The Effect of Different Body Positions and Channel Sheaths on RIRS

September 21, 2024 updated by: Guohua Zeng, The First Affiliated Hospital of Guangzhou Medical University

The Effect of Different Body Positions and Channel Sheaths on Retrograde Intrarenal Stone Surgery(RIRS) Treatment of Lower Pole Renal Stones: a Randomized Controlled Trial

Retrograde flexible ureteroscopy (RIRS) is currently the first-line treatment for renal stones < 2cm. Lower pole renal stones(LPS) are a difficult problem for urologists. The flexible negative pressure suction ureteral sheath(f-UAS) can facilitate RIRS to flush out the fragments and dust in time, and provide a clear vision and reduce the renal pelvis pressure(RPP) during operation.Standard lithotomy position is the most commonly used position for RIRS. Besides, T-tilt position is also available for RIRS in special cases. Investigators were inspired by this and proposed the lateral position, which is available in cases of LPS.In long-term practice, investigators have found that the change of position and the use of f-UAS can improve stone-free rate(SFR). Investigators aimed to conduct a prospective randomized controlled trial to compare the SFR of different positions and different ureteral sheaths.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Urolithiasis was one of the most frequently noted diseases in urology clinic, with an incidence ranged from 5 to 15% around the world. Retrograde flexible ureteroscopy (RIRS) is currently the first-line treatment for renal stones < 2cm in size. Lower pole renal stones(LPS) are a difficult problem for urologists. The inborn sharp infundibular-pelvic angle (IPA) designated an inferior stone-free rate(SFR) of 65-82.5% in LPS when compared to middle and/or upper pole stone. The flexible negative pressure suction ureteral sheath(f-URS) can facilitate RIRS to flush out the fragments and dust in time, and provide a clear vision and reduce the renal pelvis pressure(RPP) during operation. Therefore, in cases of LPS, f-URS combined with RIRS may show advantages. However, there is currently a lack of relevant prospective randomized controlled studies. Standard lithotomy position is the most commonly used position for RIRS. Besides the standard lithotomy position, other positions, such as the T-tilt position, are also available for RIRS in special cases. Investigators were inspired by this and proposed the lateral position, which is available for RIRS in cases of LPS.Theoretically, in standard lithotomy position, the renal pelvis and renal calyces were mostly distributed in a '-<' shaped structure on the horizontal plane. However, the renal pelvis and renal calyxes would be stood up in a 'Y'-shaped structure when patients laid in lateral position. And gravity will make the calyceal stones at the dome fall into the renal pelvis naturally during the lithotripsy. In long-term clinical practice, researchers have found that the change of position and the use of f-UAS can improve SFR. The investigators aimed to conduct a prospective randomized controlled trial to compare the SFR of different positions and different ureteral sheaths.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510230
        • Recruiting
        • Department of Urology, Minimally invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • LPS with a diameter of 10-20 mm
  • American Society of Anesthesiologists(ASA) score Ⅰ,Ⅱ and Ⅲ
  • Adult patients

Exclusion Criteria:

  • Ureteric stricture
  • Urethral deformity
  • Renal malformation, including horseshoe kidney, ectopic kidney and transplanted kidney
  • Pregnancy
  • Multiple stones in diferent calyces, including upper pole and middle pole

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RIRS with f-UAS, lateral position
In group 1, patients were placed on operating table in lateral position. A flexible negative-pressure suction ureteric access sheath (f-UAS) is placed under the pelvi-ureteral junction (PUJ) in RIRS.
Procedure: RIRS with f-UAS, lateral position
In this intervention, patients were placed on operating table in lateral position. The coronal plane of the patient body was perpendicular to the operating table. The upper limbs were extended and fxed with brackets. A f-UAS is placed under the pelvi-ureteric junction (PUJ) in RIRS. The tip of the UAS has good flexibility and deformability. It can passively bend with the bending of the flexible ureteroscope (f-URS).
Experimental: RIRS with f-UAS, lithotomy position
In group 2, patients were placed on operating table in lithotomy position. A flexible negative-pressure suction ureteral access sheath (f-UAS) is placed under the pelvi-ureteric junction (PUJ) in RIRS.
Procedure: RIRS with f-UAS, lithotomy position
In this intervention, patients were placed on operating table in lithotomy position. This position is common and standard. A f-UAS is placed under the pelvi-ureteric junction (PUJ) in RIRS. The tip of the UAS has good flexibility and deformability. It can passively bend with the bending of the flexible ureteroscope (f-URS).
Experimental: RIRS with traditional UAS, lateral position
In group 3, patients were placed on operating table in lateral position. A traditional ureteric access sheath (UAS) is placed under the pelvi-ureteral junction (PUJ) in RIRS.
Procedure: RIRS with traditional UAS, lateral position
In this intervention, patients were placed on operating table in lateral position. The coronal plane of the patient body was perpendicular to the operating table. The upper limbs were extended and fxed with brackets. A traditional UAS is placed under the pelvi-ureteric junction (PUJ) in RIRS.
Active Comparator: RIRS with traditional UAS, lithotomy position
In group 4, patients were placed on operating table in lithotomy position. A traditional ureteral access sheath (UAS) is placed under the pelvi-ureteric junction (PUJ) in RIRS.
Procedure: RIRS with traditional UAS, lithotomy position
In this intervention, patients were placed on operating table in lithotomy position. This position is common and standard. A traditional UAS is placed under the pelvi-ureteric junction (PUJ) in RIRS.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stone-free rate
Time Frame: 1 day
A low-dose and ultrathin 2-mm spiral CT was performed at 1 day postoperatively for evaluation of fnal SFR. Stone-free status was defined as no fragments observed or clinically insignifcant residual fragments (CIRF)<2 mm.
1 day
Stone-free rate
Time Frame: 1 month
A low-dose and ultrathin 2-mm spiral CT was performed at 1 month postoperatively for evaluation of fnal SFR. Stone-free status was defined as no fragments observed or clinically insignifcant residual fragments (CIRF)<2 mm.
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin drop
Time Frame: 1 day after surgery
Change of hemoglobin level 1 day after surgery comparing to pre-operative value, g/L
1 day after surgery
Operative time
Time Frame: During surgery
Surgery duration, minutes
During surgery
Hospital stay
Time Frame: 1 week
Duration of hospital stay after surgery, days
1 week
Complication rate
Time Frame: 1 month after sugery
Complication is defined as any adverse event occurred intraoperatively or ≤1 month postoperatively, including intraoperative bleeding, postoperative pain and so on.The investigator will invaluate perioperative complications by modified Clavien system
1 month after sugery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Guangzhou Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 23, 2024

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

November 1, 2024

Study Registration Dates

First Submitted

May 24, 2024

First Submitted That Met QC Criteria

May 30, 2024

First Posted (Actual)

June 3, 2024

Study Record Updates

Last Update Posted (Actual)

September 24, 2024

Last Update Submitted That Met QC Criteria

September 21, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MRER(84)2024

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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