Comparison of Single-incision laparoscopic cholecystectomy and mini-laparoscopic cholecystectomy in Shariati hospital between 2012 to 2014: A Randomized Clinical Trial Study
The aim of this study is the comparison between mini-laparoscopic cholecystectomy (MLC) and single-incision laparoscopic cholecystectomy (SILC). This study is a randomized clinical trial conducted on the patients admitted to Shariati Hospital of Tehran that diagnosed with chronic cholecystitis, symptomatic cholelithiasis, with indications for laparoscopic cholecystectomy. The exclusion criteria included: ages more than 60, having CBD stone, obesity (BMI equal or more than 40), acute cholelithiasis, and previous surgeries in the upper abdominal areas. 40 patients with symptomatic cholelithiasis who met the criteria will be enrolled in the study. After obtaining informed consent, they will be randomly assigned to SILC or MLC (20 in each group). The duration of the surgery and the events occurring during the surgery will be registered. Also, the two groups will be compared in terms of levels of pain (with visual analog scale: VAS), hospitalization period, the postsurgical complications including wound infection, and postoperative nausea and vomiting.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201206072982N10
Registration date:2015-09-04, 1394/06/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-09-04, 1394/06/13
Registrant information
Name
Zhamak Khorgami
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8490 2450
Email address
khorgami@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Tehran University of Medical Sciences
Expected recruitment start date
2012-03-19, 1390/12/29
Expected recruitment end date
2014-03-20, 1392/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Single-incision laparoscopic cholecystectomy and mini-laparoscopic cholecystectomy in Shariati hospital between 2012 to 2014: A Randomized Clinical Trial Study
Public title
Comparison of Single-incision laparoscopic cholecystectomy and mini-laparoscopic cholecystectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: patients being admitted in Tehran Shariati Hospital with symptomatic cholelithiasis who are candidates of laparoscopic cholecystectomy.
Exclusion criteria: ages more than 60; having Common Bile Duct stone, obesity (BMI equal or more than 40), acute cholelithiasis, and previous surgeries in the upper abdominal areas.
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
40
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
Ethics committee Tehran University of Medical Sciences
Street address
Surgery department, Imam khomeini hospital, Keshavarz boulvard
City
Teharn
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
10234
Health conditions studied
1
Description of health condition studied
Calculus of gallbladder without cholecystitis
ICD-10 code
K80.2
ICD-10 code description
Any condition listed in K80.5 with cholangitis
Primary outcomes
1
Description
duration of durgery
Timepoint
from the time the skin was cut until the time it was closed.
Method of measurement
recorded by surgeon
Secondary outcomes
1
Description
pain after surgery
Timepoint
8, 16, and 24 hours after surgery
Method of measurement
measuring levels of pain using visual analog scale(VAS)
2
Description
Nausea and vomiting after surgery
Timepoint
in the first 24 hours after surgery
Method of measurement
subjective, recorded by observer from the questionnaire
3
Description
intraoperative complications
Timepoint
at the end of operation
Method of measurement
recorded by surgeon
4
Description
Medical complications after surgery: hypertension, ischemia or cardiac arrhythmia
Timepoint
at the time of discharge
Method of measurement
based on medical chart
5
Description
hernia at the site of incisions
Timepoint
12 months after after surgery
Method of measurement
clinical exam and imagings
6
Description
wound infection
Timepoint
up to 1 month after surgery
Method of measurement
office visits and medical charts
7
Description
Postoperative narcotic usage for pain control
Timepoint
up to 48 hours after surgery
Method of measurement
recorded by nurse in the questionnaire
8
Description
Total Length of wounds
Timepoint
at the end of operation
Method of measurement
ruler with one millimeter percision
Intervention groups
1
Description
In the MLC group, a 10- millimeter port was placed in the lower area of the navel, a 2.7- millimeter port was placed in the epigastric region, a 2.7-millimeter port was placed 2 centimeters below the ribs, and another 2.7- millimeter port was placed in the lower right side of the anterior axillary line. A 10- millimeter camera was sent in from the first port and the grasper holding the fundus of the gallbladder was sent in through the last port. The gallbladder was then taken out from the 10- millimeter port. After the laparoscopic cholecystectomy, the patients underwent the recovery period of the operating room and were transferred to the ward. Paracetamol was used as the base pain reliever and was given to the patients for 48 hours, 1 gram every 8 hours. In case of severe pain, 25 grams of Pethidine was slowly injected into the vein.
Category
Treatment - Surgery
2
Description
In the SLIC Group: the main port was placed in the lower area of the navel, and the graspers and camera was entered through same port and cholecystectomy was performed. Then, the gallbladder was taken out from the navel location. The fascia and skin will be closed at the site of navel.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati Hospital, General Surgery Ward
Full name of responsible person
Dr. Zhamak Khorgami
Street address
General Surgery Ward, 3rd. Floor, Shariati Hospital, North Kargar St.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Tehran University of Medical Sciences
Full name of responsible person
Office of Research & Technology Management
Street address
6th. Floor, Central Organization of Tehran University of Medical Sciences, Quds St.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research of Tehran 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
Tehran University of Medical Sciences - Shariati Hospital
Full name of responsible person
Dr. Zhamak Khorgami
Position
General Surgeon / faculty of surgery department
Other areas of specialty/work
Street address
General Surgery Ward, Shariati Hospital, North Kargar St.
City
Tehran
Postal code
1411713135
Phone
+98 21 8490 2450
Fax
+98 21 8863 3039
Email
khorgami@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences - Shariati hospital
Full name of responsible person
Dr. Zhamak Khorgami
Position
General Surgeon / faculty of surgery department
Other areas of specialty/work
Street address
General Surgery Ward, Shariati Hospital, North Kargar St.
City
Tehran
Postal code
1411713135
Phone
+98 21 8490 2450
Fax
+98 21 8863 3039
Email
khorgami@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences - Shariati hospital
Full name of responsible person
Dr. Zhamak Khorgami
Position
General Surgeon / faculty of surgery department
Other areas of specialty/work
Street address
General surgery Ward, Shariati Hospital, North Kargar St.
City
Tehran
Postal code
1411713135
Phone
+98 21 8490 2450
Fax
+98 21 8863 3039
Email
khorgami@tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)