Post-operative urinary retention (POUR) is a common complication after inguinal hernia repair with a reported incidence up 34%. It can be described as the inability to initiate urination or properly empty one's bladder following surgery. It is usually self-limited, but it requires the use of catheterization to empty the bladder in order to prevent further injury to the bladder or kidneys and to relief the discomfort of a full bladder. Tamsulosin is a medication that is commonly used in men with urinary symptoms related to an enlarged prostate. There is some evidence to suggest that it may also potentially be beneficial for preventing post-operative urinary retention. The purpose of this study is to determine if tamsulosin ("TAMSULOSIN Mepha Ret Depocaps 0.4 mg") is effective in preventing post-operative urinary retention following endoscopic total extraperitoneal inguinal hernia repair and its impact on hospital length of stay.
In this RCT subjects are randomly and parallel assigned to one of two groups: one (the experimental group) receiving "Tamsulosin 0.4 mg"/ day, 5 days prior to the day of laparoscopic inguinal hernia repair surgery, at the day of surgery and for 1 day following surgery. (5+1+1), and the other (the control group) receiving one placebo capsule matching the active study drug per day from 5 days prior to the day of surgery, at the day of surgery and for 1 day following surgery. (5+1+1). There will be effective (concealed) randomization of the subjects to the intervention/control groups (to eliminate selection bias and minimize confounding variables). Both groups will be treated identically in all respects except for the intervention being tested and to this end patients, investigators, care providers and outcomes assessors will be blinded to which group an individual is assigned. Group assignment will be performed using a covariate-adaptive allocation procedure to provide a balance for selected covariates (Site, IPSS-Score, Age, "uni- or bilateral surgery" and "history of prostate or bladder surgery". To achieve that; Minimization, first described by Taves \[and expanded by Pocock and Simon \[the most commonly used covariate-adaptive randomization method will be applied. It achieves the balance in treatment assignments across factor levels by choosing the allocation for the new subject that would lead to the smallest degree of imbalance possible across the set of his baseline characteristics. The two groups are then followed up to 3 days after surgery to see if there are any differences between them in primary and secondary outcomes. Patients are analyzed within the group to which they were allocated, irrespective of whether they experienced the intended intervention (intention to treat analysis). This RCT is designed as a superiority trial and aims to demonstrate the superiority of Tamsulosin in prevention of POUR compared to placebo. We anticipate the detection of a 65% relative risk reduction of POUR in the experimental group in comparison with the placebo group. To detect a 65% reduction of POUR in the experimental group (2.9% anticipated) in comparison with the placebo group (8.3% anticipated) and to assure a study power of 80% with a Fisher's Exact Test and a significance level of 5% and adjusting for a drop-out rate of 2% we need 634 patients in total; 317 in each group. Our target population consists of male patients ≥ 60 yrs, scheduled for elective endoscopic inguinal hernia repair. The studied sample is appropriate to the hypothesis being tested so that any results will be appropriately generalizable.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
312
0.4mg/day Tamsulosin hydrochloride ("TAMSULOSIN Mepha Ret Depocaps 0.4 mg") from 5 days prior to the day of surgery, at the day of surgery and for 1 day following surgery. (5+1+1)
One placebo capsule matching the active study drug per day from 5 days prior to the day of surgery, at the day of surgery and for 1 day following surgery. (5+1+1)
Kantonsspital Baden
Baden, Canton of Aargau, Switzerland
Post operative urinary retention (Need for any catheterization postoperatively)
Need for any catheterization postoperatively (Yes/No)
Time frame: up to 3 days after surgery
Time to first voiding after surgery
secondary outcomes in Non-POUR Patients
Time frame: up to 3 days after surgery
Urinary Volume measurement at defined points in time (n)
secondary outcomes in all Patients
Time frame: up to 12 hours after surgery
Volume of first micturition after surgery
secondary outcomes in Non-POUR Patients
Time frame: up to 12 hours after surgery
Post-operative Pain (Quantity of Pain / VAS-Score)
Quantity of pain is verified at arrival in the PACU and at every 6 hours by the nursing staff, using the standardised numeric rating scale. The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain. It is for adults and children 10 years old or older.
Time frame: up to 3 days after surgery
Need for opioid analgesics post operatively
secondary outcomes in all Patients
Time frame: up to 3 days after surgery
Quantity of post-operative opioid use (opioid dosage will be converted to oral morphine equivalence dose)
opioid use is documented in the patient's record, opioid dosage will be converted to oral morphine equivalence dose
Time frame: up to 3 days after surgery
Intraoperative applications of opioid analgesics (Yes/No)
Opioid use during surgery is documented in the patient's record, this is a binary endpoint opioid use; (yes/ no)
Time frame: intra-operative period
Quantity of intra-operative opioid use opioid dosage will be converted to oral morphine equivalence dose)
Opioid use during surgery is documented in the patient's record, opioid dosage will be converted to oral morphine equivalence dose
Time frame: intra-operative period
Amount of intraoperative fluid administration
Intraoperative fluid administration (in milliliter) is documented in the patient's record
Time frame: intra-operative period
International Prostate Symptom Score (IPSS score) pre-surgery (-5d)
0-7 Mildly symptomatic / 8-19 Moderately symptomatic / 20-35 Severely symptomatic
Time frame: min. 5 days prior to surgery
International Prostate Symptom Score (IPSS score) post-surgery (3d)
0-7 Mildly symptomatic / 8-19 Moderately symptomatic / 20-35 Severely symptomatic
Time frame: 3 days post surgery
Change in International Prostate Symptom Score (IPSS score) from baseline prior to surgery (-5d) to day 3(+3d) after surgery
0-7 Mildly symptomatic / 8-19 Moderately symptomatic / 20-35 Severely symptomatic
Time frame: 3 days post surgery
Side-effects of study medication (orthostatic hypotension, retrograde ejaculation, Floppy-Iris-Syndrom)
Will be documented in the patient record by the study personnel, binary endpoint (Yes/No)
Time frame: 5 days prior to surgery (-5d) to day 3(+3d) after surgery
In hospital complications (using the evaluated standard classification for complication in surgery (Classification Grade I-V) )
secondary outcomes in all Patients
Time frame: as long as the patient is labeled inpatient, on average 1-3 days
Length of hospital stay in days (Inpatients)
secondary outcomes in all Patients
Time frame: as long as the patient is labeled inpatient, on average 1-3 days
Time to discharge after surgery in hours (outpatients)
secondary outcomes in all Patients
Time frame: up to 12 hours after surgery
Residual urinary volume after catherization
secondary outcomes in POUR Patients
Time frame: up to 12 hours after surgery
Macrohematuria
secondary outcomes in POUR Patients
Time frame: 3 days post surgery
Relevant injury to the urethra (Presence of a Via falsa diagnosed by a urologist)
secondary outcomes in POUR Patients
Time frame: 3 days post surgery
Catheter-related infections
secondary outcomes in POUR Patients
Time frame: 3 days post surgery
Catheter-related bladder discomfort ( (Ggrading according to the 3three Ggrades (mild, moderate, severe)
secondary outcomes in POUR Patients
Time frame: 3 days post surgery
Prostatitis
secondary outcomes in POUR Patients
Time frame: 3 days post surgery
Failed first trial without catheter (TWOC: need for a second catheter insertion due to insufficient voiding after TWOC).
secondary outcomes in POUR Patients
Time frame: 1 day post surgery
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