Colorectal Anastomosis
Conditions
Keywords
Colorectal Anastomosis, Colorectal Resection, Tachosil
Brief 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.
Interventions
DRUGTachoSil®
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.
Sponsors
Nycomed
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- at screening: * 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?
Exclusion criteria
-at screening: * 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: • Is the subject pregnant or breast feeding? Exclusion - peroperative * 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?
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Primary Endpoint is the Feasibility of the TachoSil® Application, Reported by the Combined Assessment of the Investigator and External Assessor | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Secondary Endpoint is the Feasibility of the TachoSil® Application, Assessed by the Investigator. | 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. |
Countries
Germany, Netherlands, United Kingdom
Participant flow
Pre-assignment details
Subjects were divided into * Surgery method: open or laparoscopic * Location of the anastomosis: * anastomotic line in the low segment (approx. 0-5 cm from the anal verge) * anastomotic line in the mid or upper segment (approx. 5-12 cm from the anal verge)
Participants by arm
| Arm | Count |
|---|---|
| Group 1: Open Surgery Lower | 7 |
| Group 2: Open Surgery Middle/Upper | 9 |
| Group 3: Laparoscopic Surgery Lower | 4 |
| Group 4: Laparoscopic Surgery Middle/Upper | 5 |
| Total | 25 |
Baseline characteristics
| Characteristic | Group 3: Laparoscopic Surgery Lower | Group 4: Laparoscopic Surgery Middle/Upper | Total | Group 1: Open Surgery Lower | Group 2: Open Surgery Middle/Upper |
|---|---|---|---|---|---|
| Age Continuous | 68.5 years STANDARD_DEVIATION 9.9 | 65.2 years STANDARD_DEVIATION 12 | 65.1 years STANDARD_DEVIATION 10.6 | 63.7 years STANDARD_DEVIATION 8.5 | 64.6 years STANDARD_DEVIATION 12.8 |
| Sex: Female, Male Female | 0 Participants | 5 Participants | 8 Participants | 0 Participants | 3 Participants |
| Sex: Female, Male Male | 4 Participants | 0 Participants | 17 Participants | 7 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 3 / 7 | 3 / 9 | 1 / 4 | 1 / 5 |
| serious Total, serious adverse events | 3 / 7 | 1 / 9 | 3 / 4 | 0 / 5 |
Outcome results
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.
Time frame: Day of surgery
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Open Surgery Lower | The Primary Endpoint is the Feasibility of the TachoSil® Application, Reported by the Combined Assessment of the Investigator and External Assessor | Video not available | 1 participants |
| Group 1: Open Surgery Lower | The Primary Endpoint is the Feasibility of the TachoSil® Application, Reported by the Combined Assessment of the Investigator and External Assessor | Not feasible | 4 participants |
| Group 1: Open Surgery Lower | The Primary Endpoint is the Feasibility of the TachoSil® Application, Reported by the Combined Assessment of the Investigator and External Assessor | Feasible | 2 participants |
| Group 2: Open Surgery Middle/Upper | The Primary Endpoint is the Feasibility of the TachoSil® Application, Reported by the Combined Assessment of the Investigator and External Assessor | Video not available | 2 participants |
| Group 2: Open Surgery Middle/Upper | The Primary Endpoint is the Feasibility of the TachoSil® Application, Reported by the Combined Assessment of the Investigator and External Assessor | Not feasible | 2 participants |
| Group 2: Open Surgery Middle/Upper | The Primary Endpoint is the Feasibility of the TachoSil® Application, Reported by the Combined Assessment of the Investigator and External Assessor | Feasible | 5 participants |
| Group 3: Laparoscopic Surgery Lower | The Primary Endpoint is the Feasibility of the TachoSil® Application, Reported by the Combined Assessment of the Investigator and External Assessor | Feasible | 2 participants |
| Group 3: Laparoscopic Surgery Lower | The Primary Endpoint is the Feasibility of the TachoSil® Application, Reported by the Combined Assessment of the Investigator and External Assessor | Video not available | 1 participants |
| Group 3: Laparoscopic Surgery Lower | The Primary Endpoint is the Feasibility of the TachoSil® Application, Reported by the Combined Assessment of the Investigator and External Assessor | Not feasible | 1 participants |
| Group 4: Laparoscopic Surgery Middle/Upper | The Primary Endpoint is the Feasibility of the TachoSil® Application, Reported by the Combined Assessment of the Investigator and External Assessor | Video not available | 2 participants |
| Group 4: Laparoscopic Surgery Middle/Upper | The Primary Endpoint is the Feasibility of the TachoSil® Application, Reported by the Combined Assessment of the Investigator and External Assessor | Not feasible | 0 participants |
| Group 4: Laparoscopic Surgery Middle/Upper | The Primary Endpoint is the Feasibility of the TachoSil® Application, Reported by the Combined Assessment of the Investigator and External Assessor | Feasible | 3 participants |
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.
Time frame: Day of surgery
Population: Data are presented for the 25 subjects treated with TachoSil®. They constitute the intention-to-treat (ITT) and the safety analysis set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Open Surgery Lower | The Secondary Endpoint is the Feasibility of the TachoSil® Application, Assessed by the Investigator. | Feasible | 6 participants |
| Group 1: Open Surgery Lower | The Secondary Endpoint is the Feasibility of the TachoSil® Application, Assessed by the Investigator. | Not feasible | 1 participants |
| Group 2: Open Surgery Middle/Upper | The Secondary Endpoint is the Feasibility of the TachoSil® Application, Assessed by the Investigator. | Not feasible | 0 participants |
| Group 2: Open Surgery Middle/Upper | The Secondary Endpoint is the Feasibility of the TachoSil® Application, Assessed by the Investigator. | Feasible | 9 participants |
| Group 3: Laparoscopic Surgery Lower | The Secondary Endpoint is the Feasibility of the TachoSil® Application, Assessed by the Investigator. | Feasible | 4 participants |
| Group 3: Laparoscopic Surgery Lower | The Secondary Endpoint is the Feasibility of the TachoSil® Application, Assessed by the Investigator. | Not feasible | 0 participants |
| Group 4: Laparoscopic Surgery Middle/Upper | The Secondary Endpoint is the Feasibility of the TachoSil® Application, Assessed by the Investigator. | Feasible | 5 participants |
| Group 4: Laparoscopic Surgery Middle/Upper | The Secondary Endpoint is the Feasibility of the TachoSil® Application, Assessed by the Investigator. | Not feasible | 0 participants |