Comparison of perioperative Outcomes following four port, three port and single incision laparoscopic cholecystectomy in patients of shariati hospital in 2011
This study compares perioperative outcomes between 3-port, 4-port and single incision laparoscopic cholecystectomy. In this double-blind randomized clinical trial, 90 patients are randomly assigned into 3 equal groups with 3-port, 4-port or single-incision laparoscopic cholecystectomy. The duration of surgery and intraoperative events is recorded. After surgery, intensity of pain (based on visual analog scale) and received intravenous analgesics, length of hospital stay, postoperative complications including wound infection, nausea and vomiting will be recorded and compared between the groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201105152982N4
Registration date:2011-12-23, 1390/10/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-12-23, 1390/10/02
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
University grant for Clinical Residency Thesis, Tehran University of Medical Sciences
Expected recruitment start date
2011-06-01, 1390/03/11
Expected recruitment end date
2011-12-31, 1390/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of perioperative Outcomes following four port, three port and single incision laparoscopic cholecystectomy in patients of shariati hospital in 2011
Public title
Comparison of perioperative Outcomes following four-port, three-port and single incision laparoscopic cholecystectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Indication for laparoscopic cholecystectomy, Informed consent for participating in the study
Exclusion Criteria: Severe inflammation of gallbladder, Bile duct stone needing bile exploration, Drug addiction, planned surgery not progressed
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
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
Tehran University of Medical Sciences
Street address
Central building, Qhods avenue
City
Tehran
Postal code
Approval date
2010-12-06, 1389/09/15
Ethics committee reference number
1106 / 130 / د / 89
Health conditions studied
1
Description of health condition studied
cholecystitis
ICD-10 code
K81.9
ICD-10 code description
کله سیستیت، مشخص نشده (حاد یا مزمن)
Primary outcomes
1
Description
postoperative narcotic usage
Timepoint
Continousely recorded and measured at the time of discharge
Method of measurement
Patient controlled analgesia device
Secondary outcomes
1
Description
postoperative nausea and vomiting
Timepoint
12 hours intervals till discharge
Method of measurement
History taking
2
Description
wound infection
Timepoint
At the time of discharge and 7 days later
Method of measurement
Physical examination
3
Description
intraoperative adverse events
Timepoint
At the end of surgery
Method of measurement
Questionnaire for the surgeon
4
Description
Surgeon opinion about surgery difficulty
Timepoint
At the end of surgery
Method of measurement
Questionn to the surgeon with likert scale
5
Description
post operathve Hospital stay
Timepoint
At the time of discharge
Method of measurement
based on medical reocords
6
Description
Patient's satisfaction about cosmetic outcome
Timepoint
3 months after surgery
Method of measurement
Question with likert scale
7
Description
Other systematic postoperative complication
Timepoint
At the time of discharge and 30 days later
Method of measurement
History taking and clinical records
8
Description
Postoperative pain
Timepoint
6 hours intervals for 24 hours
Method of measurement
Visual analogue scale
9
Description
Surgery duration
Timepoint
At the end of surgery
Method of measurement
Stopwatch
10
Description
Bile leakage or bile duct trauma
Timepoint
At the time of discharge and 30 days later
Method of measurement
Clinical records
Intervention groups
1
Description
Control group(4 port): In this group, 4 laparoscopic port are used for cholesystemy. 10-mm port in the umblicus, 5 mm port in epigastric area (sub-xiphoid), 5 mm port in midclavicular line about 2 cm below the costal margine and the last 5 mm port is placed in the right lower quadrantat at the anterior axillary line.
Camera is inserted from the first 10-mm port into the abdomen and other instrumensare inserted from other ports. Perioperative outcomes are assessed during and after surgery.
Category
Treatment - Surgery
2
Description
Intervention group 1 (3 port cholecystectomy): In this group one 10-mm port in inserted from the umblical area and two 5 mm ports are inserted in epigastric area (sub-xiphoid) and right midclavicular line about 2 cm below the costal margin respectively. Camera is inserted from the 10-mm port and other instruments are inserted from another ports. the principals of cholecytectomy is the same as other groups. Perioperative outcomes are assessed during and after surgery.
Category
Treatment - Surgery
3
Description
Intervention group 2 (Single incision laparoscopic cholecystectomy): In this group a 2 cm vertical incision is made in the umblicus and all three ports (one 10-mm and two 5-mm ports) are inserted from the umblical area. The camera is entered from the 10-mm port and other instruments are inserted from other ports. The principals of cholecytectomy is the same as other groups. Perioperative outcomes are assessed during and after surgery.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati Hospital
Full name of responsible person
Zhamak Khorgami
Street address
Shariati Hospital, North Kargar Avenue,
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Shahin Akhonzade
Street address
Research deputy, Medicine faculty, Poursina avenue, Keshavarz Blvd
City
Tehran
Grant name
در قالب بودجه پایان نامه دستیار تخصصی
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Zhamak Khorgami
Position
General Surgeon / faculty of surgery department
Other areas of specialty/work
Street address
Shariati Hospital, North Kargar Avenue
City
Tehran
Postal code
Phone
+98 21 8490 2450
Fax
+98 21 8863 3039
Email
khorgami@gmail.com
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
Zhamak Khorgami
Position
General Surgeon / faculty of surgery department
Other areas of specialty/work
Street address
Shariati Hospital, North Kargar Avenue
City
Tehran
Postal code
Phone
+98 21 8490 2450
Fax
+98 21 8863 3039
Email
khorgami@gmail.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)