NCT07616713

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2025

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 3, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 11, 2026

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2026

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

March 13, 2026

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 1, 2026

Completed
Last Updated

June 1, 2026

Status Verified

May 1, 2026

Enrollment Period

1 year

First QC Date

March 13, 2026

Last Update Submit

May 27, 2026

Conditions

Keywords

Ambulatory Emergency Cholecystectomy

Outcome Measures

Primary Outcomes (1)

  • 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.

    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.

    From the immediate postoperative period to discharge.

  • Spontaneous urination

    From the immediate postoperative period to discharge.

  • Return of bowel function.

    From the postoperative period to discharge.

  • Penrose drain

    From the postoperative period to discharge, in the case it was left in place.

  • Postoperative pain.

    From the postoperative period to discharge.

Study Arms (1)

Emergency Laparoscopic Cholecystectomy

EXPERIMENTAL

Emergency Laparoscopic Cholecystectomy, on an ambulatory basis

Procedure: Laparoscopic Cholecystectomy

Interventions

Emergency Laparoscopic Cholecystectomy, on an ambulatory basis

Emergency Laparoscopic Cholecystectomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chihuahua City General Hospital "Dr. Salvador Zubirán Anchondo" Chihuahua, Chihuahua, Mexico 31000

Chihuahua City, Chihuahua, 31100, Mexico

Location

MeSH Terms

Conditions

Cholecystitis, Acute

Interventions

Cholecystectomy, Laparoscopic

Condition Hierarchy (Ancestors)

CholecystitisGallbladder DiseasesBiliary Tract DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

CholecystectomyBiliary Tract Surgical ProceduresDigestive System Surgical ProceduresSurgical Procedures, OperativeLaparoscopyEndoscopyMinimally Invasive Surgical Procedures

Study Officials

  • Rubén Cuevas-Martínez, MD, MSc

    Chihuahua City General Hospital "Dr. Salvador Zubirán Anchondo"

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Acute cholecystitis managed as an emergency, on an ambulatory basis
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2026

First Posted

June 1, 2026

Study Start

February 3, 2025

Primary Completion

February 11, 2026

Study Completion

February 27, 2026

Last Updated

June 1, 2026

Record last verified: 2026-05

Locations