NCT05640219

Brief Summary

Benha modification for renal track creation in percutaneous nephrolithotomy (PCNL) Our modification aims to decrease the complications of PCNL in large stones

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

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

November 16, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

December 7, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

January 25, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 7, 2023

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 17, 2023

Completed
Last Updated

January 25, 2023

Status Verified

December 1, 2022

Enrollment Period

1 month

First QC Date

November 16, 2022

Last Update Submit

January 22, 2023

Conditions

PCNL

Keywords

complications, partial staghorn stones, PCNL

Outcome Measures

Primary Outcomes (2)

  • decrease the intraoperative complication

    assessing the operative time in minutes

    intraoperative

  • blood loss in the operative theatre

    pre and postoperative haemoglobine in gram/dl

    intraoperative

Secondary Outcomes (1)

  • early postoperative impact and incidence of complication

    withen 10 days postoperative

Interventions

laparoscopic trocar 12mmDEVICE

long laparoscopic trocar 12mm (36 french) with central hole from its tip till its handle with transparent sheath

Eligibility Criteria

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

You may qualify if:

  • patients with partial staghorn stone more than 4 cm occupying the renal pelvis and the lower calyx +/\_ the upper calyx in patints 18 years old or more

You may not qualify if:

  • patients with uncorrected bleeding disorders, moderate or high risk cardiac patients , active urinary tract infection , skletal deformities or patients with complete staghorn

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

November 16, 2022

First Posted

December 7, 2022

Study Start

January 25, 2023

Primary Completion

March 7, 2023

Study Completion

March 17, 2023

Last Updated

January 25, 2023

Record last verified: 2022-12