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

Kocaeli University

Status: Completed

Conditions: Endometrium Cancer; Lymphocele; Lymphocele After Surgical Procedure

Treatments: Drug: Thrombi-Gel; Procedure: Conventional Pelvic lymphadenectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT04205864

KIA 2019/93

Details and patient eligibility

About

To compare the incidence of lymphocele in Endometrial cancer patients with thrombin gel matrix used and not used during pelvic lymph node dissection.

Full 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.

Enrollment: 72 patients

Sex: Female

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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72 participants in 2 patient groups

Conventional pelvic lymphadenectomy

Active Comparator group

Description:

Conventional pelvic lymphadenectomy

Treatment:

Procedure: Conventional Pelvic lymphadenectomy

Thrombin gel matrix pelvic lymphadenectomy

Experimental group

Description:

Thrombin gel matrix applicated after conventional pelvic lymphadenectomy

Treatment:

Drug: Thrombi-Gel