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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-007254-62 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TachoSil® | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria - at screening:
For females of childbearing potential:
Exclusion Criteria -at screening:
For females of childbearing potential:
• Is the subject pregnant or breast feeding?
Exclusion - peroperative
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| Name | Affiliation | Role |
|---|---|---|
| Nycomed Clinical Trial Operations | Headquarters | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational site | Berlin | Germany | ||||
| Investigational site |
Subjects were divided into
Surgery method: open or laparoscopic
Location of the anastomosis:
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: Open Surgery Lower | Open colorectal resection. The anastomotic line in the low segment approximately 0-5 cm from the anal verge. |
| FG001 | Group 2: Open Surgery Middle/Upper | Open colorectal resection. The anastomotic line in the middle/upper segment 5-12 cm from the anal verge. |
| FG002 | Group 3: Laparoscopic Surgery Lower | Laparoscopic colorectal resection. The anastomotic line in the low segment approximately 0-5 cm from the anal verge. |
| FG003 | Group 4: Laparoscopic Surgery Middle/Upper | Laparasocopic colorectal resection. The anastomotic line in the mid/upper segment 5-12 cm from the anal verge. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: Open Surgery Lower | |
| BG001 | Group 2: Open Surgery Middle/Upper | |
| BG002 | Group 3: Laparoscopic Surgery Lower |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | ITT + Safety Analysis Set. All applications recorded as "not feasible" by external assessor was because he was not able to see it all the way around the anastomosis. The implication is that the primary endpoint was not really reporting the true feasibility, as it was hindered due to technical/practical problems recording the whole anastomosis. | Posted | Number | participants | Day of surgery |
|
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The safety population consists of all 25 subjects that received trial treatment.
SAE/AE assessment by neutral questioning "Have you experienced any health problems since the last contact?" by the investigator at each contact (visit or phone).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1: Open Surgery Lower |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA | Systematic Assessment | SAE was reported as not related to TachoSil®. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Operations | Nycomed | +45 4677 1111 | clinicaltrials@nycomed.com |
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| ID | Term |
|---|---|
| C518955 | TachoSil |
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|
| Day of surgery |
| Utrecht |
| Netherlands |
| Investigational site | Dartford | Kent | United Kingdom |
| BG003 | Group 4: Laparoscopic Surgery Middle/Upper |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Description |
|---|
| OG000 | Group 1: Open Surgery Lower | |
| OG001 | Group 2: Open Surgery Middle/Upper | |
| OG002 | Group 3: Laparoscopic Surgery Lower | |
| OG003 | Group 4: Laparoscopic Surgery Middle/Upper |
|
|
| Secondary | 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. | Data are presented for the 25 subjects treated with TachoSil®. They constitute the intention-to-treat (ITT) and the safety analysis set. | Posted | Number | participants | Day of surgery |
|
|
|
| 3 |
| 7 |
| 3 |
| 7 |
| EG001 | Group 2: Open Surgery Middle/Upper | 1 | 9 | 3 | 9 |
| EG002 | Group 3: Laparoscopic Surgery Lower | 3 | 4 | 1 | 4 |
| EG003 | Group 4: Laparoscopic Surgery Middle/Upper | 0 | 5 | 1 | 5 |
|
| Small bowel obstruction caused by adhesions requiring small bowel resection done open | Gastrointestinal disorders | MedDRA | Systematic Assessment | SAE was reported as not related to TachoSil®. |
|
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment | SAE was reported as not related to TachoSil®. |
|
| Anastomotic leakage | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | SAE was reported as not related to TachoSil®. |
|
| Minor anastomotic leakage | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | SAE was reported as not related to TachoSil®. |
|
| Stomaprolaps | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | SAE was reported as not related to TachoSil®. |
|
| Renal failure | Renal and urinary disorders | MedDRA | Systematic Assessment | SAE was reported as not related to TachoSil®. |
|
| Aspiration pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment | SAE was reported as not related to TachoSil®. |
|
| Pelvic haematoma | Vascular disorders | MedDRA | Systematic Assessment | SAE was reported as not related to TachoSil®. |
|
| Presacral haematoma | Vascular disorders | MedDRA | Systematic Assessment | SAE was reported as not related to TachoSil®. |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
After publication of the results or 24 months after Clinical Trial Report has been finalised, whichever comes first, Nycomed acknowledge the Investigator's rights to publish results from this trial. Any such scientific paper, presentation, communication, or other information concerning the investigation described in this protocol, must be submitted to Nycomed prior to submission for publication/presentation for review. Review comments will be given within a month from receipt of the manuscript.
| Not feasible |
|