Protocol summary

Summary
The study population is comprised women at reproductive and premenopausal ages whom refer to gynecology clinic in Rasool-e Akram Tertiary and a private Hospitals in Tehran. The candidates will be select for total laparoscopy hysterectomy and bilateral salpingo-oophorectomy. Any vaginal infection that reveals by examination will be treated. The exclusion criteria's are: patients with recent history like smoking, diabetes, mellitus, immune deficiency, vascular diseases, coagulation disorders, consuming corticosteroids, abnormal Pap smear and suspicious to cancer and menopausal women. Patients who have inclusion criteria's after filling of consent form, by using the randomization table randomly assigned to two groups: 1) conventional and 2) new techniques for vaginal cuff closure. Patients were not aware of the type of intervention they performed on them. After placement of 11 mm umbilical trocar and two 5 mm lateral and 11 mm suprapubic trocars, under general anesthesia, every bites are cut by ligasure or bipolar and scissors. After the securing the angle of incision, a full thickness needle bite is taken suturing 1 cm away from the margin of the incision and coming out at 0.5 cm from the edge of the vaginal epithelium. After then, the entering perform at 0.5 cm to the vaginal epithelium of opposite edge and come out 1 cm away from of the margin of the incision in oblique fashion. A superficial bite is taken encircling the outer margins without biting vaginal epithelium. Base of length of the cuff, 3-5 stiches are running the same fashion. The patients will be discharge after 48 hours and educate for amount of vaginal bleeding. If the 1/4, 1/2 or entire of the pad is being wet, the volume of bleeding is classified to low, moderate and severe. The patient will be follow in three month by phone call. Every week for six weeks and then biweekly. If the patients have any severe vaginal bleeding, profuse or malodor vaginal discharge, fever and chills, it is recommended to refer to our GYN clinic.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016052728109N1
Registration date: 2017-07-18, 1396/04/27
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-07-18, 1396/04/27
Registrant information
Name
Kobra Tahermanesh
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6435 2562
Email address
tahermanesh.k@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research & Technology, Iran University of Medical Scciences (IUMS)
Expected recruitment start date
2017-07-23, 1396/05/01
Expected recruitment end date
2018-10-30, 1397/08/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparision of two methods of vaginal cuff clouser during laparoscopy hysterectomy:A new technique
Public title
Comparision of two methods of vaginal cuff clouser during laparoscopy hysterectomy
Purpose
Treatment
Inclusion/Exclusion criteria
The exclusion criteria's are: patients with recent history like smoking, diabetes, mellitus, immune deficiency, vascular diseases, coagulation disorders, consuming corticosteroids, abnormal Pap smear and suspicious to cancer and menopausal women.
Age
From 17 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 20
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 Sciences (IUMS)
Street address
Hemmat Highway, Iran University of Medical Sciences (IUMS)
City
Tehran
Postal code
Approval date
2017-05-14, 1396/02/24
Ethics committee reference number
IR.IUMS.REC1395.95-03-218-29670

Health conditions studied

1

Description of health condition studied
Hysterectomy
ICD-10 code
O82.2
ICD-10 code description
Delivery by caesarean hysterectomy

Primary outcomes

1

Description
Bleeding
Timepoint
After hysterectomy until the 3 months
Method of measurement
tampons

Secondary outcomes

1

Description
prolaps
Timepoint
After hysterectomy until the 3 months
Method of measurement
visit

Intervention groups

1

Description
intervention group: surgery with new method control group: surgery with common method
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Rasoul-e Akram Tertiary Hospital
Full name of responsible person
Banafsheh Tajbakhsh
Street address
City
Tehran

2

Recruitment center
Name of recruitment center
Farmanieh Hospital
Full name of responsible person
Elham Akbari
Street address
Famarieh Hospital, Farmanieh Blvd
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Administration of Iran University of Medical Sciences (IUMS)
Full name of responsible person
Dr. Kobra Tahermanesh
Street address
Rasoul-e Akram Tertiary Hospital
City
Tehran
Grant name
Grant code / Reference number
95-03-218-29670
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Administration of Iran University of Medical Sciences (IUMS)
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
Rasoul-e Akram Tertiary Hospital
Full name of responsible person
Banafsheh Tajbakhsh
Position
Fellowship of Minimally Invasive Gynecology
Other areas of specialty/work
Street address
Niayesh st., Rasoul-e Akram Tertiary Hospital
City
Tehran
Postal code
Phone
+98 21 6650 9283
Fax
Email
tajviolet@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rasoul-e Akram Tertiary Hospital
Full name of responsible person
Dr. Kobra Tahermanesh
Position
Fellowship of Minimally Invasive Gynecology
Other areas of specialty/work
Street address
Niayesh St., Rasoul-e Akram Tertiary Hospital
City
Tehran
Postal code
Phone
+98 21 6650 9283
Fax
Email
tahermanesh.k@iums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences (IUMS)
Full name of responsible person
Banafsheh Tajbakhsh
Position
Fellowship of Minimally Invasive Gynecology
Other areas of specialty/work
Street address
Rasoul-e Akram tertiary Hospital, Niayesh St., Sattarkhan St.
City
Tehran
Postal code
Phone
+98 91266509283
Fax
Email
tajviolet@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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