Preliminary Results of Laparoscopic Assisted Transanal Proximal Rectosigmoidectomy Combined With Malone Antegrade Continence Enema for the Management of Intractable Functional Constipation in Children
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- soiling
研究概览
简要总结
Technique for surgical management of intractable functional constipation
详细描述
Background: Intractable functional constipation (IFC) in children poses a significant clinical challenge when standard medical interventions are unsuccessful. The laparoscopic-assisted transanal proximal rectosigmoidectomy (LATPRS) procedure is a surgical option that combines the precision of laparoscopic techniques with the functional benefits of transanal dissection.
Patients and methods: A prospective trial was conducted at Al-Azhar pediatric surgery departments from January 2022 to January 2025, with a focus on children diagnosed with IFC. Each participant underwent LATPRS combined with a Malone Antegrade continence enema (MACE). The comprehensive data collection process included patient demographics, surgical details, postoperative recovery, complications, and functional outcomes. These data were recorded and subsequently analysed. Furthermore, a validated symptom severity (SS) scoring system and the Pediatric Quality of Life Inventory (PedsQoL) were employed to assess outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged four years or older with intractable functional constipation
- •Documented BMP failure, defined as persistent fecal impaction, chronic dependence on laxatives, or intolerance to enemas despite prolonged conservative therapy.
排除标准
- •Patients with a history of abdominal surgery or
- •Identifiable organic causes for constipation and soiling (e.g., Hirschsprung's disease, anorectal malformations, or metabolic disorders) .
研究组 & 干预措施
children diagnosed with IFC
. Each participant underwent LATPRS combined with a Malone Antegrade continence enema (MACE)
干预措施: laparoscopic assisted transanal proximal rectosigmoidectomy (Procedure)
结局指标
主要结局
soiling
时间窗: 3 years
Number of soiling episodes in pre-operative and post-operative period. Soiling refers to the inadvertent passage of fecal material into inappropriate places, such as underwear or other clothing.
soiling
时间窗: 3 years
Number of soiling episodes in pre-operative and post-operative period. Soiling refers to the inadvertent passage of fecal material into inappropriate places, such as underwear or other clothing.
次要结局
- symptoms severity score(3 years)
- symptoms severity score(3 years)
- The Pediatric Quality of Life Inventory (The PedsQoL™ questionnaires)(3 years)
研究者
Mohamed Abdelmaboud
Assistant professor of pediatric surgery
Al-Azhar University