Clinical trial NCT02001857: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Prostate or Bladder Cancer
Keywords: patients,
undergoing
pelvic
lymph
node
dissection.
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: Takeda
First posted: 2013-12-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: development of a radiographic lymphocele on abdominal ultrasonography
timeFrame: at week 1 post-surgery
measure: volume of radiographic lymphoceles
timeFrame: at week 1 post-surgery
measure: duration of postoperative drainage catheter
timeFrame: Daily during standard postoperative care until removal of the catheter, with an expected average of 1 day.
measure: volume produced by postoperative drainage catheter (lymphorrhea)
timeFrame: Daily during standard postoperative care until removal of the drain, with an expected average of 1 day.
measure: time between operation and first flatus, first peristalsis, first passing of stool and removal of gastrostomy tube (signs of ileus recuperation).
timeFrame: 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.
measure: development of a radiographic lymphocele on abdominal ultrasonography
timeFrame: at week 4 post-surgery
measure: volume of radiographic lymphoceles
timeFrame: at week 4 post-surgery
Secondary outcomes:
measure: development of a symptomatic lymphocele.
timeFrame: at week 1 post-surgery
measure: decrease in serum hemoglobin on the first postoperative day
timeFrame: at week 1 post-surgery
measure: duration of hospital stay
timeFrame: at week 1 post-surgery
measure: total cost
timeFrame: at week 1 post-surgery
measure: development of a symptomatic lymphocele.
timeFrame: at week 4 post-surgery
measure: decrease in serum hemoglobin on the first postoperative day
timeFrame: at week 4 post-surgery
measure: duration of hospital stay
timeFrame: at week 4 post-surgery
measure: total cost
timeFrame: at week 4 post-surgery
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital
Study officials:
affiliation: University Hospital, Ghent
name: Nicolaas Lumen, MD, PhD, FEBU
role: PRINCIPAL_INVESTIGATOR
References: