Short Term Outcomes of Acute Cholecystitis Managed at a University Hospital

February 22, 2019 updated by: Munirah Fetaini, King Abdulaziz University
The aim of this retrospective study was to assess the different outcomes of early (performed on the patient's first admission for acute cholecystitis) and delayed cholecystectomy (done on a second admission) at King Abdulaziz University Hospital in Jeddah, Saudi Arabia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study was conducted retrospectively through reviewing patients medical records

Study Type

Observational

Enrollment (Actual)

88

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
    • Makkah Region
      • Jeddah, Makkah Region, Saudi Arabia, 23534
        • King Abulaziz University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The data were collected retrospectively from the electronic medical records data system at KAUH. We included all adult patients who presented to the Emergency Department of KAUH with an acute cholecystitis between January 2010 and April 2018

Description

Inclusion Criteria:

Male and female patients who presented to the Emergency Department of KAUH with an acute cholecystitis

Exclusion Criteria:

  • Patients with no acute cholecystitis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
First Admission
Cholecystectomy during first admission
Procedure: Cholecystectomy
Cholecystectomy (removal of the gallbladder) for acute cholecystitis
Second Admission
Cholecystectomy during second admission
Procedure: Cholecystectomy
Cholecystectomy (removal of the gallbladder) for acute cholecystitis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Type of surgery
Time Frame: Intraoperative (during surgery) - surgery takes an hour on an average
Laparoscopic cholecystectomy or Laparoscopic cholecystectomy converted to open
Intraoperative (during surgery) - surgery takes an hour on an average
Blood Transfusion need
Time Frame: Intraoperative (during surgery) - surgery takes an hour on an average
  • Yes
  • No
Intraoperative (during surgery) - surgery takes an hour on an average
ICU admission:
Time Frame: Post operation "after surgery" immediately
  • Yes
  • No
Post operation "after surgery" immediately
Duration of Surgery
Time Frame: minutes "intraoperative" (surgery takes 1 hour on an average)
How many minutes did the surgery take (range)
minutes "intraoperative" (surgery takes 1 hour on an average)
Time to operation room (hours)
Time Frame: hours pre surgery
How many hours from admission to surgery
hours pre surgery
Length of stay after surgery
Time Frame: Days ( usually 2 days on an average )
How many days did patients stay after surgery (range)
Days ( usually 2 days on an average )

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Abdulaziz University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 26, 2017

Primary Completion (Actual)

September 14, 2018

Study Completion (Actual)

November 29, 2018

Study Registration Dates

First Submitted

February 19, 2019

First Submitted That Met QC Criteria

February 22, 2019

First Posted (Actual)

February 25, 2019

Study Record Updates

Last Update Posted (Actual)

February 25, 2019

Last Update Submitted That Met QC Criteria

February 22, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D/39/3441

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

The datasets generated and analyzed during this study are available upon request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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