NCT05736003

Brief Summary

Gallbladder stone affects 10-15% of the adult population, and about 15-25% of these patients presented with acute cholecystitis (AC). Laparoscopic cholecystectomy (LC) is considered the treatment of choice for patients with AC, and recent studies suggest that early laparoscopic cholecystectomy (ELC) is preferable. However, the optimal time for ELC in AC is still controversial. Early laparoscopic cholecystectomy (ELC) was advised for patients presented within 72 hours, while conservative treatment and planned delayed laparoscopic cholecystectomy (DLC) after six weeks was recommended for patients presented after 72 hours. Surgeons almost always encounter patients with AC lasting more than 72 hours and these patients consistently refuse conservative treatment and postpone for the DLC.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
437

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

Longer than P75 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2023

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

February 9, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 21, 2023

Completed
Last Updated

June 6, 2023

Status Verified

June 1, 2023

Enrollment Period

4 years

First QC Date

February 9, 2023

Last Update Submit

June 3, 2023

Conditions

Acute Cholecystitis

Outcome Measures

Primary Outcomes (1)

  • Overall morbidity

    The overall morbidity included failure of initial conservative treatment, emergency consultation, unplanned hospital readmission for recurrent attacks of AC or gallstone-related complications, subtotal cholecystectomy, and intra- and postoperative complications

    30 days

Secondary Outcomes (8)

  • Morbidity

    30 days

  • Mortality

    30 days

  • Total length of hospital saty

    3 years

  • Total Cost

    3 years

  • Total antibiotic duration

    3 years

  • +3 more secondary outcomes

Study Arms (2)

Prolonged laparoscpic cholecystectomy

EXPERIMENTAL

Patients received laparoscopic cholecystectomy for acute cholecystitis after 27 hours of symptoms

Procedure: Laparoscopic cholecystectomy

Delayed laparoscpic cholecystectomy

ACTIVE COMPARATOR

Patients received laparoscopic cholecystectomy for acute cholecystitis after 6 weeks of symptoms

Procedure: Laparoscopic cholecystectomy

Interventions

Laparoscopic cholecystectomyPROCEDURE

Removal of gallbladder laparoscopically

Delayed laparoscpic cholecystectomyProlonged laparoscpic cholecystectomy

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with acute cholecystitis beyond 72 hours of symptoms onset,
  • American Society of Anesthesiologists (ASA) scores I - III,
  • Aged 20-70 years,
  • Agreement to complete the study

You may not qualify if:

  • Gallbladder polyp,
  • common bile duct stones,
  • acute biliary pancreatitis,
  • cholangitis,
  • perforated cholecystitis,
  • biliary peritonitis,
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mohammed Ahmed Omar

Luxor, 83523, Egypt

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

  • Mohammed A Omar, M.D.

    General Surgery Department, Faculty of Medicine, South Valley University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor of surgery

Study Record Dates

First Submitted

February 9, 2023

First Posted

February 21, 2023

Study Start

January 1, 2019

Primary Completion

December 30, 2022

Study Completion

January 30, 2023

Last Updated

June 6, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will share

After publication

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
For 1 year
Access Criteria
After publication

Locations

EG(1)