The role of ketotifen in the treatment of post-operative ileus

ISRCTN	ISRCTN34927143
DOI	https://doi.org/10.1186/ISRCTN34927143
Protocol serial number	N/A
Sponsor	Academic Medical Center (AMC) (The Netherlands)
Funders	The Technology Foundation (Stichting voor de Technische Wetenschappen) (STW-NOW) (The Netherlands), Academic Medical Centre (AMC) (The Netherlands)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr G E E Boeckxstaens
Scientific

Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Phone	+31 (0)20 566 7375
Email	g.e.boeckxstaens@amc.uva.nl

Primary study design	Interventional
Study design	Randomised, placebo controlled, parallel group, double blinded trial
Secondary study design	Randomised controlled trial
Scientific title	The role of ketotifen, a mast-cell stabiliser, in the treatment of post-operative ileus
Study objectives	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(s)	Ethics approval received from the local ethics committee.
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Ketotifen
Primary outcome measure(s)	Gastric emptying.
Key secondary outcome measure(s)	Symptoms.
Completion date	01/01/2006

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	48
Key inclusion criteria	Laparotomy for (malignant) process originating from colon or female reproduction organs.
Key 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)
Date of first enrolment	01/04/2004
Date of final enrolment	01/01/2006

Meibergdreef 9

Amsterdam
1105 AZ
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan