Enema versus high doses of PEG 3350 in the treatment of rectal faecal impaction
| ISRCTN | ISRCTN71579145 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN71579145 |
| Secondary identifying numbers | NTR602 |
- Submission date
- 08/03/2006
- Registration date
- 08/03/2006
- Last edited
- 16/04/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
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 M A Benninga
Scientific
Scientific
Academic Medical Centre (AMC)
Department of Pediatrics
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
| Phone | +31 (0)20 566 3053 |
|---|---|
| m.a.benninga@amc.nl |
Study information
| Study design | Prospective randomised controlled study with a non-inferiority design |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | The Leopard study |
| Study objectives | 1. High dose of PEG is more effective and more tolerable in the treatment of faecal impaction compared to rectal enemas 2. Faecal impaction results in a delayed colonic transit time, which will improve during successful disimpaction |
| Ethics approval(s) | Received from the local ethics committee |
| Health condition(s) or problem(s) studied | Constipation |
| Intervention | At intake a standardised questionnaire is obtained by a physician from the parents and patient. Physical examination, including abdominal and rectal examination is acquired by the physician to define the presence of faecal impaction. Faecal impaction is defined as a large faecal mass of hard stools in the rectum. After intake, on 6 consecutive days, all patients will ingest one capsule with 10 radio-opaque markers to assess the colonic transit time. During these days, no laxative medication will be given and a diary is filled out by child and parents. On day 7 an abdominal radiograph is obtained. Subsequently on day 8 the disimpaction therapy will be started with either 6 days of enemas or 6 days of PEG, according to randomisation. A diary is filled out by the child and the parents. This diary concerns topics on defecation pattern, faecal incontinence, abdominal pain and possible side effects of administered medications. During this study period the colonic transit time will be measured again, according to the above described method. On day 14, a second abdominal radiograph is obtained to measure colonic transit time. The presence or absence of faecal impaction is assessed by abdominal and rectal examination as well as by the second abdominal X-ray. Thereafter, all patients receive laxative medication (enemas or PEG 3350) according to their defaecation pattern and symptoms. A second follow-up visit will be scheduled on day 28 and diaries will be reviewed regarding symptoms and possible adverse effects. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | PEG 3350 |
| Primary outcome measure | Rectal faecal impaction evaluated by rectal examination/abdominal x-ray. |
| Secondary outcome measures | 1. Defaecation frequency/week 2. Faecal incontinence frequency/week 3. The number of side effects, such as abdominal pain, bloating, flatulence, nausea, bad taste 4. Total and segmental colonic transit time |
| Overall study start date | 01/01/2006 |
| Completion date | 01/08/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 4 Years |
| Upper age limit | 18 Years |
| Sex | Both |
| Target number of participants | 90 |
| Key inclusion criteria | 1. Aged 4 - 18 years 2. Faecal impaction upon rectal exam |
| Key exclusion criteria | 1. Previous colonic surgery 2. Organic cause of constipation 3. Allergy/sensitivity to PEG solutions or phosphates 4. Allergy/sensitivity to sodium ducosate or sorbitol ('Klyx' enema) |
| Date of first enrolment | 01/01/2006 |
| Date of final enrolment | 01/08/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Centre (AMC)
Amsterdam
1100 DD
Netherlands
1100 DD
Netherlands
Sponsor information
Academic Medical Centre (AMC) (Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Pediatrics
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
| Website | http://www.amc.uva.nl |
|---|---|
"ROR" |
https://ror.org/03t4gr691 |
Funders
Funder type
Hospital/treatment centre
Academic Medical Centre (AMC) (Netherlands) - Department of Pediatrics
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 |
