In this study in the period of time 60 patiens(30 patient in each group)who operated with traditional (4 ports)or new(one port)laparoscopic cholecystectomy evaluated about post operative pain and need for analgesic,length of surgery ,rate of change to open surgery,rate of gall bllader rupture,intra operative hemorrhage,days of admission,wound infection and conclusions compaired in two groupes.Inclusion criteria is included:patients with symptomatic cholelithiasis; without complications;between 14to70 years old ; BMI less than 35 ; no history of other diseases ; no history of previous abdominal surgery.Exclusion criteria is included :patients with complicated cholelithiasis ;less than 14years old ;more than 70 years old ;BMI more than 35 ; history of other diseases ; history of previous abdominal Surgery.
. In this study primary outcome is post operative pain and other outcomes are secondary outcome.severity of pain in both groap evaluated by VAS in period of3,6,12,24hours and three days after surgery.Volume of bleeding estimated by volume of blood that suctioned during surgery.If no complication not occurred patients followed monthly to two monthes by phone contact or outpatient visits.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201105026359N1
Registration date:2011-07-18, 1390/04/27
Registration timing:prospective
Last update:
Update count:0
Registration date
2011-07-18, 1390/04/27
Registrant information
Name
Alireza Barband
Name of organization / entity
Tabriz University Of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 41 1542 2862
Email address
soroushm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University Of Medical Sciences and Health Services
Expected recruitment start date
2011-08-22, 1390/05/31
Expected recruitment end date
2017-01-19, 1395/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparision between result of single port laparoscopic cholecystectomy with 4 ports cholecystectomy
Public title
The comparision between result of single port laparoscopic cholecystectomy with 4 ports cholecystectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : patients with symptomatic cholelithiasis; without complications; between 14to70 years old; BMI less than 35 ; no history of other diseases ; no history of previous abdominal surgery.
Exclusion criteria:: patients with complicated cholelithiasis ;less than 14 years old ,more than 70 years old ; BMI more than 35 ; history of other diseases; history of previous abdominal surgery
Age
From 14 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University Of Medical Sciences and Health Services
Street address
Tabriz University Of Medical Sciences and Health Services , Golgasht Ave, Tabriz
City
Tabriz
Postal code
5166614756
Approval date
2011-04-10, 1390/01/21
Ethics committee reference number
391/5/4
Health conditions studied
1
Description of health condition studied
Cholelithiasis
ICD-10 code
K80
ICD-10 code description
Cholelithiasis
Primary outcomes
1
Description
post operative pain
Timepoint
3,6,12,24hours and three days after surgery
Method of measurement
VAS
Secondary outcomes
1
Description
Length of operation
Timepoint
In the period of operation
Method of measurement
minute
2
Description
Rate of change to open surgery
Timepoint
In the period of operation
Method of measurement
Number percent
3
Description
Rate of gall bllader rupture
Timepoint
In the period of operation
Method of measurement
Number percent
4
Description
Rate of intraoperative bleeding
Timepoint
In the period of operation
Method of measurement
Millilitre(ml)
5
Description
Length of admission
Timepoint
Admission to Discharge
Method of measurement
Day
6
Description
Rate of wound infection
Timepoint
Until two monthes after surgery
Method of measurement
Number percent
Intervention groups
1
Description
In the cases laparoscopic cholecystectomy made with only one umblical port but in control with standard 4 port
Category
Treatment - Surgery
2
Description
In case group laparoscopic cholecystectomy made only by one umblical port.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Sina Hospital
Full name of responsible person
Dr.Mohammad Soroush
Street address
Sina Hospital , between Montazeri and Hafez, Azadi Ave, Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University Of Medical Sciences and Health Services
Full name of responsible person
Miss Maghami
Street address
Tabriz University Of Medical Sciences and Health Services, Golgasht Ave, Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University Of Medical Sciences and Health Services
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
Tabriz University Of Medical Sciences and Health Services
Full name of responsible person
Dr.Mohammad Soroush
Position
Rezident Of General Sergury
Other areas of specialty/work
Street address
Tabriz University Of Medical Sciences and Health Services , Golgasht Ave, Tabriz
City
Tabriz
Postal code
5166614756
Phone
+98 41 1335 5921
Fax
+98 413355944
Email
Soroushm@tbzmed.ac.ir
Web page address
www.tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
General Surgery Group Sina Hospital
Full name of responsible person
Dr.Alireza Barband
Position
Associate Professor Of General Surgery
Other areas of specialty/work
Street address
Sina Hospital between Montazeri and Hafez , Azadi Ave, Tabriz
City
Tabriz
Postal code
51636398888
Phone
+98 41 1542 2862
Fax
+98 41 1542 9060
Email
Soroushm@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University Of Medical Sciences and Health Services
Full name of responsible person
Dr.Mohammad Soroush
Position
Rezident Of General Sergury
Other areas of specialty/work
Street address
Tabriz University Of Medical Sciences and Health Services, Golgasht Ave, Tabriz
City
Tabriz
Postal code
5166614756
Phone
+98 41 1335 5921
Fax
+98 41 1335 5944
Email
Soroushm@tbzmed.ac.ir
Web page address
WWW.tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)