Many complications during surgery may occur during hysterectomy, vaginal cuff complications such as bleeding, infection, organ prolapse and Disruption of the vaginal cuff, the side effects are rare but serious in hysterectomy. However, brief study to determine the exact cause and prevalence of vaginal cuff complication during laparoscopic hysterectomy has conducted. So we decided in this study to compare v lock and vicryle sutures for closure of the vaginal cuff and their association with bleeding during surgery, duration of surgery, incidence of vaginal cuff complications such as bleeding, infection, vaginal cuff dehiscence . This study will take place in the women's unit of Hazrat Rasoul Akram Hospital. 60 patient whom admitted for laparoscopic hysterectomy due to benign diseases in 95-96, according to the type of suture ,patients will be divided into two groups sutured v-lock = 30 and vicryle = 30 laparoscopic hysterectomy, will be done with laparoscopic team. Kind of energy will be used during laparoscopic hysterectomy is monopolar or bipolar or harmonic. In vicryle group suturing will be done continually. during surgery amount of bleeding, duration of surgery and timing of vaginal cuff closure will be written .all patients after transferring to unit from operative room will control for bleeding, and will follow up after discharge for 1 month (4 weeks) and 4 months (12 weeks) later post laparoscopy surgery. They have been called up for coming to clinic and will investigate the effects of vaginal cuff complications. Medical information’s of all patients on study due to inclusion criteria will be collected.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017013123666N5
Registration date:2017-02-28, 1395/12/10
Registration timing:registered_while_recruiting
Last update:
Update count:1
Registration date
2017-02-28, 1395/12/10
Registrant information
Name
Abolfazl Mehdizadeh kashi
Name of organization / entity
Iran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 216651500
Email address
mehdizadeh.a@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran university of medical scince
Expected recruitment start date
2017-01-24, 1395/11/05
Expected recruitment end date
2018-01-25, 1396/11/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of vicryle suture and v-lock suture using for vaginal cuff repair on incidence of post laparoscopic hysterectomy complications.
Public title
Comparison the effect of vicryle suture and v-lock suture for repairing vaginal cuff
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 17 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran University of Medical Science
Street address
Iran . Tehran . Hemat Highway . Milad Tower
City
Tehran
Postal code
1449614535
Approval date
2017-01-23, 1395/11/04
Ethics committee reference number
IR.IUMS.REC 1395.95-03-218-29659
Health conditions studied
1
Description of health condition studied
complication of vaginal cuff
ICD-10 code
N99.9
ICD-10 code description
Other disorders of the genitourinary system
Primary outcomes
1
Description
vaginal bleeding
Timepoint
3 months after surgery
Method of measurement
visit and reports
2
Description
infection of vaginal cuff
Timepoint
3 months after surgery
Method of measurement
visit and reports
3
Description
Dehiscence of vaginal cuff
Timepoint
3 months after surgery
Method of measurement
visit and reports
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group: in this group suturing vaginal cuff during laparoscopic hysterectomy will done with v lock
Category
Treatment - Surgery
2
Description
Control Group: In this group suturing vaginal cuff during laparoscopic hysterectomy will done with vicryle
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul-e-akram hospital- womens unit
Full name of responsible person
Abolfazal Mehdizadeh kashi
Street address
Niayesh Av. Sattar khan st. Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr.mehdizadeh
Street address
rasoul akram hospital- obstetric gynecology unit
City
Tehran
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
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Science
Full name of responsible person
Dr. mania kaveh
Position
Resident of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Niayesh Av. Sattar khan St. Tehran, Iran
City
Tehran
Postal code
1445613131
Phone
+98 21 6650 9283
Fax
+98 66509283
Email
maniakaveh@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Science
Full name of responsible person
Dr. shahla chaichian
Position
Professor of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Niayesh Av. Sattar khan st. Tehran, Iran.
City
Tehran
Postal code
1445613131
Phone
+98 21 6650 9283
Fax
+98 66509283
Email
shahlachaichian@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Science
Full name of responsible person
Dr.mania kaveh
Position
MD, Assistant professor of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Niayesh Av. Sattar khan st. Tehran, Iran.
City
Tehran
Postal code
1445613131
Phone
+98 21 6650 9283
Fax
+98 66509283
Email
maniakaveh@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)