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

Hernia, Inguinal Clinical Trial

Official title:

Randomized Clinical Trial Comparing Day-case and Inpatient Care Following Inguinal Hernia Repair in Elderly Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01041430
• Other study ID #: T102010087a
• Status: Completed
• Phase: N/A
• First received: December 30, 2009
• Last updated: April 17, 2015
• Start date: February 2006

Study information

• Verified date: April 2015
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Data Protection BoardFinland: Ethics CommitteeFinland: Ministry of Social Affairs and Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal

Intervention

Other:
• day surgery group
inguinal hernia repair, discharge from the hospital on the day of surgery
• inpatient group
inguinal hernia repair, patient admitted overnight to hospital

Locations

Country	Name	City	State
Finland	Jorvi Hospital, Helsinki University Hospital	Espoo	HUS

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient satisfaction	satisfaction based on type of care	2 weeks postoperatively	Yes
Secondary	short term outcome	rate of complications, unplanned admissions, unplanned visits to the hospital, unplanned visits to primary health care	2 weeks postoperatively	Yes