Anastomotic leakage MedDRA version: 14.1 Level: LLT Classification code 10065961 Term: Esophageal anastomotic leak System Organ Class: 10022117 - Injury, poisoning and procedural complications MedDRA version: 14.1 Level: LLT Classification code 10065890 Term: Oesophageal anastomotic leak System Organ Class: 10022117 - Injury, poisoning and procedural complications
Conditions
Interventions
Trade Name: TachoSil medicated sponge
Product Name: TachoSil medicated sponge
Pharmaceutical Form: Absorbable coated sponge
INN or Proposed INN: human fibrinogen
CAS Number: 9001-32-5
Other descriptiv
Sponsors
University Medical Center Utrecht
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients undergoing an elective total gastrectomy with an esophago-jejunostomy or esophagectomy with a planned esophagogastric anastomosis • Ages 18-80 • Signed informed consent 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 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: • Emergency resections of esophagus of stomach • History of hypersensitivity reactions to human fibrinogen, human thrombin, or collagen. • Patients having difficulty understanding the Dutch and English language • Mentally incapable patients • Pregnancy or breast feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of the feasibility of Tachosil application on esophageal anastomoses.;Secondary Objective: Evaluation of the safety of Tachosil application on esophageal anastomoses.;Primary end point(s): The primary efficacy parameter is the feasibility of TachoSil® application on esophageal anastomoses, which is assessed by 2 investigators who will evaluate video recordings. Feasibility is measured by the adherence and location of the TachoSil® patch, defined according to the following criteria: • Adherence of complete TachoSil® patch • TachoSil® covers at least 1 cm beyond the margins of anastomotic line • Overlap of at least 1 cm if multiple patches are used;Timepoint(s) of evaluation of this end point: Duration of construction of the anastomosis, during surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety • Mortality - 30-day (n) - 60-day (n) - in hospital (n) • Serious adverse events (n) • Adverse events (n) • Anastomotic leakage (n) • Location of anastomotic leakage - Cervical (n) - Intrathoracic (n) • Anastomotic stricture (n) • Post-operative complications (n): Respiratory complications (pneumonia, ARDS, respiratory insufficiency), cardiac complications (ischemic and arrhythmic), lymphorrhea, vocal-cord paralysis, sepsis, urinary tract infection, wound infection, fistula, mediastinitis, thorax empyema. • Postoperative course: - Duration of Intensive Care stay (days) - Duration of Medium Care stay (days) - Total duration of hospital stay (days) - Mechanical ventilation (days) ;Timepoint(s) of evaluation of this end point: Day of Surgery (day 0) Day of discharge from surgical ward 3 months after surgery 9 months after surgery | — |
Countries
Netherlands
Contacts
Public ContactLeonie Haverkamp
UMC Utrecht
Outcome results
None listed