It is the intention with this clinical trial to evaluate wheter TachoSil may reduce the formation of postoperative haematomas on the vaginal cuff following hysterectomi. The presence of a postoperative haematoma is correlated to postoperative complications such as fever, abdomimal pain and prolonged recovery. It the incidence of haematomas may be reduced, the number of postoperative complications is expected to be reduced as well. MedDRA version: 9.1 Level: LLT Classification code 10044080 Term
Conditions
Interventions
Trade Name: TachoSil
Product Name: TachoSil
Product Code: Local haemostatics
Pharmaceutical Form: Medicated plaster
Other descriptive name: HUMAN FIBRINOGEN
Concentration unit: mg milligram(s)
Concent
Sponsors
Hvidovre Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subject aged 18 or above? Informed written consent? Elective abdominal hysterectomy for on benign indication Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: History of allergic reactions after applications of human fibrinogen, human thrombin and/or collagen of any origin Participation in a clinical trial less than 30 days prior to inclusion in present trial. Participation in a clinical trial concomitantly with present trial. Intraoperative use of Cyclocapron
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: It is the objective of this clinical trial to evaluate the efficacy and safety for haemostasis in women undergoing hysterectomy. The purpose is the gain data on the prevalence of haematomas to enable a power calculation for a randomised controlled trial. The purpose of a randomised controlled trial will be to evaluate the efficacy of TachoSil on the basis of reduction of clinically relevant haematomas at the vaginal cuff.. A clinically relevant haematoma is defined as a haematoma with postoperative clinical symptoms: Fever, abdominal pain, vaginal bleeding, transfusion, re-operation, prolonged hospital stay, prolonged reconvalesense, or any combination hereof. ;Secondary Objective: Abdominal pain will be registered pre-operatively, at follow up after 1 week and 30 days by means of a VAS score and a QoL questionnaire in order to evaluate whether a haematoma has a clinical significance in terms of long-term postoperative abdominal pain and quality of life. ;Primary end point(s): Number of patients with haematoma at the vaginal cuff 1 week ± 2 days after surgery as assessed by ultrasound. | — |
Countries
Denmark
Outcome results
None listed