Clinical trial NCT03621514: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Urethral Catheter; Complications
Keywords: Painless indwelling urethral catheter
uniportal video-assisted thoracoscopic surgery
Lobectomy
Lung cancer
Lead sponsor: Shengjing Hospital
Sponsor class: OTHER
First posted: 2018-08-08
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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:

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.

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Primary outcomes:
measure: Urine retention rate
timeFrame: 10 days
Secondary outcomes:
measure: Urinary tract infection
timeFrame: 10 days
measure: Postoperative bedtime
timeFrame: 2 days
measure: Postoperative hospital stay
timeFrame: 15 days
measure: The total cost of hospitalization
timeFrame: 15 days
measure: Postoperative pain level
timeFrame: 3 days
Other outcomes:
Locations:
city: Shenyang
country: China
facility: The Fourth Affiliated Hospital of China Medical University
state: Liaoning
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.