Skip to main content
Clinical Trials/CTRI/2024/12/078061
CTRI/2024/12/078061
Completed
Phase 4

A Comparative study of early versus late removal of per urethral catheter after anterior anastomotic and buccal mucosal onlay urethroplasty.

Sai Bharath Nandula1 site in 1 country70 target enrollmentStarted: December 30, 2024Last updated:

Overview

Phase
Phase 4
Status
Completed
Sponsor
Sai Bharath Nandula
Enrollment
70
Locations
1
Primary Endpoint
Extravasation rates, duration of catheterization.

Overview

Brief Summary

This is a parallel arm, randomized controlled study in which after urethroplasty surgery patients are followed up. Early removal of catheter has advantages of reduced urinary tract infection rates, better comfort to the patient and reduced recurrence rate of stricture, In the intervention group, per urethral urethrogram  is done  7 days early than comparator group which is within the optimum range of duration of catheterization. The extravasation rates are measured and catheter is removed when there is no extravasation. The extravasation rates, duration of catheterization and recurrence rates of both groups are compared and the feasibility of early removal is to be determined.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

Ages
20.00 Year(s) to 70.00 Year(s) (—)
Sex
Male

Inclusion Criteria

  • Patients diagnosed with urethral stricture disease and who underwent anastomotic and buccal mucosal onlay urethroplasty.

Exclusion Criteria

  • Patients with history of previous repair, chronic kidney disease, uncontrolled diabetes mellitus and who received radiotherapy.

Outcomes

Primary Outcomes

Extravasation rates, duration of catheterization.

Time Frame: Extravasation rates on 7th, 14th for anastomotic urethroplasty and 14th and 21st day for buccal mucosal onlay urethroplasty. Duration of catheterization measured on 21st day.

Secondary Outcomes

  • Recurrence of stricture rates.(Recurrence rates studied at 3 & 6 months after surgery.)

Investigators

Sponsor
Sai Bharath Nandula
Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

Sai Bharath Nandula

IPGMER and SSKM Hospital, Kolkata

Study Sites (1)

Loading locations...

Similar Trials