Contact information
Type
Scientific
Primary contact
Dr G E E Boeckxstaens
ORCID ID
Contact details
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
+31 (0)20 566 7375
g.e.boeckxstaens@amc.uva.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
The role of ketotifen, a mast-cell stabiliser, in the treatment of post-operative ileus
Acronym
Study hypothesis
This is a randomised, placebo-controlled, double-blind study with patients who will undergo abdominal surgery. They will be treated with ketotifen 4 mg or 12 mg or placebo per day. The patient will start his medication intake three days before surgery until two days after surgery. Post-operative effectivity will be determined by scintigraphy to look at gastric retention and colon transit. This scintigraphy will take place 24 hours after surgery. The patients will be clinical evaluated by filling out a daily symptom score list.
Ethics approval
Ethics approval received from the local ethics committee.
Study design
Randomised, placebo controlled, parallel group, double blinded trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Post-operative ileus
Intervention
Ketotifen 4 mg or 12 mg or placebo per day for three days before surgery until two days after surgery.
Intervention type
Drug
Phase
Not Specified
Drug names
Ketotifen
Primary outcome measures
Gastric emptying.
Secondary outcome measures
Symptoms.
Overall trial start date
01/04/2004
Overall trial end date
01/01/2006
Reason abandoned
Eligibility
Participant inclusion criteria
Laparotomy for (malignant) process originating from colon or female reproduction organs.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
48
Participant exclusion criteria
1. Pre-operative radiation
2. Intake of medication with effect on the gastrointestinal motility
3. Intake of immunosuppressives
4. Intake of anti-allergy medication
5. Intra-abdominal inflammation (cholecystitis or abscess included)
Recruitment start date
01/04/2004
Recruitment end date
01/01/2006
Locations
Countries of recruitment
Netherlands
Trial participating centre
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
Sponsor information
Organisation
Academic Medical Center (AMC) (The Netherlands)
Sponsor details
Emma Kinderziekenhuis
Postbus 22660
Amsterdam
1105 AZ
Netherlands
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
The Technology Foundation (Stichting voor de Technische Wetenschappen) (STW-NOW) (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Academic Medical Centre (AMC) (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary