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临床试验/NCT03621514
NCT03621514Unknown不适用

The Feasibility and Advantages of Painless Indwelling Catheter in Uniportal Video-assisted Thoracoscopic Surgery Lobectomy of Lung Cancer: A Prospective Cohort Study

Xueying Yang1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2018年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
200
试验地点
1
主要终点
Urine retention rate

研究概览

简要总结

This study is a prospective cohort study.The main study content is the feasibility and advantages of painless indwelling catheter in perioperative period of uniportal video-assisted thoracoscopic surgery in lobectomy of lung cancer,divided into exposed and non-exposed groups.The exposed group was painless indwelled urethral catheter, the non-exposed group was indwelled urethral catheter routinely.

详细描述

This study is a prospective cohort study.The main study content is the feasibility and advantages of painless indwelling catheter in perioperative period of uniportal video-assisted thoracoscopic surgery in radical resection of lung cancer,divided into exposed and non-exposed groups,divided into exposed and non-exposed groups.Communicating with the surgeon and patients who meet the inclusion criteria, decide whether to enter the exposed or non-exposed group.The exposed group was painless indwelled urethral catheter, the non-exposed group was indwelled urethral catheter routinely.By collecting personal information of two groups of patients and the corresponding observation indicators to analyze whether the painless indwelling urethral catheters in lobectomy of lung cancer is more beneficial than the indwelled urethral catheter routinely in lobectomy of lung cancer, and it is safe and feasible.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

This study is a prospective cohort study.Participants,Care Provider, and Investigator all know the grouping situation. The Investigator collect the information and observation indicators of the two groups of participants and send to the Outcomes Assessor . The Outcomes Assessor does not know the grouping situation of each participant.

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •1.18 to 75-year old patient with lung cancer who is eligible for Uniportal Video-assisted Thoracoscopic Surgery in lobectomy.
  • •2.The result of rapid pathology is primary lung cancer.
  • •3.Electrocardiogram, pulmonary function, color Doppler echocardiography, arteriovenous color Doppler ultrasound and other preoperative examination results are normal.
  • •4.The patient agreed to participate in the study and signed the informed consent form.

排除标准

  • •Patients have severe urinary system diseases (medium-to-severe BPH, urethral stricture, urinary calculi, infections, tumors, etc.) ,and/or have undergone abdominal and pelvic surgery before surgery.
  • •There is a potential infection before surgery.
  • •Heart and lung serious organic diseases.
  • •Combined thoracic adhesions, patients with severe coagulation insufficiency.
  • •The time of anesthesia is more than 4 hours.

研究组 & 干预措施

painless indwelling catheter

Other

This group of patients underwent catheterization after anesthesia. At the end of the operation, the patient was removed from the catheter before anesthesia was awakened.

干预措施: painless indwelling catheter (Procedure)

indwelling catheter

Other

This group of patients underwent catheterization after anesthesia,and the catheter was indwelled. The patient was routinely removed for 24 to 72 hours after surgery.

干预措施: indwelling catheter (Procedure)

结局指标

主要结局

Urine retention rate

时间窗: 10 days

Urine retention rate

次要结局

  • Urinary tract infection(10 days)
  • Postoperative bedtime(2 days)
  • The total cost of hospitalization(15 days)
  • Postoperative pain level(3 days)
  • Postoperative hospital stay(15 days)

研究者

发起方
Xueying Yang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Xueying Yang

Professor

Shengjing Hospital

研究点 (1)

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