All patients that are older then 18 years who have an insufficient anastomosis within 5 cm from the upper border of the anal canal are eligible.
Conditions
Interventions
As soon as the anastomotic insufficiency is diagnosed, the anastomosis is defunctioned if not done so primarily. If the CT scan shows extravasation of enteral contrast in a presacral cavity, the patie
Sponsors
AMC
Eligibility
Inclusion criteria
Inclusion criteria: 1. Anastomotic leakage after LAR (max 5 cm of the anus). 2. Confirmed anastomotic leakage on CT-scan or endoscopy. 3. Deviated ileostoma in situ before the start of endo-sponge treatment. 4. Maximal time interval of 6 weeks between the operation and the start of the endo-sponge treatment. 5. Age > 18 years and mental competent. 6. Abscess cavity is accessible by endoscopy. 7. Patient can be followed for 2 years.
Exclusion criteria
Exclusion criteria: 1. Female patient with an ventrally located anastomotic defect 2. Signs of sepsis for which treatment is mandatory, i.e. ICU admittance 3. Steroids of more than 20 mg/day 4. Anastomotic leakage in the medical history
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome parameters are the number of ostomies successfully closed within 3 months. Success is be defined as normal defecation after stoma closure without signs of sepsis 3 months after closure. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary parameters are number of anastomotic defects closed within 2-3 weeks, time to closure of the defunctioning ostomy, quality of life, costs, functional outcome after closure, duration of endosponge treatment an the need for surgical re-intervention for each closure technique. | — |
Contacts
Public ContactW.A. Bemelman
Academic Medical Center (AMC), Department of Surgery P.O. Box 22660
Outcome results
None listed