Retrograde versus antegrade placement of a double-J catheter in patients with extrinsic ureter obstruction

Retrograde versus antegrade placement of a double-J catheter in patients with extrinsic ureter obstruction - RAPPER - trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON42126

Enrollment

214

Registered

2014-11-19

Start date

2016-03-04

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

blockage of the kidney drainage tube Extrinsic ureteral obstruction

Interventions

Subjects will be randomized to receive a double J catheter inserted by a retrograde or an antegrade approach.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: CT or MR diagnosis of extrinsic ureter obstruction

Exclusion criteria

Exclusion criteria: Active infection (temperature >38°C) Macroscopic haematuria INR > 2,0 or Thrombocytes

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the immediate technical success rate.	—

Secondary

Measure	Time frame
Secondary study endpoints are VAS score immediately after the procedure, technical success rate at 30 days, mortality within 30 days, major complications (i.e. transfusion required retroperitoneal bleeding, perforation, sepsis) and minor complications (i.e. urinary tract infection, macroscopic haematuria, inflammation of the skin) within 30 days, renal function at 7 days and 30 days and score on the EQ5D questionnaire at 30 days after intervention.	—

Measure

Time frame

Secondary study endpoints are VAS score immediately after the procedure, technical success rate at 30 days, mortality within 30 days, major complications (i.e. transfusion required retroperitoneal bleeding, perforation, sepsis) and minor complications (i.e. urinary tract infection, macroscopic haematuria, inflammation of the skin) within 30 days, renal function at 7 days and 30 days and score on the EQ5D questionnaire at 30 days after intervention.

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)