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

Primary Purpose

Urolithiasis

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

RIRS with ureteral access sheath

RIRS without ureteral access sheath

About this trial

This is an interventional treatment trial for Urolithiasis focused on measuring renal stone, retrograde intrarenal surgery, ureteral access sheath, pain

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Selcuk University, School of Medicine, Department of Urology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

UAS (+)

UAS (-)

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

Postoperative pain level

Postoperative pain levels of the patients in both groups will be evaluated by using visual analog score (VAS).

Postoperative pain level

Postoperative pain levels of the patients in both groups will be evaluated by using verbal rating score (VRS).

Secondary Outcome Measures

Full Information

NCT ID

NCT02501525

First Posted

July 11, 2015

Last Updated

November 15, 2019

Sponsor

Selcuk University

1. Study Identification

Unique Protocol Identification Number

NCT02501525

Brief Title

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

Official Title

Effect of Ureteral Access Sheath Use on Postoperative Pain Level in Patients Undergoing Retrograde Intrarenal Surgery (RIRS)

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Completed

Study Start Date

August 2015 (undefined)

Primary Completion Date

May 2016 (Actual)

Study Completion Date

May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Selcuk University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Urolithiasis

Keywords

renal stone, retrograde intrarenal surgery, ureteral access sheath, pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

UAS (+)

Arm Type

Active Comparator

Arm Description

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).

Arm Title

UAS (-)

Arm Type

Experimental

Arm Description

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).

Intervention Type

Device

Intervention Name(s)

RIRS with ureteral access sheath

Intervention Description

Ureteral access sheath will be used during RIRS.

Intervention Type

Device

Intervention Name(s)

RIRS without ureteral access sheath

Intervention Description

Ureteral access sheath will not be used during RIRS.

Primary Outcome Measure Information:

Title

Postoperative pain level

Description

Postoperative pain levels of the patients in both groups will be evaluated by using visual analog score (VAS).

Time Frame

Within the first 2 hours after the surgery (RIRS)

Title

Postoperative pain level

Description

Postoperative pain levels of the patients in both groups will be evaluated by using verbal rating score (VRS).

Time Frame

Within the first 2 hours after the surgery (RIRS)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ozcan Kilic, M.D.

Organizational Affiliation

Selcuk University, School of Medicine, Department of Urology

Official's Role

Principal Investigator

Facility Information:

Facility Name

Selcuk University, School of Medicine, Department of Urology

City

Konya

ZIP/Postal Code

42075

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

22840867

Citation

Resorlu B, Unsal A, Gulec H, Oztuna D. A new scoring system for predicting stone-free rate after retrograde intrarenal surgery: the "resorlu-unsal stone score". Urology. 2012 Sep;80(3):512-8. doi: 10.1016/j.urology.2012.02.072. Epub 2012 Jul 26.

Results Reference

background

PubMed Identifier

24881777

Citation

Cepeda M, Amon JH, Mainez JA, Rodriguez V, Alonso D, Martinez-Sagarra JM. Flexible ureteroscopy for renal stones. Actas Urol Esp. 2014 Nov;38(9):571-5. doi: 10.1016/j.acuro.2014.03.014. Epub 2014 Jun 2. English, Spanish.

Results Reference

background

PubMed Identifier

15006050

Citation

Auge BK, Pietrow PK, Lallas CD, Raj GV, Santa-Cruz RW, Preminger GM. Ureteral access sheath provides protection against elevated renal pressures during routine flexible ureteroscopic stone manipulation. J Endourol. 2004 Feb;18(1):33-6. doi: 10.1089/089277904322836631.

Results Reference

background

PubMed Identifier

11176469

Citation

Kourambas J, Byrne RR, Preminger GM. Does a ureteral access sheath facilitate ureteroscopy? J Urol. 2001 Mar;165(3):789-93.

Results Reference

background

PubMed Identifier

16040093

Citation

L'esperance JO, Ekeruo WO, Scales CD Jr, Marguet CG, Springhart WP, Maloney ME, Albala DM, Preminger GM. Effect of ureteral access sheath on stone-free rates in patients undergoing ureteroscopic management of renal calculi. Urology. 2005 Aug;66(2):252-5. doi: 10.1016/j.urology.2005.03.019.

Results Reference

background

PubMed Identifier

17338606

Citation

Stern JM, Yiee J, Park S. Safety and efficacy of ureteral access sheaths. J Endourol. 2007 Feb;21(2):119-23. doi: 10.1089/end.2007.9997.

Results Reference

background

PubMed Identifier

12470467

Citation

Lallas CD, Auge BK, Raj GV, Santa-Cruz R, Madden JF, Preminger GM. Laser Doppler flowmetric determination of ureteral blood flow after ureteral access sheath placement. J Endourol. 2002 Oct;16(8):583-90. doi: 10.1089/089277902320913288.

Results Reference

background

PubMed Identifier

24231214

Citation

Torricelli FC, De S, Hinck B, Noble M, Monga M. Flexible ureteroscopy with a ureteral access sheath: when to stent? Urology. 2014 Feb;83(2):278-81. doi: 10.1016/j.urology.2013.10.002. Epub 2013 Nov 12.

Results Reference

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

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