Prostate or Bladder Cancer Clinical Trial
Official title:
Effect of TachoSil® on Incidence of Symptomatic and Radiographic Lymphoceles After Extended Pelvic Lymph Node Dissection in Prostate and Bladder Cancer.
| Verified date | August 2017 |
| Source | University Hospital, Ghent |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 200 |
| Est. completion date | August 2017 |
| Est. primary completion date | February 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 99 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Ghent University Hospital | Ghent |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Ghent | Takeda |
Belgium,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | development of a radiographic lymphocele on abdominal ultrasonography | at week 1 post-surgery | ||
| Primary | volume of radiographic lymphoceles | at week 1 post-surgery | ||
| Primary | duration of postoperative drainage catheter | Daily during standard postoperative care until removal of the catheter, with an expected average of 1 day. | ||
| Primary | volume produced by postoperative drainage catheter (lymphorrhea) | Daily during standard postoperative care until removal of the drain, with an expected average of 1 day. | ||
| Primary | 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. | |
| Primary | development of a radiographic lymphocele on abdominal ultrasonography | at week 4 post-surgery | ||
| Primary | volume of radiographic lymphoceles | at week 4 post-surgery | ||
| Secondary | development of a symptomatic lymphocele. | at week 1 post-surgery | ||
| Secondary | decrease in serum hemoglobin on the first postoperative day | at week 1 post-surgery | ||
| Secondary | duration of hospital stay | at week 1 post-surgery | ||
| Secondary | total cost | Total cost includes: surgical procedure, hospitalization and possible complications up to the first month post-surgery. | at week 1 post-surgery | |
| Secondary | development of a symptomatic lymphocele. | at week 4 post-surgery | ||
| Secondary | decrease in serum hemoglobin on the first postoperative day | at week 4 post-surgery | ||
| Secondary | duration of hospital stay | at week 4 post-surgery | ||
| Secondary | total cost | Total cost includes: surgical procedure, hospitalization and possible complications up to the first month post-surgery. | at week 4 post-surgery |