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

Primary Purpose

Lymphocele, Lymphocele After Surgical Procedure, Endometrium Cancer

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Thrombi-Gel
Conventional Pelvic lymphadenectomy
Sponsored by
Kirsehir Ahi Evran University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Lymphocele

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Kocaeli University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional pelvic lymphadenectomy

Thrombin gel matrix pelvic lymphadenectomy

Arm Description

Conventional pelvic lymphadenectomy

Thrombin gel matrix applicated after conventional pelvic lymphadenectomy

Outcomes

Primary Outcome Measures

Frequency of pelvic lymphocele
Frequency pelvic lymphocele at post-operative 2th month

Secondary Outcome Measures

Volume of radiographic lymphoceles
Volume of lymphocele detected with radiographic imagining at post-operative 2th month (the two largest dimensions measured in centimetres)
duration of postoperative drainage catheter
duration of postoperative drainage catheter
Postoperative drain amount (ml: milliliters)
Postoperative drain amount (ml: milliliters)

Full Information

First Posted
December 13, 2019
Last Updated
July 2, 2020
Sponsor
Kirsehir Ahi Evran University
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1. Study Identification

Unique Protocol Identification Number
NCT04205864
Brief Title
Application of Thrombin Gel Matrix for the Prevention of Lymphocele in Patients With Endometrial Cancer.
Official Title
Application of Thrombin Gel Matrix for the Prevention of Lymphocele in Patients With Endometrial Cancer.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
December 20, 2019 (Actual)
Primary Completion Date
July 1, 2020 (Actual)
Study Completion Date
July 2, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kirsehir Ahi Evran University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
Pelvic lymph node dissection is the most accurate staging tool to determine lymph node involvement in endometrial cancer. Lymphoceles developed after surgery can cause serious morbidity, additional costs and delays in chemotherapy or radiotherapy. In this study, conventional pelvic lymphadenectomy will be compared with thrombin gel matrix application after pelvic lymphadenectomy. Our goal is to prospectively assess the lymphostatic effect of thrombin gel matrix in endometrial cancer patients undergoing pelvic lymph node dissection.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphocele, Lymphocele After Surgical Procedure, Endometrium Cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Application of Thrombin gel matrix after Pelvic lymphadenectomy. And compare this application with Conventional Pelvic Lymphadenectomy.
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional pelvic lymphadenectomy
Arm Type
Active Comparator
Arm Description
Conventional pelvic lymphadenectomy
Arm Title
Thrombin gel matrix pelvic lymphadenectomy
Arm Type
Experimental
Arm Description
Thrombin gel matrix applicated after conventional pelvic lymphadenectomy
Intervention Type
Drug
Intervention Name(s)
Thrombi-Gel
Intervention Description
Thrombin gel Matrix applied on pelvic lymphadenectomy areas after lympadenectomy
Intervention Type
Procedure
Intervention Name(s)
Conventional Pelvic lymphadenectomy
Intervention Description
Conventional Pelvic lymphadenectomy
Primary Outcome Measure Information:
Title
Frequency of pelvic lymphocele
Description
Frequency pelvic lymphocele at post-operative 2th month
Time Frame
post-operative 2th month
Secondary Outcome Measure Information:
Title
Volume of radiographic lymphoceles
Description
Volume of lymphocele detected with radiographic imagining at post-operative 2th month (the two largest dimensions measured in centimetres)
Time Frame
post-operative 2th month
Title
duration of postoperative drainage catheter
Description
duration of postoperative drainage catheter
Time Frame
up to post-operative 1 week
Title
Postoperative drain amount (ml: milliliters)
Description
Postoperative drain amount (ml: milliliters)
Time Frame
with 1 weeks after surgery

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Women
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Endometrial cancer patients who need laparotomic bilateral PLND Patients suitable for surgery Exclusion Criteria: Previous pelvic surgery Previous Chemotherapy or Radiotherapy Patients who undergo only lymph node sampling Patients who have not signed Informed Consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Şener Gezer, M.D
Organizational Affiliation
Kirsehir Ahi Evran University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kocaeli University
City
Kocaeli
ZIP/Postal Code
41380
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28382800
Citation
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.
Results Reference
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Application of Thrombin Gel Matrix for the Prevention of Lymphocele in Patients With Endometrial Cancer.

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