Back to resultsAcute Cholecystitis: Early Versus Delayed Laparoscopic Cholecystectomy; Randomized Prospective Study
Primary Purpose
Acute Cholecystitis
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Early cholecystectomy
Delayed cholecystectomy
Sponsored by
About this trial
This is an interventional treatment trial for Acute Cholecystitis focused on measuring Laparoscopic cholecystectomy, Acute cholecystitis, Early, Delayed
Eligibility Criteria
Inclusion Criteria:
- Proved acute cholecystitis clinical, radiologic
Exclusion Criteria:
- Evidence of peritonitis
- ASA III or IV
- Previous upper abdominal surgery
- Pregnancy
Sites / Locations
- mansoura university hospital, EGYPT, central hafr elbatin hospital, Saudia ArabiaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Early cholecystectomy
Delayed cholecystectomy
Arm Description
Laparoscopic cholecystectomy well be done after the immediate admission
Laparoscopic cholecystectomy after a period of conservative treatment
Outcomes
Primary Outcome Measures
Operative time
Operative time is assessed in minutes ,
Secondary Outcome Measures
Perioperative complications
Intraoperative complications like bleeding , injury,
Conversion rate
Conversion rate from laparoscopic to open and reason of conversion.
hospital stay in days
hospital stay in days
Period of giving antibiotics in days
Number of days giving the antibiotics
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02130245
Brief Title
Acute Cholecystitis: Early Versus Delayed Laparoscopic Cholecystectomy; Randomized Prospective Study
Official Title
Acute Cholecystitis: Early Versus Delayed Laparoscopic Cholecystectomy; Randomized Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
September 2013 (undefined)
Primary Completion Date
January 2016 (Anticipated)
Study Completion Date
January 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The best management of the acute cholecystitis is to do laparoscopic cholecystectomy. The hypothesis is that to do it as an early intervention after patient admission is better than delayed cholecystectomy regarding the hospital stay, interval for antibiotic, the easiness of the operative maneuver reflected by operative time, conversion and intraoperative complications.
Detailed Description
Doing laparoscopic cholecystectomy for patients with acute cholecystitis as an early intervention after patient admission ( first group) or to do it after a while of treatment and conservation as a delayed cholecystectomy (second group) points of study include the hospital stay, interval for antibiotic, the easiness of the operative maneuver reflected by operative time, conversion and intraoperative complications.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Cholecystitis
Keywords
Laparoscopic cholecystectomy, Acute cholecystitis, Early, Delayed
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Early cholecystectomy
Arm Type
Active Comparator
Arm Description
Laparoscopic cholecystectomy well be done after the immediate admission
Arm Title
Delayed cholecystectomy
Arm Type
Active Comparator
Arm Description
Laparoscopic cholecystectomy after a period of conservative treatment
Intervention Type
Procedure
Intervention Name(s)
Early cholecystectomy
Other Intervention Name(s)
First group
Intervention Description
Early laparoscopic cholecystectomy for acute cholecystitis after admission
Intervention Type
Procedure
Intervention Name(s)
Delayed cholecystectomy
Other Intervention Name(s)
Second group
Intervention Description
Laparoscopic cholecystectomy well be done after a period on conservation
Primary Outcome Measure Information:
Title
Operative time
Description
Operative time is assessed in minutes ,
Time Frame
1 DAY
Secondary Outcome Measure Information:
Title
Perioperative complications
Description
Intraoperative complications like bleeding , injury,
Time Frame
5 weeks
Title
Conversion rate
Description
Conversion rate from laparoscopic to open and reason of conversion.
Time Frame
1 DAY
Title
hospital stay in days
Description
hospital stay in days
Time Frame
2 weeks
Title
Period of giving antibiotics in days
Description
Number of days giving the antibiotics
Time Frame
2 WEEKS
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Proved acute cholecystitis clinical, radiologic
Exclusion Criteria:
Evidence of peritonitis
ASA III or IV
Previous upper abdominal surgery
Pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
mohamed e abdellatif, md
Phone
00201115051680
Email
surg_latif@hotmail.com
Facility Information:
Facility Name
mansoura university hospital, EGYPT, central hafr elbatin hospital, Saudia Arabia
City
Mansoura,
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
mohamed E abd ellatif, PhD
Phone
00966543973660
Email
SURG_LATIF@HOTMAIL.COM
First Name & Middle Initial & Last Name & Degree
MOHAMED E ABD ELLATIF, PHD
12. IPD Sharing Statement
Links:
URL
http://www.mans.edu.eg/en
Description
Related Info
Learn more about this trial
Acute Cholecystitis: Early Versus Delayed Laparoscopic Cholecystectomy; Randomized Prospective Study
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