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| Name | Class |
|---|---|
| Universitaire Ziekenhuizen KU Leuven | OTHER |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham stimulation | Sham Comparator | no stimulation of vagus nerve |
|
| Vagus stimulation | Active Comparator | Stimulation of the vagus nerve at the beginning and the end of the surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sham stimulation | Procedure | Sham stimulation |
| |
| Vagus stimulation |
| Measure | Description | Time Frame |
|---|---|---|
| The gastrointestinal transit (geometric mean) | From postoperative day 3 until postoperative day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Gastric stasis (volume of gastric fluid produced by gastric tube on postoperative day 1 | From the date of surgery until postoperative day 1 | |
| Time to first flatus | From the date of surgery until the date of discharge from the hospital (on average 14 days) |
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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 | 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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| ID | Term |
|---|---|
| D055536 | Vagus Nerve Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
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| Procedure |
Vagus stimulation |
|
| 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) |
| Time to first defecation | From the date of surgery until the date of discharge from the hospital (on average 14 days) |
| 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) |