Impact of Ureteral Stent and Sheaths Size on Post-Operative Pain

N/AEnrolling By InvitationNCT06979583

Mayo Clinic100 enrolled

Overview

The purpose of this study is to determine if post-operative stent size impacts stent-related pain and discomfort.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

100

Conditions

Ureteral Stent-Related Symptom Retrograde Intra-renal Surgery

Interventions

4.8 Fr Ureteral stentsDEVICE

After surgery, patients will have the Boston Scientific 4.8 Fr ureteral stent placed.

7 Fr Ureteral stentsDEVICE

After surgery, patients will have the Bard 7 Fr ureteral stent placed.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: • Patients undergoing a retrograde intra-renal surgery (RIRS) (only patients undergoing the procedure for stone treatment will be included) who will require post-operative indwelling ureteral stent placement on a string at the conclusion of the procedure. Exclusion Criteria: * Patients with intra-operative ureteral injury who will require ureteral stent for extended time (more than 10 days, in that case a stent without a string will be used). * Patient undergoing ureteroscopy for any indication other than stone extraction. * Patients who are currently pregnant as determined by clinical presurgical screening.

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Pain score post ureteroscopy procedure until stent removal determined by the primary operating team. Stent will be on a string

Post-operatively, patient will be contacted by study coordinators every day until stent is removed (usually 7-14 days after the surgery) to scale their stent pain on a scale from 1-5 as following: No pain: 1; Mild pain with no need for additional medication: 2; Mild pain with need for additional medication (anticholinergics): 3; Moderate stent pain (requiring narcotics): 4; Severe stent pain (requiring ER visit): 5.

Time frame: Starting post-operatively, daily, until stent is removed (estimated 7-14 days)

Secondary Outcomes

Volume of post-operative correspondence between patients and medical system.

Total number of communications received from patient post-operatively.

Time frame: 14 days

Data from ClinicalTrials.gov

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