Determination of the Effect of Early and Delayed Laparoscopic Cholecystectomy in Patients with Mild to moderate Acute Biliary Pancreatitis
Design
208 patients with mild to moderate ABP were prospectively randomized to either an early cholecystectomy group (104 patients) or delayed Cholecystectomy group (104 patients).
Settings and conduct
This is a clinical randomized controlled study including all patients have mild to moderate ABP who met the inclusion criteria. The study was performed at kashan shahid beheshti general Hospital, Iran.
A total of 208 patients were enrolled. Of them, 104 were randomized to the early group and 104 patients to the delayed group. To demonstrate a reduction of recurrent biliary events with power of 9% and two sided test of 5%, 104 patients will have to be included in each group. Clinical signs of pancreatitis, e.g., upper abdominal pain, nausea, vomiting, and epigastric tenderness; (2) an elevated serum amylase level of at least thrice the upper limit of normal; and presence of stones in the gallbladder or biliary ducts. On ultra-solography, computed tomography (CT) or magnetic resonance imaging (MRI).
Participants/Inclusion and exclusion criteria
Inclusion Criteria: All patients aged 18 to 81 years with clinical diagnosis of acute mild to Moderate biliary pancreatitis.
Exclusion Criteria: Pregnancy, Pancreatitis due to alcohol abuse, Cholecystitis necrotizing pancreatitis, cholecystitis Cholangitis.
Intervention groups
Early cholecystectomy: Laparoscopic cholecystectomy was done during the first 48 hours of admission in patients with biliary pancreatitis.
Delay cholecystectomy: Laparoscopic cholecystectomy was done after 7 days.
Main outcome variables
Difficulty of cholecystectomy, Operative time, Cholecystectomy related complications, Hospital stay
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180205038627N2
Registration date:2019-05-21, 1398/02/31
Registration timing:retrospective
Last update:2019-05-21, 1398/02/31
Update count:0
Registration date
2019-05-21, 1398/02/31
Registrant information
Name
Abdoulhossein Davoodabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 3154
Email address
davoodabadi_ab@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-18, 1397/02/28
Expected recruitment end date
2019-04-09, 1398/01/20
Actual recruitment start date
2018-05-18, 1397/02/28
Actual recruitment end date
2019-03-21, 1398/01/01
Trial completion date
2019-04-17, 1398/01/28
Scientific title
Comparison of Outcomes of Early and Delayed laparoscopic Cholecystectomy in Patients with Acute Biliary Pancreatitis.
Public title
Assessment of Early Cholecystectomy in mild to moderate Acute Biliary Pancreatitis.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients aged 18 to 81 years with acute mild to Moderate biliary pancreatitis
Exclusion criteria:
pancreatitis due to alcohol abuse and cholecystitis
necrotizing pancreatitis
pregnancy
cholecystitis
Cholangitis
Age
From 18 years old to 81 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
208
Actual sample size reached:
208
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization with random numbers
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kashan University of Medical Sciences
Street address
Kashan University of Medical Sciences, Ghotbe Ravandi Blvd.
City
Kashan
Province
Isfehan
Postal code
8715981151
Approval date
2018-05-03, 1397/02/13
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1397.006
Health conditions studied
1
Description of health condition studied
cholecystectomy
ICD-10 code
Z90.4
ICD-10 code description
Acquired absence of other parts of digestive tract
Primary outcomes
1
Description
Operative time
Timepoint
At the end of surgery
Method of measurement
Clock
2
Description
Difficulty of cholecystectomy
Timepoint
At the end of surgery
Method of measurement
Ask the surgeon with likert scale
3
Description
Hospital stay after surgery
Timepoint
At the time of discharge
Method of measurement
Based on medical reocords
4
Description
Cholecystectomy related complications
Timepoint
At the time of discharge and 30 days later
Method of measurement
Descriptive history and clinical records
Secondary outcomes
empty
Intervention groups
1
Description
Group l: Comprised of 104 patients with acute mild to Moderate biliary pancreatitis were operated during the 48 hours. laparoscopic Cholecystectomies were done by expert surgeon. LC was carried out with three ports technique . An additional fourth port was used when required. All dissections were performed with the harmonic scalpel.C-reactive protein (CRP) level was used to monitor patient progress.
Category
Treatment - Surgery
2
Description
Group 2: Comprised of 104 patients with acute mild to Moderate Biliary Pancreatitis were operated. after 7 days. laparoscopic Cholecystectomies were done by expert surgeon. LC was carried out with three ports technique . An additional fourth port was used when required. All dissections were performed with the harmonic scalpel.C-reactive protein (CRP) level was used to monitor patient progress.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shaheed Beheshti Hospital
Full name of responsible person
Mohammad Reza Fazel
Street address
Shahid Beheshti Hospital, Ghotbe Ravandi Blvd.
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0026
Email
drmfazel@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Gholam Ali Hamidi
Street address
Kashan University of Medical Sciences, Ghotbe Ravandi Blvd.
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 2999
Fax
+98 31 5554 8900
Email
hamidi_gh@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
عبدالحسین داودابادی
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Thoracic surgery
Street address
Kashan University of Medical Sciences, Ghotbe Ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 3154
Email
davoodabadi_ab@kaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Abdoulhossein Davoodabadi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Thoracic surgery
Street address
Kashan University of Medical Sciences, Ghotbe Ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 3154
Email
davoodabadi_ab@kaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Abdoulhossein Davoodabadi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Thoracic surgery
Street address
Kashan University of Medical Sciences, Ghotbe Ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 3154
Email
davoodabadi_ab@kaums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All of collected primary outcome and data measure after intervention will be shared .
When the data will become available and for how long
20 years after publication
To whom data/document is available
general population
Under which criteria data/document could be used
no any require criteria
From where data/document is obtainable
email addresses
What processes are involved for a request to access data/document