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 depth of lateral thermal damage in cervical tissues obtained from patients
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:2018-09-30, 1397/07/08
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
empty
Actual recruitment end date
empty
Trial completion date
empty
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
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 Akram hospital
Full name of responsible person
Shahla Chaichian
Street address
Rasoul Akram Hospital, Satarkhan St
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 6650 9283
Email
mansourehgorginzadeh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Vice Chancellor for Administration of Iran University of Medical Sciences (IUMS)
Street address
Iran University of Medical Science, Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
mansourehgorginzadeh@gmail.com
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