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

Sponsor
Xueying Yang (Other)
Overall Status
Unknown status
CT.gov ID
NCT03621514
Collaborator
(none)
200
1
2
13
15.4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: painless indwelling catheter
  • Procedure: indwelling catheter
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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:
Single (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.
Primary Purpose:
Treatment
Official Title:
The Feasibility and Advantages of Painless Indwelling Catheter in Uniportal Video-assisted Thoracoscopic Surgery Lobectomy of Lung Cancer: A Prospective Cohort Study
Actual Study Start Date :
Jul 1, 2018
Anticipated Primary Completion Date :
Jul 1, 2019
Anticipated Study Completion Date :
Aug 1, 2019

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Urine retention rate [10 days]

      Urine retention rate

    Secondary Outcome Measures

    1. Urinary tract infection [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.

    2. Postoperative bedtime [2 days]

      The time from the patient's postoperative pushback to the first bedtime

    3. Postoperative hospital stay [15 days]

      Postoperative hospital stay

    4. The total cost of hospitalization [15 days]

      The total cost of hospitalization

    5. Postoperative pain level [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Fourth Affiliated Hospital of China Medical University Shenyang Liaoning China 110004

    Sponsors and Collaborators

    • Xueying Yang

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Xueying Yang, Professor, Shengjing Hospital
    ClinicalTrials.gov Identifier:
    NCT03621514
    Other Study ID Numbers:
    • EC-2018-KS-032
    First Posted:
    Aug 8, 2018
    Last Update Posted:
    Aug 8, 2018
    Last Verified:
    Jul 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Xueying Yang, Professor, Shengjing Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 8, 2018