Clinical trial: Effects of Butyrate Enemas on Postoperative Intestinal Mobility Disorders in Hirschsprung's Disease (NCT03660176)

Eligibility 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
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.

Subject must be at most 17 Years

Patient description (medical language): A 7-month-old boy is brought to emergency by his parents due to irritability and inability to defecate for the past 3 days.  The patient has had constipation and discomfort with bowel movements since birth.  His symptoms worsened after eating semi-solid foods.  Vital signs are normal.  Abdominal examination shows distension and tenderness to palpation with presence of bowel sounds.  Xray with barium shows a narrow rectum and rectosigmoid area.  The rest of the colon proximal to this segment is dilated. Digital rectal exam revealed burst of feces out of the anus. The biopsy showed absence of submucosal ganglia in the last segment of the large intestine.

Patient description (patient's own words): My baby boy just turned 7 months old but my wife and I cannot get a hold of him! He has not been able to poop for 3 days! My poor little thing has been having constipation and bowel problems since birth. But since he ate some semi-solid food it has just been worse! The doctor said his vitals are normal but his belly is tense and tender with his bowels making noise. They did an X-ray and found out that he had a narrow rectum. His colon is dilated. They also performed a touch rectal exam and he could finally poop! The biopsy revealed that there is no submucosal ganglia in his large intestine.

Does the patient match the trial criteria? Contradiction