Condition category
Digestive System
Date applied
08/03/2006
Date assigned
08/03/2006
Last edited
16/04/2009
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 M A Benninga

ORCID ID

Contact details

Academic Medical Centre (AMC)
Department of Pediatrics
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
+31 (0)20 566 3053
m.a.benninga@amc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR602

Study information

Scientific title

Acronym

The Leopard study

Study hypothesis

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

Received from the local ethics committee

Study design

Prospective randomised controlled study with a non-inferiority design

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Applicable

Drug names

PEG 3350

Primary outcome measures

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 trial start date

01/01/2006

Overall trial end date

01/08/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 4 - 18 years
2. Faecal impaction upon rectal exam

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

90

Participant 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)

Recruitment start date

01/01/2006

Recruitment end date

01/08/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

Academic Medical Centre (AMC)
Amsterdam
1100 DD
Netherlands

Sponsor information

Organisation

Academic Medical Centre (AMC) (Netherlands)

Sponsor details

Department of Pediatrics
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.amc.uva.nl

Funders

Funder type

Hospital/treatment centre

Funder name

Academic Medical Centre (AMC) (Netherlands) - Department of Pediatrics

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