The aim of this study is to investigate the effect of drainage on post operation complications in uncomplicated laparoscopic cholecystectomy. In this non-randomized clinical trial, 86 patients with biliary colic undergoing Laparoscopic cholecystectomy and meet the inclusion and exclusion criteria, are randomly assigned in the intervention or control groups. In the intervention group the drain is placed in the bed of the liver at the end of operation but will not be embedded in the control group. Collection, postoperative pain, hospital stay, drain site infection and needed back surgery were measured and compared in both groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201109147542N1
Registration date:2011-10-01, 1390/07/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-10-01, 1390/07/09
Registrant information
Name
Hassan Talebzadeh Farooji
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1562 0320
Email address
talebzade_h@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Sciences
Expected recruitment start date
2011-08-23, 1390/06/01
Expected recruitment end date
2012-03-19, 1390/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of drainage on post operation complications in uncomplicated laparoscopic cholecystectomy
Public title
The effect of drainage on post operation complications in uncomplicated laparoscopic cholecystectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients aged 18 to 80 years old with biliary colic undergoing laparoscopic cholecystectomy with no complications during the procedure (damage to internal viscera), not experience
Exclusion criteria: any complications in laparoscopic cholecystectomy during laparoscopic surgery, which it sees, a history of abdominal surgery, Laparoscopic surgery for more than one hour
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:
86
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kashan University of Medical Sciences
Street address
5th km of Ravandi ghotb Blv
City
Kashan
Postal code
8713781147
Approval date
2011-08-09, 1390/05/18
Ethics committee reference number
1383/1/5/29/پ
Health conditions studied
1
Description of health condition studied
biliary colic
ICD-10 code
K81.1
ICD-10 code description
Chronic cholecystitis
Primary outcomes
1
Description
postoperative pain
Timepoint
24 hour after surgery
Method of measurement
visual analog scale
2
Description
Fluid accumulation in the liver bed
Timepoint
Seven days after surgery
Method of measurement
The ultrasound
3
Description
Hospital stay
Timepoint
Discharge
Method of measurement
day
4
Description
The recovery rate
Timepoint
Seven days after surgery
Method of measurement
No need for surgical intervention during the first seven days after surgery
Secondary outcomes
1
Description
Back Surgery
Timepoint
During the first seven days after surgery
Method of measurement
Complications requiring reoperation
2
Description
Drain site infection
Timepoint
When you pull the drain on the second day
Method of measurement
The View
Intervention groups
1
Description
Intervention group: placement of drains in the liver bed after laparoscopic cholecystectomy
Category
Treatment - Surgery
2
Description
Control group: drain won’t be inserted into the liver bed after laparoscopic cholecystectomy
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Beheshti Hospital, Kashan
Full name of responsible person
Mohammad Eidi
Street address
Beheshti Hospital, 5th km of ghotb ravandi Blvd, Kashan
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences research
Full name of responsible person
Gholamali Hamidi
Street address
Kashan University of Medical Sciences research, 5th km ravandi ghotb Blvd, Kashan
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Sciences research
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
Kashan University of Medical Sciences
Full name of responsible person
Hassan Talebzadeh Farooji
Position
General Surgery Assistant
Other areas of specialty/work
Street address
University Residential Site, 5th km ravandi ghotb Blv
City
Kashan
Postal code
Phone
+98 913 641 2379
Fax
Email
talebzade_h@kaums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mohammad Eidi
Position
Assistant Professor
Other areas of specialty/work
Street address
University Residential Site, 5th km ravandi ghotb Blvd
City
Kashan
Postal code
Phone
+98 36 1555 0026
Fax
Email
m_eidy1356@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hassan Talebzadeh Farooji
Position
General Surgery Assistant
Other areas of specialty/work
Street address
University Residential Site, 5th km ravandi ghotb Blvd
City
Kashan
Postal code
Phone
+98 913 641 2379
Fax
Email
h_faroj@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)