NCT02418078

Brief Summary

The aim of this study is to compare the geriatric patients with the non-geriatrics undergoing outpatient unilateral herniorrhapy in terms of local anesthesia, sedation, recovery and early morbidity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
370

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

February 1, 2015

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

February 14, 2015

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 16, 2015

Completed
Last Updated

April 16, 2015

Status Verified

February 1, 2015

Enrollment Period

28 days

First QC Date

February 14, 2015

Last Update Submit

April 12, 2015

Conditions

Outcome Measures

Primary Outcomes (4)

  • discharge time

    postoperative 2 hours

  • discharge delay

    postoperative 2 hours

  • local anesthetic doses

    intraoperative

  • sedative doses

    intraoperative

Secondary Outcomes (3)

  • complications (hypertension, tachycardia, bradycardia, hypotension, nausea, vomiting)

    intraoperative

  • early morbidity

    postoperative 2 hours

  • morbidity

    postopative 1 week

Study Arms (2)

Geriatri

patients ageing ≥ 65 yr undergoing herniorrhaphy with local infiltration anesthesia and sedation

Procedure: local infiltration anesthesia and sedation

non-geriatri

patients ageing 19-64 yr undergoing herniorrhaphy with local infiltration anesthesia and sedation

Procedure: local infiltration anesthesia and sedation

Interventions

the surgical site is infiltrated with local anesthetic agents and the patients are sedated with intravenous agents

Also known as: local anesthesia and sedation
Geriatrinon-geriatri

Eligibility Criteria

Age19 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients with a unilateral inguinal hernia

You may qualify if:

  • patients with a unilateral inguinal hernia undergoing herniorrhaphy

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dıskapı TRH

Ankara, Turkey (Türkiye)

Location

Related Publications (3)

  • Mattila K, Hynynen M; Intensium Consortium Study Group. Day surgery in Finland: a prospective cohort study of 14 day-surgery units. Acta Anaesthesiol Scand. 2009 Apr;53(4):455-63. doi: 10.1111/j.1399-6576.2008.01895.x. Epub 2009 Feb 23.

  • Majholm B, Engbaek J, Bartholdy J, Oerding H, Ahlburg P, Ulrik AM, Bill L, Langfrits CS, Moller AM. Is day surgery safe? A Danish multicentre study of morbidity after 57,709 day surgery procedures. Acta Anaesthesiol Scand. 2012 Mar;56(3):323-31. doi: 10.1111/j.1399-6576.2011.02631.x.

  • Dallas KB, Froylich D, Choi JJ, Rosa JH, Lo C, Colon MJ, Telem DA, Divino CM. Laparoscopic versus open inguinal hernia repair in octogenarians: a follow-up study. Geriatr Gerontol Int. 2013 Apr;13(2):329-33. doi: 10.1111/j.1447-0594.2012.00902.x. Epub 2012 Jun 21.

MeSH Terms

Conditions

Hernia, Inguinal

Interventions

Anesthesia, Local

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Officials

  • Hakan Kulacoglu, Prof

    Diskapi Teaching and Research Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DR

Study Record Dates

First Submitted

February 14, 2015

First Posted

April 16, 2015

Study Start

February 1, 2015

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

April 16, 2015

Record last verified: 2015-02

Locations