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临床试验/NCT06270745
NCT06270745招募中不适用

ICG Anastomotic Control in Digestive System Surgery

Shandong Linglong Yingcheng Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2018年1月1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
招募中
发起方
入组人数
200
试验地点
1
主要终点
Anastomotic leak at 30 days

研究概览

简要总结

This was a parallel single-center retrospective cohort study conducted at Linglong Yingcheng Hospital, Shandong, China. The purpose of this study was to investigate the effect of indocyanine green (ICG) on patients undergoing digestive system surgery (subtotal gastrectomy, partial hepatectomy, transverse colectomy, left colectomy, including sigmoid resection, and splenic colic resection). ) of anastomotic leakage (AL). Secondary objectives were to detect and study the impact of various risk factors on AL and on morbidity and surgical performance within 30 days of surgery.

详细描述

This was a parallel single-center retrospective cohort study observing a series of consecutive patients who underwent colorectal surgery at our institution between January 1, 2018, and December 31, 2023.

The primary endpoint of the study is AL at 30 days, and the secondary endpoint is postoperative morbidity of Clavien-Dindo score ≥ III within 30 days after surgery, including readmission and redo surgery, lymph node disease in patients with neoplastic disease Harvest, surgical site infection, laparoscopic surgery rate, and protected stoma rate.

According to the American Joint Committee on Cancer (AJJC) 8th edition, gender, body mass index, smoking, diabetes, cardiovascular disease, and tumor stage will be considered confounding factors in the development of AL.

A patient electronic database will be collected from medical records extracted from surgical logs and each digital medical record will be scanned to include perioperative outcomes and post-operative follow-up for 30 days after surgery, final readmission to the emergency room or any other department based on The following inclusion criteria, performed in the specialist ward of our local health institution: elective surgery, left colon segmental surgery: splenic colic resection, transverse colic resection and left hemicolectomy, defined as left hemicolectomy, low Mesenteric artery ligation and sigmoid resection, regardless of benign or malignant pathology, minimum 30 days of postoperative follow-up (available from medical documentation), primary colostomy or colorectal anastomosis with or without prophylactic ostomy ) and age of adulthood.

Exclusion criteria were distal colostomy without anastomosis after removal step, extended transverse right hemicolectomy, left hemicolectomy with high vascular ligation, resection of associated bowel or other viscera (ie, tumor infiltration), previous colic Surgery, synchronous tumors, failure to report vessel ligation in surgery form details, lack of medical record reporting of primary outcome, stage IV cancer, American Society Of Anestheasiologists (ASA) IV, under 18 years of age, and emergencies.

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 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • elective setting of surgery
  • digestive system surgery for benign or malignant pathology
  • 30 days of post-operative follow-up at least available from medical documentation
  • primary colo-colic or colo-rectal anastomosis with or without preventing ostomy
  • more than 18 years old, less than 90 years old

排除标准

  • 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
  • less than 18 years old, more then 90 years old
  • emergency setting

研究组 & 干预措施

Indocyanine Green

Indocyanine green infusion during digestive system surgery

干预措施: indocyanine green (Drug)

non-Indocyanine Green

No indocyanine green infusion during digestive system surgery

干预措施: indocyanine green (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
Shandong Linglong Yingcheng Hospital
申办方类型
Network
责任方
Sponsor

研究点 (1)

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