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| Name | Class |
|---|---|
| Universitaire Ziekenhuizen KU Leuven | OTHER |
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Hypothesis:
Electrical stimulation of the abdominal vagus nerve has an anti-inflammatory effect and represents a new therapeutic approach to shorten postoperative ileus.
Aims:
In the present pilot study, the investigators want to evaluate the anti-inflammatory effect of peroperative electrical stimulation of the vagus nerve. To this end, the following aims are formulated:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham stimulation | No Intervention | No stimulation of nervus vagus | |
| Vagus stimulation 1 | Active Comparator | 2 times 2 minutes (beginning and end of surgery) stimulation at 5 Hz, 500 micro s, 2.5 mA |
|
| Vagus stimulation 2 | Active Comparator | 2 times 2 minutes (beginning and end of surgery) stimulation at 20 Hz, 500 micro s, 2.5 mA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vagus stimulation 1 | Procedure | 2 times 2 minutes (beginning and end of surgery) stimulation at 5 Hz, 500 micro s, 2.5 mA |
|
| Measure | Description | Time Frame |
|---|---|---|
| levels of pro-inflammatory cytokines in serum, peritoneal lavage and supernatant of stimulated PBMCs (peripheral blood mononuclear cell) | From date of surgery until the date of lab analysis (in short time period after taking the blood sample) .Blood samples will be taken before surgery, 2, 24 and 48 hrs after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| gastric stasis (volume of gastric fluid produced by gastric tube on postoperative day 1) | From date of surgery until postoperative day 1. | |
| time to first flatus | From date of surgery until the date of discharge from the hospital. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guy Boeckxstaens, M.D. | Catholic University Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University hospitals Leuven | Leuven | Vlaams-Brabant | 3000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10486602 | Background | Kalff JC, Buchholz BM, Eskandari MK, Hierholzer C, Schraut WH, Simmons RL, Bauer AJ. Biphasic response to gut manipulation and temporal correlation of cellular infiltrates and muscle dysfunction in rat. Surgery. 1999 Sep;126(3):498-509. | |
| 9833803 | Background | Kalff JC, Schraut WH, Simmons RL, Bauer AJ. Surgical manipulation of the gut elicits an intestinal muscularis inflammatory response resulting in postsurgical ileus. Ann Surg. 1998 Nov;228(5):652-63. doi: 10.1097/00000658-199811000-00004. |
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| Vagus stimulation 2 | Procedure | 2 times 2 minutes (beginning and end of surgery) stimulation at 20 Hz, 500 micro s, 2.5 mA |
|
| time to tolerance of oral food intake | From date of surgery until the date of discharge from the hospital |
| time to tolerance of oral food intake AND first defecation | From date of surgery until the date of discharge from the hospital |
| gastrointestinal symptoms (nausea, pain, bloating) | From date of surgery until the date of discharge from the hospital |
| Time to first defecation | From date of surgery until the date of discharge from the hospital. |
| 26011782 | Derived | Peters EG, De Jonge WJ, Smeets BJ, Luyer MD. The contribution of mast cells to postoperative ileus in experimental and clinical studies. Neurogastroenterol Motil. 2015 Jun;27(6):743-9. doi: 10.1111/nmo.12579. |