Clinical trial NCT05941806: Prophylactic Use of Tamsulosin in the Prevention of Post-operative Urinary Retention in Men After Rectum Resection
Official title: Prophylactic Use of Tamsulosin in the Prevention of Post-operative Urinary Retention in Men After Rectum Resection: a Double-blind Placebo-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Urinary Retention
Colorectal Surgery
Rectal Resection
Post-operative Urinary Retention
Tamsulosin
Lead sponsor: CHU de Quebec-Universite Laval
Sponsor class: OTHER
Collaborators: name: Fédération des médecins résidents du Québec
First posted: 2023-07-12
Enrollment: 220
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Our study will be a phase III double-blind randomized clinical trial. A period of 12 to 24 months is planned for recruitment. 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.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: Participants will be recruited consecutively during their preoperative visit to the outpatient clinic. Participants will be followed by a logbook throughout the follow-up period, as well as by their surgical and research teams. Follow-up will begin on the first day of pre-operative medication and will end 30 days after surgery. Patients randomized to the intervention group will receive 0.4 mg tamsulosin capsules, administered orally, once a day for 5 days before surgery, the morning of surgery and the day after surgery. 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. All patients will have a foley catheter inserted for surgery. Their urinary catheter (foley catheter) will be removed at 6:00 AM the day after their surgery (post-operative day 1). The diagnosis of urinary retention will be suspected by a member of the patient's medical team if a patient has no miction for 8 hours or more or 4 hours or more after removal of foley catheter or after the surgery. In these cases, a portable bladder scanner will be used. The diagnosis of post-operative urinary retention (POUR) will be confirmed in two situations: 1. If there is 500ml of urine or more in the bladder 2. If there is 300ml or urine or more with at least 1 of the following symptoms: urge to urinate with inability to urinate, suprapubic pain or signs and symptoms of delirium. When the diagnosis of POUR will be made, urine will be removed from the bladder using an in/out bladder catheterization. After using a bladder catheterization, a portable bladder scanner will be used again if a patient has no spontaneous urination for the first 4 hours after catheterization. A second bladder catheterization will be done once again in the same two situations as described above. At the third bladder catheterization, a urinary (foley) catheter will be inserted. The catheter will be left in place for 24h before attempting a trial of void. A member of the medical team will then collect the information in the patient's logbook and medical record. Adherence to drug intake will be self-reported to the patient's diary. The patient can indicate why he missed one or more doses of the drug. Patients will receive a list of potential side effects of tamsulosin with their logbook. The side effects will be self-reported by the patient to the logbook each day. The patients' logbook will be analysed by the research team. Two independent reviewers of the research team will collect the other variables. They will perform a standardized retrospective revision of the medical records according to a pre-established data collection grid. We will perform an intention-to-treat analysis in this prospective randomized study. Postoperative urinary retention remains a frequent complication and causes significant discomfort in men undergoing rectal resection. The decrease in its incidence could then significantly reduce the number of bladder catheterizations required postoperatively, and thus reduce the incidence of complications associated with it. The prevention of POUR will allow patients a more harmonious postoperative recovery, limited in inconvenience and side effects, and an earlier return home. Ultimately, the health care costs associated with this postoperative complication may be reduced.

Eligibility criteria: Inclusion Criteria:

* Male patients
* 18 years and older
* Scheduled for rectal resection during the study period.

Exclusion Criteria:

* Patients undergoing revisional surgery
* Patients taking alpha-blocker medication,
* Patients who have an indwelling urinary catheter,
* Patients who have undergone urinary tract surgery,
* Patients who will have an intraoperative trauma of the urinary tract,
* Patients who will keep their urinary catheter for more than 24 hours after surgery,
* Patients who have an intolerance to alpha-blocking drugs or who take one of the following drugs (potential interaction): anti-retroviral, antifungal, clarithromycin, erythromycin, paroxetine, terbinafine, cimetidine, coumadin or phosphodiesterase inhibitors.
* Patients who will have an epidural anesthesia

Primary outcomes:
measure: Postoperative urinary retention
timeFrame: During the length of hospital stay: up to two weeks
Secondary outcomes:
measure: Length of stay
timeFrame: During hospital stay: up to two weeks
measure: Number of urinary catheterizations
timeFrame: During hospital stay: up to two weeks
measure: Number of urine catheter reinsertions
timeFrame: During hospital stay: up to two weeks
measure: Total duration of urinary catheter being in-situ
timeFrame: During hospital stay: up to two weeks
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Hotel Dieu de Quebec
state: Que
city: Québec
country: Canada
facility: Hôpital Saint-François d'Assise
Study officials:
name: Frédérique Beauchamp, MD
role: PRINCIPAL_INVESTIGATOR
References: