Non-interventional Trial About Treatment of Haemorrhages in Cholecystectomy With TachoSil (TC-027-DE)

• Status: Completed
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

Summary

• Effectiveness and reliability of TachoSil in cholecystectomy (elective and acute)

• Evaluation of TachoSil in laparoscopic cholecystectomy

• Risk profile of patient under anticoagulant therapy undergoing acute cholecystectomy

• Pharmaco-economic evaluation

• Recording of AE's/SAE's Considering the total number of cholecystectomies in Germany (170.000 cases/y), out of them about 75% laparoscopic and 10.000 conversions totally it seems urgent to record data about usage of TachoSil in such procedures. For the time being TachoSil is applied in about 2% of the gall bladder procedures.

Aim is to evaluate a possible patient and procedure profile where TachoSil is most beneficial.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nycomed
• Treatments: Thrombin

Criteria

Inclusion Criteria:

• Patients undergoing elective or acute cholecystectomy

• The only restrictions of use will be those resulting from the contraindications (see section 4.3 of the Summary of Product Characteristics)