Ignite Creation Date:
2025-12-24 @ 6:36 PM
Ignite Modification Date:
2026-01-22 @ 2:11 AM
Study NCT ID:
NCT02001857
Status:
COMPLETED
Last Update Posted:
2017-08-25
First Post:
2013-10-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of TachoSil® on Incidence of Symptomatic and Radiographic Lymphoceles After Extended Pelvic Lymph Node Dissection in Prostate and Bladder Cancer.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-24', 'studyFirstSubmitDate': '2013-10-28', 'studyFirstSubmitQcDate': '2013-11-28', 'lastUpdatePostDateStruct': {'date': '2017-08-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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.', 'description': 'specific for bladder cancer'}, {'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'}], 'secondaryOutcomes': [{'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', 'description': 'Total cost includes: surgical procedure, hospitalization and possible complications up to the first month 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', 'description': 'Total cost includes: surgical procedure, hospitalization and possible complications up to the first month post-surgery.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['patients,', 'undergoing', 'pelvic', 'lymph', 'node', 'dissection.'], 'conditions': ['Prostate or Bladder Cancer']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years old\n* Diagnosis of prostate cancer or bladder cancer on pathology\n* Undergoing transperitoneal pelvic lymph node dissection.\n\nExclusion Criteria:\n\n* Previous pelvic surgery or irradiation.\n* Any type of clotting disorder.'}, 'identificationModule': {'nctId': 'NCT02001857', 'briefTitle': 'Effect of TachoSil® on Incidence of Symptomatic and Radiographic Lymphoceles After Extended Pelvic Lymph Node Dissection in Prostate and Bladder Cancer.', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Ghent'}, 'officialTitle': 'Effect of TachoSil® on Incidence of Symptomatic and Radiographic Lymphoceles After Extended Pelvic Lymph Node Dissection in Prostate and Bladder Cancer.', 'orgStudyIdInfo': {'id': 'EC/2013/472'}, 'secondaryIdInfos': [{'id': '2013-000782-36', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TachoSil', 'description': 'TachoSil', 'interventionNames': ['Drug: 1 TachoSil hemostatic sponge (9,5 cm x 4,8 cm) placed on each side on the external iliac artery.']}, {'type': 'NO_INTERVENTION', 'label': 'No TachoSil', 'description': 'No TachoSil'}], 'interventions': [{'name': '1 TachoSil hemostatic sponge (9,5 cm x 4,8 cm) placed on each side on the external iliac artery.', 'type': 'DRUG', 'description': 'at the end of surgery', 'armGroupLabels': ['TachoSil']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'Ghent University Hospital', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}], 'overallOfficials': [{'name': 'Nicolaas Lumen, MD, PhD, FEBU', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Ghent'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Ghent', 'class': 'OTHER'}, 'collaborators': [{'name': 'Takeda', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}