Anastomotic leakage, colorectal surgery, drainage fluid, biomarkers Naadlekkage, colorectale chirurgie, drainvocht
Conditions
Interventions
Prophylactic drainage after colorectal surgery is common practice. When a drain is left behind during operation the patient can be included in the study. The only difference with routine practice is t
Sponsors
Erasmus MC, Rotterdam, The Netherlands
Eligibility
Inclusion criteria
Inclusion criteria: 1. All patients in which a drain has been placed at the anastomotic site after one of the following procedures: - Left hemicolectomy - Sigmoid resection - Anterior resection (high & low) - Total Mesorectal Excision - Subtotal colectomy with ileo- rectal or ileo-anal anastomosis 2. Informed consent 3. Primary anastomosis
Exclusion criteria
Exclusion criteria: 1. Pregnancy 2. Age < 18 years 3. Refusing to participate 4. Urgent operation 5. No drain
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure of the APPEAL-study is anastomotic leakage, defined as an insufficiency of the anastomosis, demonstrated by either endoscopy, radiologic studies or operation and leading to a clinical state that requires an intervention. These interventions are: a) Therapeutic drainage b) Use of therapeutic antibiotics c) Any surgical intervention, for example: • Construction diverting stoma • Construction new anastomosis • Surgical disconnection of the anastomosis • Suturing | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of the studied potential biomarkers in terms of speed, accuracy and cost-effectiveness Study the capacity of the potential biomarkers to distinguish between clinically manifest and subclinical anastomotic leakage | — |
Contacts
Public ContactN. Komen
Department of Surgery Dr. Molewaterplein 50 Erasmus MC
Outcome results
None listed