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NCT Number: NCT02001857

Effect of TachoSil® on Incidence of Symptomatic and Radiographic Lymphoceles After Extended Pelvic Lymph Node Dissection in Prostate and Bladder Cancer.

Pelvic lymph node dissection (PLND) is the most accurate staging tool to determine lymph node involvement in prostate and bladder cancer. The main complication of PLND is development of a lymphocele, which can cause symptoms including lower abdominal pain, leg or penile/scrotal edema, bladder outlet obstruction, deep venous thrombosis or infection/sepsis. The incidence of radiographic (asymptomatic) and symptomatic lymphoceles following PLND varies between 12,6-63% and 1,6-33% respectively. Medicated sponges such as Tachosil® are indicated in surgery for improvement of haemostasis and to promote tissue sealing. They could reduce lymphocele development by increased tissue sealing, due to a mechanical effect of the sponge itself and a lymphostatic effect of the included thrombin and fibrinogen. Our goal is to prospectively assess the lymphostatic effect of Tachosil(r) in patients undergoing transperitoneal PLND with or without radical prostatectomy or PLND with bladder cancer surgery.

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Key information

Conditions

Prostate or Bladder Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Site Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ghent University Hospital

Ghent, 9000, Belgium

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age > 18 years old
  • Diagnosis of prostate cancer or bladder cancer on pathology
  • Undergoing transperitoneal pelvic lymph node dissection.

Exclusion criteria

  • Previous pelvic surgery or irradiation.
  • Any type of clotting disorder.

Treatment and study plan

1 TachoSil hemostatic sponge (9,5 cm x 4,8 cm) placed on each side on the external iliac artery.

Drug

at the end of surgery

Primary outcomes

  1. development of a radiographic lymphocele on abdominal ultrasonography

    Time frame: at week 1 post-surgery

  2. volume of radiographic lymphoceles

    Time frame: at week 1 post-surgery

  3. duration of postoperative drainage catheter

    Time frame: Daily during standard postoperative care until removal of the catheter, with an expected average of 1 day.

  4. volume produced by postoperative drainage catheter (lymphorrhea)

    Time frame: Daily during standard postoperative care until removal of the drain, with an expected average of 1 day.

  5. time between operation and first flatus, first peristalsis, first passing of stool and removal of gastrostomy tube (signs of ileus recuperation).

    Time frame: Daily during standard postoperative care up to date of first flatus, first peristalsis, first passing of stool and removal of gastrostomy tube (signs of ileus recuperation), with an expected average of 1 day.

    specific for bladder cancer

  6. development of a radiographic lymphocele on abdominal ultrasonography

    Time frame: at week 4 post-surgery

  7. volume of radiographic lymphoceles

    Time frame: at week 4 post-surgery

Secondary outcomes

  1. development of a symptomatic lymphocele.

    Time frame: at week 1 post-surgery

  2. decrease in serum hemoglobin on the first postoperative day

    Time frame: at week 1 post-surgery

  3. duration of hospital stay

    Time frame: at week 1 post-surgery

  4. total cost

    Time frame: at week 1 post-surgery

    Total cost includes: surgical procedure, hospitalization and possible complications up to the first month post-surgery.

  5. development of a symptomatic lymphocele.

    Time frame: at week 4 post-surgery

  6. decrease in serum hemoglobin on the first postoperative day

    Time frame: at week 4 post-surgery

  7. duration of hospital stay

    Time frame: at week 4 post-surgery

  8. total cost

    Time frame: at week 4 post-surgery

    Total cost includes: surgical procedure, hospitalization and possible complications up to the first month post-surgery.

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

  • Takeda

Registry information

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Dec 5, 2013
Registry last updated
Aug 25, 2017

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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