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临床试验/NCT06036641
NCT06036641已完成不适用

The Effects of Prolonged Head-Down Tilt Lithotomy Position on Lower Limb Haemodynamics in Adults Undergoing Minimally Invasive Abdominopelvic Surgery: An Intraoperative Observational Study

University of Portsmouth2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2024年7月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
26
试验地点
2
主要终点
Cutaneous blood flow

研究概览

简要总结

During certain bowel surgeries for cancer (colorectal surgery), individuals frequently have to be placed in a head-down position to enable surgeons have optimal access to the cancer site. This position usually also involves bending the hips and knees while supporting the legs in stirrups. However, lying in this position for long periods of time can lower the flow of blood to the legs, which can potentially cause injury. This rare but severe consequence is called Well-Leg Compartment Syndrome (WLCS). If WLCS is not diagnosed quickly, it can lead to other difficult complications and a significant delay in recovery. Unfortunately, because the individual is under anaesthesia, diagnosis is delayed in many cases. There is very little information in the medical literature about how this damage to the legs progresses over the course of the surgery. To better understand how WLCS, how well blood vessels work during surgery will be assessed. The flow of blood and oxygen in the calf muscle will be assessed in 25 individuals placed in a head-down position during colorectal surgery. Likewise, blood samples will be obtained in order to measure the biological markers that may contribute to the development of WLCS.

详细描述

The development of lower limb compartment syndrome in the absence of trauma (known as well-leg compartment syndrome, WLCS) is a severe complication reported during prolonged pelvic surgery. WLCS is characterised by muscular ischaemia and secondary necrosis from the increase in hydrostatic pressure in a closed fascial compartment.

The aetiology of WLCS appears to be primarily related to ischaemia of the lower limbs after a prolonged period in the head-down tilt lithotomy (HDTL) position, which is commonly used to access the pelvis and perineum during urological, colorectal, and gynaecological surgery. Elevation of the lower limbs above the heart results in a ~2 mmHg drop in mean arterial pressure at the mid-calf for every 2.5 cm that the limbs are raised. These hemodynamic changes are accompanied by an increase in compartment pressures associated with limb elevation and are further exacerbated by a steep (>15°) head-down tilt. The outcome of these changes ultimately leads to the development of significant and (often unrecognised) intraoperative ischemia in the lower limbs.

Prolonged reductions in lower limb perfusion during HDTL can cause the development of localised tissue oedema, leading to marked intracompartmental hypertension, which is further exacerbated once the limbs are lowered and reperfusion of ischemic muscle occurs. This is a consequence known as ischaemic-reperfusion injury (IRI), a phenomenon where reperfusion per se may result in a local and systemic inflammatory response that may augment tissue injury in excess of that produced by ischaemia alone.

Microvascular injury is considered one of the major determinants of IRI, particularly due to increased permeability of capillaries and arterioles that lead to an increase in diffusion and fluid filtration across the tissues. Subsequently, activated endothelial cells produce more reactive oxygen species and less nitric oxide, and this imbalance results in a corresponding inflammatory response and increased oxidative stress, which if sufficiently severe lead to further lower limb muscle and nerve injury.

The incidence of WLCS is unpredictable and as the individual is anaesthetised, the diagnosis is delayed in many cases, so the residual motor-sensory deficit may be severe, even after fasciotomy. Although there are many published case reports of this condition, it is likely that many cases of WLCS go unreported, and some may be mild and escape clinical detection. However, in cases that have been reported, the incidence of permanent disability after the development of WLCS ranges from ≈30% to ≈100%.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults scheduled to undergo colorectal surgery in the HDTL position

排除标准

  • History of myocardial infarction or cerebro-vascular events in the last 12 months
  • Previous revascularisation procedure in their lower limbs
  • BMI > 40 kg/m2
  • Inability to give informed consent
  • Other serious medical conditions, which in the opinion of study investigators, would interfere with safety or data interpretation

研究组 & 干预措施

Colorectal surgery

Individuals scheduled for colorectal surgery in the HDTL position

干预措施: NIRS monitoring (Device)

Colorectal surgery

Individuals scheduled for colorectal surgery in the HDTL position

干预措施: Laser Doppler flowmetry (Device)

Colorectal surgery

Individuals scheduled for colorectal surgery in the HDTL position

干预措施: Inflammatory and Oxidative stress biomarkers (Other)

结局指标

主要结局

Cutaneous blood flow

时间窗: baseline, during the surgery

Change over time in cutaneous blood flow in the legs relative to a vascular occlusion test (VOT) during surgery in the HDTL position.

次要结局

  • Muscle tissue oxygenation(baseline, during the surgery)
  • Plasma interleukin-6 (IL-6) concentration(baseline, during the surgery)
  • Plasma Superoxide Dismutase (SOD) concentration(baseline, during the surgery)
  • Plasma nitrate concentration(baseline, during the surgery)
  • Plasma nitrite concentration(baseline, during the surgery)
  • Mean arterial pressure (MAP)(baseline, during the surgery)
  • Plasma Tumour Necrosis Factor Alpha (TNF-α) concentration(baseline, during the surgery)
  • Plasma Protein Carbonyl concentration(baseline, during the surgery)
  • Skin temperature(baseline, during the surgery)
  • Brain tissue oxygenation(continuous measurement during the surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Maria Perissiou

Senior Lecturer

University of Portsmouth

研究点 (2)

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