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

Endometrium Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04205864
• Other study ID #: KIA 2019/93
• Status: Completed
• Phase: N/A
• Start date: December 20, 2019
• Est. completion date: July 2, 2020

Study information

• Verified date: July 2020
• Source: Kocaeli University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: July 2, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometrial Neoplasms
• Endometrium Cancer
• Lymphocele
• Lymphocele After Surgical Procedure

Intervention

Drug:
• Thrombi-Gel
Thrombin gel Matrix applied on pelvic lymphadenectomy areas after lympadenectomy

Procedure:
• Conventional Pelvic lymphadenectomy
Conventional Pelvic lymphadenectomy

Locations

Country	Name	City	State
Turkey	Kocaeli University	Kocaeli

Sponsors (1)

Lead Sponsor	Collaborator
Kocaeli University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Kim YH, Shin HJ, Ju W, Kim SC. Prevention of lymphocele by using gelatin-thrombin matrix as a tissue sealant after pelvic lymphadenectomy in patients with gynecologic cancers: a prospective randomized controlled study. J Gynecol Oncol. 2017 May;28(3):e37. doi: 10.3802/jgo.2017.28.e37. Epub 2017 Feb 28. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of pelvic lymphocele	Frequency pelvic lymphocele at post-operative 2th month	post-operative 2th month
Secondary	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
Secondary	duration of postoperative drainage catheter	duration of postoperative drainage catheter	up to post-operative 1 week
Secondary	Postoperative drain amount (ml: milliliters)	Postoperative drain amount (ml: milliliters)	with 1 weeks after surgery