Lymph Node ResectionSEALNCT01920958
Use of Tachosil® for Lymph Sealing During Surgery
An observational study of Lymph Node Resection, run by Takeda at 1 site in Germany.
Trial summary
The purpose of this study is to describe effectiveness and reliability of TachoSil® in lymph sealing after lymphadenectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymph Node Resection
- What is being tested?
- TachoSil®
- How many people
- 233 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2012to Mar 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Stationary patients in whom a lymph node resection was planned to be performed
Who may be able to join
- Stationary patients undergoing lymph node resection.
Who cannot join
- Contraindications, such as hypersensitivity to the active pharmaceutical ingredient or to another ingredient.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Tachosil® for Lymph Sealing During Surgery. A Non-Interventional Study
The purpose of this study is to describe effectiveness and reliability of TachoSil® in lymph sealing after lymphadenectomy.
Read the 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.
- Conditions
- Lymph Node Resection
- Being tested
- TachoSil®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TachoSil®Other
TachoSil® is a collagen sponge that is coated with the active substances human fibrinogen and human thrombin and that supports hemostasis and tissue sealing in surgery.
| Study group | Role | What they receive |
|---|---|---|
| TachoSil® | TachoSil®, sterile absorbable patch, topical application, used during surgery in participants who had lymphadenectomy according to the Summary of Product Characteristics. Receives: Other: TachoSil® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Post-Operative Seroma Formation Over Time as Determined at Hospital Discharge
Measured: Up to 50 Days
Secondary outcomes (12)
Assessment of TachoSil® by the Surgeon With Respect to Handling Using a 10-Point Numerical Rating Scale
The surgeon evaluated handling of TachoSil® using a 10-point scale where: 1=very good to 10=very poor.
Measured: Peri- and post-surgery (Up to 50 Days)
Assessment of TachoSil® by the Surgeon With Respect to Utility in Operation Using a 10-Point Numerical Rating Scale
The surgeon evaluated Utility in Operation of TachoSil® using a 10-point scale where: 1=very useful to 10=completely useless.
Measured: Peri- and post-surgery (Up to 50 Days)
Assessment of TachoSil® by the Surgeon With Respect to Satisfaction Using a 10-Point Numerical Rating Scale
The surgeon evaluated Satisfaction in Operation of TachoSil® using a 10-point scale where: 1=very satisfied to 10=totally unsatisfied.
Measured: Peri- and post-surgery (Up to 50 Days)
Percentage of Participants With at Least One Drainage Inserted
The total number of participants where at least one drainage was used during the operation.
Measured: Baseline (Day of Surgery)
Percentage of Participants With Change in Length of Drainage Stay and Drainage Volume
Measured: Up to 50 Days
Length of Hospital and ICU Stay
Length of stay includes time (days) spent in the intensive care unit (ICU) and normal hospital station.
Measured: Up to 50 Days
Percentage of Participants With Pharmacoeconomic Benefit Based on Savings of Operating Time
Pharmacoeconomic benefit was assessed by the surgeon based on savings/shortening of operating time in minutes.
Measured: Peri- and post-surgery (Up to 50 Days)
Percentage of Participants With Pharmacoeconomic Benefit Based on Shortening of Hospital Stay
Pharmacoeconomic benefit was assessed by the surgeon at hospital discharge based on shortening of hospital stay in days.
Measured: Up to 50 Days
Percentage of Participants With Pharmacoeconomic Benefit in Shortening of Time Spent in ICU
Pharmacoeconomic benefit was assessed by the surgeon at hospital discharge based on shortening of time spent in ICU in days.
Measured: Up to 50 Days
Percentage of Participants With Pharmacoeconomic Benefit Based on Drainage Time Reduced
Pharmacoeconomic evaluation as assessed by the surgeon at hospital discharge based on drainage time reduced in days.
Measured: Up to 50 Days
Percentage of Participants With Pharmacoeconomic Benefit Based on Drainage Volume Reduced
Pharmacoeconomic benefit was assessed by the surgeon at hospital discharge based on the drainage volume reduced in milliliters.
Measured: Up to 50 Days
Percentage of Participants With Post-Operative Complications and Adverse Events
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.
Measured: Up to 50 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2013 (estimated)
- Study startSep 2012
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lymph Node ResectionStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 233 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Takeda Pharma Vertrieb GmbH & Co. KG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01920958
- Sponsor's protocol ID
- TC-2402-401-DE
- Other IDs
- U1111-1142-0279
- Acronym
- SEAL
- Status last verified
- Oct 2016
- First submitted
- 19 Jul 2013
- Last updated
- 19 Dec 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Tachosil® for Lymph Sealing During Surgery. A Non-Interventional Study
- ClinicalTrials.gov ID
- NCT01920958
- Acronym / sponsor ID
- SEAL / TC-2402-401-DE
- Conditions
- Lymph Node Resection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 233 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 12 Aug 2013 (estimated)
- Results
- Posted 19 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TachoSil® | – | Other: TachoSil®TachoSil®, sterile absorbable patch, topical application, used during surgery in participants who had lymphadenectomy according to the Summary of Product Characteristics. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stationary patients in whom a lymph node resection was planned to be performed
Key inclusion criteria (1 listed)
- Stationary patients undergoing lymph node resection.
Key exclusion criteria (1 listed)
- Contraindications, such as hypersensitivity to the active pharmaceutical ingredient or to another ingredient.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TachoSil®TachoSil® is a collagen sponge that is coated with the active substances human fibrinogen and human thrombin and that supports hemostasis and tissue sealing in surgery. | Other | TachoSil® |
Primary outcome
Percentage of Participants With Post-Operative Seroma Formation Over Time as Determined at Hospital Discharge
Time frame: Up to 50 Days
12 secondary outcomes
Assessment of TachoSil® by the Surgeon With Respect to Handling Using a 10-Point Numerical Rating Scale
Time frame: Peri- and post-surgery (Up to 50 Days)
Assessment of TachoSil® by the Surgeon With Respect to Utility in Operation Using a 10-Point Numerical Rating Scale
Time frame: Peri- and post-surgery (Up to 50 Days)
Assessment of TachoSil® by the Surgeon With Respect to Satisfaction Using a 10-Point Numerical Rating Scale
Time frame: Peri- and post-surgery (Up to 50 Days)
Percentage of Participants With at Least One Drainage Inserted
Time frame: Baseline (Day of Surgery)
Percentage of Participants With Change in Length of Drainage Stay and Drainage Volume
Time frame: Up to 50 Days
Length of Hospital and ICU Stay
Time frame: Up to 50 Days
Percentage of Participants With Pharmacoeconomic Benefit Based on Savings of Operating Time
Time frame: Peri- and post-surgery (Up to 50 Days)
Percentage of Participants With Pharmacoeconomic Benefit Based on Shortening of Hospital Stay
Time frame: Up to 50 Days
Percentage of Participants With Pharmacoeconomic Benefit in Shortening of Time Spent in ICU
Time frame: Up to 50 Days
Percentage of Participants With Pharmacoeconomic Benefit Based on Drainage Time Reduced
Time frame: Up to 50 Days
Percentage of Participants With Pharmacoeconomic Benefit Based on Drainage Volume Reduced
Time frame: Up to 50 Days
Percentage of Participants With Post-Operative Complications and Adverse Events
Time frame: Up to 50 Days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Takeda Pharma Vertrieb GmbH & Co. KG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymph Node Resection, run by Takeda at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Post-Operative Seroma Formation Over Time as Determined at Hospital Discharge (time frame: Up to 50 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2016.