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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Mexico
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Emergency Laparoscopic Cholecystectomy
Emergency Laparoscopic Cholecystectomy, on an ambulatory basis
Procedure: Laparoscopic Cholecystectomy
Emergency Laparoscopic Cholecystectomy, on an ambulatory basis

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospital General de Chihuahua - Dr. Salvador Zubirán Anchondo

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 3, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 11, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 27, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 13, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 1, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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