Postoperative Ileus
Conditions
Keywords
Vagus nerve stimulation, Postoperative ileus
Brief summary
Hypothesis: Electrical stimulation of the abdominal vagus nerve has anti-inflammatory effects which lead to a faster postoperative recovery after abdominal surgery. Aims: In the present study, the investigators want evaluate the anti-inflammatory effect of peroperative electrical stimulation of the vagus nerve. In addition, the investigators want to determine whether vagus nerve stimulation leads to a faster postoperative recovery. To this end, the following aims are formulated: 1. to determine whether vagus nerve stimulation leads to an improvement in gastrointestinal transit using radiological testing 2. to evaluate whether electrical stimulation of the vagus nerve leads to clinical improvement (daily questionnaire) 3. to show that electrical stimulation of the intra-abdominal vagus nerve reduces the inflammatory response to abdominal surgery
Interventions
PROCEDURESham stimulation
Sham stimulation
PROCEDUREVagus stimulation
Vagus stimulation
Sponsors
Universitaire Ziekenhuizen KU Leuven
KU Leuven
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients with ovarium, pancreas or colorectal carcinoma eligible for resection
Exclusion criteria
* preoperative therapeutic abdominal radiation shorter than 2 weeks prior to surgery * evident intra-abdominal inflammation (diagnosed by imaging and/or laboratory test results, including abscess or cholecystitis) * American Society of Anesthesiologists physical-health status classification (ASA-PS) \> 3 * poorly regulated diabetes (\> 200 mg/dl (= 11 mmol/l) * surgery due to chronic pancreatitis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The gastrointestinal transit (geometric mean) | From postoperative day 3 until postoperative day 7 |
Secondary
| Measure | Time frame |
|---|---|
| Time to first flatus | From the date of surgery until the date of discharge from the hospital (on average 14 days) |
| Time to tolerance of oral food intake | From the date of surgery until the date of discharge from the hospital (on average 14 days) |
| Time to tolerance of oral food intake and first defecation | From the date of surgery until the date of discharge from the hospital (on average 14 days) |
| Gastric stasis (volume of gastric fluid produced by gastric tube on postoperative day 1 | From the date of surgery until postoperative day 1 |
| Gastrointestinal symptoms (nausea, pain, vomiting, bloating) | From the date of surgery until the date of discharge from the hospital (on average 14 days) |
| Time to discharge from the hospital | From the date of surgery until the date of discharge from the hospital (on average 14 days) |
| Levels of pro-inflammatory cytokines in intestinal tissue, serum, peritoneal lavage and supernatant of stimulated whole blood | From the date of surgery until the date of lab analysis (up to 6 months) |
| Time to first defecation | From the date of surgery until the date of discharge from the hospital (on average 14 days) |
Countries
Belgium
Outcome results
None listed