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

August 7, 2018 updated by: Xueying Yang

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Liaoning
      • Shenyang, Liaoning, China, 110004
        • Recruiting
        • The Fourth Affiliated Hospital of China Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

    -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: painless indwelling catheter
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.
Procedure: painless indwelling catheter
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).
Other Names:
  • 14 F Foley's catheter
  • lidocaine ointment
Other: indwelling catheter
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.
Procedure: indwelling catheter
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.
Other Names:
  • 14 F Foley's catheter
  • lidocaine ointment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urine retention rate
Time Frame: 10 days
Urine retention rate
10 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative hospital stay
Time Frame: 15 days
Postoperative hospital stay
15 days
Urinary tract infection
Time Frame: 10 days
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.
10 days
Postoperative bedtime
Time Frame: 2 days
The time from the patient's postoperative pushback to the first bedtime
2 days
The total cost of hospitalization
Time Frame: 15 days
The total cost of hospitalization
15 days
Postoperative pain level
Time Frame: 3 days
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.
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xueying Yang

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2018

Primary Completion (Anticipated)

July 1, 2019

Study Completion (Anticipated)

August 1, 2019

Study Registration Dates

First Submitted

July 23, 2018

First Submitted That Met QC Criteria

August 7, 2018

First Posted (Actual)

August 8, 2018

Study Record Updates

Last Update Posted (Actual)

August 8, 2018

Last Update Submitted That Met QC Criteria

August 7, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC-2018-KS-032

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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