A Phase 3 interventional study of Sham stimulation and Vagus stimulation in Postoperative Ileus, sponsored by KU Leuven. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-10.
Sponsored by KU Leuven · Phase 3, Interventional, and Treatment
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:
167 studies on the registry are indexed under Ileus; 23 are open to participants now.
This study's enrollment of 130 is above the median of 90 across 138 interventional studies indexed under Ileus.
Browse Ileus studies →KU Leuven is the lead sponsor of 373 studies on the registry; 65 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
no stimulation of vagus nerve
Procedure: Sham stimulation
Stimulation of the vagus nerve at the beginning and the end of the surgery
Procedure: Vagus stimulation
Sham stimulation
Vagus stimulation
The gastrointestinal transit (geometric mean)
Time frame: From postoperative day 3 until postoperative day 7
Gastric stasis (volume of gastric fluid produced by gastric tube on postoperative day 1
Time frame: From the date of surgery until postoperative day 1
Time to first flatus
Time frame: From the date of surgery until the date of discharge from the hospital (on average 14 days)
Time to tolerance of oral food intake
Time frame: 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
Time frame: From the date of surgery until the date of discharge from the hospital (on average 14 days)
Time to first defecation
Time frame: From the date of surgery until the date of discharge from the hospital (on average 14 days)
Gastrointestinal symptoms (nausea, pain, vomiting, bloating)
Time frame: From the date of surgery until the date of discharge from the hospital (on average 14 days)
Time to discharge from the hospital
Time frame: 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
Time frame: From the date of surgery until the date of lab analysis (up to 6 months)
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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