Trial Outcomes & Findings for RollOut -Pre-Rolled TachoSil in Laparoscopic Utilisation. A Non-Interventional Study (NCT NCT02685007)
NCT ID: NCT02685007
Last Updated: 2020-03-19
Results Overview
Investigators were asked to evaluate the overall manageability and satisfaction with TachoSil in laparoscopic surgery. The overall manageability and satisfaction of TachoSil application was assessed using Likert scale. It is a 5-point scale, that ranges from 1-5, where 1=easy to use/satisfied to 5=difficult to use/not satisfied. Higher scores indicates difficulty and less satisfaction. The mean manageability satisfaction with the application of TachoSil were reported.
COMPLETED
131 participants
Post-surgery until hospital discharge (up to 13 days)
2020-03-19
Participant Flow
Participants took part in the study at 7 investigative sites in Austria from 05 April 2016 to 14 August 2017.
Participants planned for laparoscopic surgery in the field of gynecology, urology or visceral surgery were enrolled in this study to use pre-rolled TachoSil according to the local Summary of Product Characteristics (SmPC) based on physician decision and the data was collected under routine standard of care.
Participant milestones
| Measure |
TachoSil
TachoSil, sealant matrix coated with fibrinogen and thrombin, epilesional application, applied during surgery in participants who had laparoscopic surgery, in the field of gynecology, urology and visceral surgery according to the local SmPC.
|
|---|---|
|
Overall Study
STARTED
|
131
|
|
Overall Study
COMPLETED
|
131
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
TachoSil
n=131 Participants
TachoSil, sealant matrix coated with fibrinogen and thrombin, epilesional application, applied during surgery in participants who had laparoscopic surgery, in the field of gynecology, urology and visceral surgery according to the local SmPC.
|
|---|---|
|
Age, Customized
20-83 years
|
131 participants
n=131 Participants
|
|
Sex: Female, Male
Female
|
81 Participants
n=131 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=131 Participants
|
|
Region of Enrollment
Austria
|
131 participants
n=131 Participants
|
|
Participants With Height From 152 to 190 Centimeter (cm)
|
131 Participants
n=131 Participants
|
|
Participants With Weight from 46.5 to 180 Kilogram (kg)
|
131 Participants
n=131 Participants
|
PRIMARY outcome
Timeframe: Post-surgery until hospital discharge (up to 13 days)Population: The safety analysis set included all participants who were treated with TachoSil and completed the study.
Investigators were asked to evaluate the overall manageability and satisfaction with TachoSil in laparoscopic surgery. The overall manageability and satisfaction of TachoSil application was assessed using Likert scale. It is a 5-point scale, that ranges from 1-5, where 1=easy to use/satisfied to 5=difficult to use/not satisfied. Higher scores indicates difficulty and less satisfaction. The mean manageability satisfaction with the application of TachoSil were reported.
Outcome measures
| Measure |
TachoSil
n=131 Participants
TachoSil, sealant matrix coated with fibrinogen and thrombin, epilesional application, applied during surgery in participants who had laparoscopic surgery, in the field of gynecology, urology and visceral surgery according to the local SmPC.
|
|---|---|
|
Investigators Assessment of Tachosil
Overall manageability
|
1.91 score on a scale
Standard Deviation 0.76
|
|
Investigators Assessment of Tachosil
Overall satisfaction
|
1.86 score on a scale
Standard Deviation 0.80
|
SECONDARY outcome
Timeframe: From date of surgery until hospital discharge (up to 13 days)Population: The safety analysis set included all participants who were treated with TachoSil and completed the study.
Outcome measures
| Measure |
TachoSil
n=131 Participants
TachoSil, sealant matrix coated with fibrinogen and thrombin, epilesional application, applied during surgery in participants who had laparoscopic surgery, in the field of gynecology, urology and visceral surgery according to the local SmPC.
|
|---|---|
|
Duration of Hospital Stay
|
5 days
Interval 3.0 to 13.0
|
SECONDARY outcome
Timeframe: Intra-surgery and post-surgery until hospital discharge (up to 13 days)Population: The safety analysis set included all participants who were treated with TachoSil and completed the study.
Pharmaco-economic evaluation based on surgeon's assessment included surgery time, intensive care unit (ICU) time, total care time, and other advantages. Other advantages included reduced or no risk of secondary bleeding, and the easier application and manageability.
Outcome measures
| Measure |
TachoSil
n=131 Participants
TachoSil, sealant matrix coated with fibrinogen and thrombin, epilesional application, applied during surgery in participants who had laparoscopic surgery, in the field of gynecology, urology and visceral surgery according to the local SmPC.
|
|---|---|
|
Number of Participants With Pharmaco-economic Evaluation Based on Surgeon's Assessment
Participants with reduction of surgery time
|
10 participants
|
|
Number of Participants With Pharmaco-economic Evaluation Based on Surgeon's Assessment
Participants with reduction of ICU time
|
0 participants
|
|
Number of Participants With Pharmaco-economic Evaluation Based on Surgeon's Assessment
Participants with reduction of total care time
|
0 participants
|
|
Number of Participants With Pharmaco-economic Evaluation Based on Surgeon's Assessment
Participants with other advantages
|
8 participants
|
SECONDARY outcome
Timeframe: Baseline up to 13 daysPopulation: The safety analysis set included all participants who were treated with TachoSil and completed the study.
Outcome measures
| Measure |
TachoSil
n=131 Participants
TachoSil, sealant matrix coated with fibrinogen and thrombin, epilesional application, applied during surgery in participants who had laparoscopic surgery, in the field of gynecology, urology and visceral surgery according to the local SmPC.
|
|---|---|
|
Number of Participants With Intra-operative and Post-operative Adverse Events (AEs)
|
2 participants
|
Adverse Events
TachoSil
Serious adverse events
| Measure |
TachoSil
n=131 participants at risk
TachoSil, sealant matrix coated with fibrinogen and thrombin, epilesional application, applied during surgery in participants who had laparoscopic surgery, in the field of gynecology, urology and visceral surgery according to the local SmPC.
|
|---|---|
|
Gastrointestinal disorders
Abdominal incarcerated hernia
|
0.76%
1/131 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first application of open label study drug up to end of study (up to 13 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.76%
1/131 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first application of open label study drug up to end of study (up to 13 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER