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van CCT (UK)

van CCT (UK)

Stimuleren van het onwillekeurige zenuwstelsel bij patienten die een darmoperatie ondergaan.

- candidate number9362
- NTR NumberNTR2867
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR26-apr-2011
- Secondary IDs08-T-70 METC
- Public TitleStimuleren van het onwillekeurige zenuwstelsel bij patienten die een darmoperatie ondergaan.
- Scientific TitleStimulation of the autonomic nervous system in colorectal surgery.
- hypothesisChewing gum before and directly after colorectal surgery stimulates the autonomic nervous system leading to an antiinflammatory effect.
- Healt Condition(s) or Problem(s) studiedPostoperative ileus, Colorectal surgery, Enteral nutrition, Intestinal damage, Inflammation
- Inclusion criteria1. Resectable colorectal carcinoma;
2. Age >18 years.
- Exclusion criteria1. Previous esofageal/ stomach surgery;
2. Neurological disorders influencing acetylcholine metabolism;
3. Use of SSRI;
4. Depression;
5. Inflammatory bowel disease;
6. Medication influencing gut motility;
7. Allergy for mint;
8. Metastatic disease;
9. Stoma.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 3-okt-2008
- planned closingdate1-dec-2012
- Target number of participants120
- InterventionsIntervention group: PatiŽnts will receive chewing gum pre-operative from the moment they are sober untill the operation. They will start again four hours after the operation untill normal food is again taken.
Control groups: These patiŽnts will receive a plaster as a placebo.
- Primary outcome1. Lenght of stay;
2. Time to first flatus/ defaecation;
3. Infectious complications.
- Secondary outcome1. Effect on inflammation (cytokines);
2. Effect on intestinal damage;
3. Effect on gastrointestinal passage (ultrasound);
4. Morbidity and mortality.
- TimepointsBlood samples: 2u, 4u, 6u, 12u, 24u, 48u;
Ultrasound: Day 2.
- Trial web siteN/A
- statusopen: patient inclusion
- Sponsor/Initiator Orbis Medisch Centrum, Catharina Hospital Eindhoven
- Funding
(Source(s) of Monetary or Material Support)
Catharina Hospital Eindhoven, Orbis Medisch Centrum
- PublicationsN/A
- Brief summaryWe hypothesized that stimulation of the autonomic nervos system via de vagal nerve reduces the postoperative inflammatory response after colorectal surgery. In this way, complications such as postoperative ileus will be reduced and recovery after surgery is enhanced. Experimental studies already showed that vagal nerve stimulation reduces postoperative ileus and decreases the inflammatory response following hemorrhagic shock, endotoxemia and ischemia/ reperfusion. Stimulation of the autonomic nervous system releases acetylcholine that binds to nictotinic receptors located on inflammatory cells. Hereby, production of inflammatory mediators is directly inhibited. It is thought that the chewing of gum activates the autonomic nervous system vai de vagus nerve. Patients undergoing colorectal surgery will be included in this study and divided into two groups. Group one will receive chewing gum three hours preoperatively until time of surgery. Three hours postoperatively chewing gum will be distributed again to the patients until the start of enteral nutrition. All patients in group two, the placebo controlled group, will receive a dermal patch three hours preoperatively. This dermal patch will be removed until the first moment of oral nutrition is achieved. Preoperatively the vagal activity of all patients will be measured by variation of the heartbeat via blood pressure measurements, electrocardiographs and impedance cardiographs.

Primary study parameters/outcome of the study: Length of hospital stay, occurrence of postoperative ileus.
Secundary study parameters/outcome of the study: Inflammatory cytokines and acute phase proteins (TNF-alpha, IL-6, CRP). Mediators of the inflammatory response in bowel tissue. Expression of nitric oxide synthases and their precursor arginine in plasma. The effect on tissue damage in the bowel, specified by measuring tissue damage markers in plasma and specifying bowel damage in the removed specimens and 24h-urine. Morbidity and mortality.
- Main changes (audit trail)
- RECORD26-apr-2011 - 6-mei-2011

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