- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01629992
Preoperative Counseling in Cholecystectomy
Preoperative Counseling in Cholecystectomy. A Randomized Trial
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
This was a randomized, single-blinded, clinical study carried out at the Julio Muller University Hospital (Mato Grosso State, Brazil). This study was conducted according to the guidelines laid down in the Declaration of Helsinki and all procedures involving human subjects/patients were approved by the hospital Research Ethics Committee registered under number 697/CEP-HUJM/09. Written informed consent was obtained from all patients.
Except for the preoperative counseling which was received only by the intervention group, all patients received the same protocol of perioperative care.
The main endpoint of the study was the presence and the intensity of postoperative symptoms such as nausea, vomiting and pain. A questionnaire containing a visual analogue scale (VAS) was applied 24h after the operation to measure the intensity of postoperative pain, nausea and the well-being. The VAS consisted of a horizontal line, 100 mm in length, anchored by word descriptors at each end to represent the lowest and the highest intensity of all the symptoms analyzed. The patient was asked to mark in the straight line the point that most likely represents the symptom at the moment. The VAS score of each individual was determined by measuring in millimeters from the left end of the line to the point marked. The questions were: "how severe was your pain during this period of 24h after the operation?", "how severe was the intensity of your nausea during this period of 24h after the operation? ", and "how great is your well-being at the present moment". For the first two questions the words at each end of the line were "no pain" and "severe pain", and "no nausea" and "severe nausea". For the well-being question the words were "no well-being" and "greatest well-being". The Vomiting was also recorded as a categorical variable (yes or no). The length of stay and postoperative complications were also collected.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 2
- Fase 3
Contatti e Sedi
Luoghi di studio
-
-
Mato Grosso
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Cuiaba, Mato Grosso, Brasile, 78000-000
- Hospital Universitario Julio Mullar
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-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- adult age (18-65 years-old),
- both sexes and
- candidates for an elective open cholecystectomy
Exclusion Criteria:
- having diabetes mellitus,
- chronic kidney failure,
- chronic liver disease,
- serum bilirubin > 2 mg/dL,
- body mass index (BMI) > 35 kg/m2,
- American Anesthesiologists Association (ASA) score > 3,
- gastro-esophageal reflux,
- gastroparesis or intestinal obstruction.
Patients with any non-compliance with the study protocol, who had the choledochus opened or associated operations, who experienced severe intraoperative complications (any type of shock, cardiac arrest or coagulations problems) or experienced prolonged (> 4 h) operative time were also excluded.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: Preoperative counseling
The intervention group received preoperative counseling by both orally and written.
A written leaflet containing information was provided to each patient of this group.
|
The intervention group received preoperative counseling by both orally and written.
A written leaflet containing information was provided to each patient of this group.
Altri nomi:
|
Nessun intervento: Control
The control group received no preoperative counseling either oral or written.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Visual analogue scale
Lasso di tempo: 24h after operation
|
A questionnaire containing a visual analogue scale (VAS) was applied 24h after the operation to measure the intensity of postoperative pain, nausea and the well-being.
The VAS consisted of a horizontal line, 100 mm in length, anchored by word descriptors at each end to represent the lowest and the highest intensity of all the symptoms analyzed.
The patient was asked to mark in the straight line the point that most likely represents the symptom at the moment.
The VAS score of each individual was determined by measuring in millimeters from the left end of the line to the point marked.
|
24h after operation
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Episodes of vomiting
Lasso di tempo: During the first 24h after surgery
|
Number of episodes of vomiting occurring until 24h after the operation
|
During the first 24h after surgery
|
Collaboratori e investigatori
Investigatori
- Investigatore principale: Jose Aguilar-Nascimento, MD, PhD, Federal University of Mato Grosso
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- preopcounseling
- 697/CEP-HUJM/09 (Altro identificatore: HUJM Research Ethics Committee)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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