Protocol summary
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Study aim
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Comparison of lateral thermal damage depth using ultrasonic and monopolar energy during colpotomy in laparoscopic hysterectomy
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Design
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a double-blind randomized clinical trial
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Settings and conduct
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Rasoul-e-Akram Hospital
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Participants/Inclusion and exclusion criteria
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70 women who are candidates for laparoscopic hysterectomy
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Intervention groups
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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.
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Main outcome variables
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The amount of lateral thermal damage in cervical tissues obtained from patients
The colpotomy step duration
General information
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Reason for update
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Acronym
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IRCT registration information
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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
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Registration date
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2018-09-30, 1397/07/08
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-10-07, 1397/07/15
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Expected recruitment end date
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2019-10-07, 1398/07/15
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Actual recruitment start date
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2018-10-01, 1397/07/09
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Actual recruitment end date
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2019-03-17, 1397/12/26
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Trial completion date
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2019-04-27, 1398/02/07
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Scientific title
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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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Public title
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Comparison of thermal damage between harmonic and monopolar energy in laparoscopic hysterectomy
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 60 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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Sample size
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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
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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In this study, 70 women undergoing laparoscopic hysterectomy will be divided into two groups of 35 using simple randomization method.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-08-26, 1397/06/04
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Ethics committee reference number
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IR.IUMS.REC.1397.233
Health conditions studied
1
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Description of health condition studied
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Benign uterine diseases
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ICD-10 code
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N71.9
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ICD-10 code description
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Inflammatory diseases of uterus, unspecified
Primary outcomes
1
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Description
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measuring the depth of lateral thermal damage developed in cervical tissue
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Timepoint
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within 72 hours after intervention
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Method of measurement
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measuring with specific microscope used by pathologist
Intervention groups
1
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Description
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Intervention group: 35 women for whom, ultrasonic device (Harmonic) is used for colpotomy.
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Category
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Treatment - Surgery
2
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Description
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Control group: 35 women in whom, monopolar device is used for colpotomoy.
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Category
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Treatment - Surgery
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Iran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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No more information is available
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available