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

July 2, 2020 updated by: Şener Gezer, Kocaeli University
To compare the incidence of lymphocele in Endometrial cancer patients with thrombin gel matrix used and not used during pelvic lymph node dissection.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Kocaeli, Turkey, 41380
        • Kocaeli University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 88 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventional pelvic lymphadenectomy
Procedure: Conventional Pelvic lymphadenectomy
Conventional Pelvic lymphadenectomy
Experimental: Thrombin gel matrix pelvic lymphadenectomy
Thrombin gel matrix applicated after conventional pelvic lymphadenectomy
Drug: Thrombi-Gel
Thrombin gel Matrix applied on pelvic lymphadenectomy areas after lympadenectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of pelvic lymphocele
Time Frame: post-operative 2th month
Frequency pelvic lymphocele at post-operative 2th month
post-operative 2th month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Volume of radiographic lymphoceles
Time Frame: post-operative 2th month
Volume of lymphocele detected with radiographic imagining at post-operative 2th month (the two largest dimensions measured in centimetres)
post-operative 2th month
duration of postoperative drainage catheter
Time Frame: up to post-operative 1 week
duration of postoperative drainage catheter
up to post-operative 1 week
Postoperative drain amount (ml: milliliters)
Time Frame: with 1 weeks after surgery
Postoperative drain amount (ml: milliliters)
with 1 weeks after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kocaeli University

Investigators

  • Principal Investigator: Şener Gezer, M.D, Kocaeli University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 20, 2019

Primary Completion (Actual)

July 1, 2020

Study Completion (Actual)

July 2, 2020

Study Registration Dates

First Submitted

December 13, 2019

First Submitted That Met QC Criteria

December 19, 2019

First Posted (Actual)

December 20, 2019

Study Record Updates

Last Update Posted (Actual)

July 7, 2020

Last Update Submitted That Met QC Criteria

July 2, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KIA 2019/93

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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