2025-523094-42-00招募中3 期
Effects of butyrate enemas on postoperative intestinal motility disorders in Hirschsprung’s disease
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 58
- 试验地点
- 20
- 主要终点
- Time to recovery of bowel function after the curative surgery
研究概览
简要总结
Assess the short-term efficacy of preoperative butyrate enemas at reducing the time to recovery of bowel function after curative surgery in HD patients.
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Newborn with a diagnosis of Hirschsprung’s disease the 2 first months of life managed successfully with colonic decompressions/irrigations before curative surgery
- •Born at or after 35 weeks of gestation (37 weeks of amenorrhea)
- •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)
- •Uncomplicated form (without enterocolitis as defined by the HAEC score 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
排除标准
- •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)
- •Neonates under tutorship or guardianship
研究组 & 干预措施
-
Auxiliary
Participants receiving -
干预措施: - (Drug)
结局指标
主要结局
Time to recovery of bowel function after the curative surgery
Time to recovery of bowel function after the curative surgery
次要结局
- Assessmenof postoperative functional intestinal obstructive symptoms
- Stool consistency evaluated using the validated ‘Bristol’ stool form scale modified for children
- Red carmine total intestinal transit time measured
- HAEC episode(s) defined by the HAEC score (Pastor et al., 2009; Frykman et al., 2017) and grading of HAEC (Gosain et al, 2017).
- Fecal calprotectin measurement
研究者
Pediatric surgeon
Scientific
Assistance Publique Hopitaux De Marseille
研究点 (20)
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