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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04205864
Other study ID # KIA 2019/93
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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