Short Term Outcomes of Acute Cholecystitis Managed at a University Hospital

• Sponsor: King Abdulaziz University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03853408
• Collaborator: (none)
• Enrollment: 88
• Location: 1
• Actual Duration (Months): 16.1
• Patients Per Site Per Month: 5.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Cholecystitis	Procedure: Cholecystectomy

Detailed Description

This study was conducted retrospectively through reviewing patients medical records

Study Design

• Study Type: Observational
• Actual Enrollment: 88 participants
• Observational Model: Other
• Time Perspective: Retrospective
• Official Title: Short Term Outcomes of Acute Cholecystitis Managed at a University Hospital
• Actual Study Start Date: Jul 26, 2017
• Actual Primary Completion Date: Sep 14, 2018
• Actual Study Completion Date: Nov 29, 2018

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Type of surgery [Intraoperative (during surgery) - surgery takes an hour on an average]

   Laparoscopic cholecystectomy or Laparoscopic cholecystectomy converted to open

2. Blood Transfusion need [Intraoperative (during surgery) - surgery takes an hour on an average]

   Yes No

3. ICU admission: [Post operation "after surgery" immediately]

   Yes No

4. Duration of Surgery [minutes "intraoperative" (surgery takes 1 hour on an average)]

   How many minutes did the surgery take (range)

5. Time to operation room (hours) [hours pre surgery]

   How many hours from admission to surgery

6. Length of stay after surgery [Days ( usually 2 days on an average )]

   How many days did patients stay after surgery (range)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	King Abulaziz University	Jeddah	Makkah Region	Saudi Arabia	23534

Sponsors and Collaborators

• King Abdulaziz University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Munirah Fetaini, Principal Investigator, King Abdulaziz University
• ClinicalTrials.gov Identifier: NCT03853408
• Other Study ID Numbers: D/39/3441
• First Posted: Feb 25, 2019
• Last Update Posted: Feb 25, 2019
• Last Verified: Feb 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Munirah Fetaini, Principal Investigator, King Abdulaziz University: Acute cholecystitis; Cholecystectomy; overweight; BMI; early; delayed
• Additional relevant MeSH terms: Cholecystitis; Acalculous Cholecystitis; Cholecystitis, Acute

Study Results

No Results Posted as of Feb 25, 2019