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