Jang 2012.
| Study characteristics | ||
| Methods |
Study design: RCT Dates study conducted: May 2007‐September 2010 |
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| Participants |
Number of participants: 113 eligible; 94 randomised (abstract reports 105 randomised); 94 reported (abstract reports 105) Country: Korea Population: mixed Age (mean and range): A 54.0 (48.0‐62.0); B 59.0 (54.0‐66.0) Inclusion criteria: rectal cancer patients 20‐80 years old in general good health, willing to participate in the study, understand and accept to sign the informed consent form, receiving proctectomy for rectal cancer located ≤ 15 cm of the anal verge Condition for hospitalisation: surgery for rectal cancer Exclusion criteria: documented problem of pre‐operative urinary dysfunction, any post‐surgery change in patient condition that requires insertion of IUC after surgery, past history of recurrent UTI 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), kidney dysfunction (serum creatinine ≥ 3 mg/dL) Use of antibiotic prophylaxis: all patients were given IV injections of a single dose of antibiotic during anaesthesia induction and before the operation |
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| Interventions |
Group A (n = 47 (abstract reports 51)): tamsulosin 0.2 mg/day orally from the day of the operation to post‐operative day 7 Group B (n = 47 (abstract reports 54)): no intervention Size and type of catheter used (e.g. Foley 16F): 16F or 18F Foley Study definition of short‐term catheterisation (days): not reported Intended duration of catheterisation for each group: Groups A and B: 3 days after operation. On post‐operative day 3, the maximum and average flow rates were checked after removing the IUC. Voided volume, residual urine volume, and IPSS* were checked on post‐op day 7. A IUC was reinserted if the patient failed to void successfully after removing the catheter. Unsuccessful voiding was defined as follows: (1) no voiding sensation for > 6 h after removing the catheter; (2) voided volume < 100 mL; or (3) residual urine volume < 200 mL |
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| Outcomes | N requiring recatheterisation on post‐op day 3 Voided volume on post‐op day 7 (mL) Residual volume on post‐op day 7 (mL) Hospital stay (days) (median, IQR, N) Other complications (excluding acute voiding difficulty) Wound problem Chylous ascites Ileus Intraluminal bleeding UTI Rectovaginal fistula Anastomotic leakage IPSS (post‐op day 7) QoL due to urinary symptoms |
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| Definition of CAUTI or bacteriuria | Not reported | |
| Sponsorship/funding | Not reported | |
| Ethical approval | Approved and overseen by the institutional review board of our hospital (approval no. B‐0702‐042‐006) (Seoul National University Bundang Hospital) | |
| Notes | *Scores for individual domains of IPSS also reported, if needed (0–35 scale, higher score = more severe symptoms. QoL component of IPSS (0‐6 scale, higher score = lower QoL) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: “patients were randomized (1:1)… using computer generated numbers” Comment: adequate method of randomisation |
| Allocation concealment (selection bias) | Unclear risk | Not reported |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Control group gets no intervention at all. Protocol is available on Clinicaltrials.gov record states "double blind (Subject, Caregiver, Investigator)" but there is no description of placebo intervention. Lack of blinding or lack of placebo could influence the care provided or the perception of symptoms. |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported in published version of the report. Protocol is available on Clinicaltrials.gov record states "double blind (Subject, Caregiver, Investigator)" |
| Blinding of microbiological outcome (detection bias) | Low risk | Not reported |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No withdrawals reported |
| Selective reporting (reporting bias) | Low risk | Outcomes specified in clinicaltrials.gov record are reported |
| Other bias | Low risk | Nothing to indicate any other source of bias |