Homework in Retrograde Intrarenal Surgery

January 27, 2025 updated by: Bedreddin Kalyenci, Adiyaman University

Homework to Help with Stone Dissolution in Retrograde Intrarenal Surgery

To evaluate the effectiveness of this homework on stone clearance rates after retrograde intrarenal surgery (RIRS) by instructing the patient in the home environment and suggesting percussion and movement/position changes to assist in spontaneous stone passage.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

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 Locations

  • Turkey
      • Adıyaman, Turkey, 02400
        • Recruiting
        • Adıyaman 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:

  • Patients with an indication for RIRC

Exclusion Criteria:

  • Patients with anatomic abnormalities such as horseshoe kidney, fragments in the calyx diverticulum, infundibular stenosis, pelvi-ureteral junction obstruction or ureteral stenosis.
  • Patients with morbid obesity, uncontrolled hypertension, previous cerebrovascular accident, skeletal deformity such as significant coronary artery disease or symptomatic gastro-esophageal reflux disease.
  • Patients with lumbar disc herniation who have undergone spinal surgery and are unable to undergo behavioral therapy.

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Homework to Help with Stone Dissolution in Retrograde Intrarenal Surgery
Behavioral: Percussion and position change in retrograde intrarenal surgery
To evaluate the effectiveness of this homework on stone clearance rates after RIRC by giving instructions to the patient in the home environment and suggesting percussion (tapping) and movement/position changes to help spontaneous stone passage.
No Intervention: Standard Retrograde Intrarenal Surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
stone free rates
Time Frame: 1 month after the intervention/procedure/surgery
1 month after the intervention/procedure/surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Patients with complications and Number of Patients with need for secondary surgery after retrograde intrarenal surgery
Time Frame: 1 month after the intervention/procedure/surgery
1 month after the intervention/procedure/surgery

Collaborators and Investigators

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

Sponsor

Adiyaman 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)

January 21, 2025

Primary Completion (Estimated)

October 31, 2025

Study Completion (Estimated)

November 30, 2025

Study Registration Dates

First Submitted

January 21, 2025

First Submitted That Met QC Criteria

January 25, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 27, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HRÜ/24.21.21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

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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