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

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ClinicalTrials.gov Identifier: NCT02001857
Recruitment Status : Completed
First Posted : December 5, 2013
Last Update Posted : August 25, 2017
Sponsor:
Collaborator:
Takeda
Information provided by (Responsible Party):
University Hospital, Ghent

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Prostate or Bladder Cancer Drug: 1 TachoSil hemostatic sponge (9,5 cm x 4,8 cm) placed on each side on the external iliac artery. Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of TachoSil® on Incidence of Symptomatic and Radiographic Lymphoceles After Extended Pelvic Lymph Node Dissection in Prostate and Bladder Cancer.
Study Start Date : September 2013
Actual Primary Completion Date : February 2017
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer
Drug Information available for: TachoSil

Arm Intervention/treatment
Experimental: TachoSil
TachoSil
Drug: 1 TachoSil hemostatic sponge (9,5 cm x 4,8 cm) placed on each side on the external iliac artery.
at the end of surgery

No Intervention: No TachoSil
No TachoSil



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02001857


Locations
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Belgium
Ghent University Hospital
Ghent, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
Takeda
Investigators
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Principal Investigator: Nicolaas Lumen, MD, PhD, FEBU University Hospital, Ghent

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Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT02001857    
Other Study ID Numbers: EC/2013/472
2013-000782-36 ( EudraCT Number )
First Posted: December 5, 2013    Key Record Dates
Last Update Posted: August 25, 2017
Last Verified: August 2017
Keywords provided by University Hospital, Ghent:
patients,
undergoing
pelvic
lymph
node
dissection.
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Lymphocele
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Cysts
Lymphatic Diseases
Hemostatics
Coagulants