Effects of Butyrate Enemas on Postoperative Intestinal Mobility Disorders in Hirschsprung's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03660176
• Date of registration: 04/09/2018
• Prospective Registration: Yes
• Primary sponsor: Assistance Publique Hopitaux De Marseille
• Public title: Effects of Butyrate Enemas on Postoperative Intestinal Mobility Disorders in Hirschsprung's Disease Buty-Hirsch
• Scientific title: Effects of Butyrate Enemas on Postoperative Intestinal Mobility Disorders in Hirschsprung's
• Date of first enrolment: January 2, 2019
• Target sample size: 58
• Recruitment status: Not yet recruiting
• URL: https://clinicaltrials.gov/show/NCT03660176
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

France

Contacts

• Name: ANNE DARIEL, MD

• Name: EMILIE GARRIDO PRADALIE
• Affiliation: APHM

Key inclusion & exclusion criteria

Inclusion Criteria:

- Newborn with a diagnosis of Hirschsprung's disease the 2 first months of life,

- Born at or after 35 weeks of gestation (37 weeks of amenorrhea),

- With a short-segment Hirschsprung's disease limited to the rectum and/or sigmoid colon
diagnosed on rectal biopsy with established pathological criteria (absence of
ganglionic cells +/- hypertrophic extrinsic nerve fibres) (Kapur, Sem Ped Surg 2009),

- Managed successfully with colonic decompressions/irrigations before curative surgery
(usually performed 2-3 times a day),

- Uncomplicated form (without enterocolitis and/or diverting colostomy),

- Curative surgery and follow-up in one of the included centres,

- With consent of the 2 parents or legal(s) representative(s),

- Absence of severe or lethal associated malformations,

- Affiliation with the French social security system.

Exclusion Criteria:

- - Long segment Hirschsprung's disease prior to the junction between the left colon and
the sigmoid colon,

- Hirschsprung's disease not managed successfully with colonic
decompressions/irrigations and requiring a diverting colostomy before the curative
surgery,

- Hirschsprung-associated enterocolitis occurring before the randomization,

- Severe or lethal associated malformation, including Down syndrome,

- Intestinal associated malformations (intestinal atresia, gastroschisis, omphalocele,
intestinal malrotation and volvulus),

- Any pathological condition that can modify intestinal motility or intestinal transit
time (cystic fibrosis, hypothyroidism),

- Refusal of parent(s) or legal representative(s).

- Patients under curatorship or tutorship



Age minimum: N/A
Age maximum: 17 Years
Gender: All

Health Condition(s) or Problem(s) studied

Hirschsprung's Disease

Intervention(s)

Other: routine management

Drug: butyrate enemas + routine management

Primary Outcome(s)

The time to recovery of bowel function after the curative surgery. A 25% decrease of the time to recovery of bowel function in the experimental group as compared to the control group will be considered as clinically effective. [Time Frame: 5 YEARS]

Secondary Outcome(s)

The postoperative medium/long-term efficacy of butyrate enemas [Time Frame: 5 YEARS]

The red carmin total transit time will be measured before the surgery [Time Frame: 5 YEARS]

Secondary ID(s)

2018-02

Source(s) of Monetary Support

Please refer to primary and secondary sponsors