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临床试验/NCT05981937
NCT05981937已完成不适用

Indocyanine Green ICG in Segmentary Resection in Colo-rectal Surgery is Usefull to Decrease Leak Threshold: A Paralel Retrospetive Cohort Study

Azienda Unità Sanitaria Locale di Piacenza1 个研究点 分布在 1 个国家目标入组 115 人开始时间: 2023年7月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
115
试验地点
1
主要终点
Anastomotic leak at 30 days

研究概览

简要总结

This is a parallel monocentric, retrospective cohort study in Guglielmo da Saliceto Hospital, Piacenza, Italy. Aim of this study is to investigate the protective role of Indocyanine green (ICG) for Anastomotic leak (AL) in patients underwent elective segmentary colic resection (transverse colic resection, left colectomy including sigmoidectomy, splenic colic flexure resection). Secondary aims are to detect and to investigate the impact of various risk factors on AL and morbidity and surgical performance within 30 days to surgery.

详细描述

This is a parallel monocentric, retrospective cohort study observing consecutive series of patients underwent colo-rectal surgery at our institution between 1 January 2017 and 31 July 2023.

The primary endpoint of the study is Anastomotic Leak (AL) at 30 days while secondary endpoints are post-operative morbidity Clavien-Dindo score ≥III within 30 days from surgery including readmission and redo-surgery, harvested nodes for patients with neoplastic disease, Surgical Site Infection, rate of laparoscopic surgical procedure and rate of protection stoma.

Sex, Body Mass Index, smoking, diabetes mellitus, cardiovascular disease, tumor stage according to AJJC 8th edition will be considered confounding factor for onset of AL.

Patients electronic database will be collected from extraction of medical record in operating log and every digital medical record will be scanned including peri-operative outcomes and 30 days post-operative follow-up from post-operative visit, eventually readmission in emergency department or any other specialistic wards of our local health institution according to following inclusion criteria: elective setting of surgery, segmentary left colon surgery: splenic colic resection, transverse colic resection and left colectomy defined as left hemicolectomy with low mesenteric artery-ligation and sigmoidectomy even for benign or malign pathology, at least 30 days of post-operative follow-up available from medical documentation, primary colo-colic or colo-rectal anastomosis with or without preventing ostomy and adult age.

Exclusion criteria are terminal colonic stoma without anastomosis creation after demolitive step, extended transverse right hemicolectomy, left hemicolectomy with high vascular ligation, associated bowel or another splanchnic resection (i.e. neoplastic infiltration), previous colic surgery, synchronous neoplasm, not reporting in operating form details about vascular ligation, lack in reporting in medical records of primary outcomes, stage IV cancer, ASA IV, less than 18 years old and emergency setting.

研究设计

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

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Indocyanine Green

Indocyanine green infusion in left-side colorectal surgery (elective segmentary colic resection)

干预措施: ICG solution (Drug)

结局指标

主要结局

Anastomotic leak at 30 days

时间窗: 30 days

Anastomotic leak (a defect of intestinal wall at anastomotic site leading to a communication between the intra- and extraluminal compartments)at 30 days: abdominal CT scan IV and a Clavien Dindo Score ≥III

次要结局

  • Post-operative morbidity(30 days)

研究者

发起方
Azienda Unità Sanitaria Locale di Piacenza
申办方类型
Other
责任方
Principal Investigator
主要研究者

Elena Orlandi

Principal Investigator, Medical Doctor

Azienda Unità Sanitaria Locale di Piacenza

研究点 (1)

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