dissection.

Conditions

Lymphocele; Lymphocele After Surgical Procedure; Endometrium Cancer

Outcome Measures

Primary Outcomes (1)

• Frequency of pelvic lymphocele

  Frequency pelvic lymphocele at post-operative 2th month

  post-operative 2th month

Secondary Outcomes (3)

• Volume of radiographic lymphoceles

  post-operative 2th month

• duration of postoperative drainage catheter

  up to post-operative 1 week

• Postoperative drain amount (ml: milliliters)

  with 1 weeks after surgery

Study Arms (2)

Conventional pelvic lymphadenectomy

ACTIVE COMPARATOR

Conventional pelvic lymphadenectomy

Procedure: Conventional Pelvic lymphadenectomy

Thrombin gel matrix pelvic lymphadenectomy

EXPERIMENTAL

Thrombin gel matrix applicated after conventional pelvic lymphadenectomy

Drug: Thrombi-Gel

Interventions

Thrombi-Gel DRUG

Thrombin gel Matrix applied on pelvic lymphadenectomy areas after lympadenectomy

Thrombin gel matrix pelvic lymphadenectomy

Conventional Pelvic lymphadenectomy PROCEDURE

Conventional Pelvic lymphadenectomy

Conventional pelvic lymphadenectomy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Gender Eligibility Details: Women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Endometrial cancer patients who need laparotomic bilateral PLND
• Patients suitable for surgery

You may not qualify if:

• Previous pelvic surgery
• Previous Chemotherapy or Radiotherapy
• Patients who undergo only lymph node sampling
• Patients who have not signed Informed Consent

Sponsors & Collaborators

• Kocaeli University: lead

Study Sites (1)

Kocaeli University

Kocaeli, 41380, Turkey (Türkiye)

Location

Related Publications (1)

• Kim YH, Shin HJ, Ju W, Kim SC. Prevention of lymphocele by using gelatin-thrombin matrix as a tissue sealant after pelvic lymphadenectomy in patients with gynecologic cancers: a prospective randomized controlled study. J Gynecol Oncol. 2017 May;28(3):e37. doi: 10.3802/jgo.2017.28.e37. Epub 2017 Feb 28.

  PMID: 28382800 BACKGROUND

MeSH Terms

Conditions

Lymphocele; Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Cysts; Neoplasms; Lymphatic Diseases; Hemic and Lymphatic Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Şener Gezer, M.D

  Kocaeli University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Application of Thrombin gel matrix after Pelvic lymphadenectomy. And compare this application with Conventional Pelvic Lymphadenectomy.

Study Record Dates

• First Submitted: December 13, 2019
• First Posted: December 20, 2019
• Study Start: December 20, 2019
• Primary Completion: July 1, 2020
• Study Completion: July 2, 2020
• Last Updated: July 7, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)