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Effect of Ureteral Access Sheath Use on Postoperative Pain Level in Patients Undergoing RIRS

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ClinicalTrials.gov Identifier: NCT02501525
Recruitment Status : Completed
First Posted : July 17, 2015
Last Update Posted : November 18, 2019
Sponsor:
Information provided by (Responsible Party):
Ozcan Kilic, Selcuk University

Brief Summary:
This study will include patients aged between 18 and 70 who will undergo retrograde intrarenal surgery (RIRS) due to renal stone(s). A total of 80 patients (male or female) will be recruited, and will be randomized into 2 groups consisting of 40 patients in each group. The first group of patients will undergo RIRS with a ureteral access sheath (UAS) positioned prior to surgery; and the second group will undergo RIRS without UAS. As use of UAS decreases the pressure in the renal pelvis during RIRS, it is aimed to evaluate whether using UAS or not affects the level of pain felt by patients in the postoperative period.

Condition or disease Intervention/treatment Phase
Urolithiasis Device: RIRS with ureteral access sheath Device: RIRS without ureteral access sheath Not Applicable

Detailed Description:
The level of pain of the patients in both groups will be evaluated by using visual analog score (VAS) and verbal rating score (VRS) in the postoperative 0 min (the moment patients gets consciousness after he/she wakes up from general anesthesia), 10th min, 30th min, 60th min and 120th min.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Ureteral Access Sheath Use on Postoperative Pain Level in Patients Undergoing Retrograde Intrarenal Surgery (RIRS)
Study Start Date : August 2015
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Arm Intervention/treatment
Active Comparator: UAS (+)
RIRS with ureteral access sheath: A ureteral access sheath (UAS) will be positioned into the ureter of the patient prior to the insertion of the flexible ureterorenoscope (RIRS).
Device: RIRS with ureteral access sheath
Ureteral access sheath will be used during RIRS.

Experimental: UAS (-)
RIRS without ureteral access sheath: A ureteral access sheath (UAS) will not be positioned into the ureter of the patient prior to the insertion of the flexible ureterorenoscope (RIRS).
Device: RIRS without ureteral access sheath
Ureteral access sheath will not be used during RIRS.




Primary Outcome Measures :
  1. Postoperative pain level [ Time Frame: Within the first 2 hours after the surgery (RIRS) ]
    Postoperative pain levels of the patients in both groups will be evaluated by using visual analog score (VAS).

  2. Postoperative pain level [ Time Frame: Within the first 2 hours after the surgery (RIRS) ]
    Postoperative pain levels of the patients in both groups will be evaluated by using verbal rating score (VRS).



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Being between 18-70 years old
  • Having an indication of retrograde infrarenal surgery (RIRS) due to kidney stone

Exclusion Criteria:

  • Patients with uncontrolled diabetes mellitus and diabetic nephropathy
  • Patients with blood pressure > 140/80 mmHg despite regular use of antihypertensive agent(s)
  • Patients with chronic kidney failure who need dialysis
  • Patients who have had prerenal, renal or postrenal acute kidney failure 3 months or much earlier
  • Patients who have had pyelonephritis 3 months or much earlier
  • Patients younger than 18 years or older than 70 years
  • Patients who have undergone a kidney surgery within the last 3 months and have abnormal kidney function tests
  • Patients with a concomitant ureter stone who will undergo an endoscopic ureter stone treatment at the same session
  • Patients using any kind of medication that can affect his/her perception of pain

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02501525


Locations
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Turkey
Selcuk University, School of Medicine, Department of Urology
Konya, Turkey, 42075
Sponsors and Collaborators
Selcuk University
Investigators
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Principal Investigator: Ozcan Kilic, M.D. Selcuk University, School of Medicine, Department of Urology
Publications:

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Responsible Party: Ozcan Kilic, M.D., Assoc. Prof. Dr., Selcuk University
ClinicalTrials.gov Identifier: NCT02501525    
Other Study ID Numbers: SU-RIRS-UAS-03
First Posted: July 17, 2015    Key Record Dates
Last Update Posted: November 18, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Ozcan Kilic, Selcuk University:
renal stone
retrograde intrarenal surgery
ureteral access sheath
pain
Additional relevant MeSH terms:
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Urolithiasis
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Urologic Diseases