evaluation of safety and efficacy of an assembled loop for ovarian lifting and immobilization during laparoscopic cystectomy
Design
This study is a parallel-group double-blind, randomized controlled trial. 30 women with ovarian cysts will be randomly divided into two groups of 15 each using a table of random numbers.
Settings and conduct
The present study is a clinical trial study. The study population in this study is women with ovarian cysts who undergo laparoscopic surgery. The setting of the study is Hazrat-e Rasool Akram affiliated with Iran University of Medical of Science. The objectives of the study are explained to women and written consent is obtained. 30 women will be divided into intervention and control groups (15 people in each group) using a random number table.
Participants/Inclusion and exclusion criteria
The participants will be premenopausal women with ovarian cyst
Intervention groups
An intervention group is a group in which the ovarian suspension loop is used to lift and immobilize the ovary during laparoscopic cystectomy.
Main outcome variables
The primary outcome will be the surgical time and ease of use for surgeons.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160527028109N3
Registration date:2021-04-26, 1400/02/06
Registration timing:registered_while_recruiting
Last update:2021-04-26, 1400/02/06
Update count:0
Registration date
2021-04-26, 1400/02/06
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
Expected recruitment start date
2021-04-21, 1400/02/01
Expected recruitment end date
2021-09-22, 1400/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Safety and efficacy of ovarian suspension loop: an assembled device for ovarian lifting and immobilization during laparoscopic cystectomy
Public title
Safety and efficacy of ovarian lifting and immobilization during laparoscopic cystectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Premenopausal women
women with ovarian cyst
Exclusion criteria:
unwillingness to cooperate at the study
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation in this study is limited to intervention and control groups using randomization. Random allocation law is the simplest and most limited method of randomization. This method represents a large block for the total sample size. For this purpose, the researchers first determine a total sample size and then randomly divide a set of them into groups A and B. For example, in this study with a sample size of 26 people. 13 balls for intervention group A and 13 balls for intervention group B are placed inside a lottery container and then the balls are randomly removed from the container and a sequence is created. This method is used for two- or multi-group experiments.
Blinding (investigator's opinion)
Double blinded
Blinding description
The outcome assessor and data analyst will not know how the groups are assigned. But because patients' consent must be obtained, the patient knows in which group. For this purpose, before random allocation, a complete explanation of the interventions is given and the patient is told that they will be randomly placed in one of the groups
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, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2020-11-11, 1399/08/21
Ethics committee reference number
IR.IUMS.REC.1399.789
Health conditions studied
1
Description of health condition studied
Reduce surgical time
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
How long it takes for an ovarian cyst to come out
Timepoint
During the surgery
Method of measurement
Chronometer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Women with ovarian cysts, in which ovarian loops are used during laparoscopic surgery. To assemble the ovary suspension ring, depending on the thickness of the abdominal wall, about 25-35 cm of nylon suture is cut and also, depending on the length of the mesarium, about 8 to 12 cm is cut from the scalp vein catheter tube. The nylon thread is then passed through the scalp vein catheter and tied to create a loop at both ends. The node can be placed inside the catheter to hide. The assembled device is guided through one of the laparoscopic portals to the pelvic cavity and under the camera, along with the mapping of the abdominal surface, to the best point of placement of the ovarian cyst. The facial clouser is then inserted and the nylon thread is guided to the jaw. The facial clouser is pulled out of the abdomen and held in place by the Kelly clamp to prevent it from slipping back into the abdomen. The two ends of the tube catheter are taken with two graspers and guided under the ovary containing the cyst, and after ensuring the correct placement, the amount of lifting with Kelly is guided out of the abdomen and fixed. It should be noted that excessive stretching causes impaired blood flow to the ovaries, so excessive tension should be avoided and a cystectomy can be performed.
Category
Treatment - Surgery
2
Description
Control group: Women with ovarian cysts, in which ovarian loops aren't used during laparoscopic surgery.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul Akram hospital
Full name of responsible person
Kobra Tahermanesh
Street address
Rasoul Akram Hospital, Satarkhan St, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 6650 9283
Email
tahermanesh.k@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Seyed Abbas Motevalian-Vice President for Research of Iran University of Medical Sciences
Street address
Iran University of Medical Science, Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
tahermanesh.k@iums.ac.ir
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
Kobra Tahermanesh
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Rasoul Akram Hospital, Satarkhan St, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 64351
Email
tahermanesh.k@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Kobra Tahermanesh
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Rasoul Akram Hospital, Satarkhan St, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 64351
Email
tahermanesh.k@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Kobra Tahermanesh
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Rasoul Akram Hospital, Satarkhan St,Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 64351
Email
tahermanesh.k@iums.ac.ir
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
There is no more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
There is no more information
When the data will become available and for how long
After article publishing
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
There is no more information
From where data/document is obtainable
main investigator
What processes are involved for a request to access data/document