- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01041430
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
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
HUS
-
Espoo, HUS, Finnland, 00029
- Jorvi Hospital, Helsinki University Hospital
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Aktiver Komparator: Day Surgery Group
discharge planned on day of surgery, inguinal hernia repair
|
inguinal hernia repair, discharge from the hospital on the day of surgery
|
|
Aktiver Komparator: Inpatient Group
overnight admission at the hospital, inguinal hernia repair
|
inguinal hernia repair, patient admitted overnight to hospital
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Patient satisfaction
Zeitfenster: 2 weeks postoperatively
|
satisfaction based on type of care
|
2 weeks postoperatively
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
short term outcome
Zeitfenster: 2 weeks postoperatively
|
rate of complications, unplanned admissions, unplanned visits to the hospital, unplanned visits to primary health care
|
2 weeks postoperatively
|
Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Kristiina Mattila, MD PhD, Helsinki University Central Hospital
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- T102010087a
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