Condition category
Surgery
Date applied
04/08/2005
Date assigned
04/08/2005
Last edited
10/06/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.amc.uva.nl/

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

Publication citations

Additional files

Editorial Notes