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NCT02418078 Clinical Trial

Retrospective Analysis of the Geriatric Patients Underwent Unilateral Inguinal Herniorrhaphy

Inguinal Hernia Clinical Trial

Official title:
Retrospective Analysis of the Geriatric Patients Underwent Unilateral Inguinal Herniorrhaphy at Our Institution

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02418078
Other study ID # Geriatri Hernia
Secondary ID
Status Completed
Phase N/A
First received February 14, 2015
Last updated April 12, 2015
Start date February 2015
Est. completion date March 2015

Study information
Verified date February 2015
Source Diskapi Teaching and Research Hospital
Contact n/a
Is FDA regulated No
Health authority Turkey: Ministry of Health
Study type Observational

Clinical Trial 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.

Description:

A retrospective data analysis will be conducted and the patient records will be evaluated for patient characteristics local anesthesia, sedation, recovery and early morbidity.

Recruitment information / eligibility
Status Completed
Enrollment 370
Est. completion date March 2015
Est. primary completion date March 2015
Accepts healthy volunteers No
Gender Both
Age group 19 Years to 90 Years
Eligibility Inclusion Criteria:

patients with a unilateral inguinal hernia undergoing herniorrhaphy

Exclusion Criteria:

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Procedure:
• local infiltration anesthesia and sedation
the surgical site is infiltrated with local anesthetic agents and the patients are sedated with intravenous agents

Locations
Country Name City State
Turkey Diskapi TRH Ankara

Sponsors (1)
Lead Sponsor Collaborator
Diskapi Teaching and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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 201 — View Citation

Majholm B, Engbæk J, Bartholdy J, Oerding H, Ahlburg P, Ulrik AM, Bill L, Langfrits CS, Møller 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: 10.11 — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary discharge time postoperative 2 hours No
Primary discharge delay postoperative 2 hours No
Primary local anesthetic doses intraoperative No
Primary sedative doses intraoperative No
Secondary complications (hypertension, tachycardia, bradycardia, hypotension, nausea, vomiting) intraoperative No
Secondary early morbidity postoperative 2 hours No
Secondary morbidity postopative 1 week No
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