Protocol summary
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Study aim
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Comparing the effect of vicryle suture and v-lock suture using for vaginal cuff repair on incidence of post laparoscopic hysterectomy complications
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Design
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This research is a randomized clinical trial with a control group, parallel, double-blind, and 30-member groups in each group.
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Settings and conduct
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This study is carried out at Rasoul-e-Akram Hospital in Tehran. During surgery, the amount of bleeding and the time of surgery from the time of cutting the skin and entering the trowel until the end of surgery and sewing the skin, as well as the duration of vaginal cavity restoration in the two groups, will be investigated. All patients are referred to the laparoscopy clinic after transfer to the women's department for bleeding and after discharge for two routine follow-ups and vaginal examination at intervals of 1 and 3 months after surgery, and will be investigated for the complications of vaginal cuff.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
1) 65 years of age
2) hysterectomy due to benign uterine
3) the absence of prolapse of grade 3 and 4
4) the absence of a body mass index above 35,
5) lack of internal diseases
Exclusion criteria:
1) age over 65 years
2 ) pelvic prolapse grade 3 or 4
3) obesity (BMI) higher than 35
4) conditions that impair wound healing is: malnutration, anemia, DM, immuno compmised,smoking, steroids cansumation, rheumatologic disease, internal disease
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Intervention groups
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Intervention Group: suturing vaginal cuff during laparoscopic hysterectomy with v lock
Control Group: suturing vaginal cuff during laparoscopic hysterectomy with vicryle
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Main outcome variables
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Complications caused by suturing vaginal cuff
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:
IRCT2017013123666N5
Registration date:
2017-02-28, 1395/12/10
Registration timing:
registered_while_recruiting
Last update:
2018-06-02, 1397/03/12
Update count:
1
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Registration date
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2017-02-28, 1395/12/10
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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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Iran university of medical scince
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Expected recruitment start date
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2017-01-24, 1395/11/05
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Expected recruitment end date
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2018-01-25, 1396/11/05
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparing the effect of vicryle suture and v-lock suture using for vaginal cuff repair on incidence of post laparoscopic hysterectomy complications.
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Public title
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Comparison the effect of vicryle suture and v-lock suture for repairing vaginal cuff
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
65 years of age
hysterectomy due to benign uterine
the absence of prolapse of grade 3 and 4
the absence of a body mass index above 35
lack of internal diseases
Exclusion criteria:
age over 65 years
pelvic prolapse grade 3 or 4
obesity (BMI) higher than 35
conditions that impair wound healing is: malnutration, anemia, DM, immuno compmised,smoking, steroids cansumation, rheumatologic disease, internal disease
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Age
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From 17 years old to 65 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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- Participant
- Outcome assessor
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization was performed using the "= RANDBETWEEN(1,60)" function in excel software. So that the patients are assigned to two intervention and control groups before the surgery, after the informed consent.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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The study is done in double blind, so that subjects and outcome evaluator do not know the allocation of the two groups.
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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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2017-01-23, 1395/11/04
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Ethics committee reference number
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IR.IUMS.REC 1395.95-03-218-29659
Health conditions studied
1
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Description of health condition studied
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complication of vaginal cuff
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ICD-10 code
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N99.9
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ICD-10 code description
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Other disorders of the genitourinary system
Primary outcomes
1
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Description
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vaginal bleeding
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Timepoint
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3 months after surgery
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Method of measurement
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visit and reports
2
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Description
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infection of vaginal cuff
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Timepoint
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3 months after surgery
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Method of measurement
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visit and reports
3
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Description
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Dehiscence of vaginal cuff
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Timepoint
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3 months after surgery
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Method of measurement
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visit and reports
Intervention groups
1
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Description
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Intervention Group: in this group suturing vaginal cuff during laparoscopic hysterectomy will done with v lock
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Category
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Treatment - Surgery
2
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Description
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Control Group: In this group suturing vaginal cuff during laparoscopic hysterectomy will done with vicryle
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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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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available