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The Feasibility and Advantages of Painless Indwelling Catheter in Uniportal VATS Lobectomy of Lung Cancer

Primary Purpose

Urethral Catheter; Complications

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
painless indwelling catheter
indwelling catheter
Sponsored by
Xueying Yang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urethral Catheter; Complications focused on measuring Painless indwelling urethral catheter, uniportal video-assisted thoracoscopic surgery, Lobectomy, Lung cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

  1. 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.
  2. There is a potential infection before surgery.
  3. Heart and lung serious organic diseases.
  4. Combined thoracic adhesions, patients with severe coagulation insufficiency.

  5. The time of anesthesia is more than 4 hours.

    -

Sites / Locations

  • The Fourth Affiliated Hospital of China Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

painless indwelling catheter

indwelling catheter

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Urine retention rate
Urine retention rate

Secondary Outcome Measures

Urinary tract infection
The two groups of patients were each examined for middle urine after extubation. Refer to the clinical diagnostic criteria of the 2006 Hospital Infection Diagnostic Criteria (Trial): If the urinary leukocyte male ≥ 5 / high power field, female ≥ 10 / high power field, accompanied or not accompanied by urinary frequency, urgency, dysuria, etc. Symptoms of urinary tract irritation; or pain in the lower abdomen, pain in the kidney area, with or without fever.
Postoperative bedtime
The time from the patient's postoperative pushback to the first bedtime
Postoperative hospital stay
Postoperative hospital stay
The total cost of hospitalization
The total cost of hospitalization
Postoperative pain level
Using visual analogue scale/score (VAS), the degree of discomfort (pain and urinary sensation) is represented by 11 numbers from 0 to 10, with 0 being painless and no urine, and 10 being the most painful. (or) The sense of urinary sensation is strong, so that the patient can choose the number according to the feeling of self, indicating the degree. 0 degree: 0 points, no discomfort; I degree (mild): 1 to 3 points, with slight pain and/or urinary sensation, can tolerate; II degree (moderate): 4 to 7 points, patient pain And/or urinary sensation and affect sleep, can tolerate; III degree (severe): 8 to 10 points, the patient has progressively strong pain and/or urinary sensation, pain is unbearable, affecting appetite, affecting sleep.

Full Information

First Posted
July 23, 2018
Last Updated
August 7, 2018
Sponsor
Xueying Yang
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1. Study Identification

Unique Protocol Identification Number
NCT03621514
Brief Title
The Feasibility and Advantages of Painless Indwelling Catheter in Uniportal VATS Lobectomy of Lung Cancer
Official Title
The Feasibility and Advantages of Painless Indwelling Catheter in Uniportal Video-assisted Thoracoscopic Surgery Lobectomy of Lung Cancer: A Prospective Cohort Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
July 1, 2019 (Anticipated)
Study Completion Date
August 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Xueying Yang

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urethral Catheter; Complications
Keywords
Painless indwelling urethral catheter, uniportal video-assisted thoracoscopic surgery, Lobectomy, Lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Non-Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
painless indwelling catheter
Arm Type
Other
Arm Description
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.
Arm Title
indwelling catheter
Arm Type
Other
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
painless indwelling catheter
Other Intervention Name(s)
14 F Foley's catheter, lidocaine ointment
Intervention Description
Catheterization after anesthesia (14 F Foley's urinary catheter), the patient was removed before the anesthesia was awakened and the catheter was removed(Fully lubricate the anterior end of the catheter with a lidocaine ointment 2.5g before catheterization).
Intervention Type
Procedure
Intervention Name(s)
indwelling catheter
Other Intervention Name(s)
14 F Foley's catheter, lidocaine ointment
Intervention Description
The patients underwent catheterization(14 F Foley's catheter) after anesthesia,and the catheter was indwelled(Fully lubricate the anterior end of the catheter with a lidocaine ointment 2.5g before catheterization). The patient was routinely removed for 24 to 72 hours after surgery.
Primary Outcome Measure Information:
Title
Urine retention rate
Description
Urine retention rate
Time Frame
10 days
Secondary Outcome Measure Information:
Title
Urinary tract infection
Description
The two groups of patients were each examined for middle urine after extubation. Refer to the clinical diagnostic criteria of the 2006 Hospital Infection Diagnostic Criteria (Trial): If the urinary leukocyte male ≥ 5 / high power field, female ≥ 10 / high power field, accompanied or not accompanied by urinary frequency, urgency, dysuria, etc. Symptoms of urinary tract irritation; or pain in the lower abdomen, pain in the kidney area, with or without fever.
Time Frame
10 days
Title
Postoperative bedtime
Description
The time from the patient's postoperative pushback to the first bedtime
Time Frame
2 days
Title
Postoperative hospital stay
Description
Postoperative hospital stay
Time Frame
15 days
Title
The total cost of hospitalization
Description
The total cost of hospitalization
Time Frame
15 days
Title
Postoperative pain level
Description
Using visual analogue scale/score (VAS), the degree of discomfort (pain and urinary sensation) is represented by 11 numbers from 0 to 10, with 0 being painless and no urine, and 10 being the most painful. (or) The sense of urinary sensation is strong, so that the patient can choose the number according to the feeling of self, indicating the degree. 0 degree: 0 points, no discomfort; I degree (mild): 1 to 3 points, with slight pain and/or urinary sensation, can tolerate; II degree (moderate): 4 to 7 points, patient pain And/or urinary sensation and affect sleep, can tolerate; III degree (severe): 8 to 10 points, the patient has progressively strong pain and/or urinary sensation, pain is unbearable, affecting appetite, affecting sleep.
Time Frame
3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xueying Yang, M.D.
Phone
86-24-62255001
Email
yangxy@sj-hospital.org
First Name & Middle Initial & Last Name or Official Title & Degree
Lei Zhang, M.M.
Phone
86-24-62043537
Ext
862462043537
Email
18900913119@163.com
Facility Information:
Facility Name
The Fourth Affiliated Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110004
Country
China
Individual Site Status
Recruiting

12. IPD Sharing Statement

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The Feasibility and Advantages of Painless Indwelling Catheter in Uniportal VATS Lobectomy of Lung Cancer

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