Use of Tachosil® for Lymph Sealing During Surgery

Completed

• Conditions: Lymph Node Resection
• Interventions: Other: TachoSil®

• Registration Number: NCT01920958
• Lead Sponsor: Takeda

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.

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2013-07-19
• Study First Submitted QC: 2013-08-08
• Study First Posted: 2013-08-12
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Results First Submitted: 2015-05-07
• Status Verified: 2016-10
• Results First Submitted QC: 2016-10-26
• Last Update Submitted: 2016-10-26
• Results First Posted: 2016-12-19
• Last Update Posted: 2016-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 233

Inclusion Criteria

• Stationary patients undergoing lymph node resection.

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TachoSil®	TachoSil®	TachoSil®, sterile absorbable patch, topical application, used during surgery in participants who had lymphadenectomy according to the Summary of Product Characteristics.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Post-Operative Seroma Formation Over Time as Determined at Hospital Discharge	Up to 50 Days

Secondary Outcome Measures

Name	Time	Method
Assessment of TachoSil® by the Surgeon With Respect to Handling Using a 10-Point Numerical Rating Scale	Peri- and post-surgery (Up to 50 Days)	The surgeon evaluated handling of TachoSil® using a 10-point scale where: 1=very good to 10=very poor.
Assessment of TachoSil® by the Surgeon With Respect to Utility in Operation Using a 10-Point Numerical Rating Scale	Peri- and post-surgery (Up to 50 Days)	The surgeon evaluated Utility in Operation of TachoSil® using a 10-point scale where: 1=very useful to 10=completely useless.
Assessment of TachoSil® by the Surgeon With Respect to Satisfaction Using a 10-Point Numerical Rating Scale	Peri- and post-surgery (Up to 50 Days)	The surgeon evaluated Satisfaction in Operation of TachoSil® using a 10-point scale where: 1=very satisfied to 10=totally unsatisfied.
Percentage of Participants With at Least One Drainage Inserted	Baseline (Day of Surgery)	The total number of participants where at least one drainage was used during the operation.
Percentage of Participants With Change in Length of Drainage Stay and Drainage Volume	Up to 50 Days
Length of Hospital and ICU Stay	Up to 50 Days	Length of stay includes time (days) spent in the intensive care unit (ICU) and normal hospital station.
Percentage of Participants With Pharmacoeconomic Benefit Based on Savings of Operating Time	Peri- and post-surgery (Up to 50 Days)	Pharmacoeconomic benefit was assessed by the surgeon based on savings/shortening of operating time in minutes.
Percentage of Participants With Pharmacoeconomic Benefit Based on Shortening of Hospital Stay	Up to 50 Days	Pharmacoeconomic benefit was assessed by the surgeon at hospital discharge based on shortening of hospital stay in days.
Percentage of Participants With Pharmacoeconomic Benefit in Shortening of Time Spent in ICU	Up to 50 Days	Pharmacoeconomic benefit was assessed by the surgeon at hospital discharge based on shortening of time spent in ICU in days.
Percentage of Participants With Pharmacoeconomic Benefit Based on Drainage Time Reduced	Up to 50 Days	Pharmacoeconomic evaluation as assessed by the surgeon at hospital discharge based on drainage time reduced in days.
Percentage of Participants With Pharmacoeconomic Benefit Based on Drainage Volume Reduced	Up to 50 Days	Pharmacoeconomic benefit was assessed by the surgeon at hospital discharge based on the drainage volume reduced in milliliters.
Percentage of Participants With Post-Operative Complications and Adverse Events	Up to 50 Days	An Adverse Event (AE) is defined as any untoward medical occurrence in a participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.