Randomized Controlled Trial of Miniaturized Percutaneous Nephrolithotomy With Vacuum-Assisted Access Sheaths Versus Conventional Sheaths for Treatment of Nephrolithiasis

Sponsor

The Cleveland Clinic (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05993546

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this study is to compare two variations of the mini-PCNL procedure using either a vacuum-assisted sheath or standard sheath which are both used for the surgical treatment of kidney stones. Both procedure types are commonly used in the treatment of kidneys stones and they have been shown to be safe and effective in the treatment of stones similar in size and location to your own.

Condition or Disease	Intervention/Treatment	Phase
Kidney Stone	Device: vacuum assisted sheath Device: passive suction via conventional sheath	N/A

Detailed Description

In this study we aim to compare two variations of the miniaturized percutaneous nephrolithotomy (Mini-PCNL) procedure which are both used for the surgical treatment of kidney stones. This procedure involves accessing the kidney via a small temporary tract that is placed through the patient's back during surgery. Both procedure types are commonly used in the treatment of kidneys stones and they have been shown to be safe and effective in the treatment of stones similar in size and location to your own.

Two procedure types will be investigated:

Miniaturized percutaneous nephrolithotomy performed using a 16 Fr (6 mm diameter) vacuum-assisted tube with suction capability to assess the kidney and extract the stone.
Miniaturized percutaneous nephrolithotomy performed using a 16 Fr (6 mm diameter) standard tube to assess the kidney and extract the stone.

Approximately 90 people will take part in this study at Cleveland Clinic. The duration of the study will include the day of the surgery and following hospital stay until postoperative follow-up appointment with the surgeon approximately 4-6 weeks after the procedure.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Randomized Controlled Trial of Miniaturized Percutaneous Nephrolithotomy With Vacuum-Assisted Access Sheaths Versus Conventional Sheaths for Treatment of Nephrolithiasis

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2024

Anticipated Study Completion Date :

Sep 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: vacuum-assisted sheath	Device: vacuum assisted sheath allows for simultaneous suction with continuous irrigation throughout the case to enhance visibility and facilitate stone retrieval
Active Comparator: passive suction via conventional sheath	Device: passive suction via conventional sheath conventional access sheath for stone retrieval using current technique via passive suction

Arm

Intervention/Treatment

Active Comparator: vacuum-assisted sheath

Device: vacuum assisted sheath

allows for simultaneous suction with continuous irrigation throughout the case to enhance visibility and facilitate stone retrieval

Active Comparator: passive suction via conventional sheath

Device: passive suction via conventional sheath

conventional access sheath for stone retrieval using current technique via passive suction

Outcome Measures

Primary Outcome Measures

Aim 1: Stone free rate [6 weeks]
The primary outcome of SFR will be measured using conventional follow up of post-operative NCCT at 6 weeks. NCCT provides the most definitive assessment for post-operative stone burden and allows assessment of radiolucent stones when compared to ultrasound or abdominal x-ray
Aim 2: Intraoperative variables [3-7 days]
Patients with positive cultures will be treated with appropriate pre-operative antibiotics between 3 to 7 days depending on symptoms. Antibiotics on day of surgery will be selected according to their last pre-operative urine culture which is our standard of care for patients undergoing PCNL
Aim 3: Post-operative Outcomes and Complications [1 day]
Post-operative pain scores will be evaluated using a visual analogue scale (VAS) in the post-anesthesia care unit (PACU) and on postoperative day 1. The questionnaire may be filled out on a paper survey or an electronic REDCap survey sent via email. An electronic VAS has shown to be reliable and interchangeable with a paper VAS

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with planned prone mini-PCNL and a preoperative NCCT
Primary stone size: 10-25 mm
Pre-existing indwelling nephrostomy tube or ureteral stent permitted
Age: ≥ 18 years old
Gender: all
Ethnicity: all
Capable of giving informed consent
Capable and willing to fulfill requirements of the study

Exclusion Criteria:

Anticoagulated or history of coagulopathy
Congenital renal anomalies
Prior ipsilateral upper urinary tract reconstructive procedures
Conversion to open procedure
Multiple access tracts
Inability to give informed consent or unable to meet requirements of the study for any reason

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

The Cleveland Clinic

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

The Cleveland Clinic

ClinicalTrials.gov Identifier:

NCT05993546

Other Study ID Numbers:

23-104

First Posted:

Aug 15, 2023

Last Update Posted:

Aug 21, 2023

Last Verified:

Jun 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Kidney Calculi

Nephrolithiasis

Study Results

No Results Posted as of Aug 21, 2023