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

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Pre-operative Studies for Prediction of Lymph Nodes Involvement in Endometrial Cancer Patients Crizotinib in c-MET Mutation Metastatic/Recurrent/Persistent Endometrial Cancer Thunderbeat Technology vs Standard Bipolar Electro-surgery in Total Laparoscopic Hysterectomy With Pelvic Lymphadenectomy for Endometrial Cancer Liposomal Doxorubicin in Treating Patients With Advanced or Recurrent Endometrial Cancer Evaluation of the Molecular Effects of Metformin on the Endometrium in Patients With Endometrial Cancer Study of Niraparib and TSR-042 in Recurrent Endometrial Cancer Endometrial Cancer – LOHP Alone and With 5FU Exemestane in Advanced and Recurrent Endometrial Carcinoma SLNM in Endometrial Cancer Combined With OSNA FESPET Study: Female EStrogen recePtor in Endometrial Cancer Treatment Gemcitabine and Cisplatin for Advanced or Recurrent Endometrial Cancer A Pre-Op Window Study Evaluating Anti-Proliferative Effects of Atorvastatin on the Endometrium the Effectiveness of a Weight Management Program in Patients Who Have Completed Treatment for Endometrial Cancer Preoperative Window Study of Metformin for the Treatment of Endometrial Cancer Intravenous Weekly Topotecan In Subjects With Recurrent Or Persistent Endometrial Cancer Endometrial Cancer Biomarker Changes Following Exposure to Metformin Letrozole and RAD001 With Advanced or Recurrent Endometrial Cancer Neoadjuvant Celecoxib in Newly Diagnosed Patients With Endometrial Carcinoma Safety and Efficacy of Metronomic Cyclophosphamide, Metformin and Olaparib in Endometrial Cancer Patients Oxaliplatin in Treating Patients With Persistent or Recurrent Endometrial Cancer Flavopiridol in Treating Patients With Recurrent or Persistent Endometrial Cancer Irofulven in Treating Patients With Persistent or Recurrent, Refractory Endometrial Cancer Role of Uterine Manipulator in Hysterectomy – Ro.Man.HY TREC Lifestyle Beyond Cancer Study in Endometrial Cancer Survivors Mirena® ± Metformin as Fertility-preserving Treatment for Young Asian Women With Early Endometrial Cancer Lifestyle Change and Quality of Life in Obese Patients With Stage I/II Endometrial Cancer in Remission Compare the Performance of Targeted Biopsy Versus Aspiration Biopsy With a Pipette for the Diagnosis of Endometrial Cancer External-Beam Radiation Therapy Compared With Vaginal Brachytherapy After Surgery for Stage I Endometrial Cancer Cost-utility of Ambulatory Surgery in the Management of Endometrial Cancer(AMBU-ENDO) Phase II Study of Atezolizumab + Bevacizumab in Endometrial Cancer Aminopterin in Treating Patients With Recurrent or Refractory Endometrial Cancer Doxorubicin and Cisplatin With or Without Paclitaxel in Treating Patients With Locally Advanced, Metastatic, and/or Relapsed Endometrial Cancer Endometrial Cancer and Robotic-assisted Versus Traditional Laparoscopy Letrozole in Treating Women With Recurrent or Metastatic Endometrial Cancer Epidemiological Analysis on Endometrial Cancer in Guangdong Province of China Window of Opportunity Study of Pembrolizumab in Early Stage, High Grade Obesity-driven Endometrial Cancer Study of LY3023414 for the Treatment of Recurrent or Persistent Endometrial Cancer Doxorubicin, Paclitaxel, and Carboplatin in Treating Patients With Primary Stage III, Stage IV, or Recurrent Endometrial Cancer Prospective, Observational Study of Low-risk Criteria for Node Metastasis in Endometrial Cancer A Safety and Efficacy of CCRT With Paclitaxel as Adjuvant Therapy to Post-Operative Advanced Endometrial Cancer Patients VIrtual REality Glasses for the Enhancement of Acute BRACHYtherapy Tolerance for Endometrial Cancer Patients. Abemaciclib With Letrozole in Recurrent or Persistent Endometrial Cancer Feasibility Study of Laparoendoscopic Single Site Surgical Staging for Endometrial Cancer Photoacoustic Endoscopy in Endometrial Cancer RAD001 in Recurrent Endometrial Cancer Patients Carboplatin, Paclitaxel With or Without Avelumab in Advanced or Recurrent Endometrial Cancer Everolimus in Treating Patients With Relapsed or Metastatic Endometrial Cancer Psychosocial Benefits of Exercise in Endometrial Cancer Survivors Evaluating the Effect of Perioperative Caloric Restriction Program on Perioperative Outcomes in Patients With Obesity and Endometrial Cancer Letrozole in the Treatment of Advanced or Recurrent Hormone Receptor Positive Endometrial Cancer A Study of Dostarlimab (TSR-042) Plus Carboplatin-paclitaxel Versus Placebo Plus Carboplatin-paclitaxel in Patients With Recurrent or Primary Advanced Endometrial Cancer Selective Targeting of Adjuvant Therapy for Endometrial Cancer (STATEC) Scale Down for Endometrial Cancer Feasibility Study Using the Xoft System for the Treatment of Endometrial Cancer Phase III Study Comparing 3D Conformal Radiotherapy and Conformal Radiotherapy IMRT to Treat Endometrial Cancer Combination Chemotherapy Compared With Hormone Therapy in Treating Patients With Recurrent, Stage III, or Stage IV Endometrial Cancer Trial Between Two Follow up Regimens With Different Test Intensity in Endometrial Cancer Treated Patients GINECO-EN102b – BKM120 as Monotherapy in the Treatment of Initial or Recurrent Metastatic Endometrial Cancer Preliminary Study of Endometrial Hyperplasia Groundwork for a Study to Define Precursors of Endometrial Cancer Biomarkers in Tissue Samples From Patients With Stage I or Stage III Endometrial Cancer Intraoperative Pathological Evaluation for Surgical Treatment & Staging for Endometrial Cancer Patient’s Experience and Choice Between Investigations for Endometrial Cancer in Postmenopausal Bleeding Factors Affecting the Prognosis of Patients With Endometrial Cancer Anti-PD-1 Antibody Combined With Anlotinib in the Treatment of Endometrial Cancer 2D Versus 3D Radical Laparoscopic Hysterectomy for Endometrial Cancer: a Prospective Randomized Trial Risk Factors for Endometrial Cancer in Black Women Retrospective Study to Evaluate the Feasibility of Ovarian Preservation in Patients With Endometrial Carcinoma Sexual Functioning in Endometrial Cancer An Endometrial Cancer Study for Women With Recurrent or Persistent Endometrial Cancer A Randomized, Controlled, Comparative Study of a Levonorgestrel Intrauterine System for the Prevention of Endometrial Cancer in Patients Aged 40-50 With BMI Greater Than 35 Molecular Staging of Endometrial Cancer Danazol in Treating Patients With Advanced or Recurrent Endometrial Cancer Evaluation of Mirvetuximab Soravtansine (IMGN853) in Women With Folate Receptor-α Positive Endometrial Cancer Hormone Therapy With Arzoxifene Hydrochloride in Treating Women With Recurrent, Advanced, or Metastatic Endometrial Cancer Sentinel Node Mapping in High Risk Endometrial Cancer Cytologic Analysis of Distention Media as a Screening Test for Endometrial Cancer Selective Surgical Staging for the Treatment of Endometrial Cancer Based on Intraoperative Consultation Can 3D Ultrasound be Used as an Alternative to MRI to Assess Myometrial Invasion in 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