The Effect of a Pre- and Postoperative Oral Supplement of Arginine, Zinc and Vitamin C on Collagen Synthesis in Surgical Inguinal Hernia Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Changes in CICP levels in serum. CICP is the biomarker of type I collagen synthesis (carboxy-terminal propeptide of type I procollagen)
研究概览
简要总结
Collagen synthesis is depressed systemically in the immediate postoperative period. Arginine, zinc and vitamin C impact collagen synthesis.
The aim of this study is to investigate the effect of a pre and postoperative oral supplement consisting of arginine, zinc and vitamin C on collagen synthesis in patients undergoing inguinal hernia repair.
详细描述
The trial investigates the effect of a pre and postoperative oral supplement consisting of arginine, zinc and vitamin C on collagen type I synthesis in patients undergoing inguinal hernia repair.
The patients in the intervention group are given 55 mg zinc, 1251 mg vitamin C, and 15 g arginine once daily 14 days pre-operatively and post-operatively. Both groups receive high quality protein (1.5 g protein/kg body weight) daily during the same period. Hernia repair is done using the Lichtenstein technique. Drainage tubes are placed in the wound during the surgery. Epidermal wounds (10 mm) are made via the suction blister method on the ventral forearm of the patients on the day of surgery. Blood samples are drawn at day -14, day 0, day 1 and day 2. The surgical drain is emptied and fluid collected at day 1 and day 2.The healing of the suction blisters is assessed by clinical criteria until healing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age above 18 years
- •Patients undergoing hernia repair using the Lichtenstein technique
- •Written informed consent
排除标准
- •Former surgery in the same area within 5 years
- •Dysregulated diabetes
- •Systemic corticosteroid treatment
- •Liver disease
- •Kidney disease
- •Cancer within 5 years
- •Need of interpreter
研究组 & 干预措施
Control
Total daily protein intake: 1.5 g protein/kg body weight
干预措施: Control (Dietary Supplement)
Intervention
55 mg zinc/day, 1251 mg vitamin C/day, and 15 g arginine/day. Total daily protein intake: 1.5 g protein/kg body weight
干预措施: Intervention (Dietary Supplement)
结局指标
主要结局
Changes in CICP levels in serum. CICP is the biomarker of type I collagen synthesis (carboxy-terminal propeptide of type I procollagen)
时间窗: Day 2
CICP is measured by enzyme-linked immunosorbent assay
次要结局
- Changes in Zinc levels in wound fluid collected from suction blisters(Day 0)
- Healing of suction blisters(Day 3 to Suction Blister healing)
- Compliance(Day -14 to Suction Blister healing)
- Changes in CICP levels in wound fluid collected from suction blisters. CICP is the biomarker of type I collagen synthesis (carboxy-terminal propeptide of type I procollagen).(Day 0)
- Changes in Zinc levels in serum(Day -14, day 0, day 1 and day 2)
- Changes in Zinc levels in wound fluid collected from surgical drain(Day 1 and day 2)
- Changes in CICP levels in wound fluid collected from surgical drain. CICP is the biomarker of type I collagen synthesis (carboxy-terminal propeptide of type I procollagen).(Day 1 and day 2)
- Changes in Arginine levels in serum(Day -14, day 0, day 1 and day 2)
研究者
Lars Nannestad Jorgensen
Professor, MD, DrMedSci
Bispebjerg Hospital