The primary efficacy variable is if the TachoSil application was feasible. A feasible application implies that the entire TachoSil adhere, TachoSil covers at least 1 cm beyond the margins of the anastomosis line and if more TachoSil sponges are used…
ID
Source
Brief title
Condition
- Anal and rectal conditions NEC
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary efficacy endpoint is whether or not the TachoSil application was
feasible?
A feasible application implies that the entire Tachosil adheresl, TachoSil
covers at least 1 cm beyond the margins of the anastomosis line and if more
than one TachoSil sponge is used, they must overlab by at least 1 cm.
Secondary outcome
To establish and describe the optimal application method, the following
information will be collected:
· Use of suture or stapler for anastomosis formation
· Instruments used to facilitate the application
· Possibility of applying pressure on TachoSil sponge
· Number of TachoSil used
Background summary
The scope of this trial is to evaluate if it is possible to apply TachoSil
around rectal anastomosis and be able to use it in future clinical trials.
Therefore the only focus is on the validation of the TachoSil application
method and a control group is not feasible.
The adherence of the entire TachoSil and the location around the anastomotic
line will be evaluated immediately following the application. The score will be
assisted by video recording. To ensure an independent and uniform assessment,
the recording will be assessed by an external, blinded assessor. In case of
discrepancies, the assessment of the blinded assessor will be valid.
Furthermore, for educational purposes knowledge about the application will be
gathered to describe the optimal process.
Study objective
The primary efficacy variable is if the TachoSil application was feasible.
A feasible application implies that the entire TachoSil adhere, TachoSil covers
at least 1 cm beyond the margins of the anastomosis line and if more TachoSil
sponges are used they must overlap by at least 1 cm.
Study design
Non-randomised, open, multi-center trial evaluating feasibility and safety of
TachoSilÒ on a colorectal anastomosis.
Intervention
All patients will receive Tachosil
Study burden and risks
No additional risks are expected than those which could happen according the
SPC of Tachosil
Jupiterstraat 250
2132 HK Hoofddorp
NL
Jupiterstraat 250
2132 HK Hoofddorp
NL
Listed location countries
Age
Inclusion criteria
At screening
1. Has the patient given informed consent according to local requirements before any trial-related activities? A trial-related activity is any procedure that would not have been performed during the routine management of the subject
2. Is the subject 18 years of age or above?
3. Is the subject scheduled for elective resection of the rectum?
4. Is a colorectal anastomosis below the peritoneal reflexion planned?;For females of childbearing potential:
5. Does the patient use an acceptable contraceptive method (contraceptive pills, injection of prolonged gestagen, subdermal implantation, hormonal vaginal devices, transdermal patches or intrauterine device (IUD))?
6. Is the urine pregnancy test negative?
Exclusion criteria
Exclusion Criteria
At screening
1. Is the subject scheduled for emergency resection of the rectum?
2. Does the subject suffer from inflammatory bowel diseases?
3. Does the subject have a history of hyper sensitivity reactions after application of human fibrinogen, human thrombin and/or collagen of any origin?
4. Has the subject participated in any other trial with an investigational medical product (IMP) or device within 30 days before inclusion in this trial?
5. Does the subject participate or plan to participate in another clinical trial during the trial period?
For females of childbearing potential:
7. Is the subject pregnant or breast feeding?;Peroperative
7. Was an anastomosis different from the one defined in the inclusion criterias performed?
8. Did the subject receive any fibrin sealant glue, excluding TachoSil, during surgery?
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2007-007254-62-NL |
| CCMO | NL22494.041.08 |