Use of Beetroot Juice to Protect Against Postoperative Ileus (POI) Following Colorectal Surgery: a Pilot Study.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Time until recovery of gastrointestinal function.
研究概览
简要总结
The BEET IT study investigates the possible protective effect of beetroot juice on POI following colorectal surgery in (partially) blinded single-center phase 2 randomized trial (pilot study).
详细描述
Postoperative ileus (POI) is a transient impairment of gastrointestinal motility following abdominal surgery, which leads to increased morbidity, prolonged hospitalization and increased healthcare cost. The pathogenesis of POI involves inflammation and oxidative stress, similar to ischemia/reperfusion injury that can be counteracted with beetroot juice. Beetroot juice is a source of inorganic nitrate, which by conversion of nitrate to nitrite in the body, exerts its protective effect. We before demonstrated in a preclinical model that administration of exogenous nitrite was shown to protect against POI. The aim of this pilot study is to investigate the possible protective effect of beetroot juice ingestion on POI following colorectal surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
Patients undergoing colorectal surgery will be randomized (n=10) to receive one week daily 70 ml of beetroot juice (~ 7 mmol inorganic nitrate) or (n=10) an equivalent volume of nitrate-depleted beetroot juice (control group 1). An additional control group (n=10) is added to the pilot study, in which patients will receive an equivalent volume of water (control group 2); this allows us to investigate whether the antioxidants present in beetroot juice contribute to the protective effect of beetroot juice in POI. Beetroot juice and nitrate-depleted beetroot juice cause discoloration of urine (beeturia) and feces from the purple betacyanin pigments in beetroot; for the control group that receives water, this will not be the case and blinding for this group is thus not possible.
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients undergoing colonic or upper rectum laparoscopic surgery.
排除标准
- •Pregnancy or breast feeding
- •Psychiatric pathology capable of affecting comprehension and judgment faculty
- •History of metastatic disease
- •History of prior abdominal bowel surgery
- •Abdominal radiation treatment
- •Chronic constipation (defined as two or fewer bowel movements per week)
- •Gut motility influencing agents (e.g. tricyclic antidepressants, chronic use of laxatives)
- •Frequent use of mouthwash, as this affects the enterosalivary circulation of nitrate
- •Current use of broad-spectrum antibiotics, which will affect the oral flora and likely affect the nitrate reductase activity
- •More than one bowel anastomosis during this surgery
研究组 & 干预措施
Beetroot juice
干预措施: Beetroot juice (Dietary Supplement)
Control group 1
干预措施: Nitrate-depleted beetroot juice (Dietary Supplement)
Control group 2
干预措施: Water (Dietary Supplement)
结局指标
主要结局
Time until recovery of gastrointestinal function.
时间窗: up to 30 days after surgery
Recovery of gastrointestinal function is defined as the interval (in days) from the end of surgery until passage of stool AND tolerance of solid food.
次要结局
- Time until passage of stool, flatus or until tolerance of (semi-)solid oral diet (in days).(up to 30 days after surgery)
- Overall post-operative complication rate defined according to the Clavien-Dindo Classification.(3 months postoperatively)
- Presence of prolonged postoperative ileus.(up to 30 days after surgery)