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

Study Overview
=================
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.

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

Conditions
-----------------
Lymphocele, Lymphocele After Surgical Procedure, Endometrium Cancer

Intervention / Treatment
-----------------
* Drug: Thrombi-Gel
* Procedure: Conventional Pelvic lymphadenectomy


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Application of Thrombin gel matrix after Pelvic lymphadenectomy. And compare this application with Conventional Pelvic Lymphadenectomy.
Masking: Double


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of pelvic lymphocele | 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 | 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 | duration of postoperative drainage catheter | up to post-operative 1 week | 
| Postoperative drain amount (ml: milliliters) | Postoperative drain amount (ml: milliliters) | with 1 weeks after surgery |