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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
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
HUS
-
Espoo, HUS, Finland, 00029
- Jorvi Hospital, Helsinki University Hospital
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Actieve vergelijker: Day Surgery Group
discharge planned on day of surgery, inguinal hernia repair
|
inguinal hernia repair, discharge from the hospital on the day of surgery
|
|
Actieve vergelijker: Inpatient Group
overnight admission at the hospital, inguinal hernia repair
|
inguinal hernia repair, patient admitted overnight to hospital
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Patient satisfaction
Tijdsspanne: 2 weeks postoperatively
|
satisfaction based on type of care
|
2 weeks postoperatively
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
short term outcome
Tijdsspanne: 2 weeks postoperatively
|
rate of complications, unplanned admissions, unplanned visits to the hospital, unplanned visits to primary health care
|
2 weeks postoperatively
|
Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Kristiina Mattila, MD PhD, Helsinki University Central Hospital
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- T102010087a
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