NCT04846699

Brief Summary

To assess the impact of percutaneous renal access technique on outcomes of percutaneous nephrolithotomy in management of renal stones by comparing the Triangulation and ''eye of the needle'' (or bull's eye) and the stone targeted techniques in the following:-

  1. 1.Stone free rate (SFR) (primary outcome).
  2. 2.Complicatins of surgery (primary outcome).
  3. 3.Change in haematocrit pre and postoperative (secondary outcome).
  4. 4.Operative time (secondary outcome).
  5. 5.Duration of hospitalization (secondary outcome). .

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

April 12, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 15, 2021

Completed
5 days until next milestone

Study Start

First participant enrolled

April 20, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2023

Completed
Last Updated

April 15, 2021

Status Verified

April 1, 2021

Enrollment Period

2 years

First QC Date

April 12, 2021

Last Update Submit

April 12, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • stone free rate

    outcome of residual stone postoperative

    48 hours postoperative

  • complication of surgery

    fever , urine leakage , stent of ureter , sepsis, other intervention

    from day one post-operative to 3 months

Study Arms (3)

group 1

bulls eye localization

Procedure: per-cutaneous stone extraction

group 2

stone targeted technique renal access

Procedure: per-cutaneous stone extraction

group 3

triangulation renal access technique

Procedure: per-cutaneous stone extraction

Interventions

percutaneous nephrolithotripsy for renal stones by different renal access

group 1group 2group 3

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

all patients presented to endourology clinic by renal stone and complianting and fit for surgery.

You may qualify if:

  • \- The study will include all adult patients that with renal stones larger than 2 cm in diameter who will attend our endourology outpatient clinic from Jan 2021 to February 2023 and consented to participate in the study.

You may not qualify if:

  • \- 1-Patients with urinary system anomalies as horseshoe kidney, ectopic pelvic kid.
  • Patients with skeletal malformations. 3-Bleeding tendency and ongoing anticoagulant therapy. 4-Pregnancy. 5-Patients who refuse to be involved in the trial documentation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NIH

Asyut, 20892, Egypt

Location

Related Publications (3)

  • Schmahl FW, Betz E, Talke H, Hohorst HJ. [Energy rich phosphates and metabolites of energy metabolism in the cerebral cortex in the cat]. Biochem Z. 1965 Sep 30;342(5):518-31. No abstract available. German.

    PMID: 5866850BACKGROUND
  • Ashley FL. Implications of wound healing research. A meeting ground for experimental biology and clinical medicine. Plast Reconstr Surg. 1969 Feb;43(2):190-1. No abstract available.

    PMID: 5765923BACKGROUND
  • Meshkov SL, Seltzer SE, Finberg HJ. CT detection of intraabdominal disease in patients with lower extremity signs and symptoms. J Comput Assist Tomogr. 1982 Jun;6(3):497-501. doi: 10.1097/00004728-198206000-00010.

    PMID: 7096695BACKGROUND

Central Study Contacts

mahmoud abdo eldardery

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
dr mahmoud abdo el dardery

Study Record Dates

First Submitted

April 12, 2021

First Posted

April 15, 2021

Study Start

April 20, 2021

Primary Completion

April 20, 2023

Study Completion

April 20, 2023

Last Updated

April 15, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations