NCT01041430

Brief Summary

The aim of the study was to evaluate the feasibility of day surgery for elderly patients undergoing elective open inguinal hernia repair. Medically stable patients aged 65 years or older, with postoperative care available at home, were randomized to receive treatment either as day-cases or inpatients. Younger day-case patients undergoing the same procedure served as controls. Outcome measures during two postoperative weeks were complications, unplanned admissions and visits to the hospital, unplanned visits to primary health care and patients' acceptance of the type of provided care. The investigators expected to find a higher degree of satisfaction in the patient group receiving day-case care.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
89

participants targeted

Target at P50-P75 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

December 30, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 31, 2009

Completed
Last Updated

April 21, 2015

Status Verified

April 1, 2015

Enrollment Period

2 years

First QC Date

December 30, 2009

Last Update Submit

April 17, 2015

Conditions

Hernia, Inguinal

Keywords

Ambulatory SurgeryAged

Outcome Measures

Primary Outcomes (1)

  • Patient satisfaction

    satisfaction based on type of care

    2 weeks postoperatively

Secondary Outcomes (1)

  • short term outcome

    2 weeks postoperatively

Study Arms (2)

Day Surgery Group

ACTIVE COMPARATOR

discharge planned on day of surgery, inguinal hernia repair

Other: day surgery group

Inpatient Group

ACTIVE COMPARATOR

overnight admission at the hospital, inguinal hernia repair

Other: inpatient group

Interventions

day surgery groupOTHER

inguinal hernia repair, discharge from the hospital on the day of surgery

Day Surgery Group
inpatient groupOTHER

inguinal hernia repair, patient admitted overnight to hospital

Inpatient Group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • referral for open repair of inguinal hernia

You may not qualify if:

  • severe comorbidity (ASA class IV, unstable ASA class III)
  • postoperative care at home not available
  • not willing to receive day-case care
  • unable to understand numeric rating scale

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jorvi Hospital, Helsinki University Hospital

Espoo, HUS, 00029, Finland

Location

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Kristiina Mattila, MD PhD

    Helsinki University Central Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

December 30, 2009

First Posted

December 31, 2009

Study Start

February 1, 2006

Primary Completion

February 1, 2008

Last Updated

April 21, 2015

Record last verified: 2015-04

Locations

FI(1)