Randomized, Quadruple Blinded, Placebo Controlled, Multi-centered Trial Investigating Prophylactic Tamsulosin in Prevention of Postoperative Urinary Retention in Men After Endoscopic Total Extraperitoneal Inguinal Hernia Repair
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 312
- 试验地点
- 1
- 主要终点
- Post operative urinary retention (Need for any catheterization postoperatively)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •≥60 years old
- •Planned uni- or bilateral endoscopic total extraperitoneal inguinal hernia repair
- •Surgery scheduled more than 6 days from the time of consent
- •Informed Consent as documented by signature (Appendix Informed Consent Form)
排除标准
- •Orthostatic hypotension (feeling of dizziness after getting up from a sitting or lying position)
- •Severe liver disease (Child Pugh C)
- •Taking strong inhibitors of CYP3A4 (ketoconazole, itraconazole, clarithromycin, ritonavir, indinavir/ritonavir, lopinavir, or conivaptan)
- •Being on alpha-blockers (alfuzosin, doxazosin, prazosin, terazosin, tamsulosin, phenoxybenzamine, or silodosin) or a combination product containing alpha-blocker (duodart)
- •History of allergy or sensitivity to tamsulosin or other alpha-blockers (alfuzosin, doxazosin, prazosin, terazosin, or phenoxybenzamine)
- •Long term Indwelling urinary or suprapubic catheter
- •Status post cystectomy
- •Inability to provide informed consent
- •Known or suspected non-compliance, drug or alcohol abuse,
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
- •Participation in another study with investigational drug within the 30 days preceding and during the present study,
- •Previous enrolment into the current study
研究组 & 干预措施
Tamsulosin Arm
p.o.
干预措施: TAMSULOSIN Mepha Ret Depocaps 0.4 mg (Drug)
Placebo Arm
p.o.
干预措施: Control Intervention (Drug)
结局指标
主要结局
Post operative urinary retention (Need for any catheterization postoperatively)
时间窗: up to 3 days after surgery
Need for any catheterization postoperatively (Yes/No)
次要结局
- Intraoperative applications of opioid analgesics (Yes/No)(intra-operative period)
- Volume of first micturition after surgery(up to 12 hours after surgery)
- Quantity of post-operative opioid use (opioid dosage will be converted to oral morphine equivalence dose)(up to 3 days after surgery)
- Need for opioid analgesics post operatively(up to 3 days after surgery)
- Time to first voiding after surgery(up to 3 days after surgery)
- Urinary Volume measurement at defined points in time (n)(up to 12 hours after surgery)
- Post-operative Pain (Quantity of Pain / VAS-Score)(up to 3 days after surgery)
- Quantity of intra-operative opioid use opioid dosage will be converted to oral morphine equivalence dose)(intra-operative period)
- Side-effects of study medication (orthostatic hypotension, retrograde ejaculation, Floppy-Iris-Syndrom)(5 days prior to surgery (-5d) to day 3(+3d) after surgery)
- Prostatitis(3 days post surgery)
- Amount of intraoperative fluid administration(intra-operative period)
- International Prostate Symptom Score (IPSS score) pre-surgery (-5d)(min. 5 days prior to surgery)
- International Prostate Symptom Score (IPSS score) post-surgery (3d)(3 days post surgery)
- Catheter-related bladder discomfort ( (Ggrading according to the 3three Ggrades (mild, moderate, severe)(3 days post surgery)
- Failed first trial without catheter (TWOC: need for a second catheter insertion due to insufficient voiding after TWOC).(1 day post surgery)
- In hospital complications (using the evaluated standard classification for complication in surgery (Classification Grade I-V) )(as long as the patient is labeled inpatient, on average 1-3 days)
- Change in International Prostate Symptom Score (IPSS score) from baseline prior to surgery (-5d) to day 3(+3d) after surgery(3 days post surgery)
- Residual urinary volume after catherization(up to 12 hours after surgery)
- Relevant injury to the urethra (Presence of a Via falsa diagnosed by a urologist)(3 days post surgery)
- Catheter-related infections(3 days post surgery)
- Length of hospital stay in days (Inpatients)(as long as the patient is labeled inpatient, on average 1-3 days)
- Time to discharge after surgery in hours (outpatients)(up to 12 hours after surgery)
- Macrohematuria(3 days post surgery)
研究者
Antonio Nocito, MD
Professor Antonio Nocito, Director of the Department of General, Visceral and Vascular Surgery and Chief Physician Surgery
Kantonsspital Baden