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

December 30, 2009
April 17, 2015
February 2006
February 2008   (final data collection date for primary outcome measure)
Patient satisfaction [ Time Frame: 2 weeks postoperatively ] [ Designated as safety issue: Yes ]
satisfaction based on type of care
Not Provided
Complete list of historical versions of study NCT01041430 on ClinicalTrials.gov Archive Site
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
Not Provided
Not Provided
Not Provided
 
Day-case or Inpatient Care Following Inguinal Hernia Repair in Elderly Patients
Randomized Clinical Trial Comparing Day-case and Inpatient Care Following Inguinal Hernia Repair in Elderly Patients

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Treatment
Hernia, Inguinal
  • Other: day surgery group
    inguinal hernia repair, discharge from the hospital on the day of surgery
  • Other: inpatient group
    inguinal hernia repair, patient admitted overnight to hospital
  • Active Comparator: Day Surgery Group
    discharge planned on day of surgery, inguinal hernia repair
    Intervention: Other: day surgery group
  • Active Comparator: Inpatient Group
    overnight admission at the hospital, inguinal hernia repair
    Intervention: Other: inpatient group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
89
Not Provided
February 2008   (final data collection date for primary outcome measure)

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
Both
65 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT01041430
T102010087a
No
Kristiina Mattila, Helsinki University Central Hospital
Helsinki University Central Hospital
Not Provided
Principal Investigator: Kristiina Mattila, MD PhD Helsinki University Hospital
Helsinki University Central Hospital
April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP