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

Urethral Catheter; Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03621514
• Other study ID #: EC-2018-KS-032
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: August 1, 2019

Study information

• Verified date: July 2018
• Source: Shengjing Hospital
• Contact: Xueying Yang, M.D.
• Phone: 86-24-62255001
• Email: yangxy[@]sj-hospital.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 1, 2019
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung Neoplasms
• Urethral Catheter; Complications

Intervention

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).
• 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.

Locations

Country	Name	City	State
China	The Fourth Affiliated Hospital of China Medical University	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
Xueying Yang

Country where clinical trial is conducted

China, 

References & Publications (12)

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. — View 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. Review. — View 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. — View 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. Review. Erratum in: J Med Eng Technol. 2016;40(2): — View 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. Review. — View 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. Epub 2016 Sep 30. Review. — View 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 Thor — View 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. — View 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. — View 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. Review. — View 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. — View 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. Review. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urine retention rate	Urine retention rate	10 days
Secondary	Urinary tract infection	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
Secondary	Postoperative bedtime	The time from the patient's postoperative pushback to the first bedtime	2 days
Secondary	Postoperative hospital stay	Postoperative hospital stay	15 days
Secondary	The total cost of hospitalization	The total cost of hospitalization	15 days
Secondary	Postoperative pain level	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