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临床试验/CTRI/2024/11/076339
CTRI/2024/11/076339招募中3 期

A Study about comparison of IndoCyanineGreen(ICG) dye use in Colorectal surgery

Lisie Hospital1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2024年11月16日最近更新:

试验速览

阶段
3 期
状态
招募中
发起方
入组人数
64
试验地点
1
主要终点
To look for anastamotic leak

研究概览

简要总结

All laproscopically operable colorectal malignancies  done in Lisie hospital for the period of 18 months

Socioeconomic,clincal labortory data will be collected as per study proform

Patients would be divided into ICG & Non ICG group based on the block  randomization given by computer

ICG groups will be given dye intraoperatively

Non ICG group patients will be proceeded without udage of any dye

Patients will be assesed on Post opeartive period .

They will be classified into different grades based on clinical presentation

Lab parametrs such a s CRP, TC, DC, Albumin, Procalcitonin would be assesed on specific Post operative days & at the time of first visitr after discharge

CT Abdomen would be done on POD7 & on 4 weeks after surgery

Results will be evaluated using SPSS software

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • All laproscopically operable colorectal malignancies.

排除标准

  • Colorectal malignancies presenting with obstruction, perforation.
  • Colorectal malignancies with inoperable metastasis.
  • Recurrence Redo Surgery.

结局指标

主要结局

To look for anastamotic leak

时间窗: On Postoperative day 1,3,5 & 7 & 2nd week & 4th week

次要结局

  • To Look for any collection or abscess in CT abdomen & Pelvis(To look for lab parameters such as Hemoglobin Total WBC count,differential count, C-Reactive protein, Procalcitonin, S.albumin)

研究者

发起方
Lisie Hospital
申办方类型
Private hospital/clinic
责任方
Principal Investigator
主要研究者

Dr Venugopal

Lisie Hospital

研究点 (1)

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