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临床试验/NCT07099820
NCT07099820已完成不适用

Role of Indexed Oxygen Delivery in Anastomotic Insufficiencies in Elective Laparoscopic Colorectal Resections for Cancer: a Prospective Observational Cohort Study

Saint Camillus International University of Health Sciences2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
2
主要终点
Post-operative anastomotic dehiscence

研究概览

简要总结

Colorectal cancer is a very commonly diagnosed malignancy worldwide, and surgical resection remains the mainstay of treatment. Outcomes depend on preoperative staging, surgical quality, complication rates, and multidisciplinary care; minimally invasive techniques have reduced local and systemic complications. However, anastomotic dehiscence (AD) remains the most significant local complication.

AD is a breach in the anastomotic integrity creating a communication between intra- and extra-luminal compartments. Mortality rates vary from 1.7% to 29%.

Reduced oxygen delivery-pre-, intra-, or post-operatively-can contribute to AD, while adequate oxygenation improves healing. Supplemental O₂ (FiO₂ 80%) has been shown to reduce AD risk after gastric surgery.

Tissue oxygen delivery can be quantified by indexed oxygen delivery (DO2I), defined as ml/min/m² and determined by cardiac output, hemoglobin, and saturation. Pulse cardiac output (CO)-Oximeter® (Masimo), allow continuous non-invasive monitoring of these parameters.

This prospective observational cohort study aims to explore the correlation between intraoperative DO2I and the risk of postoperative anastomotic dehiscence, using the non-invasive technologies described.

详细描述

Colorectal cancer is the third most commonly diagnosed malignancy worldwide, accounting for ~10% of all cancers and ranking as the fourth leading cause of cancer death, with 1.9 million new cases and ~930,000 deaths in 2020. Surgical resection remains the mainstay of treatment for nonmetastatic cases and plays a crucial role in managing metastatic disease. Outcomes depend on preoperative staging, surgical quality, complication rates, and multidisciplinary care. Since Jacobs' 1991 report of 20 laparoscopic resections, minimally invasive techniques have reduced local and systemic complications. However, anastomotic dehiscence (AD) remains the most significant local complication, increasing hospital stays, costs, morbidity, mortality, and negatively affecting overall prognosis.

The International Study Group of Rectal Cancer defines AD as a breach in the anastomotic integrity creating a communication between intra- and extra-luminal compartments. Mortality rates vary widely, from 1.7% in an Australian cohort to as high as 29% in other reports, with AD accounting for roughly one-third of postoperative colorectal surgery deaths. Incidence is site-dependent: 1-20% in colo-rectal, 0-2% in colo-colic, and 0.02-4% in ileo-colic anastomoses.

Risk factors are categorized as local or systemic. Local factors include anastomotic level, technique (mechanical vs. manual), surgeon experience, bowel prep, use of laparoscopy, diverting stomas, drains, radiotherapy, chemotherapy, and gut microbiota. Systemic factors include male sex, malnutrition, hypoalbuminemia, anemia, comorbidities, American Society of Anesthesiologists (ASA) score, nonsteroidal anti-inflammatory drug (NSAID) use, smoking, alcohol, peripheral vascular disease, obesity, and diabetes. Reduced oxygen delivery-pre-, intra-, or post-operatively-can contribute to AD, while adequate oxygenation improves healing. Supplemental O₂ (FiO₂ 80%) has been shown to reduce AD risk after gastric surgery.

Tissue oxygen delivery can be quantified by indexed oxygen delivery (DO2I), defined as ml/min/m² and determined by cardiac output, hemoglobin, and saturation. A DO2I < 400 ml/min/m² is associated with increased AD risk; normal values range from 450-550 ml/min/m². Below this, compensation through increased extraction fails beyond a critical threshold, leading to anaerobic metabolism and lactic acidosis. Accurate DO2I calculation requires cardiac output monitoring.

While the esophageal Doppler is the standard for cardiac output measurement, its invasiveness and operator dependence limit use. Less invasive alternatives, like pulse-contouring (e.g., PiCCO, Vigileo) or fully non-invasive methods like ClearSight®, offer continuous hemodynamic data. ClearSight® uses the volume-clamp method via a finger cuff and photoplethysmography to measure real-time arterial pressure and advanced parameters such as cardiac output and stroke volume.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • • Age > 18 years
  • Candidates for elective laparoscopic colo-rectal surgery for neoplastic pathology with ileo-colic, colo-colic and colo-rectal anastomosis.

排除标准

  • • Age < 18 years
  • Inability to give valid informed consent
  • Candidates for operations involving other wards
  • Candidates for emergency surgery
  • Candidates for laparotomic surgery
  • Colo- or ileo-stomy
  • Contraindications to the use of the volume clamp system for haemodynamic monitoring (conditions with significant alteration of finger perfusion, such as Raynaud's disease).

研究组 & 干预措施

Patients suffering from neoplasm of the colo-rectum

Patients underwent colic resection

结局指标

主要结局

Post-operative anastomotic dehiscence

时间窗: perioperatively

Breach in the anastomotic integrity creating a communication between intra- and extra-luminal compartments

次要结局

  • Mortality(perioperatively)
  • Transfusions(perioperatively)
  • Length of Stay(perioperatively)

研究者

发起方
Saint Camillus International University of Health Sciences
申办方类型
Other
责任方
Principal Investigator
主要研究者

Diego Fiume

Principal Investigator

Saint Camillus International University of Health Sciences

研究点 (2)

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