Endometrium Cancer, Lymphocele, Lymphocele After Surgical Procedure
Conditions
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.
Interventions
DRUGThrombi-Gel
Thrombin gel Matrix applied on pelvic lymphadenectomy areas after lympadenectomy
PROCEDUREConventional Pelvic lymphadenectomy
Conventional Pelvic lymphadenectomy
Sponsors
Kocaeli University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Application of Thrombin gel matrix after Pelvic lymphadenectomy. And compare this application with Conventional Pelvic Lymphadenectomy.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of pelvic lymphocele | post-operative 2th month | Frequency pelvic lymphocele at post-operative 2th month |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Volume of radiographic lymphoceles | post-operative 2th month | Volume of lymphocele detected with radiographic imagining at post-operative 2th month (the two largest dimensions measured in centimetres) |
| duration of postoperative drainage catheter | up to post-operative 1 week | duration of postoperative drainage catheter |
| Postoperative drain amount (ml: milliliters) | with 1 weeks after surgery | Postoperative drain amount (ml: milliliters) |
Countries
Turkey (Türkiye)
Outcome results
None listed