Effect of Zinc Supplementation on Gastrointestinal Mucosal Integrity of Colonic Surgery in Pediatrics: a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- CBC
研究概览
简要总结
The goal of this randomized controlled clinical trial is to evaluate the role of perioperative zinc supplementation on postoperative outcomes (specifically gastrointestinal mucosal integrity and inflammation) in children aged 1 month to 18 years undergoing elective or semi-urgent colonic surgery with anastomosis.
The main questions it aims to answer are:
- Does perioperative zinc supplementation significantly optimize complete blood count (CBC) parameters, serum C-reactive protein (CRP), and serum zinc levels at 48 hours and 5 days postoperatively?
- Does zinc supplementation improve secondary clinical outcomes, such as wound healing scores on day 7, time to full enteral feeds, and length of hospital stay? Researcher will compare Group A (routine postoperative care plus perioperative zinc supplementation) to Group B (routine postoperative care only) to see if the zinc supplement enhances gut integrity, downregulates systemic inflammation, and reduces postoperative clinical complications.
Participants will:
- Undergo their scheduled elective or semi-urgent colonic surgery with anastomosis.
- Be randomly assigned to receive either routine postoperative care alone or routine care supplemented with perioperative zinc.
- Provide blood samples at baseline (preoperatively), 48 hours postoperatively, and 5 days postoperatively for sequential monitoring of CBC, CRP, and serum zinc levels.
- Undergo clinical and ward assessments during hospitalization until day 7 to monitor clinical parameters (e.g., fever, timing of passage of stool/gases) and wound healing scores.
详细描述
This study is a single-center, single-blinded, parallel-group randomized controlled clinical trial conducted at Nile of Hope Hospital for Pediatric Congenital Anomalies Surgery in Alexandria, Egypt.
- Pathophysiology & Rationale: Pediatric colonic surgical procedures-indicated for conditions such as Hirschsprung disease, anorectal malformations, colonic atresia, colonic resections, or colostomy closures-trigger a complex, multi-phase intestinal mucosal healing response involving initial inflammation, cell proliferation, and tissue remodeling. Impaired healing increases the risk of severe complications such as anastomotic leaks and surgical site infections, necessitating prolonged parenteral nutrition and intensive supportive care. Zinc is a critical trace element in maintaining gastrointestinal mucosal barrier integrity. It stabilizes epithelial cell tight junctions, diminishes intestinal permeability, and protects against oxidative tissue damage via antioxidant enzyme activation (e.g., superoxide dismutase and metallothioneins). Following surgical trauma, circulating serum zinc levels typically decline due to systemic inflammatory redistribution, accelerated urinary excretion, and temporary cessation of oral intake. Concurrently, acute-phase inflammatory markers such as C-reactive protein (CRP)-regulated primarily by interleukin-6 (IL-6)-and complete blood count (CBC) inflammatory indices (e.g., white blood cell count and neutrophil-to-lymphocyte ratio) rise.
Perioperative zinc supplementation is hypothesized to mitigate this inflammatory surge, downregulate pro-inflammatory cytokine activity (including TNF-alpha and IL-6), accelerate mucosal re-epithelialization, and improve systemic and local surgical recovery.
- Randomization, Allocation & Blinding: Eligible pediatric patients undergoing elective or semi-urgent colonic surgery with anastomosis are enrolled via consecutive screening. Participants are allocated in a 1:1 ratio using a computer-generated permuted block randomization sequence, stratified by age group and specific type of colonic surgery.
- This trial utilizes a single-blind design:
Unblinded personnel: Caregivers, ward nurses, and treating clinicians manage drug administration and direct patient care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Month 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 1 month to 18 years.
- •Undergoing elective or semi urgent colonic surgery with anastomosis (e.g., Hirschsprung's disease, anorectal malformations, colonic atresia, colonic resection, closure of colostomy).
- •Parent/guardian able to give informed consent and agree to follow-up.
排除标准
- •Preoperative serum zinc deficiency
- •Development of major postoperative surgical complications that would interfere with the intervention or outcome assessment.
- •Known severe renal impairment (eGFR below local pediatric threshold).
- •Known severe hepatic failure.
- •Current participation in another interventional trial that would interfere with outcomes.
- •Immunodeficiency (primary or secondary) or neutropenia (because of atypical healing responses).
- •Neonates <1 month old (due to safety and dosing differences).
研究组 & 干预措施
Treatment Group
Group Receiving Perioperative Zinc Supplementation beside the standard care
干预措施: Perioperative Zinc Supplementation (Drug)
Control Group
Group receiving only standard care
结局指标
主要结局
CBC
时间窗: Baseline, 48 hrs post-surgery and 5 days post-surgery
Complete blood count
Zinc Level
时间窗: Baseline, 48 hrs post-surgery and 5 days post-surgery
CRP quantitative
时间窗: Baseline, 48 hrs post-surgery and 5 days post-surgery
次要结局
- Fever (°C)(Within 7 days post surgery)
- Wound healing score(On day 7 post-surgery)
- • Time to full enteral feeds (hours).(through study completion, an average of 1 year)
- Length of hospital stay (days)(Perioperative)
- Bowel movement return (Days)(Within 7 days post surgery)
- Need for reoperation (Days)(Within 7 days post-surgery)