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

Not Applicable

Completed

• Conditions: Lymphocele After Surgical Procedure; Endometrium Cancer; Lymphocele
• Interventions: Procedure: Conventional Pelvic lymphadenectomy; Drug: Thrombi-Gel

• Registration Number: NCT04205864
• Lead Sponsor: Kocaeli University

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 Timeline

• Study First Submitted: 2019-12-13
• Study First Submitted QC: 2019-12-19
• Study Start: 2019-12-20
• Study First Posted: 2019-12-20
• Status Verified: 2020-07
• Primary Completion: 2020-07-01
• Study Completion: 2020-07-02
• Last Update Submitted: 2020-07-02
• Last Update Posted: 2020-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional pelvic lymphadenectomy	Conventional Pelvic lymphadenectomy	Conventional pelvic lymphadenectomy
Thrombin gel matrix pelvic lymphadenectomy	Thrombi-Gel	Thrombin gel matrix applicated after conventional pelvic lymphadenectomy

Primary Outcome Measures

Name	Time	Method
Frequency of pelvic lymphocele	post-operative 2th month	Frequency pelvic lymphocele at post-operative 2th month

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Kocaeli University; 🇹🇷 Kocaeli, Turkey