Trial Outcomes & Findings for Evaluation of TachoSil® Application on a Colorectal Anastomosis (TC-029-IM) (NCT NCT00713661)

Last Updated: 2012-05-08

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

25 participants

Primary outcome timeframe

Day of surgery

Results posted on

2012-05-08

Participant Flow

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)

Participant milestones

Participant milestones
Measure	Group 1: Open Surgery Lower Open colorectal resection. The anastomotic line in the low segment approximately 0-5 cm from the anal verge.	Group 2: Open Surgery Middle/Upper Open colorectal resection. The anastomotic line in the middle/upper segment 5-12 cm from the anal verge.	Group 3: Laparoscopic Surgery Lower Laparoscopic colorectal resection. The anastomotic line in the low segment approximately 0-5 cm from the anal verge.	Group 4: Laparoscopic Surgery Middle/Upper Laparasocopic colorectal resection. The anastomotic line in the mid/upper segment 5-12 cm from the anal verge.
Overall Study STARTED	7	9	4	5
Overall Study COMPLETED	7	9	4	5
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of TachoSil® Application on a Colorectal Anastomosis (TC-029-IM)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1: Open Surgery Lower n=7 Participants	Group 2: Open Surgery Middle/Upper n=9 Participants	Group 3: Laparoscopic Surgery Lower n=4 Participants	Group 4: Laparoscopic Surgery Middle/Upper n=5 Participants	Total n=25 Participants Total of all reporting groups
Age Continuous	63.7 years STANDARD_DEVIATION 8.5 • n=5 Participants	64.6 years STANDARD_DEVIATION 12.8 • n=7 Participants	68.5 years STANDARD_DEVIATION 9.9 • n=5 Participants	65.2 years STANDARD_DEVIATION 12.0 • n=4 Participants	65.1 years STANDARD_DEVIATION 10.6 • n=21 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	5 Participants n=4 Participants	8 Participants n=21 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	6 Participants n=7 Participants	4 Participants n=5 Participants	0 Participants n=4 Participants	17 Participants n=21 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Group 1: Open Surgery Lower n=7 Participants	Group 2: Open Surgery Middle/Upper n=9 Participants	Group 3: Laparoscopic Surgery Lower n=4 Participants	Group 4: Laparoscopic Surgery Middle/Upper n=5 Participants
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	2 participants	1 participants	2 participants
The Primary Endpoint is the Feasibility of the TachoSil® Application, Reported by the Combined Assessment of the Investigator and External Assessor Feasible	2 participants	5 participants	2 participants	3 participants
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	2 participants	1 participants	0 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Group 1: Open Surgery Lower n=7 Participants	Group 2: Open Surgery Middle/Upper n=9 Participants	Group 3: Laparoscopic Surgery Lower n=4 Participants	Group 4: Laparoscopic Surgery Middle/Upper n=5 Participants
The Secondary Endpoint is the Feasibility of the TachoSil® Application, Assessed by the Investigator. Feasible	6 participants	9 participants	4 participants	5 participants
The Secondary Endpoint is the Feasibility of the TachoSil® Application, Assessed by the Investigator. Not feasible	1 participants	0 participants	0 participants	0 participants

Adverse Events

Group 1: Open Surgery Lower

Serious events: 3 serious events

Other events: 3 other events

Deaths: 0 deaths

Group 2: Open Surgery Middle/Upper

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Group 3: Laparoscopic Surgery Lower

Serious events: 3 serious events

Other events: 1 other events

Deaths: 0 deaths

Group 4: Laparoscopic Surgery Middle/Upper

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Group 1: Open Surgery Lower n=7 participants at risk	Group 2: Open Surgery Middle/Upper n=9 participants at risk	Group 3: Laparoscopic Surgery Lower n=4 participants at risk	Group 4: Laparoscopic Surgery Middle/Upper n=5 participants at risk
Cardiac disorders Atrial fibrillation	0.00% 0/7 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).	0.00% 0/9 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).	25.0% 1/4 • Number of events 1 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).	0.00% 0/5 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).
Gastrointestinal disorders Small bowel obstruction caused by adhesions requiring small bowel resection done open	0.00% 0/7 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).	0.00% 0/9 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).	25.0% 1/4 • Number of events 1 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).	0.00% 0/5 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).
Infections and infestations Urinary tract infection	0.00% 0/7 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).	0.00% 0/9 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).	25.0% 1/4 • Number of events 1 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).	0.00% 0/5 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).
Injury, poisoning and procedural complications Anastomotic leakage	14.3% 1/7 • Number of events 1 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).	0.00% 0/9 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).	0.00% 0/4 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).	0.00% 0/5 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).
Injury, poisoning and procedural complications Minor anastomotic leakage	14.3% 1/7 • Number of events 1 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).	0.00% 0/9 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).	0.00% 0/4 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).	0.00% 0/5 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).
Injury, poisoning and procedural complications Stomaprolaps	14.3% 1/7 • Number of events 1 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).	0.00% 0/9 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).	0.00% 0/4 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).	0.00% 0/5 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).
Renal and urinary disorders Renal failure	14.3% 1/7 • Number of events 1 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).	0.00% 0/9 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).	0.00% 0/4 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).	0.00% 0/5 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).
Respiratory, thoracic and mediastinal disorders Aspiration pneumonia	0.00% 0/7 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).	0.00% 0/9 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).	25.0% 1/4 • Number of events 1 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).	0.00% 0/5 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).
Vascular disorders Pelvic haematoma	0.00% 0/7 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).	11.1% 1/9 • Number of events 1 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).	0.00% 0/4 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).	0.00% 0/5 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).
Vascular disorders Presacral haematoma	0.00% 0/7 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).	0.00% 0/9 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).	25.0% 1/4 • Number of events 1 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).	0.00% 0/5 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).

Other adverse events

Other adverse events
Measure	Group 1: Open Surgery Lower n=7 participants at risk	Group 2: Open Surgery Middle/Upper n=9 participants at risk	Group 3: Laparoscopic Surgery Lower n=4 participants at risk	Group 4: Laparoscopic Surgery Middle/Upper n=5 participants at risk
Gastrointestinal disorders Nausea	0.00% 0/7 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).	22.2% 2/9 • Number of events 2 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).	0.00% 0/4 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).	0.00% 0/5 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).
Gastrointestinal disorders Vomiting	42.9% 3/7 • Number of events 3 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).	11.1% 1/9 • Number of events 1 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).	25.0% 1/4 • Number of events 1 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).	20.0% 1/5 • Number of events 1 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).

Additional Information

Clinical Trial Operations

Nycomed

Phone: +45 4677 1111

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER