Prevention of Acute Voiding Difficulty After Radical Proctectomy

Seoul National University Hospital100 enrolled

Overview

Various adrenergic blockers are used for acute voiding difficulty after proctectomy. Recently, a selective alpha5-adrenergic blocker, Tamsulosin has been reported to have benefit in reducing urinary symptom score and in reducing the rate of intermittent self-catheterization for patients with rectal cancer after radical proctectomy. This study is to evaluate the efficacy of pharmacologic prevention to ameliorate the incidence of postoperative urinary dysfunction.

Acute voiding difficulty is caused from damage to pelvic sympathetic nerve after rectal surgery, and usually resolved spontaneously within several months after the surgery. However, acute voiding difficulty results in prolonged insertion of urinary catheter and is associated risk for urinary tract infection. Various adrenergic blockers are used for acute voiding difficulty after proctectomy. Recently, a selective alpha5-adrenergic blocker, Tamsulosin has been reported to have benefit in reducing urinary symptom score and in reducing the rate of intermittent self-catheterization for patients with rectal cancer after radical proctectomy. This study is to evaluate the efficacy of pharmacologic prevention to ameliorate teh incidence of postoperative urinary dysfunction.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

100

Conditions

Rectal Cancer Urinary Retention

Interventions

TamsulosinDRUG

oral administration of Tamsulosin

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients between 20-80 years old in general good health * Patient willing to participate in the study * Patient who understands and accepts to sign the informed consent form * Patient who received proctectomy for rectal cancer located 15 cm or less of the anal verge Exclusion Criteria: * Documented problem of preoperative urinary dysfunction * Any post-surgery change in patient condition which requires insertion of urinary catheter after surgery * Past history of recurrent urinary tract infection or malignancy of urinary system organs * Past history of surgery for urinary system organs * Current administration of Finasteride or Dutasteride * Liver dysfunction (SGOT or SGPT 100 IU/L or more) * Kidney dysfunction (serum Creatinine 3mg/dl or more)

Locations (1)

Department of Surgery, Seoul National University Bundang Hospital

Seongnam, South Korea

Outcomes

Primary Outcomes

Re-insertion rate of urinary catheter after removal

Time frame: after removal of urinary catheter

Secondary Outcomes

Scores of IPSS (International Prostatic Symptom Score) and the results of uroflowmetry

Time frame: at postoperative day 7

Data from ClinicalTrials.gov

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