NCT05502744

Brief Summary

The aim of study is compare outcome of patients undergoing early laparoscopic cholecystectomy within 72 hours from the begging of symptoms to those of patients managed conservatively and operated late after 6-8weeks after the inflammatory reaction has subsided.

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
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2022

Status
unknown

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

First Submitted

Initial submission to the registry

August 6, 2022

Completed
8 days until next milestone

Study Start

First participant enrolled

August 14, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 16, 2022

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 14, 2022

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 14, 2023

Completed
Last Updated

August 16, 2022

Status Verified

August 1, 2022

Enrollment Period

1 month

First QC Date

August 6, 2022

Last Update Submit

August 13, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Incidence of intraoperative complications in urgent versus elective lap cholecystostomy.

    Collect results and see.

    Intraoperative time

Secondary Outcomes (1)

  • Incidence of postoperative complications in urgent versus elective lap cholecystectomy.

    6 months.

Study Arms (1)

Emergency Versus Elective Cholecystectomy in Acute Cholecystitis in the Era of Laparoscopy

EXPERIMENTAL

A Prospective Randomized Comparative Study.

Procedure: Laparoscopic cholecystectomy

Interventions

Laparoscopic cholecystectomy is the standard treatment for acute cholecystitis due to the advantages of small wounds, less use of abdominal drains , less need for antibiotics and analgesics and less postoperative hospital stay time.Laparoscopic cholecystectomy in acute cholecystitis may be performed as soon as begging of the symptoms called emergency or urgent and maybe scheduled in advance after controlling acute attack after 6-8weeks called elective.

Also known as: Emergency versus elective cholecystectomy in acute cholecystits in the era of laproscopy
Emergency Versus Elective Cholecystectomy in Acute Cholecystitis in the Era of Laparoscopy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • age less than 70 years.
  • fit for surgery.

You may not qualify if:

  • patients with co-existent common bile duct stones based on imaging and biochemical criteria.
  • Patients with Pancreatitis .
  • Patients with previous upper abdominal surgery.
  • Significant medical disease rendering patient unfit for Laparoscopic surgery (e.g.Chronic Pulmonary Disease, significant Cardiac Disease)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 6, 2022

First Posted

August 16, 2022

Study Start

August 14, 2022

Primary Completion

September 14, 2022

Study Completion

August 14, 2023

Last Updated

August 16, 2022

Record last verified: 2022-08