Tamsulosin to Prevent Postoperative Urinary Retention in Laparoscopic Inguinal Hernia Repair

Study Overview
=================
Brief Summary
-----------------
To investigate the effect of tamsulosin on the development of post-operative urinary retention (PUR) after elective laparoscopic inguinal hernia repair (LIHR). This will be accomplished by administering a pre-operative dose of tamsulosin. The primary outcome is the rate of urinary retention necessitating straight catheterization or insertion of foley catheter prior to discharge.

Detailed Description
-----------------
Patients who are scheduled for elective laparoscopic inguinal hernia repair will be consented in the office by the attending physician. An order will be placed during surgery scheduling for tamsulosin with instruction to administer one dose in the preoperative holding area on the day of surgery. The Jewish hospital pharmacy will be responsible for providing randomization and placebo medications for double blinding effect. PUR will be tracked on the basis of urinary catheterization performed prior to hospital discharge. Criteria for catheterization include: i) Inability to urinate within 6 hours post-operatively, and bladder scan showing >400 mL. ii) Inability to urinate at any time postoperatively with symptoms of urinary retention (i.e. urgency, bladder discomfort). Women of childbearing age will need to have a confirmed negative urine or serum pregnancy test prior to surgery. This will be completed on arrival to the preoperative holding area. To detect the difference between the treated group and control group with a significant alpha (0.5) and power (80%), at least 178 patients will be needed in each group. This was generated using the Pearson Chi-square test for Two proportions. This study will be conducted in the hospital setting at a single institution. Patients will be consented for the study in the pre-admission holding area and followed until discharged from the post anesthesia care unit.

Official Title
-----------------
The Use of Tamsulosin to Prevent Postoperative Urinary Retention in Laparoscopic Inguinal Hernia Repair: A Randomized Double-Blind Placebo-Controlled Study

Conditions
-----------------
Post Operative Urinary Retention

Intervention / Treatment
-----------------
* Drug: Tamsulosin
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients undergoing elective laparoscopic inguinal hernia repair, unilateral or bilateral. ≥18 years of age. Patients must leave the operating room without at indwelling urinary catheter. Exclusion Criteria: History of neurogenic bladder requiring routine intermittent catheterization Emergent laparoscopic hernia repair. Elective laparoscopic hernia repair in conjuncture with an additional operation (e.g. nephrectomy, pelvic surgery) that requires the patient to have a planned, indwelling urinary catheter in the postoperative period. Pregnant women.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: One group will be randomized to tamsulosin and the second group randomized to placebo
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Patients undergoing laparoscopic inguinal hernia repair will randomized to one dose of placebo in the preoperative holding area 2 hours before surgery. | Drug: Placebo<br>* placebo will be given to a randomized group of patients<br>|
| Experimental: Interventional<br>Patients undergoing laparoscopic inguinal hernia repair will be randomized to one dose of 0.4 mg tamsulosin in the preoperative holding area 2 hours before surgery. | Drug: Tamsulosin<br>* 0.4 mg tamsulosin will be given to a randomized group of patients<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of postoperative urinary retention. | Patients undergoing laparoscopic inguinal hernia repair will be assessed for postoperative urinary retention in the post anesthesia care unit. Postoperative urinary retention will be tracked on the basis of urinary catheterization performed prior to hospital discharge. Criteria for catheterization include: i) Inability to urinate within 6 hours post-operatively, and bladder scan showing >400 mL. ii) Inability to urinate at any time postoperatively with symptoms of urinary retention (i.e. urgency, bladder discomfort). | Within 24 hours of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of risk factors for postoperative urinary retention in patients undergoing laparoscopic inguinal hernia repair. | Retrospective chart review will be utilized to asses the incidence of risk factors of postoperative urinary retention in patients undergoing laparoscopic inguinal hernia repair. Risk factors including age >60, total IV fluids, length of procedure, opioid use, bilateral vs unilateral repair, BMI >30, diabetes mellitus, coronary artery disease, and benign prostatic hyperplasia will be assessed. These risk factors will then undergo statistical analysis to determine if they are associated with postoperative urinary retention. | within 24 hours of surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
laparoscopic inguinal hernia repair, tamsulosin