NCT03853408

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2017

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

July 26, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 14, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 29, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 25, 2019

Completed
Last Updated

February 25, 2019

Status Verified

February 1, 2019

Enrollment Period

1.1 years

First QC Date

February 19, 2019

Last Update Submit

February 22, 2019

Conditions

Keywords

Acute cholecystitisCholecystectomyoverweightBMIearlydelayed

Outcome Measures

Primary Outcomes (6)

  • Type of surgery

    Laparoscopic cholecystectomy or Laparoscopic cholecystectomy converted to open

    Intraoperative (during surgery) - surgery takes an hour on an average

  • Blood Transfusion need

    * Yes * No

    Intraoperative (during surgery) - surgery takes an hour on an average

  • ICU admission:

    * Yes * No

    Post operation "after surgery" immediately

  • Duration of Surgery

    How many minutes did the surgery take (range)

    minutes "intraoperative" (surgery takes 1 hour on an average)

  • Time to operation room (hours)

    How many hours from admission to surgery

    hours pre surgery

  • Length of stay after surgery

    How many days did patients stay after surgery (range)

    Days ( usually 2 days on an average )

Study Arms (2)

First Admission

Cholecystectomy during first admission

Procedure: Cholecystectomy

Second Admission

Cholecystectomy during second admission

Procedure: Cholecystectomy

Interventions

Cholecystectomy (removal of the gallbladder) for acute cholecystitis

First AdmissionSecond Admission

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • Patients with no acute cholecystitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Abulaziz University

Jeddah, Mecca Region, 23534, Saudi Arabia

Location

MeSH Terms

Conditions

Cholecystitis, AcuteOverweight

Interventions

Cholecystectomy

Condition Hierarchy (Ancestors)

CholecystitisGallbladder DiseasesBiliary Tract DiseasesDigestive System DiseasesOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biliary Tract Surgical ProceduresDigestive System Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 19, 2019

First Posted

February 25, 2019

Study Start

July 26, 2017

Primary Completion

September 14, 2018

Study Completion

November 29, 2018

Last Updated

February 25, 2019

Record last verified: 2019-02

Locations