Objectives: Determine the effect of drainage on postoperative complications of laparoscopic cholecystectomy. Design: Randomized, single-blind, single-center, phase II trial. Setting and conduct: For group A, drain is placed within substrate of liver at the end of the location of surgery and for group B, drain is not placed. Postoperative pain, hospital stay and infection drains and needed a second surgery is measured in two groups. Inclusion criteria include patients undergoing drains for laparoscopic cholecystectomy; exclusion criteria include conversion of laparoscopic surgery to open surgery. Intervention: drain is placed for intervention group and drain is not placed for control group. Main outcome measures variable: Pain after placement of drain.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016013126281N1
Registration date:2016-03-03, 1394/12/13
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-03-03, 1394/12/13
Registrant information
Name
Mahmoud Heydari
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 3821 1291
Email address
mheydari@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kermanshah University of Medical Sciences
Expected recruitment start date
2016-03-20, 1395/01/01
Expected recruitment end date
2016-05-21, 1395/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of drain following an uncomplicated laparoscopic cholecystectomy
Public title
Efficacy of drain on uncomplicated of cholecystectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients undergoing drains for laparoscopic cholecystectomy. Exclusion criteria: Conversion of laparoscopic surgery to open surgery.
Age
From 18 years old to 80 years old
Gender
Male
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kermanshah University of Medical Sciences
Street address
Building No 1, Kermanshah University of Medical Sciences, Shahid Beheshti Blvd.
City
Kermanshah
Postal code
Approval date
2015-02-17, 1393/11/28
Ethics committee reference number
53288
Health conditions studied
1
Description of health condition studied
Biliary colic
ICD-10 code
K80.5
ICD-10 code description
Calculus of bile duct without cholangitis or cholecystitis
Primary outcomes
1
Description
Pain
Timepoint
12 h and 24 h after drain placement
Method of measurement
According to the VAS scale
2
Description
Nausea and vomiting
Timepoint
12 h and 24 h after drain placement
Method of measurement
According to the visual scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Placement of drain in substrate of liver at the end of operation
Category
Treatment - Surgery
2
Description
Control group: Non-placement of drain in substrate of liver at the end of operation
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Mahmoud Heydari
Street address
Surgery Department, Imam Reza Hospital, Sorkhalizheh.
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kermanshah University of Medical Sciences
Full name of responsible person
Behrozeh Hamzeh
Street address
Building No 2, Kermanshah University of Medical Sciences, Shahid Beheshti Blvd. Kermanshah
City
Kermanshah
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, Kermanshah 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
Kermanshah University of Medical sciences
Full name of responsible person
Behnam Reza Makhsoosi
Position
Specialist in General Surgery
Other areas of specialty/work
Street address
Surgery Department, Imam Reza Hospital, Sorkhalizheh.
City
Kermanshah
Postal code
Phone
+98 83 3721 2766
Fax
Email
Drmakhsosy@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical sciences
Full name of responsible person
Mahmoud Heydari
Position
Resident of General Surgery
Other areas of specialty/work
Street address
Surgery Department, Imam Reza Hospital, Sorkhalizheh.
City
Kermanshah
Postal code
Phone
+98 83 3428 2668
Fax
Email
mheydari@kums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical sciences
Full name of responsible person
Mahmoud Heydari
Position
Resident of General Surgery
Other areas of specialty/work
Street address
Surgery Department, Imam Reza Hospital, Sorkhalizheh.
City
Kermanshah
Postal code
Phone
+98 83 3428 2668
Fax
Email
mheydari@kums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)