Clinical trial NCT01920958: Use of Tachosil® for Lymph Sealing During Surgery
Official title: Use of Tachosil® for Lymph Sealing During Surgery. A Non-Interventional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymph Node Resection
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2013-08-12
Enrollment: 233
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stationary patients in whom a lymph node resection was planned to be performed

Brief summary: The purpose of this study is to describe effectiveness and reliability of TachoSil® in lymph sealing after lymphadenectomy.

Detailed description: The aim of this non-interventional study (NIS) was to collect further knowledge on the routine use of TachoSil ® in lymph node surgery where its sealing property helps to reduce the rate of postoperative complications, especially of seroma formation. Some data are already available from gynecology, urology and thoracic surgery.

Eligibility criteria: Inclusion Criteria:

* Stationary patients undergoing lymph node resection.

Exclusion Criteria:

* Contraindications, such as hypersensitivity to the active pharmaceutical ingredient or to another ingredient.

Primary outcomes:
measure: Percentage of Participants With Post-Operative Seroma Formation Over Time as Determined at Hospital Discharge
timeFrame: Up to 50 Days
Secondary outcomes:
measure: Assessment of TachoSil® by the Surgeon With Respect to Handling Using a 10-Point Numerical Rating Scale
timeFrame: Peri- and post-surgery (Up to 50 Days)
measure: Assessment of TachoSil® by the Surgeon With Respect to Utility in Operation Using a 10-Point Numerical Rating Scale
timeFrame: Peri- and post-surgery (Up to 50 Days)
measure: Assessment of TachoSil® by the Surgeon With Respect to Satisfaction Using a 10-Point Numerical Rating Scale
timeFrame: Peri- and post-surgery (Up to 50 Days)
measure: Percentage of Participants With at Least One Drainage Inserted
timeFrame: Baseline (Day of Surgery)
measure: Percentage of Participants With Change in Length of Drainage Stay and Drainage Volume
timeFrame: Up to 50 Days
measure: Length of Hospital and ICU Stay
timeFrame: Up to 50 Days
measure: Percentage of Participants With Pharmacoeconomic Benefit Based on Savings of Operating Time
timeFrame: Peri- and post-surgery (Up to 50 Days)
measure: Percentage of Participants With Pharmacoeconomic Benefit Based on Shortening of Hospital Stay
timeFrame: Up to 50 Days
measure: Percentage of Participants With Pharmacoeconomic Benefit in Shortening of Time Spent in ICU
timeFrame: Up to 50 Days
measure: Percentage of Participants With Pharmacoeconomic Benefit Based on Drainage Time Reduced
timeFrame: Up to 50 Days
measure: Percentage of Participants With Pharmacoeconomic Benefit Based on Drainage Volume Reduced
timeFrame: Up to 50 Days
measure: Percentage of Participants With Post-Operative Complications and Adverse Events
timeFrame: Up to 50 Days
Other outcomes:
Locations:
city: Greifswald
country: Germany
Study officials:
affiliation: Takeda Pharma Vertrieb GmbH & Co. KG
name: Medical Director
role: STUDY_DIRECTOR
References: