Back to resultsEffect of TachoSil® on Incidence of Symptomatic and Radiographic Lymphoceles After Extended Pelvic Lymph Node Dissection in Prostate and Bladder Cancer.
Primary Purpose
Prostate or Bladder Cancer
Status
Completed
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
1 TachoSil hemostatic sponge (9,5 cm x 4,8 cm) placed on each side on the external iliac artery.
Sponsored by
About this trial
This is an interventional prevention trial for Prostate or Bladder Cancer focused on measuring patients,, undergoing, pelvic, lymph, node, dissection.
Eligibility 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.
Sites / Locations
- Ghent University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
TachoSil
No TachoSil
Arm Description
TachoSil
No TachoSil
Outcomes
Primary Outcome Measures
development of a radiographic lymphocele on abdominal ultrasonography
volume of radiographic lymphoceles
duration of postoperative drainage catheter
volume produced by postoperative drainage catheter (lymphorrhea)
time between operation and first flatus, first peristalsis, first passing of stool and removal of gastrostomy tube (signs of ileus recuperation).
specific for bladder cancer
development of a radiographic lymphocele on abdominal ultrasonography
volume of radiographic lymphoceles
Secondary Outcome Measures
development of a symptomatic lymphocele.
decrease in serum hemoglobin on the first postoperative day
duration of hospital stay
total cost
Total cost includes: surgical procedure, hospitalization and possible complications up to the first month post-surgery.
development of a symptomatic lymphocele.
decrease in serum hemoglobin on the first postoperative day
duration of hospital stay
total cost
Total cost includes: surgical procedure, hospitalization and possible complications up to the first month post-surgery.
Full Information
NCT ID
NCT02001857
First Posted
October 28, 2013
Last Updated
August 24, 2017
Sponsor
University Hospital, Ghent
Collaborators
Takeda
1. Study Identification
Unique Protocol Identification Number
NCT02001857
Brief Title
Effect of TachoSil® on Incidence of Symptomatic and Radiographic Lymphoceles After Extended Pelvic Lymph Node Dissection in Prostate and Bladder Cancer.
Official Title
Effect of TachoSil® on Incidence of Symptomatic and Radiographic Lymphoceles After Extended Pelvic Lymph Node Dissection in Prostate and Bladder Cancer.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
August 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
Collaborators
Takeda
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate or Bladder Cancer
Keywords
patients,, undergoing, pelvic, lymph, node, dissection.
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TachoSil
Arm Type
Experimental
Arm Description
TachoSil
Arm Title
No TachoSil
Arm Type
No Intervention
Arm Description
No TachoSil
Intervention Type
Drug
Intervention Name(s)
1 TachoSil hemostatic sponge (9,5 cm x 4,8 cm) placed on each side on the external iliac artery.
Intervention Description
at the end of surgery
Primary Outcome Measure Information:
Title
development of a radiographic lymphocele on abdominal ultrasonography
Time Frame
at week 1 post-surgery
Title
volume of radiographic lymphoceles
Time Frame
at week 1 post-surgery
Title
duration of postoperative drainage catheter
Time Frame
Daily during standard postoperative care until removal of the catheter, with an expected average of 1 day.
Title
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.
Title
time between operation and first flatus, first peristalsis, first passing of stool and removal of gastrostomy tube (signs of ileus recuperation).
Description
specific for bladder cancer
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.
Title
development of a radiographic lymphocele on abdominal ultrasonography
Time Frame
at week 4 post-surgery
Title
volume of radiographic lymphoceles
Time Frame
at week 4 post-surgery
Secondary Outcome Measure Information:
Title
development of a symptomatic lymphocele.
Time Frame
at week 1 post-surgery
Title
decrease in serum hemoglobin on the first postoperative day
Time Frame
at week 1 post-surgery
Title
duration of hospital stay
Time Frame
at week 1 post-surgery
Title
total cost
Description
Total cost includes: surgical procedure, hospitalization and possible complications up to the first month post-surgery.
Time Frame
at week 1 post-surgery
Title
development of a symptomatic lymphocele.
Time Frame
at week 4 post-surgery
Title
decrease in serum hemoglobin on the first postoperative day
Time Frame
at week 4 post-surgery
Title
duration of hospital stay
Time Frame
at week 4 post-surgery
Title
total cost
Description
Total cost includes: surgical procedure, hospitalization and possible complications up to the first month post-surgery.
Time Frame
at week 4 post-surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolaas Lumen, MD, PhD, FEBU
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ghent University Hospital
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
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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