The APPEAL-study Analysis of Parameters Predictive for Evident Anastomotic Leakage
Recruiting
- Conditions
- 1001796910017998anastomotic insufficiencyleakage of intestinal suture
- Registration Number
- NL-OMON29884
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 270
Inclusion Criteria
All patients who have received a drain after the following procedures:
- left hemicolectomy
- sigmoid resection
- high anterior resection
- low anterior resection
- subtotal colectomy with ileo-rectal or ileo-anal anastomosis
Primary anastomosis
Informed consent
Exclusion Criteria
* Pregnancy
* Age < 18 years
* Refusing to participate
* Urgent procedure
* No drain
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary outcome measure<br /><br>The primary outcome measure of the APPEAL-study is anastomotic leakage, defined<br /><br>as an insufficiency of the anastomosis, demonstrated by either endoscopy,<br /><br>radiological examination or operation, leading to a clinical state that<br /><br>requires an intervention. These interventions are:<br /><br>a) Therapeutic drainage<br /><br>b) Use of therapeutic antibiotics<br /><br>c) Any surgical intervention, for example:<br /><br>* Surgical disconnection of the anastomosis<br /><br>* Construction diverting stoma<br /><br>* Suturing<br /><br>* Construction new anastomosis</p><br>
- Secondary Outcome Measures
Name Time Method <p>To compare the evaluated parameters for their accuracy, cost-effectiveness and<br /><br>speed.<br /><br>To investigate if, with these parameters, a distinction can be made between<br /><br>sub-clinical and clinical anastomotic leakage.</p><br>