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

NCT ID: NCT03621514

Last Updated: 2018-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-01

Study Completion Date

2019-08-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Urethral Catheter; Complications

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type OTHER

painless indwelling catheter

Intervention Type PROCEDURE

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).

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.

Group Type OTHER

indwelling catheter

Intervention Type PROCEDURE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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).

Intervention Type 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.

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

14 F Foley's catheter lidocaine ointment 14 F Foley's catheter lidocaine ointment

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Xueying Yang

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Xueying Yang

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The Fourth Affiliated Hospital of China Medical University

Shenyang, Liaoning, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Xueying Yang, M.D.

Role: CONTACT

86-24-62255001

Lei Zhang, M.M.

Role: CONTACT

86-24-62043537 ext. 862462043537

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 28960733 (View on PubMed)

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.

Reference Type RESULT
PMID: 29078668 (View on PubMed)

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.

Reference Type RESULT
PMID: 29221316 (View on PubMed)

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.

Reference Type RESULT
PMID: 28689818 (View on PubMed)

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.

Reference Type RESULT
PMID: 27865474 (View on PubMed)

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.

Reference Type RESULT
PMID: 27686131 (View on PubMed)

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.

Reference Type RESULT
PMID: 27134844 (View on PubMed)

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.

Reference Type RESULT
PMID: 29268519 (View on PubMed)

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.

Reference Type RESULT
PMID: 26383168 (View on PubMed)

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.

Reference Type RESULT
PMID: 28007878 (View on PubMed)

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.

Reference Type RESULT
PMID: 24215579 (View on PubMed)

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.

Reference Type RESULT
PMID: 29963301 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34329541 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

EC-2018-KS-032

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.