Acute CholecystitisNCT07616713
Patient Satisfaction After Ambulatory Emergency Laparoscopic Cholecystectomy
A study testing Laparoscopic Cholecystectomy in people with Acute Cholecystitis and Acute Cholecystitis With Obstruction, run by Hospital General de Chihuahua - Dr. Salvador Zubirán Anchondo at 1 site in Mexico.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Cholecystitis, Acute Cholecystitis With Obstruction
- What is being tested?
- Laparoscopic Cholecystectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteMexico
- Study dates
- 3 Feb 2025to 27 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Chihuahua City General Hospital "Dr. Salvador Zubirán Anchondo" Chihuahua, Chihuahua, Mexico 31000
Chihuahua City, Chihuahua, 31100
About this study
Official title: 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.
Read the 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?
- Being tested
- Laparoscopic Cholecystectomy
- Keywords
- Ambulatory Emergency Cholecystectomy
- Medical subject headings
- Cholecystitis, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic CholecystectomyProcedure or surgery
Emergency Laparoscopic Cholecystectomy, on an ambulatory basis
| Study group | Role | What they receive |
|---|---|---|
| Emergency Laparoscopic Cholecystectomy | Experimental | Emergency Laparoscopic Cholecystectomy, on an ambulatory basis Receives: Procedure: Laparoscopic Cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative satisfaction (Satiscore)
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.
Measured: From postoperative recuperation of consciousness to discharge, on the same day, and at the first postoperative outpatient consultation one week after discharge.
Secondary outcomes (5)
Return to oral intake.
Clinical process of shifting a patient from nil-by-mouth to eating and drinking by mouth.
Measured: From the immediate postoperative period to discharge.
Spontaneous urination
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.
Measured: From the immediate postoperative period to discharge.
Return of bowel function.
The spontaneous expulsion of gas (flatus) after surgery.
Measured: From the postoperative period to discharge.
Penrose drain
The quantity of drainage is typically measured by the volume (milliliters/mL) of fluid collected on the surrounding sterile dressings.
Measured: From the postoperative period to discharge, in the case it was left in place.
Postoperative pain.
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.
Measured: From the postoperative period to discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start3 Feb 2025
- Primary completion11 Feb 2026
- Study completion27 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute CholecystitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Acute cholecystitis managed as an emergency, on an ambulatory basis
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital General de Chihuahua - Dr. Salvador Zubirán Anchondo
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Rubén Cuevas-Martínez, MD, MSc, Study chair, Chihuahua City General Hospital "Dr. Salvador Zubirán Anchondo"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07616713
- Sponsor's protocol ID
- 0390/25
- Status last verified
- May 2026
- First submitted
- 13 Mar 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ambulatory Management of Emergency Laparoscopic Cholecystectomy and Patient Satisfaction.
- ClinicalTrials.gov ID
- NCT07616713
- Acronym / sponsor ID
- 0390/25
- Keywords
- Ambulatory Emergency Cholecystectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Hospital General de Chihuahua - Dr. Salvador Zubirán AnchondoOther government
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- 11 Feb 2026 (actual)
- Study completion
- 27 Feb 2026 (actual)
- First posted
- 1 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Acute cholecystitis managed as an emergency, on an ambulatory basis
| Arm | Type | Receives |
|---|---|---|
| Emergency Laparoscopic Cholecystectomy | Experimental | Procedure: Laparoscopic CholecystectomyEmergency Laparoscopic Cholecystectomy, on an ambulatory basis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic CholecystectomyEmergency Laparoscopic Cholecystectomy, on an ambulatory basis | Procedure or surgery | Emergency Laparoscopic Cholecystectomy |
Primary outcome
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.
5 secondary outcomes
Return to oral intake.
Time frame: From the immediate postoperative period to discharge.
Spontaneous urination
Time frame: From the immediate postoperative period to discharge.
Return of bowel function.
Time frame: From the postoperative period to discharge.
Penrose drain
Time frame: From the postoperative period to discharge, in the case it was left in place.
Postoperative pain.
Time frame: From the postoperative period to discharge.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
Related trials for Acute Cholecystitis
Not yet recruitingObservational study
SnapChole: An International, Time-Bound Prospective Platform Study of Management Strategies and Outcomes in Acute Calculous Cholecystitis
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Percutaneous Drainage Versus EUS-guided Gallbladder Drainage in Poor Surgical Patients With Cholecystitis
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RecruitingObservational study
Influence of Gut Microbiome in Gallstone Disease
Gall Stone, Gall Stones, Common Bile Duct
Recruiting
Repeat Biliary Point of Care Ultrasound for Detecting Early Acute Cholecystitis
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Not yet recruiting
Implementation of RICA (ERAS) Guidelines in Grade II Acute Cholecystitis Undergoing Early Laparoscopic Cholecystectomy
Cholecystitis, Acute, Cholecystectomy, Laparoscopic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rubén Cuevas-Martínez, MD, MSc study chair
Chihuahua City General Hospital "Dr. Salvador Zubirán Anchondo"
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic Cholecystectomy in people with Acute Cholecystitis and Acute Cholecystitis With Obstruction, run by Hospital General de Chihuahua - Dr. Salvador Zubirán Anchondo at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.