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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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IRCT |
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Last refreshed on:
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22 February 2018 |
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Main ID: |
IRCT201105026359N1 |
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Date of registration:
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2011-07-18 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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The comparision between result of single port laparoscopic cholecystectomy with 4 ports cholecystectomy
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Scientific title:
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The comparision between result of single port laparoscopic cholecystectomy with 4 ports cholecystectomy |
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Date of first enrolment:
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2011-08-22 |
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Target sample size:
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60 |
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Recruitment status: |
Complete |
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URL:
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http://en.irct.ir/trial/6802 |
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Study type:
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interventional |
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Study design:
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Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment.
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Phase:
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N/A
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Countries of recruitment
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Iran (Islamic Republic of)
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Contacts
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Name:
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Dr.Alireza Barband
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Address:
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Sina Hospital between Montazeri and Hafez , Azadi Ave, Tabriz
51636398888
Tabriz
Iran (Islamic Republic of) |
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Telephone:
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+98 41 1542 2862 |
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Email:
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Soroushm@tbzmed.ac.ir |
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Affiliation:
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General Surgery Group Sina Hospital |
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Name:
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Dr.Mohammad Soroush
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Address:
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Tabriz University Of Medical Sciences and Health Services , Golgasht Ave, Tabriz
5166614756
Tabriz
Iran (Islamic Republic of) |
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Telephone:
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+98 41 1335 5921 |
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Email:
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Soroushm@tbzmed.ac.ir |
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Affiliation:
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Tabriz University Of Medical Sciences and Health Services |
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Key inclusion & exclusion criteria
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Inclusion criteria: Inclusion criteria : patients with symptomatic cholelithiasis; without complications; between 14to70 years old; BMI less than 35 ; no history of other diseases ; no history of previous abdominal surgery.
Exclusion criteria:: patients with complicated cholelithiasis ;less than 14 years old ,more than 70 years old ; BMI more than 35 ; history of other diseases; history of previous abdominal surgery
Exclusion criteria:
Age minimum:
14 years
Age maximum:
70 years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cholelithiasis.
Cholelithiasis
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Cholelithiasis
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Intervention(s)
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Intervention 1: In the cases laparoscopic cholecystectomy made with only one umblical port but in control with standard 4 port. Intervention 2: In case group laparoscopic cholecystectomy made only by one umblical port.
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In case group laparoscopic cholecystectomy made only by one umblical port.
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In the cases laparoscopic cholecystectomy made with only one umblical port but in control with standard 4 port
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Treatment - Surgery
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Primary Outcome(s)
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Post operative pain. Timepoint: 3,6,12,24hours and three days after surgery. Method of measurement: VAS.
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Secondary Outcome(s)
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Rate of change to open surgery. Timepoint: In the period of operation. Method of measurement: Number percent.
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Length of admission. Timepoint: Admission to Discharge. Method of measurement: Day.
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Rate of intraoperative bleeding. Timepoint: In the period of operation. Method of measurement: Millilitre(ml).
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Rate of wound infection. Timepoint: Until two monthes after surgery. Method of measurement: Number percent.
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Length of operation. Timepoint: In the period of operation. Method of measurement: minute.
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Rate of gall bllader rupture. Timepoint: In the period of operation. Method of measurement: Number percent.
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Source(s) of Monetary Support
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Tabriz University Of Medical Sciences and Health Services
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Ethics review
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Status: Approved
Approval date:
Contact:
Tabriz University Of Medical Sciences and Health Services
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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