Clinical Trial Results:
Use of TachoSil® for the prevention of postoperative complications after groin dissection in vulva cancer patients
Summary
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EudraCT number |
2016-001191-30 |
Trial protocol |
DK |
Global end of trial date |
09 May 2022
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Results information
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Results version number |
v1(current) |
This version publication date |
16 Dec 2024
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First version publication date |
16 Dec 2024
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Other versions |
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Summary report(s) |
Abstract: USE OF TACHOSIL® FOR THE PREVENTION OF POSTOPERATIVE COMPLICATIONS AFTER GROIN DISSECTION IN VULVA CANCER PATIENTS |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
IISR-2015-101127
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Copenhagen University Hospital
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Sponsor organisation address |
Blegdamsvej 9, Rigshospitalet, Denmark, 2100
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Public contact |
Ligita Paskeviciute Frøding, Department of Obstetrics & Gynecology, Copenhagen University Hospital, Rigshospitalet, Denmark, 0045 35459719, ligitapask@dadlnet.dk
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Scientific contact |
Ligita Paskeviciute Frøding, Department of Obstetrics & Gynecology, Copenhagen University Hospital, Rigshospitalet, Denmark , 0045 35459719, ligitapask@dadlnet.dk
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
02 Sep 2024
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
09 May 2022
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Global end of trial reached? |
Yes
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Global end of trial date |
09 May 2022
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To investigate and compare the incidence of symptomatic lymphocele (defined by CTCAE 4.03 grade ≥2) within 4 weeks after surgery in women undergoing ILND for vulva cancer with or without the application of TachoSil® during surgery
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Protection of trial subjects |
Non
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 May 2017
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Denmark: 74
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Worldwide total number of subjects |
74
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EEA total number of subjects |
74
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
26
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From 65 to 84 years |
46
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85 years and over |
2
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Recruitment
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Recruitment details |
Patients with vulva cancer and inguinal lymphadenectomy were recrouted in to gynecologic oncology departments at Copenhagen University Hospital and Aarhus University Hospital | |||||||||
Pre-assignment
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Screening details |
101 patients were screened for the inclusion. 74 patients were included and 27 were excluded due to exclusion criteria. | |||||||||
Period 1
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Period 1 title |
Intervention (Overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Single blind | |||||||||
Roles blinded |
Subject | |||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Intervention | |||||||||
Arm description |
Patiens after inguinafemoral lymphadenectomy who were applied Tachosil prior standard wound closure | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Tachosil
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Investigational medicinal product code |
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Other name |
Tachosil
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Pharmaceutical forms |
Sealant
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Routes of administration |
Use in body cavities
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Dosage and administration details |
One patch per inguen
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Arm title
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Control | |||||||||
Arm description |
Patients after inguinofemoral lymphadenectomy, standard closure | |||||||||
Arm type |
No intervention | |||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Baseline characteristics reporting groups
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Reporting group title |
Intervention
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Reporting group description |
Patiens after inguinafemoral lymphadenectomy who were applied Tachosil prior standard wound closure | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Control
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Reporting group description |
Patients after inguinofemoral lymphadenectomy, standard closure | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Intervention
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Reporting group description |
Patiens after inguinafemoral lymphadenectomy who were applied Tachosil prior standard wound closure | ||
Reporting group title |
Control
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Reporting group description |
Patients after inguinofemoral lymphadenectomy, standard closure |
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End point title |
The primary outcome is the incidence of symptomatic lymphocele (defined by CTCAE 4.03 grade ≥2) within 4 weeks after surgery in women undergoing IL for vulva cancer with or without the application of TachoSil® during surgery. | |||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
4 weeks after surgery
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Statistical analysis title |
Descriptive statistics | |||||||||||||||
Comparison groups |
Control v Intervention
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Number of subjects included in analysis |
74
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | |||||||||||||||
P-value |
= 0.24 | |||||||||||||||
Method |
Chi-squared | |||||||||||||||
Confidence interval |
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Adverse events information [1]
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Timeframe for reporting adverse events |
During one year post-surgery. Wound complications after groin dissection (lymphocele (6-40%), wound breakdown (13-39%) and cellulitis (14-57%)) are common surgical complications after lymphnode dissection in groins and were not considered as AEs or ARs.
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Adverse event reporting additional description |
The clinical assesment was used. Events were considered to be possibly related to the TachoSil® if they occured in the time interval from the time of application of the patches and up to 24 hours after application. Adverse reactions occurring more than 24 hours after application were not be registered.
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Assessment type |
Systematic | ||
Dictionary used for adverse event reporting
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Dictionary name |
None | ||
Dictionary version |
1
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Frequency threshold for reporting non-serious adverse events: 5% | |||
Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: Events were considered to be possibly related to the TachoSil® if they occured in the time interval from the time of application of the patches and up to 24 hours after application. Adverse reactions occurring more than 24 hours after application were not registered. Wound complications after groin dissection (lymphocele (6-40%), wound breakdown (13-39%) and cellulitis (14-57%)) are common surgical complications after lymphnode dissection in groins and were not considered as AEs or ARs. |
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||||||
Interruptions (globally) |
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Were there any global interruptions to the trial? Yes | |||||||
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Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||||||
None reported |