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Comparison of lateral thermal damage during colpotomy using harmonic scalpel versus monopolar diathermy in women undergoing laparoscopic hysterectomy

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History
# Registration date Revision Id
2 2019-06-04, 1398/03/14 92972
1 2018-09-30, 1397/07/08 61236
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  • Protocol summary

    the depth of lateral thermal damage in cervical tissues obtained from patients
    The amount of lateral thermal damage in cervical tissues obtained from patients The colpotomy step duration
    عمق آسیب حرارتی جانبی ایجاد شده در بافت سرویکس به دست آمده از بیماران
    میزان آسیب حرارتی جانبی ایجاد شده در بافت سرویکس به دست آمده از بیماران طول مدت مرحله کولپوتومی

  • General information

    empty
    81
    empty
    2018-10-01, 1397/07/09
    empty
    2019-03-17, 1397/12/26
    empty
    2019-04-27, 1398/02/07

  • Recruitment centers

    #1
    Name of recruitment center - English: Rasoul Akram hospital
    Name of recruitment center - Persian: بيمارستان حضرت رسول اكرم (ص)
    Full name of responsible person - English: Shahla Chaichian
    Full name of responsible person - Persian: شهلا چایچیان
    Street address - English: Rasoul Akram Hospital, Satarkhan St
    Street address - Persian: خيابان ستارخان-بيمارستان رسول اكرم(ص)
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1449614535
    Phone: +98 21 6650 9283
    Fax:
    Email: mansourehgorginzadeh@gmail.com
    Web page address:
    Name of recruitment center - English: Rasoul-e-Akram hospital
    Name of recruitment center - Persian: بيمارستان حضرت رسول اكرم (ص)
    Full name of responsible person - English: Shahla Chaichian
    Full name of responsible person - Persian: شهلا چایچیان
    Street address - English: Rasoul-e-Akram Hospital, Satarkhan St
    Street address - Persian: خيابان ستارخان-بيمارستان رسول اكرم(ص)
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1449614535
    Phone: +98 21 6650 9283
    Fax:
    Email: shahlachaichian@yahoo.com
    Web page address:

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Vice Chancellor for Administration of Iran University of Medical Sciences (IUMS)
    Full name of responsible person - Persian: معاونت تحقیقات و فناوری دانشگاه علوم پزشکی ایران
    Street address - English: Iran University of Medical Science, Hemmat Highway, Tehran
    Street address - Persian: بزرگراه همت- دانشگاه علوم پزشكي ايران
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1449614535
    Phone: +98 21 86701
    Fax:
    Email: mansourehgorginzadeh@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Seyed Kazem Malakouti
    Full name of responsible person - Persian: سید کاظم ملکوتی
    Street address - English: Iran University of Medical Science, Hemmat Highway, Tehran
    Street address - Persian: بزرگراه همت- دانشگاه علوم پزشكي ايران
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1449614535
    Phone: +98 21 86701
    Fax:
    Email: malakouti.sk@iums.ac.ir
    Web page address:

Protocol summary

Study aim
Comparison of lateral thermal damage depth using ultrasonic and monopolar energy during colpotomy in laparoscopic hysterectomy
Design
a double-blind randomized clinical trial
Settings and conduct
Rasoul-e-Akram Hospital
Participants/Inclusion and exclusion criteria
70 women who are candidates for laparoscopic hysterectomy
Intervention groups
The control group includes 35 women in whom monopolar energy is used for colpotomy and the case group includes 35 women in whom harmonic scalpel is used during laparoscopic hysterectomy.
Main outcome variables
The amount of lateral thermal damage in cervical tissues obtained from patients The colpotomy step duration

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180130038567N2
Registration date: 2018-09-30, 1397/07/08
Registration timing: prospective

Last update: 2019-06-10, 1398/03/20
Update count: 1
Registration date
2018-09-30, 1397/07/08
Registrant information
Name
shahla chaichian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6650 9283
Email address
chaichian.sh@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-07, 1397/07/15
Expected recruitment end date
2019-10-07, 1398/07/15
Actual recruitment start date
2018-10-01, 1397/07/09
Actual recruitment end date
2019-03-17, 1397/12/26
Trial completion date
2019-04-27, 1398/02/07
Scientific title
Comparison of lateral thermal damage during colpotomy using harmonic scalpel versus monopolar diathermy in women undergoing laparoscopic hysterectomy
Public title
Comparison of thermal damage between harmonic and monopolar energy in laparoscopic hysterectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women in age range 18-60 Women diagnosed with benign gynecologic diseases including myoma, adnomyosis ... who are candidates for total laparoscopic hysterectomy Not suffering from background diseases affecting wound healing process including immune deficiency, long-term use of corticosteroids or history of pelvic irradiation
Exclusion criteria:
َAny woman suspicious of cervical or vaginal malignancy Presence of active vaginal infection during last 30 days Use of antibiotics other than the preoperative prophylaxis
Age
From 18 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 70
More than 1 sample in each individual
Number of samples in each individual: 4
histologic blocks of cervical tissue in four zones : anterior, posterior, right lateral and left lateral
Actual sample size reached: 81
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 70 women undergoing laparoscopic hysterectomy will be divided into two groups of 35 using simple randomization method.
Blinding (investigator's opinion)
Double blinded
Blinding description
Double-blinding ( patients and outcome investigators will not be aware of the allocation and the surgeons will be informed of randomization only on the day of surgery). Since the device is used during surgery when the patient is anesthetized, she will be actually blind to the randomization.
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, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2018-08-26, 1397/06/04
Ethics committee reference number
IR.IUMS.REC.1397.233

Health conditions studied

1

Description of health condition studied
Benign uterine diseases
ICD-10 code
N71.9
ICD-10 code description
Inflammatory diseases of uterus, unspecified

Primary outcomes

1

Description
measuring the depth of lateral thermal damage developed in cervical tissue
Timepoint
within 72 hours after intervention
Method of measurement
measuring with specific microscope used by pathologist

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 35 women for whom, ultrasonic device (Harmonic) is used for colpotomy.
Category
Treatment - Surgery

2

Description
Control group: 35 women in whom, monopolar device is used for colpotomoy.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Rasoul-e-Akram hospital
Full name of responsible person
Shahla Chaichian
Street address
Rasoul-e-Akram Hospital, Satarkhan St
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 6650 9283
Email
shahlachaichian@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyed Kazem Malakouti
Street address
Iran University of Medical Science, Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
malakouti.sk@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
Shahla Chaichian
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Rasoul-e-Akram Hospital, Satarkhan St
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 64351
Email
shahlachaichian@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Shahla Chaichian
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Rasoul-e-Akram Hospital, Satarkhan St
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 64351
Email
shahlachaichian@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mansoureh Gorginzadeh
Position
fellowship of minimally invesive gynecologic surgery
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Rasoul-e-Akram Hospital, Niayesh St., Satarkhan St.
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 6435 2562
Email
masnourehgorginzadeh@gmail.com

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
No more information is available
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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