A Trial on Conservative Treatment for Infants' Hirschsprung Disease

A Prospective, Randomized Controlled Trial of Conservative Versus Surgery Treatment of Normal and Short-segment Hirschsprung Disease for Infants

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01985646

Enrollment

Registered

2013-11-15

Start date

2009-10-31

Completion date

Unknown

Last updated

2013-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hirschsprung Disease

Keywords

Hirschsprung disease, conservative treatment, surgery treatment, infants

Brief summary

The present study was designed to compare the efficacy of conservative treatment to operative treatment for improvement of constipation symptoms in infants with short or normal-segment Hirschsprung disease.

Interventions

PROCEDUREsurgery treatment

one staged pull-through left-colectomy

BEHAVIORALanal dilation

anal dilation

BEHAVIORALcolonic lavage

colonic lavage

DRUGoral probiotic

oral probiotic

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 3 Months

Healthy volunteers

Inclusion criteria

* Hard or firm stools for twice or less per week * Age were from newborn to 3 months * Histochemical acetylcholinesterase reaction (AChE) in rectal mucosa was positive * The narrowed distal bowel on barium enema was characterized as normal or short-segment Hirschsprung disease with a 24h barium retention

Exclusion criteria

* Children \>3months of age * Patients presented severe inflammation or malnutrition, unconsciousness, and symptoms of a ruptured hollow viscus * Barium enema showed long-segment or total colonic aganglionic bowel

Design outcomes

Primary

Measure	Time frame	Description
the change of defecation frequence	6~12 months	the changes of defecation frequence at 6\ 12 months after treatment

Secondary

Measure	Time frame	Description
stool pattern	6~12 months	stool pattern as Forming soft stool or Loose stool
controlling defecation ability	6~12 months	whether patients' controlling of defecation be better or not after treatment
complications	6~12 months	complications were suffered by patients or not, such as enterolitis, anastomotic stenosis etc.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026