NCT06142734

Brief Summary

Uretropelvic junction ( UPJ ) obstruction is a common congenital disorder , but not all cases require surgical intervention. Uretropelvic junction ( UPJ ) obstruction is a common congenital disorder , but not all cases require surgical intervention. On the other hand, in children many authors reported mini incision open pyeloplasty with very small subcostal muscle splitting incision, with negligible postoperative pain and very short hospital stay

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
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Typical duration for not_applicable

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 17, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 21, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

November 21, 2023

Status Verified

November 1, 2023

Enrollment Period

2 years

First QC Date

September 17, 2023

Last Update Submit

November 20, 2023

Conditions

Pyeloplasty

Outcome Measures

Primary Outcomes (1)

  • Operative time

    From incision to last stitch

    baseline

Study Arms (2)

mini-incision open dismembered pyeloplasty

OTHER

Open surgery

Procedure: pyeloplasty

Laparoscopic dismembered pyeloplasty

OTHER

Minimally invasive surgery

Procedure: pyeloplasty

Interventions

pyeloplastyPROCEDURE

* For laparoscopic pyeloplasty: * Anaesthesia: general * Position: a 45-degree lateral decubitus position with the concerned side up. Patient is secured to the operating table. Pneumoperitoneum is adopted through a camera port lateral to the umbilicus * extra operating ports are created at subcostal and at spinoumbilial line. * the UPJ is transperitoneally accessed by incising the white line of Toldt and the ipsilateral colon is reflected and the proximal ureter and the pelvis are identified an mobilized * then Anderson- Hynes pyeloplasty is carried out with insertion of nephroureterostomy or pyeloureterostomy tube.

Laparoscopic dismembered pyeloplastymini-incision open dismembered pyeloplasty

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Children between 1-18 years , males and females with UPJ obstruction in orthotopic kidney indicated for dismembered pyeloplasty and not else

You may not qualify if:

  • Recurrent UPJ obstruction.
  • Cases that require technique other than dismembered pyeloplasty
  • Patients that have contradiction to laparoscopy.
  • comorbidities that prevent surgery e.g: uncorrected coagulopathy and vertebro-spinal deformity
  • patient refusing participation in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant lecturer of Urology

Study Record Dates

First Submitted

September 17, 2023

First Posted

November 21, 2023

Study Start

January 1, 2024

Primary Completion

January 1, 2026

Study Completion

January 1, 2026

Last Updated

November 21, 2023

Record last verified: 2023-11