Urethral Catheter; ComplicationsNCT03621514
The Feasibility and Advantages of Painless Indwelling Catheter in Uniportal VATS Lobectomy of Lung Cancer
A study testing painless indwelling catheter and indwelling catheter in people with Urethral Catheter; Complications, run by Xueying Yang at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Urethral Catheter; Complications
- What is being tested?
- painless indwelling catheter and indwelling catheter
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2018to 1 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- -
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Fourth Affiliated Hospital of China Medical University
Shenyang, Liaoning, 110004
About this study
Official title: The Feasibility and Advantages of Painless Indwelling Catheter in Uniportal Video-assisted Thoracoscopic Surgery Lobectomy of Lung Cancer: A Prospective Cohort Study
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.
Read the 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.
- Conditions
- Urethral Catheter; Complications
- Being tested
- painless indwelling catheter, indwelling catheter
- Keywords
- Painless indwelling urethral catheter, uniportal video-assisted thoracoscopic surgery, Lobectomy, Lung cancer
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
painless indwelling catheterProcedure or surgery
Also called 14 F Foley's catheter, lidocaine ointment
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 catheterProcedure or surgery
Also called 14 F Foley's catheter, lidocaine ointment
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: indwelling catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine retention rate
Urine retention rate
Measured: 10 days
Secondary outcomes (5)
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.
Measured: 10 days
Postoperative bedtime
The time from the patient's postoperative pushback to the first bedtime
Measured: 2 days
Postoperative hospital stay
Postoperative hospital stay
Measured: 15 days
The total cost of hospitalization
The total cost of hospitalization
Measured: 15 days
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.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start1 Jul 2018
- Primary completion1 Jul 2019 (estimated)
- Study completion1 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Urethral Catheter; ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xueying Yang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xueying Yang, Shengjing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03621514
- Sponsor's protocol ID
- EC-2018-KS-032
- Status last verified
- Jul 2018
- First submitted
- 23 Jul 2018
- Last updated
- 8 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 28960733Zhao 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.
PubMed 29078668Xia 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.
PubMed 29221316Boisen 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.
PubMed 28689818Yang 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.
PubMed 27865474Mineo 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.
PubMed 27686131Gonzalez-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.
PubMed 27134844Peng 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.
PubMed 29268519Feneley 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.
PubMed 26383168Petersen 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.
PubMed 28007878Tobu 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.
PubMed 24215579Assadi 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.
PubMed 29963301Zhang 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.
PubMed 34329541
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility and Advantages of Painless Indwelling Catheter in Uniportal Video-assisted Thoracoscopic Surgery Lobectomy of Lung Cancer: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT03621514
- Acronym / sponsor ID
- EC-2018-KS-032
- Conditions
- Urethral Catheter; Complications
- Keywords
- Painless indwelling urethral catheter, uniportal video-assisted thoracoscopic surgery, Lobectomy, Lung cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Xueying YangUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 1 Jul 2019 (estimated)
- Study completion
- 1 Aug 2019 (estimated)
- First posted
- 8 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| painless indwelling catheter | Other | Procedure: painless indwelling catheterThis group of patients underwent catheterization after anesthesia. At the end of the operation, the patient was removed from the catheter before anesthesia was awakened. |
| indwelling catheter | Other | Procedure: indwelling catheterThis group of patients underwent catheterization after anesthesia,and the catheter was indwelled. The patient was routinely removed for 24 to 72 hours after surgery. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| painless indwelling catheterAlso: 14 F Foley's catheter, lidocaine ointmentCatheterization 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). | Procedure or surgery | painless indwelling catheter |
| indwelling catheterAlso: 14 F Foley's catheter, lidocaine ointmentThe 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. | Procedure or surgery | indwelling catheter |
Primary outcome
Urine retention rate
Time frame: 10 days
Urine retention rate
5 secondary outcomes
Urinary tract infection
Time frame: 10 days
Postoperative bedtime
Time frame: 2 days
Postoperative hospital stay
Time frame: 15 days
The total cost of hospitalization
Time frame: 15 days
Postoperative pain level
Time frame: 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2018.
- Results publication: PubMed 28960733Caronia 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.
- Results publication: PubMed 29078668Zhao 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.
- Results publication: PubMed 29221316Xia 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.
- Results publication: PubMed 28689818Boisen 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.
- Results publication: PubMed 27865474Yang 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.
- Results publication: PubMed 27686131Mineo 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.
- Results publication: PubMed 27134844Gonzalez-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.
- Results publication: PubMed 29268519Peng 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.
- Results publication: PubMed 26383168Feneley 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.
- Results publication: PubMed 28007878Petersen 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.
- Results publication: PubMed 24215579Tobu 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.
- Results publication: PubMed 29963301Assadi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing painless indwelling catheter and indwelling catheter in people with Urethral Catheter; Complications, run by Xueying Yang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xueying Yang, M.D. (86-24-62255001, yangxy@sj-hospital.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urine retention rate (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03621514, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2018.