The loss of gut wall integrity through non-abdominal surgical trauma in adults, children and neonates

The loss of gut wall integrity through non-abdominal surgical trauma in adults, children and neonates - Gut damage and inflammation in major non- abdominal surgery

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON30582

Enrollment

Registered

2006-10-30

Start date

2006-11-01

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

complications after major surgery inflammtion

Interventions

None listed

Eligibility

Age

2 Years to 99 Years

Inclusion criteria

Inclusion criteria: Children and adults undergoing major spinal surgery and neonates undergoing thoracotomy in the University Hospital Maastricht. Patients that have an arterial line or central venous access to facilitate plasma sampling. Patients that have given informed consent

Exclusion criteria

Exclusion criteria: Patients who have any other cause for gut damage, such as inflammation (eg active inflammatory bowel disease), direct surgical trauma (eg abdominal surgery), or artificial circulation (eg cardiopulmonary bypass).

Design outcomes

Primary

Measure	Time frame
As first outcome measurement, this study will evaluate the origin of intestinal epithelial cell damage, mucosal hypoperfsuion, inflammation, bacterial translocation and postoperative complications. Complications will be defined as the presence of SIRS, sepsis, or evidence of organ failure based on internationally accepted biochemical and/or clinical criteria. We will correlate the increase of studied plasma and urinary markers for intestinal epithelial cell damage and inflammation with the occurence of post-operative morbidity and complications. The peak levels of studied markers will be correlated with the amount of hypoperfusion, measured by gastric tonometry. The release of intestinal cell damage and inflammation markers will be correlated with the amount of blood loss, duration and extension of surgery.	—

Measure

Time frame

As first outcome measurement, this study will evaluate the origin of intestinal epithelial cell damage, mucosal hypoperfsuion, inflammation, bacterial translocation and postoperative complications. Complications will be defined as the presence of SIRS, sepsis, or evidence of organ failure based on internationally accepted biochemical and/or clinical criteria. We will correlate the increase of studied plasma and urinary markers for intestinal epithelial cell damage and inflammation with the occurence of post-operative morbidity and complications. The peak levels of studied markers will be correlated with the amount of hypoperfusion, measured by gastric tonometry. The release of intestinal cell damage and inflammation markers will be correlated with the amount of blood loss, duration and extension of surgery.

—

Secondary

Measure	Time frame
Secondary outcome measurements will consist of duration of intensive care unit stay, postoperative onset of feeding, use of antibiotics.	—

Countries

Netherlands

Outcome results