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| Name | Class |
|---|---|
| University of Thessaly | OTHER |
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Open inguinal hernia repair is one of the most common surgical procedures. Despite the fact that different of anesthetic procedures are proposed as alternatives to spinal anesthesia, the combination of spinal anesthesia with open inguinal hernia repair is preferred from both surgeons and patients. One disadvantage of this combination is the high incidence of post-surgery urinary retention, especially in men above 50 years old. This complication is partially attribute to overstimulation of the a1 adrenergic receivers of the bladder and the prostate. Preoperative administration of elective a1 blockers could inhibit this effect without side effects, since this drugs don't have systemic effect.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tamsulosin group | Active Comparator | administration of 0,4mg of tamsulosin 24 hours before surgery and 0,4mg 6 hours before surgery |
|
| Placebo group | Placebo Comparator | administration of placebo 24 and 6 hours before surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tamsulosin | Drug | administration of tamsulosin tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| incidence of urinary retention | inability to voluntarily void urine up to 8 hours post surgery | 8 hours post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Prostate related Symptoms | identification of Prostate related Symptoms as preoperative risk factor of post surgery urinary retention. For the assessment of the prostate related symptomatology will be used the International Prostate Symptom Score questionnaire | Baseline |
| Scrotal hernia Repair |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Konstantinos Tepetes, MD, PHD | University Hospital of Larisa and Medical School, University of Thessaly | Study Chair |
| Georgios D Koukoulis, MD, PhD | General Hospital of Larissa | Principal Investigator |
| Konstantinos Mpouliaris, MD | General Hospital of Larissa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University General Hospital of Larissa | Larissa | 41110 | Greece | |||
| General Hospital Of Larissa |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28341140 | Background | Clancy C, Coffey JC, O'Riordain MG, Burke JP. A meta-analysis of the efficacy of prophylactic alpha-blockade for the prevention of urinary retention following primary unilateral inguinal hernia repair. Am J Surg. 2018 Aug;216(2):337-341. doi: 10.1016/j.amjsurg.2017.02.017. Epub 2017 Mar 14. | |
| 28584678 | Background |
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| Placebo oral tablet | Drug | sugar pills |
|
evaluation of Scrotal hernia repair as preoperative risk factor of post surgery urinary retention. |
| Baseline, Inta-operative |
| Duration of Surgery | Evaluation of the surgery duration as inta-operative risk factor of post surgery urinary retention. | Duration of Surgical procedure |
| Use of opioids | Evaluation of the peri-operative administration of iv opioids as a peri-operative risk factor of post surgery urinary retention. | 24 hours |
| Iv fluid administration | Evaluation of the peri-operative iv fluid administration as a peri-operative risk factor of post surgery urinary retention. | 24 hours |
| Post-operative Pain | Evaluation of the post operative pain as a risk factor of post surgery urinary retention. For the assessment of the pain will be used the Visual Analog Scale (VAS) score at 6, 12 and 24 hours after surgery. (VAS Score Scale from 0-10, 0 no pain, 10 max pain) | 24 hours |
| Larissa |
| 41221 |
| Greece |
| Basheer A, Alsaidi M, Schultz L, Chedid M, Abdulhak M, Seyfried D. Preventive effect of tamsulosin on postoperative urinary retention in neurosurgical patients. Surg Neurol Int. 2017 May 10;8:75. doi: 10.4103/sni.sni_5_17. eCollection 2017. |
| 25935942 | Background | Shaw MK, Pahari H. The role of peri-operative use of alpha-blocker in preventing lower urinary tract symptoms in high risk patients of urinary retention undergoing inguinal hernia repair in males above 50 years. J Indian Med Assoc. 2014 Jan;112(1):13-4, 16. |
| ID | Term |
|---|---|
| D006552 | Hernia, Inguinal |
| D016055 | Urinary Retention |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D000077409 | Tamsulosin |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
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