N/A
N=131
RollOut -Pre-Rolled TachoSil in Laparoscopic Utilisation. A Non-Interventional Study
Laparoscopy
Bottom Line
View on ClinicalTrials.gov: NCT02685007 ↗Enrolled (actual)
131
Serious AEs
1.5%
Results posted
Mar 2020
Primary outcome: Primary: Investigators Assessment of Tachosil — 1.91; 1.86 score on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Tachosil (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Takeda
- Primary completion
- Aug 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Investigators Assessment of Tachosil |
1.91; 1.86 | — |
| SECONDARY Duration of Hospital Stay |
5 | — |
| SECONDARY Number of Participants With Pharmaco-economic Evaluation Based on Surgeon's Assessment |
10; 0; 0; 8 | — |
| SECONDARY Number of Participants With Intra-operative and Post-operative Adverse Events (AEs) |
2 | — |
Summary
The purpose of this study is to describe ease of use and satisfaction with application of the pre-rolled TachoSil in laparoscopic procedures within approved therapeutic indication as per Summary of Product Characteristics (SmPC).
Eligibility Criteria
Inclusion Criteria
1- Inpatients planned for laparoscopic surgery, in the field of gynecology, urology and abdominal surgery where pre-rolled TachoSil was applied, 18 years or older.
Exclusion Criteria
- Has contraindications, such as hypersensitivity to the active pharmaceutical ingredients or to other components of pre-rolled TachoSil according to the current SmPC.
- Is participating in another clinical trial.
Data sourced from ClinicalTrials.gov (NCT02685007). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.