The role of ketotifen in the treatment of post-operative ileus
| ISRCTN | ISRCTN34927143 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN34927143 |
| Secondary identifying numbers | N/A |
- Submission date
- 04/08/2005
- Registration date
- 04/08/2005
- Last edited
- 10/06/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
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
Contact information
Dr G E E Boeckxstaens
Scientific
Scientific
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
| Phone | +31 (0)20 566 7375 |
|---|---|
| g.e.boeckxstaens@amc.uva.nl |
Study information
| Study design | Randomised, placebo controlled, parallel group, double blinded trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Ketotifen |
| Primary outcome measure | Gastric emptying. |
| Secondary outcome measures | Symptoms. |
| Overall study start date | 01/04/2004 |
| Completion date | 01/01/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
1105 AZ
Netherlands
Sponsor information
Academic Medical Center (AMC) (The Netherlands)
University/education
University/education
Emma Kinderziekenhuis
Postbus 22660
Amsterdam
1105 AZ
Netherlands
| Website | http://www.amc.uva.nl/ |
|---|---|
"ROR" |
https://ror.org/03t4gr691 |
Funders
Funder type
Research organisation
The Technology Foundation (Stichting voor de Technische Wetenschappen) (STW-NOW) (The Netherlands)
No information available
Academic Medical Centre (AMC) (The Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
