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Completed

NCT Number: NCT04205864

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

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

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Key information

Conditions

Lymphocele Cysts Endometrial Neoplasms Endometrium Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Hemic and Lymphatic Diseases Lymphatic Diseases Lymphocele After Surgical Procedure Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year–90 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kocaeli University

Kocaeli, 41380, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Thrombi-Gel

Drug

Thrombin gel Matrix applied on pelvic lymphadenectomy areas after lympadenectomy

Conventional Pelvic lymphadenectomy

Procedure

Conventional Pelvic lymphadenectomy

Primary outcomes

  1. Frequency of pelvic lymphocele

    Time frame: post-operative 2th month

    Frequency pelvic lymphocele at post-operative 2th month

Secondary outcomes

  1. Volume of radiographic lymphoceles

    Time frame: post-operative 2th month

    Volume of lymphocele detected with radiographic imagining at post-operative 2th month (the two largest dimensions measured in centimetres)

  2. duration of postoperative drainage catheter

    Time frame: up to post-operative 1 week

    duration of postoperative drainage catheter

  3. Postoperative drain amount (ml: milliliters)

    Time frame: with 1 weeks after surgery

    Postoperative drain amount (ml: milliliters)

Sponsors and collaborators

Lead sponsor

Kocaeli University

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 20, 2019
Registry last updated
Jul 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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