Colorectal AnastomosisPhase 2NCT00713661
Evaluation of TachoSil® Application on a Colorectal Anastomosis (TC-029-IM)
A Phase 2 study testing TachoSil® in people with Colorectal Anastomosis, run by Nycomed at 3 sites in 3 countries.
Trial summary
The primary objective is to evaluate if the application of TachoSil® on a colorectal anastomosis is feasible and safe. The secondary objective is to establish and describe optimal application methods to be used for educational purposes in future trials. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Anastomosis
- What is being tested?
- TachoSil®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Jun 2008to Jul 2010
- Phase
- Phase 2
- 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
Who may be able to join
- 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.
- Is the subject 18 years of age or above?
- Is the subject scheduled for elective resection of the rectum?
- Is a colorectal anastomosis below the peritoneal reflexion planned?
- For females of childbearing potential:
- 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))?
- Is the blood or urine pregnancy test negative?
Who cannot join
- Is the subject scheduled for emergency resection of the rectum?
- Does the subject suffer from inflammatory bowel diseases?
- Does the subject have a history of hypersensitivity reactions after application of human fibrinogen, human thrombin and/or collagen of any origin?
- Has the subject participated in any other trial with an investigational medical product (IMP) or device within 30 days before inclusion in this trial?
- Does the subject participate or plan to participate in another clinical trial during the trial period?
- For females of childbearing potential:
Show all 9Show fewer
- Is the subject pregnant or breast feeding?
- Was an anastomosis performed differently from what was defined in the inclusion criteria?
- Did the subject receive any fibrin sealant/glue, excluding TachoSil® , during surgery?
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: Non-randomised, Open, Multi-center Trial Evaluating Feasibility and Safety of TachoSil® Application on a Colorectal Anastomosis.
The primary objective is to evaluate if the application of TachoSil® on a colorectal anastomosis is feasible and safe.
The secondary objective is to establish and describe optimal application methods to be used for educational purposes in future trials.
- Conditions
- Colorectal Anastomosis
- Being tested
- TachoSil®
- Keywords
- Colorectal Anastomosis, Colorectal Resection, Tachosil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TachoSil®Drug
Sterile, ready-to-use, absorbable sponge for intra-operative topical application. It consists of an equine collagen sponge coated with the fibrin glue components human fibrinogen and human thrombin.
Surgery was performed according to the hospitals' local standards. When the anastomosis was performed, all enrolled subjects had TachoSil® applied around the anastomotic line. TachoSil® was therefore an add-on therapy.
| Study group | Role | What they receive |
|---|---|---|
| TachoSil® | Experimental | Not described Receives: Drug: TachoSil® |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Primary Endpoint is the Feasibility of the TachoSil® Application, Reported by the Combined Assessment of the Investigator and External Assessor
Evaluation of feasibility was assessed by investigator after application of the TachoSil® sponge on the anastomosis. A feasible application implied that the entire TachoSil® adhered and covered at least 1cm beyond the margins of the anastomotic line and that if more than one sponge was used, they overlapped by at least 1 cm. The score was assisted by video recording. To ensure an independent assessment, the recording was assessed by an external, blinded assessor. In case of discrepancies between the assessment of the investigator and the assessor, the application was regarded as not feasible.
Measured: Day of surgery
Secondary outcomes (1)
The Secondary Endpoint is the Feasibility of the TachoSil® Application, Assessed by the Investigator.
Evaluation of feasibility was assessed by investigator after application of the TachoSil® sponge on the anastomosis. A feasible application implied that the entire TachoSil® adhered and covered at least 1cm beyond the margins of the anastomotic line and that if more than one sponge was used, they overlapped by at least 1 cm. The score was assisted by video recording.
Measured: Day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2008 (estimated)
- Study startJun 2008
- Primary completionJun 2009
- Study completionJul 2010
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 Colorectal AnastomosisStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nycomed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nycomed Clinical Trial Operations, Study chair, Headquarters
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00713661
- Sponsor's protocol ID
- TC-029-IM
- Other IDs
- 2007-007254-62
- Status last verified
- Feb 2012
- First submitted
- 7 Jul 2008
- Last updated
- 8 May 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-randomised, Open, Multi-center Trial Evaluating Feasibility and Safety of TachoSil® Application on a Colorectal Anastomosis.
- ClinicalTrials.gov ID
- NCT00713661
- Acronym / sponsor ID
- TC-029-IM
- Conditions
- Colorectal Anastomosis
- Keywords
- Colorectal Anastomosis, Colorectal Resection, Tachosil
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- NycomedIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 11 Jul 2008 (estimated)
- Results
- Posted 2 Mar 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective is to evaluate if the application of TachoSil® on a colorectal anastomosis is feasible and safe.
The secondary objective is to establish and describe optimal application methods to be used for educational purposes in future trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TachoSil® | Experimental | Drug: TachoSil® |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
- Is the subject 18 years of age or above?
- Is the subject scheduled for elective resection of the rectum?
- Is a colorectal anastomosis below the peritoneal reflexion planned?
- 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))?
Key exclusion criteria (9 listed)
- Is the subject scheduled for emergency resection of the rectum?
- Does the subject suffer from inflammatory bowel diseases?
- Does the subject have a history of hypersensitivity reactions after application of human fibrinogen, human thrombin and/or collagen of any origin?
- Has the subject participated in any other trial with an investigational medical product (IMP) or device within 30 days before inclusion in this trial?
- Does the subject participate or plan to participate in another clinical trial during the trial period?
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®Sterile, ready-to-use, absorbable sponge for intra-operative topical application. It consists of an equine collagen sponge coated with the fibrin glue components human fibrinogen and human thrombin. Surgery was performed according to the hospitals' local standards. When the anastomosis was performed, all enrolled subjects had TachoSil® applied around the anastomotic line. TachoSil® was therefore an add-on therapy. | Drug | TachoSil® |
Primary outcome
The Primary Endpoint is the Feasibility of the TachoSil® Application, Reported by the Combined Assessment of the Investigator and External Assessor
Time frame: Day of surgery
Evaluation of feasibility was assessed by investigator after application of the TachoSil® sponge on the anastomosis. A feasible application implied that the entire TachoSil® adhered and covered at least 1cm beyond the margins of the anastomotic line and that if more than one sponge was used, they overlapped by at least 1 cm. The score was assisted by video recording. To ensure an independent assessment, the recording was assessed by an external, blinded assessor. In case of discrepancies between the assessment of the investigator and the assessor, the application was regarded as not feasible.
1 secondary outcome
The Secondary Endpoint is the Feasibility of the TachoSil® Application, Assessed by the Investigator.
Time frame: Day of surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2012.
- 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.
Nycomed Clinical Trial Operations study chair
Headquarters
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TachoSil® in people with Colorectal Anastomosis, run by Nycomed at 3 sites in 3 countries.
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 7 inclusion and 9 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 8 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany, Netherlands, United Kingdom. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Mar 2012). 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?
The Primary Endpoint is the Feasibility of the TachoSil® Application, Reported by the Combined Assessment of the Investigator and External Assessor (time frame: Day of surgery). 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 8 May 2012.