Are enemas indicated for treatment of children with solitair encopresis?

ISRCTN	ISRCTN28937219
DOI	https://doi.org/10.1186/ISRCTN28937219
Protocol serial number	NTR65
Sponsor	Academic Medical Centre (AMC) (Netherlands)
Funder	Academic Medical Centre (AMC) (Netherlands)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr M A Benninga
Scientific

Academic Medical Centre
Pediatric Department
P.O. Box 22660
Amsterdam
1105 AZ
Netherlands

Phone	+31 (0)20 566 3053
Email	m.a.benninga@amc.nl

Primary study design	Interventional
Study design	Randomised open label active controlled parallel group trial
Secondary study design	Randomised controlled trial
Scientific title	Are enemas indicated for treatment of children with solitair encopresis?
Study objectives	The use of enemas will result in a empty rectum and no more soiling or encopresis. In this period these children will experience and get used to a clean feeling and the advantages. This might lead to a better motivation for treatment of solitair encopresis.
Ethics approval(s)	Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studied	Functional non-retentive faecal soiling
Intervention	Group one: enemas following a schedule during three months Group two: no laxantia, but education and toilet training The anticipated end date of this trial was increased to the 31st December 2006.
Intervention type	Other
Primary outcome measure(s)	1. Defecation frequency 2. Soiling/encopresis frequency 3. Stool consistency Patients will visit our out-patient visits for follow-up at several fixed moments: intake and t = one week, two weeks, four weeks, six weeks, 12 weeks, 6 months, 12 months. During this study, all patients will record in a specific diary on primary and secondary outcome measurements.
Key secondary outcome measure(s)	Tolerance of enemas: abdominal pain, painful defecation, nausea, vomiting, flatulency.
Completion date	01/03/2005

Participant type(s)	Patient
Age group	Child
Lower age limit	8 Years
Upper age limit	17 Years
Sex	All
Target sample size at registration	78
Total final enrolment	71
Key inclusion criteria	1. Aged 8 to 17 years 2. Functional Non-Retentive Faecal Soiling (FNRFS) criteria: 2.1. defaecation frequency three times a week 2.2. encopresis frequency more than once a week 2.3. no faecal impaction with physical examination
Key exclusion criteria	1. Gastro-intestinal surgery 2. Anorectal anomaly 3. Mental retardation 4. Constipation
Date of first enrolment	01/03/2002
Date of final enrolment	01/03/2005

Academic Medical Centre

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/05/2013	07/01/2021	Yes	No

07/01/2021: Publication reference and total final enrolment added.