Health TrialsbyHealthPanel

Prophylactic Use of Tamsulosin in the Prevention of Post-operative Urinary Retention in Men After Rectum Resection

ConditionsUrinary RetentionColorectal SurgeryRectal ResectionPost-operative Urinary RetentionTamsulosin
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexMale
Age18+
SponsorCHU de Quebec-Universite Laval

About this trial

The study will be a phase III double-blind randomized clinical trial. Participants will be recruited from the Department of General Surgery of the CHU de Québec - Saint-François-d'Assise and Hôtel-Dieu de Québec. The primary outcomes are the incidence of postoperative urinary retention in men undergoing rectal resection and the efficacy of prophylactic tamsulosin to prevent this type of complication.The secondary outcomes are the length of stay between experimental and placebo groups, the number of urinary catheterizations, the number of urine catheter reinsertions and total duration of urinary catheter being in-situ.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Male patients

18 years and older

Scheduled for rectal resection during the study period.

Disqualifiers

Patients undergoing revisional surgery

Patients taking alpha-blocker medication,

Patients who have an indwelling urinary catheter,

Patients who have undergone urinary tract surgery,

Trial design

Design model

Parallel

Treatments tested in this trial

  • pr Sandoz Tamsulosin

    Drug

    Sandoz Tamsulosin, the study drug, is an alpha1-adrenergic blocking agent approved by Health Canada for men with bladder outlet obstruction symptoms associated with benign prostatic hyperplasia.

  • Glucose

    Drug

    Patients assigned to the placebo group will receive glucose capsules according to the same protocol. The glucose capsules will be manufactured by the pharmacy of the CHU de Quebec

Treatment groups

220 Participants
are divided into 2 treatment groups
Group A: Group receiving TamsulosinActive comparator 1 intervention
Group B: Group receiving PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Postoperative urinary retention

Incidence of postoperative urinary retention in men undergoing rectal resection

Time frame
During the length of hospital stay: up to two weeks

Secondary outcomes

1

Length of stay

Length of stay between experimental and placebo groups

Time frame
During hospital stay: up to two weeks
2

Number of urinary catheterizations

Number of bladder catheterization

Time frame
During hospital stay: up to two weeks
3

Number of urine catheter reinsertions

Number of urine catheter reinsertions

Time frame
During hospital stay: up to two weeks
4

Total duration of urinary catheter being in-situ

Number of days a foley catheter will be in place

Time frame
During hospital stay: up to two weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

CHU de Quebec-Universite Laval

Lead sponsor

Fédération des médecins résidents du Québec

Collaborator

Source ClinicalTrials.gov
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