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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kristiina Mattila, Helsinki University Central Hospital
ClinicalTrials.gov Identifier:
NCT01041430
First received: December 30, 2009
Last updated: April 17, 2015
Last verified: April 2015
  Purpose

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.


Condition Intervention
Hernia, Inguinal
Other: day surgery group
Other: inpatient group

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial Comparing Day-case and Inpatient Care Following Inguinal Hernia Repair in Elderly Patients

Resource links provided by NLM:


Further study details as provided by Helsinki University Central Hospital:

Primary Outcome Measures:
  • Patient satisfaction [ Time Frame: 2 weeks postoperatively ] [ Designated as safety issue: Yes ]
    satisfaction based on type of care


Secondary Outcome Measures:
  • short term outcome [ Time Frame: 2 weeks postoperatively ] [ Designated as safety issue: Yes ]
    rate of complications, unplanned admissions, unplanned visits to the hospital, unplanned visits to primary health care


Enrollment: 89
Study Start Date: February 2006
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Day Surgery Group
discharge planned on day of surgery, inguinal hernia repair
Other: day surgery group
inguinal hernia repair, discharge from the hospital on the day of surgery
Active Comparator: Inpatient Group
overnight admission at the hospital, inguinal hernia repair
Other: inpatient group
inguinal hernia repair, patient admitted overnight to hospital

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01041430

Locations
Finland
Jorvi Hospital, Helsinki University Hospital
Espoo, HUS, Finland, 00029
Sponsors and Collaborators
Helsinki University Central Hospital
Investigators
Principal Investigator: Kristiina Mattila, MD PhD Helsinki University Hospital
  More Information

No publications provided

Responsible Party: Kristiina Mattila, MD, PhD, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT01041430     History of Changes
Other Study ID Numbers: T102010087a
Study First Received: December 30, 2009
Last Updated: April 17, 2015
Health Authority: Finland: Data Protection Board
Finland: Ethics Committee
Finland: Ministry of Social Affairs and Health

Keywords provided by Helsinki University Central Hospital:
Ambulatory Surgery
Aged

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Hernia, Abdominal
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 25, 2015