NCT06459323

Brief Summary

Compare outcomes of patients undergoing early laparoscopic cholecystectomy within and after72 hours of symptoms.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2025

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 15, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 14, 2024

Completed
9 months until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

June 14, 2024

Status Verified

June 1, 2024

Enrollment Period

1 year

First QC Date

May 15, 2024

Last Update Submit

June 12, 2024

Conditions

Acute Cholecystitis

Outcome Measures

Primary Outcomes (1)

  • Bile duct injury , intraoperative bleeding and operative time

    Evaluate bile duct integrity, calculate amount of blood loss and operative time from the start till the end

    One week

Study Arms (2)

Laparoscopic cholecystectomy within first 72hours

EXPERIMENTAL
Procedure: Laparoscopic cholecystectomy

Laparoscopic cholecystectomy beyond first 72hours

EXPERIMENTAL
Procedure: Laparoscopic cholecystectomy

Interventions

Laparoscopic cholecystectomyPROCEDURE

Laparoscopic cholecystectomy

Laparoscopic cholecystectomy beyond first 72hoursLaparoscopic cholecystectomy within first 72hours

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with acute cholecystitis within and after 72 hours.
  • Patients over 18 years.
  • Patients with no common bile duct stones based on imaging and biochemical criteria
  • Fit for surgery.

You may not qualify if:

  • Patients not fit for surgery
  • Patients with Pancreatitis.
  • Significant medical disease rendering patient unfit for Laparoscopic surgery (e.g. Uncontrolled Diabetes Mellitus, Chronic Pulmonary Disease, significant Cardiac Disease)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

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 Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident of general surgery Assiut university hospital

Study Record Dates

First Submitted

May 15, 2024

First Posted

June 14, 2024

Study Start

March 1, 2025

Primary Completion

March 1, 2026

Study Completion

May 1, 2026

Last Updated

June 14, 2024

Record last verified: 2024-06