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The role of Ketotofen in the treatment of postoperative ileus.


- candidate number0
- NTR NumberNTR38
- ISRCTNISRCTN34927143
- Date ISRCTN created5-aug-2005
- date ISRCTN requested18-jul-2005
- Date Registered NTR2-jun-2005
- Secondary IDsN/A 
- Public TitleThe role of Ketotofen in the treatment of postoperative ileus.
- Scientific TitleThe role of Ketotofen, a mastcell stabilizer, in the treatment of postoperative ileus.
- ACRONYMN/A
- hypothesisN/A
- Healt Condition(s) or Problem(s) studiedPostoperative ileus
- Inclusion criteriaLaparotomy for (malignant) proces originaty from colon or female reproduction organs.
- Exclusion criteriaPre-operative radiation, intake of medication with effect on the Gastrointestinal motility, intake of immunosuppressiva, intake of anti-allergy medication, intra-abdominal inflammation (cholecystitis or absces included).
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-apr-2004
- planned closingdate1-jan-2006
- Target number of participants48
- InterventionsKetotofen 4 mg or 12 mg or placebo per day.
- Primary outcomeGastric emptying.
- Secondary outcomeSymptoms.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESDr. G.E.E. Boeckxstaens
- CONTACT for SCIENTIFIC QUERIESDr. G.E.E. Boeckxstaens
- Sponsor/Initiator Academic Medical Center (AMC), Motility Center, Department of Gastroenterology
- Funding
(Source(s) of Monetary or Material Support)
Stichting voor de Technische Wetenschappen (STW-NOW), Academic Medical Center (AMC), Department of Gastroenterology
- PublicationsN/A
- Brief summaryThis is a randomized, placebo-controlled, double-blind study with patients who'll undergo abdominal surgery. They will be treated with Ketotofen 4 mg or 12 mg or placebo per day. The patient will start his medication intake 3 days before surgery till 2 days after surgery. Post operative effectivity will be determined by scintigraphy to look at gastric retention and colontransit. This scintigraphy will take place 24 hours after surgery. The patients will be clinical evaluated by filling out a daily symptom score list.
- Main changes (audit trail)
- RECORD13-jul-2005 - 16-okt-2008


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