Ignite Creation Date:
2024-10-25 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06579924
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-11
Brief Title:
Disposable Versus Disposable Nephroscope During PCNLs a Feasibility RCT
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Re-usable Versus Disposable Rigid Nephroscope During Mini-PCNLs When Treating Large-burden Kidney Stones an Feasibility Randomised Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A feasibility randomised controlled trials comparing re-usable versus disposable nephroscope when treating kidney stones during mini-PCNLs
Detailed Description:
Study Participants Patients undergoing minimally-invasive PCNLs with intention to treat renal low- to medium-burden renal stones
Inclusion Criteria
Patients undergoing mini PCNL to treat renal stones with a cumulative stone diameter 2-5 cm and completing at least a 3 months follow-up
Cases performed by surgeons beyond their learning curves
Patients aged gt 18
Unenhanced CT scan carried out within 3 months pre-operatively
Post-operative follow-up carried out according to our study protocol with NCCT carried out within 2-3 months after surgery
ASA 1-2
Patients with normal weight BMI 18-25
Participant is willing and able to give informed consent to the proposed surgical treatment and agreeing to be enrolled in the study
Exclusion Criteria
The participant may not enter the study if ANY of the following apply
Contraindications to surgical treatment
PCNL performed for proximal ureteric stones
Urinary tract with abnormal anatomy
Obese patients
ASAgt3
Patients with pyonephrosis
Patients on anticoaugulants
Preoperative CT scan not within 3 months before surgery
Pregnant patients
Patients younger than 18 years of age Study design and pathway The study will include patients with renal stones and undergoing mini-PCNL All patients should respect inclusionexclusion criteria An ultra-low dose unenhanced CT scan NCCT has to be available for all cases pre-operatively the post-operative follow-up will include NCCT within 2-3 months from treatment
Patients will complete the study at 3 months post-op when the stone free rate will be assessed Additionally 30 days post-op complications will be recorded using Clavien-Dindo system 3 months post-op stone-related events will be also registered
Prior to enroll patients participating surgeons will be asked to carry out 5 mini-PCNLs with disposable scope aiming to render them more familiar and achieve learning curve
Once the RCT will start patient will be randomized in two groups using computer software disposable group arm and non-disposable group arm
Peri-operative data collection Peri-operative data will be collected using a standardized excel database produced by main investigator site
The Stone complexity will be calculated according to database Each case should be evaluated by two experienced surgeons and appropriate scoring should be agreed
30 days post-operative complications should be recorded and reported using Clavien-Dindo classification System in its modified version for PCNLs Type of complication in each Centre should be agreed by two different surgeons
Post-operative patients quality of life will be evaluated using validated version of WISQoL in Chinese7 It will be measured at 24 hours and 7 days post-op
Definition of Stone free State no gt or equal to 2mm residual fragments measured with post-operative NCCT Size of residual fragments should be agreed with radiologist
PCNL-Trifecta achievement will also be recorded
Stone burden measurement
Authors will report maximum stone diameter and stone complexity reported using Guys8 and STONE nephrolithometry Score9 Stone characteristics should be agreed by two different surgeons If multiple stones are present the sum of their volume should be reported
Surgical technique
Patients deemed suitable and enrolled in the study will be operated as per routinary technique This will include a prone position and placement of a retrograde 5-6 Fr ureteric catheter for pyelogram and dilatation of the urinary tract
The puncture will be carried out according to surgeons preference under ultrasound fluoroscopy or combination
The track preparation will be carried out with one-shot dilator if necessary progressive dilatation can be conducted The percutaneous sheath will be 18 Fr
The Single-Use Video Cystoscope RP-U-C0102 without bendable tip produced by Redpine will be used as rigid nephroscope in disposable group arm This device has already obtained approval for endoluminal surgeries in China as well as CE and FDA approval for utilization in Western countries In the non-disposable group an equivalent size Hawk nephroscope will be used in the non-disposable arm
The lithotripsy will be done with Ho-YAG laser using a 550-micron laser fiber or ballistic lithotripter is believed appropriate
In both arms the percutaneous sheath will be 18 Fr peel-away sheath Cases can be conducted tubeless or totally tubeless if necessary If believed appropriate in the group of patients treated with disposable cystoscope surgeons are allowed to switch to a reusable nephroscope for any reason which will be documented
Definition of investigated complications
Complications will be categorized using Clavien-Dindo system Authors will also specifically investigate bleeding and infective complications
Infectious complications will include
Infection will be defined as temperature above 38C for a minimum of 24 hours andor procalcitonin gt 05 ngmL andor reactive C protein gt 10
Septic shock diagnosed using qSOFA Score
ICU admission for sepsis
Death
Perirenal abscess
Hemorragic complications will include
Transfusion
Hemoglobin drop gt2 grdL
Angioembolization
Bleeding requiring secondary operation bladder washout ureteric stent positioning
Emergency nephrectomy for uncontrollable bleeding
Hypovolemic shock requiring ICU stay
Study population
A total of 100 procedures will be included The study will involve three surgeons Each surgeon will carry out 20 procedures 10 for each arm The numerosity has been arbitrarily decided and in line with characteristics of pilot studies aiming to test feasibility of disposable PCNLs and estimate numerosity for future RCT on this topic Before enrolling patients all participating surgeons will be asked to carry out 5 mini-PCNLs with disposable scopes to render them familiar with the procedure and adjust the learning curve
Statistical analysis The Statistical Package for the Social Sciences SPSS 20 will be used for statistical analysis
Continuous variables will be presented as means SDs in cases of normal distribution and compared using the independent Students t-test while as median and interquartile range IQR in cases of skewed distributions and compared using the Mann-Whitney U-test Categorical variables will be presented as numbers with percentages and compared using chi-square or Fishers exact tests Statistical significance will be considered for two-tailed P values of lt005
Endpoints As primary endpoints authors will evaluate adequacy of disposable scopes evaluating need to switch to re-usable scopes due to breakages inadequacy failures and Stone Free Rates
Authors will also collect as secondary endpoints complication rates and patients comfort using WISQoL questionnaires
Additionally authors will use Likert scales to evaluate surgeons appreciation view handling and weight of the instruments irrigation stability of the instrument position and functionality of working channels
Authors will also monitor the number procedures where there will be need of switching to re-usable scopes due to malfunctioningbreakageinadequacy of disposable scopes
Inclusion Criteria
Patients undergoing mini PCNL to treat renal stones with a cumulative stone diameter 2-5 cm and completing at least a 3 months follow-up
Cases performed by surgeons beyond their learning curves
Patients aged gt 18
Unenhanced CT scan carried out within 3 months pre-operatively
Post-operative follow-up carried out according to our study protocol with NCCT carried out within 2-3 months after surgery
ASA 1-2
Patients with normal weight BMI 18-25
Participant is willing and able to give informed consent to the proposed surgical treatment and agreeing to be enrolled in the study
Exclusion Criteria
The participant may not enter the study if ANY of the following apply
Contraindications to surgical treatment
PCNL performed for proximal ureteric stones
Urinary tract with abnormal anatomy
Obese patients
ASAgt3
Patients with pyonephrosis
Patients on anticoaugulants
Preoperative CT scan not within 3 months before surgery
Pregnant patients
Patients younger than 18 years of age Study design and pathway The study will include patients with renal stones and undergoing mini-PCNL All patients should respect inclusionexclusion criteria An ultra-low dose unenhanced CT scan NCCT has to be available for all cases pre-operatively the post-operative follow-up will include NCCT within 2-3 months from treatment
Patients will complete the study at 3 months post-op when the stone free rate will be assessed Additionally 30 days post-op complications will be recorded using Clavien-Dindo system 3 months post-op stone-related events will be also registered
Prior to enroll patients participating surgeons will be asked to carry out 5 mini-PCNLs with disposable scope aiming to render them more familiar and achieve learning curve
Once the RCT will start patient will be randomized in two groups using computer software disposable group arm and non-disposable group arm
Peri-operative data collection Peri-operative data will be collected using a standardized excel database produced by main investigator site
The Stone complexity will be calculated according to database Each case should be evaluated by two experienced surgeons and appropriate scoring should be agreed
30 days post-operative complications should be recorded and reported using Clavien-Dindo classification System in its modified version for PCNLs Type of complication in each Centre should be agreed by two different surgeons
Post-operative patients quality of life will be evaluated using validated version of WISQoL in Chinese7 It will be measured at 24 hours and 7 days post-op
Definition of Stone free State no gt or equal to 2mm residual fragments measured with post-operative NCCT Size of residual fragments should be agreed with radiologist
PCNL-Trifecta achievement will also be recorded
Stone burden measurement
Authors will report maximum stone diameter and stone complexity reported using Guys8 and STONE nephrolithometry Score9 Stone characteristics should be agreed by two different surgeons If multiple stones are present the sum of their volume should be reported
Surgical technique
Patients deemed suitable and enrolled in the study will be operated as per routinary technique This will include a prone position and placement of a retrograde 5-6 Fr ureteric catheter for pyelogram and dilatation of the urinary tract
The puncture will be carried out according to surgeons preference under ultrasound fluoroscopy or combination
The track preparation will be carried out with one-shot dilator if necessary progressive dilatation can be conducted The percutaneous sheath will be 18 Fr
The Single-Use Video Cystoscope RP-U-C0102 without bendable tip produced by Redpine will be used as rigid nephroscope in disposable group arm This device has already obtained approval for endoluminal surgeries in China as well as CE and FDA approval for utilization in Western countries In the non-disposable group an equivalent size Hawk nephroscope will be used in the non-disposable arm
The lithotripsy will be done with Ho-YAG laser using a 550-micron laser fiber or ballistic lithotripter is believed appropriate
In both arms the percutaneous sheath will be 18 Fr peel-away sheath Cases can be conducted tubeless or totally tubeless if necessary If believed appropriate in the group of patients treated with disposable cystoscope surgeons are allowed to switch to a reusable nephroscope for any reason which will be documented
Definition of investigated complications
Complications will be categorized using Clavien-Dindo system Authors will also specifically investigate bleeding and infective complications
Infectious complications will include
Infection will be defined as temperature above 38C for a minimum of 24 hours andor procalcitonin gt 05 ngmL andor reactive C protein gt 10
Septic shock diagnosed using qSOFA Score
ICU admission for sepsis
Death
Perirenal abscess
Hemorragic complications will include
Transfusion
Hemoglobin drop gt2 grdL
Angioembolization
Bleeding requiring secondary operation bladder washout ureteric stent positioning
Emergency nephrectomy for uncontrollable bleeding
Hypovolemic shock requiring ICU stay
Study population
A total of 100 procedures will be included The study will involve three surgeons Each surgeon will carry out 20 procedures 10 for each arm The numerosity has been arbitrarily decided and in line with characteristics of pilot studies aiming to test feasibility of disposable PCNLs and estimate numerosity for future RCT on this topic Before enrolling patients all participating surgeons will be asked to carry out 5 mini-PCNLs with disposable scopes to render them familiar with the procedure and adjust the learning curve
Statistical analysis The Statistical Package for the Social Sciences SPSS 20 will be used for statistical analysis
Continuous variables will be presented as means SDs in cases of normal distribution and compared using the independent Students t-test while as median and interquartile range IQR in cases of skewed distributions and compared using the Mann-Whitney U-test Categorical variables will be presented as numbers with percentages and compared using chi-square or Fishers exact tests Statistical significance will be considered for two-tailed P values of lt005
Endpoints As primary endpoints authors will evaluate adequacy of disposable scopes evaluating need to switch to re-usable scopes due to breakages inadequacy failures and Stone Free Rates
Authors will also collect as secondary endpoints complication rates and patients comfort using WISQoL questionnaires
Additionally authors will use Likert scales to evaluate surgeons appreciation view handling and weight of the instruments irrigation stability of the instrument position and functionality of working channels
Authors will also monitor the number procedures where there will be need of switching to re-usable scopes due to malfunctioningbreakageinadequacy of disposable scopes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None