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Comparison number of lymphnode resection in open colectomy vs laparoscopy in colorectal cancer

Protocol summary

Study aim
Comparison of number of lymphnode resection in open colectomy versus laparoscopy in colorectal cancer
Design
A non randomized clinical trial with two intervention group that was not blinded. Based on the trait ratio studied in similar articles in the population, the number of patients was estimated to be about 120 patients.
Settings and conduct
This RCT was conducted on all patients admitted to Modarres hospital, Tehran, Iran in 2017 to 2019 who have been diagnosed with colorectal cancer.
Participants/Inclusion and exclusion criteria
Patients which had colorectal cancer and needs surgery which admitted in Modarres hospital, Tehran, Iran between years 2018-2020 and
Intervention groups
In this prospective study, patients aged 30-60 years who are candidate for colorectal surgery due to colorectal cancer will be included in the study. Patients are divided into two groups of open and laparascopic based on the type of surgery. For both groups of patients the checklist included demographic information, postoperative pain, duration of hospitalization, infection at site up to 30 day, number of lymph nodes removed in pathology, hemoglobin drop, urinary tract injury and duration the surgery is followed.
Main outcome variables
Number of lymphnode removed in pathology, surgical type, hemoglobin drop, infection at site up to 30 day, leak anastomosis, urinary tract injury, duration the surgery, postoperative pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160803029181N10
Registration date: 2019-12-17, 1398/09/26
Registration timing: registered_while_recruiting

Last update: 2019-12-17, 1398/09/26
Update count: 0
Registration date
2019-12-17, 1398/09/26
Registrant information
Name
Nasser Malekpour Alamdari
Name of organization / entity
Shaid Behesht University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2207 4089
Email address
nassermalekpour@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-18, 1398/03/28
Expected recruitment end date
2021-03-19, 1399/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison number of lymphnode resection in open colectomy vs laparoscopy in colorectal cancer
Public title
Comparison number of lymphnode resection in open colectomy vs laparoscopy in colorectal cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with colorectal cancer
Exclusion criteria:
Age
From 30 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Siences, Arabi street, Velenjak
City
Tehran
Province
Tehran
Postal code
1998734383
Approval date
2019-06-18, 1398/03/28
Ethics committee reference number
IR.SBMU.MSP.REC.1398.256

Health conditions studied

1

Description of health condition studied
Colorectal cancer
ICD-10 code
C19
ICD-10 code description
Malignant neoplasm of rectosigmoid junction

Primary outcomes

1

Description
Number of lymphnode resection in surgery
Timepoint
From the diagnosis of colorectal cancer and time of surgery performed
Method of measurement
Lymph node count in pathology

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Evaluation of the number of lymph nodes removed in open surgery in patient with colorectal cancer
Category
Treatment - Surgery

2

Description
Intervention group: Evaluation of the number of lymph nodes removed in laparascopic surgery in patient with colorectal cancer
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti University of Medical Science; Shahid Modaress Hospital
Full name of responsible person
Naser Malekpour
Street address
Shahid Modares Hospital; Faraz Street; Saadat Abad
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2206 9355
Email
nassermalekpour@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyyed Ali Ziai
Street address
Daneshju Ave, Velenjak
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2207 4087
Email
aliziai@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nasser Malekpour Alamdari
Position
Vascular surgeon fellowship
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
ShahidBeheshti University of Medical Sciences, Arabi street, Velenjak
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2207 4089
Fax
+98 21 2207 4101
Email
nassermalekpour@sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nasser Malekpour Alamdari
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
ShahidBeheshti University of Medical Scieces, Arabi street, Velenjak
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2207 4089
Fax
+98 21 2207 4101
Email
nassermalekpour@sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nasser Malekpour Alamdari
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Shahid Beheshti University of Medical Sciences, Arabi street, Velenjak
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2207 4089
Fax
+98 21 2207 4101
Email
nassermalekpour@sbmu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further data
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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