NCT07522619

Brief Summary

Percutaneous nephrolithotomy (PCNL) is the surgery usually done to break down kidney stones that are larger than 1.5 cm. Placing a nephrostomy tube after the surgery to drain urine is a common aspect of traditional PCNL. This tube placement is associated with post-op pain and discomfort. In tubeless PCNL, the nephrostomy tube is not placed, which may lessen pain and speed up recovery. In this randomized controlled trial, the primary objective is to assess the pain and analgesia requirements of patients at different time points after surgery who have undergone a standard PCNL or a tubeless PCNL. Secondary parameters will be recorded, like surgical time, duration of hospital stay, and time interval before the first complaint of pain. Results from this research will offer advice about whether tubeless PCNL can be considered a safe and patient-friendly option as compared to the standard method.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 24, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 23, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 23, 2022

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

March 29, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

6 months

First QC Date

March 29, 2026

Last Update Submit

April 8, 2026

Conditions

Renal StonesPostoperative Pain

Keywords

Tubeless PCNLPostoperative PainNephrostomy Tube

Outcome Measures

Primary Outcomes (2)

  • Stone-Free Rate (SFR)

    Proportion of patients with no residual renal stones or clinically insignificant fragments (\<4 mm) confirmed on postoperative imaging.

    4 weeks postoperatively

  • Postoperative Pain Score

    Visual Analogue Scale (VAS), a 100 mm scale ranging from 0 mm (no pain) to 100 mm (worst imaginable pain), where higher scores indicate worse pain.

    6 hours, 12 hours, and 24 hours postoperatively.

Secondary Outcomes (4)

  • Operative Time

    During the surgical procedure (from skin incision to completion of procedure)

  • Time to First Pain Complaint

    From end of surgery to first reported pain, assessed up to 24 hours postoperatively

  • Length of Hospital Stay

    From admission to discharge, assessed up to 5 days

  • Analgesia Requirement

    From end of surgery up to 24 hours postoperatively

Study Arms (2)

Standard PCNL

ACTIVE COMPARATOR

Patients undergo standard percutaneous nephrolithotomy (PCNL) with placement of a nephrostomy tube at the end of the procedure.

Procedure: Standard Percutaneous Nephrolithotomy (Standard PCNL)

Tubeless PCNL

EXPERIMENTAL

Patients undergo tubeless percutaneous nephrolithotomy (PCNL) without placement of a nephrostomy tube.

Procedure: Tubeless Percutaneous Nephrolithotomy (Tubeless PCNL)

Interventions

Standard Percutaneous Nephrolithotomy (Standard PCNL)PROCEDURE

Percutaneous nephrolithotomy (PCNL) is performed with placement of a nephrostomy tube at the end of the procedure.

Standard PCNL
Tubeless Percutaneous Nephrolithotomy (Tubeless PCNL)PROCEDURE

Percutaneous nephrolithotomy (PCNL) is performed without placement of a nephrostomy tube at the end of the procedure.

Also known as: Nephrostomy-Free Percutaneous Nephrolithotomy
Tubeless PCNL

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 to 80 years
  • Renal stones greater than 1.5 cm
  • Schedule for percutaneous nephrolithotomy (PCNL)
  • Ability to provide informed consent

You may not qualify if:

  • Congenital anatomical renal abnormalities
  • Known bleeding disorders
  • Pelvicalyceal system perforation
  • Refusal or inability to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indus Hospital and Health Network

Karachi, Sindh, 74900, Pakistan

Location

Related Links

MeSH Terms

Conditions

NephrolithiasisPain, Postoperative

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisMale Urogenital DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Due to the nature of the surgical intervention, blinding participants, care providers, and outcome assessors was not feasible.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two parallel groups of participants were randomly assigned to receive either tubeless percutaneous nephrolithotomy (PCNL) without a nephrostomy tube or standard PCNL with a nephrostomy tube. Outcomes were compared between the two groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant

Study Record Dates

First Submitted

March 29, 2026

First Posted

April 13, 2026

Study Start

November 24, 2021

Primary Completion

May 23, 2022

Study Completion

May 23, 2022

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared due to institutional policies, patient confidentiality concerns, and lack of formal data-sharing agreements.

Locations

PA(1)