- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07616713
Patient Satisfaction After Ambulatory Emergency Laparoscopic Cholecystectomy
May 27, 2026 updated by: 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.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
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?
Study Type
Interventional
Enrollment (Actual)
25
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Chihuahua
-
Chihuahua City, Chihuahua, Mexico, 31100
- Chihuahua City General Hospital "Dr. Salvador Zubirán Anchondo" Chihuahua, Chihuahua, Mexico 31000
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Emergency Laparoscopic Cholecystectomy
Emergency Laparoscopic Cholecystectomy, on an ambulatory basis
|
Emergency Laparoscopic Cholecystectomy, on an ambulatory basis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative satisfaction (Satiscore)
Time Frame: From postoperative recuperation of consciousness to discharge, on the same day, and at the first postoperative outpatient consultation one week after discharge.
|
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.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Return to oral intake.
Time Frame: From the immediate postoperative period to discharge.
|
Clinical process of shifting a patient from nil-by-mouth to eating and drinking by mouth.
|
From the immediate postoperative period to discharge.
|
|
Spontaneous urination
Time Frame: From the immediate postoperative period to discharge.
|
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.
|
From the immediate postoperative period to discharge.
|
|
Return of bowel function.
Time Frame: From the postoperative period to discharge.
|
The spontaneous expulsion of gas (flatus) after surgery.
|
From the postoperative period to discharge.
|
|
Penrose drain
Time Frame: From the postoperative period to discharge, in the case it was left in place.
|
The quantity of drainage is typically measured by the volume (milliliters/mL) of fluid collected on the surrounding sterile dressings.
|
From the postoperative period to discharge, in the case it was left in place.
|
|
Postoperative pain.
Time Frame: From the postoperative period to discharge.
|
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.
|
From the postoperative period to discharge.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Rubén Cuevas-Martínez, MD, MSc, Chihuahua City General Hospital "Dr. Salvador Zubirán Anchondo"
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 3, 2025
Primary Completion (Actual)
February 11, 2026
Study Completion (Actual)
February 27, 2026
Study Registration Dates
First Submitted
March 13, 2026
First Submitted That Met QC Criteria
May 27, 2026
First Posted (Actual)
June 1, 2026
Study Record Updates
Last Update Posted (Actual)
June 1, 2026
Last Update Submitted That Met QC Criteria
May 27, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Biliary Tract Diseases
- Gallbladder Diseases
- Cholecystitis
- Cholecystitis, Acute
- Surgical Procedures, Operative
- Minimally Invasive Surgical Procedures
- Endoscopy
- Digestive System Surgical Procedures
- Biliary Tract Surgical Procedures
- Laparoscopy
- Cholecystectomy
- Cholecystectomy, Laparoscopic
Other Study ID Numbers
- 0390/25
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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