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

NCT ID: NCT05941806

Last Updated: 2023-07-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2025-07-30

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.

Conditions

Urinary Retention; Colorectal Surgery; Rectal Resection; Post-operative Urinary Retention; Tamsulosin

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Group receiving Tamsulosin

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. The steady-state plasma concentration of tamsulosin is reached after 4 to 5 consecutive doses, which justify the administration duration of 5 days preoperatively. The total duration of administration of tamsulosin was established at 7 days since the study of Patel et al. showed a significant reduction in POUR after 7 days of administration.

Group Type: ACTIVE_COMPARATOR

pr Sandoz Tamsulosin

Intervention Type: 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.

Group receiving Placebo

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.

Group Type: PLACEBO_COMPARATOR

Glucose

Intervention Type: 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

Interventions

pr Sandoz Tamsulosin

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.

Intervention Type: DRUG

Glucose

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

Intervention Type: DRUG

Other Intervention Names

Tamsulosin hydrochloride

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Fédération des médecins résidents du Québec

UNKNOWN

Sponsor Role: collaborator

CHU de Quebec-Universite Laval

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frédérique Beauchamp, MD

Role: PRINCIPAL_INVESTIGATOR

Locations

Hotel Dieu de Quebec

Québec, Quebec, Canada

Hôpital Saint-François d'Assise

Québec, , Canada

Countries

Canada

Central Contacts

Frédérique Beauchamp, MD

Role: CONTACT

frederique.beauchamp.1@ulaval.ca

4182717881

Sébastien Drolet, MD FRCSC

Role: CONTACT

sebastien.drolet.chx@gmail.com

4184550900

Facility Contacts

Frédérique Beauchamp, MD

Role: primary

frederique.beauchamp.1@ulaval.ca

4182717881

Beauchamp Frédérique, MD

Role: primary

frederique.beauchamp.1@ulaval.ca

4182717881

Other Identifiers

Projet 2023-6826

Identifier Type: -

Identifier Source: org_study_id