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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Prostate or Bladder Cancer

Intervention / Treatment
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* Drug: 1 TachoSil hemostatic sponge (9,5 cm x 4,8 cm) placed on each side on the external iliac artery.


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TachoSil<br>TachoSil | Drug: 1 TachoSil hemostatic sponge (9,5 cm x 4,8 cm) placed on each side on the external iliac artery.<br>* at the end of surgery<br>|
| No Intervention: No TachoSil<br>No TachoSil | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| development of a radiographic lymphocele on abdominal ultrasonography |  | at week 1 post-surgery | 
| volume of radiographic lymphoceles |  | at week 1 post-surgery | 
| duration of postoperative drainage catheter |  | Daily during standard postoperative care until removal of the catheter, with an expected average of 1 day. | 
| volume produced by postoperative drainage catheter (lymphorrhea) |  | Daily during standard postoperative care until removal of the drain, with an expected average of 1 day. | 
| 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 | 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. | 
| development of a radiographic lymphocele on abdominal ultrasonography |  | at week 4 post-surgery | 
| volume of radiographic lymphoceles |  | at week 4 post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| development of a symptomatic lymphocele. |  | at week 1 post-surgery | 
| decrease in serum hemoglobin on the first postoperative day |  | at week 1 post-surgery | 
| duration of hospital stay |  | at week 1 post-surgery | 
| total cost | Total cost includes: surgical procedure, hospitalization and possible complications up to the first month post-surgery. | at week 1 post-surgery | 
| development of a symptomatic lymphocele. |  | at week 4 post-surgery | 
| decrease in serum hemoglobin on the first postoperative day |  | at week 4 post-surgery | 
| duration of hospital stay |  | at week 4 post-surgery | 
| total cost | Total cost includes: surgical procedure, hospitalization and possible complications up to the first month post-surgery. | at week 4 post-surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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patients,, undergoing, pelvic, lymph, node, dissection.