|- candidate number||9362|
|- NTR Number||NTR2867|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||26-apr-2011|
|- Secondary IDs||08-T-70 METC|
|- Public Title||Stimuleren van het onwillekeurige zenuwstelsel bij patienten die een darmoperatie ondergaan.|
|- Scientific Title||Stimulation of the autonomic nervous system in colorectal surgery.|
|- hypothesis||Chewing gum before and directly after colorectal surgery stimulates the autonomic nervous system leading to an antiinflammatory effect.|
|- Healt Condition(s) or Problem(s) studied||Postoperative ileus, Colorectal surgery, Enteral nutrition, Intestinal damage, Inflammation|
|- Inclusion criteria||1. Resectable colorectal carcinoma;|
2. Age >18 years.
|- Exclusion criteria||1. Previous esofageal/ stomach surgery;|
2. Neurological disorders influencing acetylcholine metabolism;
3. Use of SSRI;
5. Inflammatory bowel disease;
6. Medication influencing gut motility;
7. Allergy for mint;
8. Metastatic disease;
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||3-okt-2008|
|- planned closingdate||1-dec-2012|
|- Target number of participants||120|
|- Interventions||Intervention 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 outcome||1. Lenght of stay;|
2. Time to first flatus/ defaecation;
3. Infectious complications.
|- Secondary outcome||1. Effect on inflammation (cytokines);|
2. Effect on intestinal damage;
3. Effect on gastrointestinal passage (ultrasound);
4. Morbidity and mortality.
|- Timepoints||Blood samples: 2u, 4u, 6u, 12u, 24u, 48u;|
Ultrasound: Day 2.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Misha Luyer|
|- CONTACT for SCIENTIFIC QUERIES|| Misha Luyer|
|- Sponsor/Initiator ||Orbis Medisch Centrum, Catharina Hospital Eindhoven|
(Source(s) of Monetary or Material Support)
|Catharina Hospital Eindhoven, , Orbis Medisch Centrum|
|- Brief summary||We 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)|
|- RECORD||26-apr-2011 - 6-mei-2011|