This randomized double blind clinical trial is to evaluate the results of Laparoscopic versus Needlescopic cholecystectomy in patients with chronic cholecystitis. A total of 70 patients will be randomly assigned into two thirty five persons groups; For the first group Laparoscopic cholecystectomy and for another one Needlescopic cholecystectomy will be done and the two groups will be compared in terms of the time of surgery, volume of intra-operation bleeding, post operative pain (with visual analog scale) and IV opium drug consumption by a person who are not aware of the intervention received.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201105216542N1
Registration date:2011-07-23, 1390/05/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-07-23, 1390/05/01
Registrant information
Name
Saeed Goudarzi
Name of organization / entity
Ahwaz Jundishapour University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1333 3050
Email address
goudarzi.s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Jundishapour University of Medical Sciences
Expected recruitment start date
2010-10-23, 1389/08/01
Expected recruitment end date
2011-04-21, 1390/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison between the result of laparoscopic versus Needlescopic cholecystectomy as the surgical treatment of chronic cholecystitis
Public title
A comparison between the result of laparoscopic versus Needlescopic cholecystectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Suffering from gall stone, candidate for laparoscopic cholecystectomy, willing to participate
Exclusion criteria: Having history of coagulation disorder, having icter or history of Pancreatitis, history of surgery on upper abdomen
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Jundishapour University of Medical Sciences
Street address
Golestan Boulevard, Ahvaz
City
Ahvaz
Postal code
Approval date
2010-10-10, 1389/07/18
Ethics committee reference number
2902
Health conditions studied
1
Description of health condition studied
Choronic Cholecystitis
ICD-10 code
K80.1
ICD-10 code description
Calculus of gallbladder with other cholecystitis
Primary outcomes
1
Description
Pain after surgery
Timepoint
2 hours after surgery, 6 hours after surgery,24 hours after surgery
Method of measurement
Visual Analoge scale
Secondary outcomes
1
Description
Time of surgery
Timepoint
Time from beginning surgery to end of surgery
Method of measurement
minute
Intervention groups
1
Description
Intervention group: Needlescopic Cholecystectomy
Category
Treatment - Surgery
2
Description
Control group: Laparascopic Cholecystectomy
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz Razi Hospital
Full name of responsible person
Saeed Goudarzi
Street address
Golestan Boulevard, Ahvaz
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Jundishapour University of Medical Sciences
Full name of responsible person
Dr. Mostafa Feghhi, Vice-Chancellor for Research
Street address
Vice-Chancellor For Research, Ahvaz Jundishapour University Of Medical Sciences
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Jundishapour University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz Jundishapour University of Medical Sciences
Full name of responsible person
Dr. Saeed Goudarzi
Position
General Surgery Resident
Other areas of specialty/work
Street address
Ahvaz Razi Hospital
City
Ahvaz
Postal code
Phone
+98 916 662 5218
Fax
Email
s_goudarzi2000@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahwaz Jundishapour University of Medical Sciences
Full name of responsible person
Dr Mehdi Asgari
Position
Assistant Professor Of General Surgery
Other areas of specialty/work
Street address
Ahwaz Razi Hospital
City
Ahwaz
Postal code
Phone
+98 61 1333 3050
Fax
Email
Nil2f@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapour University of Medical Sciences
Full name of responsible person
Dr Saeed Goudarzi
Position
General surgery Resident
Other areas of specialty/work
Street address
Ahvaz Razi Hospital
City
Ahvaz
Postal code
Phone
Fax
Email
s_goudarzi2000@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)