NCT03976934

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 6, 2019

Completed
8 months until next milestone

Study Start

First participant enrolled

February 1, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2021

Completed
Last Updated

November 26, 2021

Status Verified

November 1, 2021

Enrollment Period

1.7 years

First QC Date

May 31, 2019

Last Update Submit

November 23, 2021

Conditions

Inguinal HerniaUrinary Retention

Keywords

open inguinal hernia repairspinal anaesthesiaurinary retentionelective alpha blockers

Outcome Measures

Primary Outcomes (1)

  • incidence of urinary retention

    inability to voluntarily void urine up to 8 hours post surgery

    8 hours post surgery

Secondary Outcomes (6)

  • Prostate related Symptoms

    Baseline

  • Scrotal hernia Repair

    Baseline, Inta-operative

  • Duration of Surgery

    Duration of Surgical procedure

  • Use of opioids

    24 hours

  • Iv fluid administration

    24 hours

  • +1 more secondary outcomes

Study Arms (2)

Tamsulosin group

ACTIVE COMPARATOR

administration of 0,4mg of tamsulosin 24 hours before surgery and 0,4mg 6 hours before surgery

Drug: Tamsulosin

Placebo group

PLACEBO COMPARATOR

administration of placebo 24 and 6 hours before surgery

Drug: Placebo oral tablet

Interventions

TamsulosinDRUG

administration of tamsulosin tablets

Also known as: omnic tocas
Tamsulosin group
Placebo oral tabletDRUG

sugar pills

Placebo group

Eligibility Criteria

Age50 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • unilateral inguinal hernia

You may not qualify if:

  • ASA score \>3
  • hypotension
  • prostatic hypertrophy
  • complicated inguinal hernia
  • neurological diseases
  • inguinal hernia repair under general or local anaesthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University General Hospital of Larissa

Larissa, 41110, Greece

Location

General Hospital Of Larissa

Larissa, 41221, Greece

Location

Related Publications (3)

  • 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.

    PMID: 28341140BACKGROUND

  • 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.

    PMID: 28584678BACKGROUND

  • 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.

    PMID: 25935942BACKGROUND

MeSH Terms

Conditions

Hernia, InguinalUrinary Retention

Interventions

Tamsulosin

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur Compounds

Study Officials

  • 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

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
General Surgery Consultant

Study Record Dates

First Submitted

May 31, 2019

First Posted

June 6, 2019

Study Start

February 1, 2020

Primary Completion

October 1, 2021

Study Completion

October 30, 2021

Last Updated

November 26, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

GR(2)