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

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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.

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.

Study Type

Interventional

Primary Outcome

Frequency of pelvic lymphocele

Secondary Outcome

 Volume of radiographic lymphoceles

Condition

Lymphocele

Intervention

Thrombi-Gel

Study Arms / Comparison Groups

 Conventional pelvic lymphadenectomy
Description:  Conventional pelvic lymphadenectomy

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

72

Start Date

December 20, 2019

Completion Date

July 2, 2020

Primary Completion Date

July 1, 2020

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

Gender

Female

Ages

18 Years - 90 Years

Accepts Healthy Volunteers

No

Contacts

Şener Gezer, M.D, ,

Location Countries

Turkey

Location Countries

Turkey

Administrative Informations

NCT ID

NCT04205864

Organization ID

KIA 2019/93

Responsible Party

Principal Investigator

Study Sponsor

Kocaeli University

Study Sponsor

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

Verification Date

July 2020