- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07616713
Patient Satisfaction After Ambulatory Emergency Laparoscopic Cholecystectomy
27. maj 2026 opdateret af: Hospital General de Chihuahua - Dr. Salvador Zubirán Anchondo
Ambulatory Management of Emergency Laparoscopic Cholecystectomy and Patient Satisfaction.
Acute cholecystitis is a common surgical emergency that, if left untreated, can result in significant morbidity and even death.
It is characterized by inflammation of the gallbladder, usually caused by gallstones.
The timing of surgical intervention plays a crucial role in determining patient prognosis, including the risk of complications, length of hospital stay, and overall recovery.
Nowadays, the gold standard for its treatment is the laparoscopic cholecystectomy.
In appropriately selected cases, laparoscopic cholecystectomy can be performed on an outpatient basis, with good results in terms of efficacy and safety.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Ambulatory laparoscopic cholecystectomy is the gold standard method for managing uncomplicated cholecystopathy.
In the case of an emergency cholecystectomy, could it be managed on an ambulatory basis?
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
25
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Chihuahua
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Chihuahua City, Chihuahua, Mexico, 31100
- Chihuahua City General Hospital "Dr. Salvador Zubirán Anchondo" Chihuahua, Chihuahua, Mexico 31000
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- Patients with cholecystitis from the emergency unit
- Patients who agree to participate in the study and have signed informed consent
- Patients evaluated by anesthesiology with an ASA score of 3 or lower
- Patients managed via laparoscopy
- Absence of oral anticoagulation
- BMI <35
Exclusion Criteria:
- Patients with ASA IV or higher
- Patients who decide to withdraw from the study
- Patients who, for any reason, end up in the intensive care unit or are unable to complete the satisfaction survey
- Diagnosis of choledocholithiasis
- Patients with a diagnosis or suspected pancreatitis
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Emergency Laparoscopic Cholecystectomy
Emergency Laparoscopic Cholecystectomy, on an ambulatory basis
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Emergency Laparoscopic Cholecystectomy, on an ambulatory basis
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Postoperative satisfaction (Satiscore)
Tidsramme: From postoperative recuperation of consciousness to discharge, on the same day, and at the first postoperative outpatient consultation one week after discharge.
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Patient satisfaction is an attitude resulting from a person's general orientation towards the total experience of health care, in this case the quality of service provided at the surgical wards, using a simplification of the Satiscore scale, where a score of 10-15 points is considered to have a high degree of satisfaction; a score of 16-25 points is considered to have a medium-moderate degree of satisfaction; and a score > 26 points is considered to indicate dissatisfaction.
|
From postoperative recuperation of consciousness to discharge, on the same day, and at the first postoperative outpatient consultation one week after discharge.
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Return to oral intake.
Tidsramme: From the immediate postoperative period to discharge.
|
Clinical process of shifting a patient from nil-by-mouth to eating and drinking by mouth.
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From the immediate postoperative period to discharge.
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Spontaneous urination
Tidsramme: From the immediate postoperative period to discharge.
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The patient's ability to voluntarily initiate and complete the process of passing urine without assistance from a catheter or other external intervention following a surgical procedure.
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From the immediate postoperative period to discharge.
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Return of bowel function.
Tidsramme: From the postoperative period to discharge.
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The spontaneous expulsion of gas (flatus) after surgery.
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From the postoperative period to discharge.
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Penrose drain
Tidsramme: From the postoperative period to discharge, in the case it was left in place.
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The quantity of drainage is typically measured by the volume (milliliters/mL) of fluid collected on the surrounding sterile dressings.
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From the postoperative period to discharge, in the case it was left in place.
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Postoperative pain.
Tidsramme: From the postoperative period to discharge.
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Acute pain occurring immediately after a surgical procedure, resulting from tissue damage (surgical incision), inflammation, or neural injury, measured with the help of a numerical scale from 0 to 10.
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From the postoperative period to discharge.
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Studiestol: Rubén Cuevas-Martínez, MD, MSc, Chihuahua City General Hospital "Dr. Salvador Zubirán Anchondo"
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
3. februar 2025
Primær færdiggørelse (Faktiske)
11. februar 2026
Studieafslutning (Faktiske)
27. februar 2026
Datoer for studieregistrering
Først indsendt
13. marts 2026
Først indsendt, der opfyldte QC-kriterier
27. maj 2026
Først opslået (Faktiske)
1. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
1. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
27. maj 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Sygdomme i fordøjelsessystemet
- Galdevejssygdomme
- Galdeblæresygdomme
- Kolecystitis
- Kolecystitis, akut
- Kirurgiske procedurer, operative
- Minimalt invasive kirurgiske procedurer
- Endoskopi
- Kirurgiske procedurer for fordøjelsessystem
- Kirurgiske procedurer i galdetrakten
- Laparoskopi
- Kolecystektomi
- Kolecystektomi, laparoskopisk
Andre undersøgelses-id-numre
- 0390/25
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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