Pediatric Outcomes and Recovery With Peri-Operative Iron Supplement Evaluation (PORPOISE)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Decreased incidence of blood transfusion
研究概览
简要总结
Varus-derotation osteotomy (VDRO) is a surgery to prevent or address hip displacement in children. Many children having this surgery have cerebral palsy or other neuromotor disorders, who have a higher rate of malnutrition, including low iron or anemia. This can affect their surgical outcomes, such as increasing their need for blood transfusions. This project aims to develop a preoperative nutritional program for VDRO patients, to improve their surgical outcomes and decrease their need for transfusions. This may include taking iron supplementation for patient with low iron or anemia. Participants will undergo a nutrition program before their surgery.
详细描述
Purpose:
The investigators aim to establish a multidisciplinary pathway for all patients scheduled for varus-derotation osteotomy (VDRO) surgery that incorporates comprehensive nutrition management and iron deficiency anemia assessment and management. The goal is to determine whether patients with nutritional optimization will experience improved care, including a decreased risk of adverse outcomes and improved surgical outcomes.
Hypothesis:
The primary hypothesis is that a comprehensive nutritional prehabilitation intervention for iron deficiency anemia before pediatric varus-derotational osteotomy (VDRO) surgery will decrease the risk blood transfusion, as shown by a lower incidence of blood transfusions, during the preoperative period. The investigators also aim to show that this program will improve other perioperative surgical outcomes and will be feasible and acceptable to families.
Justification:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 0 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients scheduled for VDRO and/or pelvic osteotomy surgery (prospective cohort)
- •All patients who had VDRO and/or pelvic osteotomy surgery between February 2022 and December 2024 (historical cohort)
- •Ages 0-18 years old
- •Note that the investigators will include patients who do or do not have a diagnosis of a neuromotor condition. The investigators may not include patients who are enrolled in other conflicting research studies.
排除标准
- •Patients who have undergone a major surgical intervention in the last 3 months
- •Patients who have received a nutritional intervention that includes iron testing and treatment within the last 3 months
- •Patients in whom oral/enteral iron supplementation is contraindicated
- •Patients who have a bleeding disorder
- •Patients taking erythropoietin
- •Patients who cannot read and understand English*
- •Patients and their families who cannot read and understand English will be excluded from the study because the surveys and interviews are conducted in English. These patients will still have access to the same nutrition management and interventions as study participants.
研究组 & 干预措施
Prospective (Iron Supplementation)
Patients scheduled for VDRO and/or pelvic osteotomy surgery who are aged 0 to 18 years old (n = 50-60). Note that the investigators will include patients who do or do not have a diagnosis of a neuromotor condition. All patients will be evaluated by the dietitian and have screening lab work to evaluate for iron deficiency at initial consultation. If lab results show that iron supplementation is required, patients will be allocated to the iron supplementation arm and will receive a prescription for iron supplementation, education on non-pharmacological methods to enhance iron intake and comprehensive nutrition management.
干预措施: Comprehensive Nutrition Management (Dietary Supplement)
Historical
All patients who had VDRO and/or pelvic osteotomy surgery between February 2022 and December 2024 who are aged 0 to 18 years old (n = 100-120). These participants will be enrolled as comparators and receive no intervention, as their surgery has passed.
Prospective (No Iron Supplementation)
Patients scheduled for VDRO and/or pelvic osteotomy surgery who are aged 0 to 18 years old (n = 50-60). Note that the investigators will include patients who do or do not have a diagnosis of a neuromotor condition. All patients will be evaluated by the dietitian and have screening lab work to evaluate for iron deficiency at initial consultation. If lab results show adequate iron levels, patients will be allocated to the "no iron supplementation" arm and will only receive comprehensive nutrition management, without an iron supplementation prescription.
干预措施: Comprehensive Nutrition Management (Dietary Supplement)
Prospective (Iron Supplementation)
Patients scheduled for VDRO and/or pelvic osteotomy surgery who are aged 0 to 18 years old (n = 50-60). Note that the investigators will include patients who do or do not have a diagnosis of a neuromotor condition. All patients will be evaluated by the dietitian and have screening lab work to evaluate for iron deficiency at initial consultation. If lab results show that iron supplementation is required, patients will be allocated to the iron supplementation arm and will receive a prescription for iron supplementation, education on non-pharmacological methods to enhance iron intake and comprehensive nutrition management.
干预措施: Iron Supplement (Dietary Supplement)
结局指标
主要结局
Decreased incidence of blood transfusion
时间窗: From surgery start time to discharge from hospital.
A comprehensive nutritional prehabilitation intervention for iron deficiency anemia before pediatric VDRO surgery will decrease the risk of requiring a blood transfusion, as shown by a decreased incidence of blood transfusions, in the perioperative period.
Decreased incidence of blood transfusion
时间窗: From surgery start time to discharge from hospital.
A comprehensive nutritional prehabilitation intervention for iron deficiency anemia before pediatric VDRO surgery will decrease the risk of requiring a blood transfusion, as shown by a decreased incidence of blood transfusions, in the perioperative period.
次要结局
- Resolution of anemia(From baseline to 12 months post-op.)
- Increased Iron Levels(From baseline to 12 months post-op.)
- Lower incidence of surgical site infection and pressure wounds(From the day of surgery to 30 days post-op.)
- Decreased hospital length of stay(From the date of surgery until the date of hospital discharge.)
- Resolution of anemia(From baseline to 12 months post-op.)
- Increased Iron Levels(From baseline to 12 months post-op.)
- Lower incidence of surgical site infection and pressure wounds(From the day of surgery to 30 days post-op.)
- Decreased hospital length of stay(From the date of surgery until the date of hospital discharge.)
研究者
Teresa Skelton
Clinical Associate Professor
University of British Columbia