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A clinical trial to compare the effectiveness of peritoneal lavage of normal saline with gentamicin-clindamycin on pain relief following laparoscopic colectomy

Protocol summary

Study aim
A clinical trial to compare the effectiveness of peritoneal lavage of normal saline with gentamicin-clindamycin on pain relief following laparoscopic colectomy
Design
Forty patients who were candidates for laparoscopic colectomy, clinical trial with a control group, community-based and pragmatic, parallel groups, double-blind, randomized using table of random numbers
Settings and conduct
Patients candidate for laparoscopic colectomy at the Firoozgar Hospital, Tehran, were chosen. In this double-blind study, the surgeon and assistant who visit the patient after surgery are blinded to the contents of the lavage solution.
Participants/Inclusion and exclusion criteria
Inclusion criteria: The patients with ASA class one or two, who are candidate for laparoscopic colectomy. Exclusion criteria: Allergy to the drugs studied, history of hypertension, history of uncontrolled diabetes, history of cardiovascular diseases, history of renal failure, history of cirrhosis, and history of smoking or drug abuse.
Intervention groups
The control group are administered peritoneal cavity lavage with 500 ml normal saline. The intervention group receive peritoneal cavity lavage 240 mg gentamicin and 600 mg clindamycin diluted in 500 ml normal saline.
Main outcome variables
Evaluation and comparison of pain relief based on the visual analog scale (VAS) 3, 6, 12, and 24 hours after the intervention between the control and intervention groups.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180522039782N1
Registration date: 2018-09-22, 1397/06/31
Registration timing: prospective

Last update: 2018-09-22, 1397/06/31
Update count: 0
Registration date
2018-09-22, 1397/06/31
Registrant information
Name
Behnood Farazmand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8842 9230
Email address
farazmand.b@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-01, 1397/09/10
Expected recruitment end date
2019-12-01, 1398/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial to compare the effectiveness of peritoneal lavage of normal saline with gentamicin-clindamycin on pain relief following laparoscopic colectomy
Public title
The effective of gentamicin-clindamycin on pain relief following laparoscopic colectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The patients with ASA class one or two, who are candidate for laparoscopic colectomy
Exclusion criteria:
Allergy to the drugs studied History of hypertension History of uncontrolled diabetes History of cardiovascular diseases History of renal failure History of cirrhosis History of smoking or drug abuse
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
  • Care provider
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Forty patients who are candidates for laparoscopic colectomy are randomly allocated using table of random numbers based on computer programs. To this end, a code is allocated to each of the participants to be assigned into one of the two groups of intervention or control
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients candidate for laparoscopic colectomy at the Firoozgar Hospital, Tehran, were chosen. In this double-blind study, the surgeon and assistant who visit the patient after surgery are blinded to the contents of the lavage solution
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2018-03-06, 1396/12/15
Ethics committee reference number
IR.IUMS.FMD.REC1396.118054

Health conditions studied

1

Description of health condition studied
Colectomy
ICD-10 code
Z90.4
ICD-10 code description
Acquired absence of other parts of digestive tract

Primary outcomes

1

Description
Pain relief
Timepoint
3, 6, 12, and 24 hours after the intervention
Method of measurement
Based on the visual analog scale (VAS)

Secondary outcomes

empty

Intervention groups

1

Description
Control group: patients are administered peritoneal cavity lavage with 500 ml normal saline
Category
Treatment - Drugs

2

Description
Intervention group: Patients are administered peritoneal cavity lavage 240 mg gentamicin and 600 mg clindamycin diluted in 500 ml normal saline
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Firoozgar Hospital
Full name of responsible person
Behnood Farazmand
Street address
Firoozgar Hospital, Beh Afarin Street, Karim Khan Zand Avenue, Valiasr Square
City
Tehran
Province
Tehran
Postal code
14665-354
Phone
+98 21 86709
Email
behnoood@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Kazem Malakoti
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8842 9230
Email
PR@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Behnood Farazmand
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8842 9230
Email
behnoood@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Behnood Farazmand
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8842 9230
Email
behnoood@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Behnood Farazmand
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8842 9230
Email
behnoood@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The total data to be included are the primary and secondary effects to be shared.
When the data will become available and for how long
6 months after printing results.
To whom data/document is available
Our data will only be available to researchers working in science center and university.
Under which criteria data/document could be used
Our data will be available for scholars working in science center and university.
From where data/document is obtainable
Behnood Farazmand provides the analysis code to the applicants via email: behnoood@gmail.com
What processes are involved for a request to access data/document
Data collection was done for 10 months, data were collected one month, statistical analysis of one month, information dissemination as a article six months.
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