The APPEAL-study Analysis of Parameters Predictive for Evident Anastomotic Leakage

The APPEAL-study Analysis of Parameters Predictive for Evident Anastomotic Leakage - The APPEAL-study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON29884

Enrollment

270

Registered

2006-09-04

Start date

2008-01-15

Completion date

Unknown

Last updated

2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

anastomotic insufficiency leakage of intestinal suture

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: * Pregnancy * Age

Design outcomes

Primary

Measure	Time frame
Primary outcome measure The primary outcome measure of the APPEAL-study is anastomotic leakage, defined as an insufficiency of the anastomosis, demonstrated by either endoscopy, radiological examination or operation, 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: * Surgical disconnection of the anastomosis * Construction diverting stoma * Suturing * Construction new anastomosis	—

Measure

Time frame

Primary outcome measure The primary outcome measure of the APPEAL-study is anastomotic leakage, defined as an insufficiency of the anastomosis, demonstrated by either endoscopy, radiological examination or operation, 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: * Surgical disconnection of the anastomosis * Construction diverting stoma * Suturing * Construction new anastomosis

—

Secondary

Measure	Time frame
To compare the evaluated parameters for their accuracy, cost-effectiveness and speed. To investigate if, with these parameters, a distinction can be made between sub-clinical and clinical anastomotic leakage.	—

Countries

Netherlands

Outcome results