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Day-case or Inpatient Care Following Inguinal Hernia Repair in Elderly Patients

Primary Purpose

Hernia, Inguinal

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
day surgery group
inpatient group
Sponsored by
Helsinki University Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hernia, Inguinal focused on measuring Ambulatory Surgery, Aged

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • referral for open repair of inguinal hernia

Exclusion Criteria:

  • 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

Sites / Locations

  • Jorvi Hospital, Helsinki University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Day Surgery Group

Inpatient Group

Arm Description

discharge planned on day of surgery, inguinal hernia repair

overnight admission at the hospital, inguinal hernia repair

Outcomes

Primary Outcome Measures

Patient satisfaction
satisfaction based on type of care

Secondary Outcome Measures

short term outcome
rate of complications, unplanned admissions, unplanned visits to the hospital, unplanned visits to primary health care

Full Information

First Posted
December 30, 2009
Last Updated
April 17, 2015
Sponsor
Helsinki University Central Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01041430
Brief Title
Day-case or Inpatient Care Following Inguinal Hernia Repair in Elderly Patients
Official Title
Randomized Clinical Trial Comparing Day-case and Inpatient Care Following Inguinal Hernia Repair in Elderly Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helsinki University Central Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
For repair of inguinal hernia, standard open mesh repair methods were used. For anaesthesia, local infiltration with lidocaine (10 mg/ml) and light intravenous sedation with propofol and fentanyl were primarily used. Reasons for choosing spinal or general anaesthesia were registered. For postoperative pain relief bupivacaine (5mg/ml) 10 ml was infiltered into the wound and nonsteroidal anti-inflammatory analgesics (NSAID) and paracetamol combined with codeine were prescribed, when suitable. Day-case patients were discharged home according to commonly approved criteria. Inpatients stayed on the hospital ward overnight. All patients received the same preoperative and postoperative instructions orally and in writing. Physical activity was not restricted after the operation, and patients were encouraged to resume to normal life as soon as possible. At the hospital, patient characteristics, type of anaesthesia, duration of surgery, duration of hospital stay and perioperative complications including unplanned overnight admissions were registered. The study nurse interviewed all patients on the 1st and 14th postoperative day (POD) by telephone, using standardised follow-up questionnaires. The investigated variables on both dates included: satisfaction with treatment, patient-reported overall condition and functional capacity compared to the preoperative state, intensity of pain and use of pain medication. On POD 1, patients were inquired whether convalescence had been as expected, and asked to specify if not. Also the incidence and intensity other symptoms apart from pain were questioned. On POD 14 patients were questioned of unplanned contacts with primary healthcare, unplanned hospital visits, readmissions, and corresponding reasons. Patient satisfaction with treatment in the operating room and following arrival to the postanaesthesia care unit was evaluated numerically (0-10), using the numeric rating scale (NRS), with 0 indicating lowest, and 10 highest possible satisfaction as rated by the patient. Intensity of postoperative pain was evaluated by NRS. Overall condition and functional capacity were evaluated using a 3 -point scale (good / moderate / poor). Health-related quality of life was measured using the RAND-36-instrument. Patients were inquired about the degree of impairment in the groin area at the preoperative visit, and three months postoperatively. Results are given as median (range) or mean (SD) as appropriate. Patient characteristics and surgery -related variables and NRS scores were compared using the Chi-square, Mann-Whitney-U and Kruskall-Wallis tests when appropriate. Intergroup comparisons were performed using the Wilcoxon test for related samples. P-values < 0.05 were considered statistically significant.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernia, Inguinal
Keywords
Ambulatory Surgery, Aged

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
89 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Day Surgery Group
Arm Type
Active Comparator
Arm Description
discharge planned on day of surgery, inguinal hernia repair
Arm Title
Inpatient Group
Arm Type
Active Comparator
Arm Description
overnight admission at the hospital, inguinal hernia repair
Intervention Type
Other
Intervention Name(s)
day surgery group
Intervention Description
inguinal hernia repair, discharge from the hospital on the day of surgery
Intervention Type
Other
Intervention Name(s)
inpatient group
Intervention Description
inguinal hernia repair, patient admitted overnight to hospital
Primary Outcome Measure Information:
Title
Patient satisfaction
Description
satisfaction based on type of care
Time Frame
2 weeks postoperatively
Secondary Outcome Measure Information:
Title
short term outcome
Description
rate of complications, unplanned admissions, unplanned visits to the hospital, unplanned visits to primary health care
Time Frame
2 weeks postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: referral for open repair of inguinal hernia Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristiina Mattila, MD PhD
Organizational Affiliation
Helsinki University Central Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jorvi Hospital, Helsinki University Hospital
City
Espoo
State/Province
HUS
ZIP/Postal Code
00029
Country
Finland

12. IPD Sharing Statement

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Day-case or Inpatient Care Following Inguinal Hernia Repair in Elderly Patients

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