NCT03621514

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2018

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

July 23, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 8, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

August 8, 2018

Status Verified

July 1, 2018

Enrollment Period

1 year

First QC Date

July 23, 2018

Last Update Submit

August 7, 2018

Conditions

Urethral Catheter; Complications

Keywords

Painless indwelling urethral catheteruniportal video-assisted thoracoscopic surgeryLobectomyLung cancer

Outcome Measures

Primary Outcomes (1)

  • Urine retention rate

    Urine retention rate

    10 days

Secondary Outcomes (5)

  • Urinary tract infection

    10 days

  • Postoperative bedtime

    2 days

  • Postoperative hospital stay

    15 days

  • The total cost of hospitalization

    15 days

  • Postoperative pain level

    3 days

Study Arms (2)

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.

Procedure: painless indwelling catheter

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.

Procedure: indwelling catheter

Interventions

painless indwelling catheterPROCEDURE

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).

Also known as: 14 F Foley's catheter, lidocaine ointment
painless indwelling catheter
indwelling catheterPROCEDURE

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.

Also known as: 14 F Foley's catheter, lidocaine ointment
indwelling catheter

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Fourth Affiliated Hospital of China Medical University

Shenyang, Liaoning, 110004, China

RECRUITING

Related Publications (13)

  • Caronia FP, Loizzi D, Nicolosi T, Castorina S, Fiorelli A. Tubeless tracheal resection and reconstruction for management of benign stenosis. Head Neck. 2017 Dec;39(12):E114-E117. doi: 10.1002/hed.24942. Epub 2017 Sep 27.

    PMID: 28960733RESULT

  • Zhao ZR, Lau RWH, Ng CSH. Anaesthesiology for uniportal VATS: double lumen, single lumen and tubeless. J Vis Surg. 2017 Aug 21;3:108. doi: 10.21037/jovs.2017.07.05. eCollection 2017.

    PMID: 29078668RESULT

  • Xia Z, Qiao K, He J. Recent advances in the management of pulmonary tuberculoma with focus on the use of tubeless video-assisted thoracoscopic surgery. J Thorac Dis. 2017 Sep;9(9):3307-3312. doi: 10.21037/jtd.2017.08.44.

    PMID: 29221316RESULT

  • Boisen ML, Rao VK, Kolarczyk L, Hayanga HK, Gelzinis TA. The Year in Thoracic Anesthesia: Selected Highlights from 2016. J Cardiothorac Vasc Anesth. 2017 Jun;31(3):791-799. doi: 10.1053/j.jvca.2017.02.182. Epub 2017 Feb 22. No abstract available.

    PMID: 28689818RESULT

  • Yang SM, Wang ML, Hung MH, Hsu HH, Cheng YJ, Chen JS. Tubeless Uniportal Thoracoscopic Wedge Resection for Peripheral Lung Nodules. Ann Thorac Surg. 2017 Feb;103(2):462-468. doi: 10.1016/j.athoracsur.2016.09.006. Epub 2016 Nov 16.

    PMID: 27865474RESULT

  • Mineo TC, Tamburrini A, Perroni G, Ambrogi V. 1000 cases of tubeless video-assisted thoracic surgery at the Rome Tor Vergata University. Future Oncol. 2016 Dec;12(23s):13-18. doi: 10.2217/fon-2016-0348. Epub 2016 Sep 30.

    PMID: 27686131RESULT

  • Gonzalez-Rivas D, Yang Y, Guido W, Jiang G. Non-intubated (tubeless) uniportal video-assisted thoracoscopic lobectomy. Ann Cardiothorac Surg. 2016 Mar;5(2):151-3. doi: 10.21037/acs.2016.03.02. No abstract available.

    PMID: 27134844RESULT

  • Peng G, Liu M, Luo Q, Chen H, Yin W, Wang W, Huang J, Qiu Y, Guo Z, Liang L, Dong Q, Xu X, He J. Spontaneous ventilation anesthesia combined with uniportal and tubeless thoracoscopic lung biopsy in selected patients with interstitial lung diseases. J Thorac Dis. 2017 Nov;9(11):4494-4501. doi: 10.21037/jtd.2017.10.76.

    PMID: 29268519RESULT

  • Feneley RC, Hopley IB, Wells PN. Urinary catheters: history, current status, adverse events and research agenda. J Med Eng Technol. 2015;39(8):459-70. doi: 10.3109/03091902.2015.1085600. Epub 2015 Sep 18.

    PMID: 26383168RESULT

  • Petersen RH, Holbek BL, Hansen HJ, Kehlet H. Video-assisted thoracoscopic surgery-taking a step into the future. Eur J Cardiothorac Surg. 2017 Apr 1;51(4):694-695. doi: 10.1093/ejcts/ezw381. No abstract available.

    PMID: 28007878RESULT

  • Tobu S, Noguchi M, Hashikawa T, Uozumi J. Risk factors of postoperative urinary retention after hip surgery for femoral neck fracture in elderly women. Geriatr Gerontol Int. 2014 Jul;14(3):636-9. doi: 10.1111/ggi.12150. Epub 2013 Nov 12.

    PMID: 24215579RESULT

  • Assadi F. Strategies for Preventing Catheter-associated Urinary Tract Infections. Int J Prev Med. 2018 Jun 4;9:50. doi: 10.4103/ijpvm.IJPVM_299_17. eCollection 2018. No abstract available.

    PMID: 29963301RESULT

  • Zhang L, Yang X, Tian Y, Yu Q, Xu Y, Zhou D, Wu Z, Zhao X. The feasibility and advantages of immediate removal of urinary catheter after lobectomy: A prospective randomized trial. Nurs Open. 2021 Nov;8(6):2942-2948. doi: 10.1002/nop2.1006. Epub 2021 Jul 30.

    PMID: 34329541DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Catheters, Indwelling

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

CathetersEquipment and Supplies

Central Study Contacts

Xueying Yang, M.D.

CONTACT

86-24-62255001yangxy@sj-hospital.org

Lei Zhang, M.M.

CONTACT

86-24-6204353718900913119@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 23, 2018

First Posted

August 8, 2018

Study Start

July 1, 2018

Primary Completion

July 1, 2019

Study Completion

August 1, 2019

Last Updated

August 8, 2018

Record last verified: 2018-07

Locations

CN(1)