The purpose of this study is the comparison of postoperative port site pain after removing the gallbladder from umbilical port site with epigastric port site in laparoscopic cholecystectomy. This study is performed on patients who are candidate for elective cholecystectomy in Rasool -e-Akram hospital and the patients who undergo laparoscopic cholecystectomy, are studied. The patients who their surgery convert to open, are excluded. The sample size is 148 cases who randomly divided into two groups. In the control group, the gallbladder is removed through epigastric port site as usual and in case group, it is removed through umbilical port site. Operations are performed by laparoscopic fellows with the supervision of laparoscopy attending surgeons or university professors and with minimal technical errors. The post operation pain is evaluated by using visual analog score pain score at 1,6,12 and 24 hours after surgery with expert research team who they don’t know about site of gallbladder removal
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201207028588N10
Registration date:2012-10-20, 1391/07/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-10-20, 1391/07/29
Registrant information
Name
Mohadeseh Pishgahroudsari
Name of organization / entity
Mnimally Invasive Surgery Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21 6655 5447
Email address
research@lapsurg.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical sciences.
Expected recruitment start date
2012-10-06, 1391/07/15
Expected recruitment end date
2014-10-07, 1393/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of abdominal pain after removing gallbladder through the umbilical and epigastric after gallbladder surgery
Public title
Comparison of abdominal pain after gallbladder removal through two different areas
Purpose
Treatment
Inclusion/Exclusion criteria
Including criteria: the patients undergone laparoscopic cholecystectomy.
Excluding criteria : The patients who their surgery convert to open.
Age
From 15 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences.
Street address
Tehran University of Medical Sciences, corner of Ghods, Keshavarz Blvd., Tehran, Iran.
City
Tehran
Postal code
Approval date
2012-09-26, 1391/07/05
Ethics committee reference number
65797
Health conditions studied
1
Description of health condition studied
cholecystitis
ICD-10 code
K81
ICD-10 code description
Acute cholecystitis
2
Description of health condition studied
Cholelithiasis
ICD-10 code
K80
ICD-10 code description
Cholelithiasis
Primary outcomes
1
Description
pain of epigastricl port site
Timepoint
1 hour after intervention,6 hour after intervention,12 hour after intervention,24 hour after intervention,
Method of measurement
visual analog score
2
Description
pain of umbilical port site
Timepoint
1 hour after intervention,6 hour after intervention,12 hour after intervention,24 hour after intervention,
Method of measurement
visual analog score
Secondary outcomes
1
Description
The patient's request for exesive analgesic during hospitalization
Timepoint
After intervention
Method of measurement
Read the patient records
2
Description
Duration of hospitalization
Timepoint
After intervention
Method of measurement
Read the patient records
Intervention groups
1
Description
Removing the gallbladder from the epigastric port in the control group.
Category
Prevention
2
Description
Removing the gallbladder from the umbilical port in the case group