Comparison of the features of the uterine scar after Laparoscopy vs laparoscopy-assisted myomectomy, using color Doppler ultrasound imaging
Design
This study was designed as a quasi-experimental clinical trial in which 92 eligible women will be included in the study.
Settings and conduct
According to inclusion and exclusion criteria, patients will be selected for myomectomy. Pre-operation imaging will be done by pelvic MRI and ultrasound. In all cases, a 10 mm trocar will introduce at the umbilicus. After creation of pneumoperitoneum, one 10 mm suprapubic and two 5 mm lateral trocars will be inserted into the abdominal wall. Diluted vasopressin (20 U in 100 cc normal saline) will be injected between the myoma and the serosa for controlling hemorrhage. A transverse incision by monopolar needle (60 w cut mode) will be done on the myoma site. The myoma will be enucleated by using scissors and applying traction and countertraction. After complete removal of the myoma, myomectomy site will be sutured with the laparoscopic or laparoscopy-assisted method as described previously. The choice of suturing method depends on the patient's condition and availability of morcellator. All the procedures will be performed by the same laparoscopic surgery team of Arash Hospital in Tehran and the variables studied will be recorded on the checklist. 3 months after surgery, the patients will be followed and ultrasound imaging will be done by the same sonographer who is unaware of the surgical procedure.
Participants/Inclusion and exclusion criteria
Women of reproductive age with type 2 to 6 uterine myomas If there are no changes in favor of sarcoma or contraindications for laparoscopy, will be included in this study.
Intervention groups
Group I: Laparoscopic myomectomy
Group II: Laparoscopy-assisted myomectomy
Main outcome variables
Myometrial thickness; blood flow; and hematoma in the site of the uterine scar
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110530006640N5
Registration date:2018-09-30, 1397/07/08
Registration timing:registered_while_recruiting
Last update:2018-09-30, 1397/07/08
Update count:0
Registration date
2018-09-30, 1397/07/08
Registrant information
Name
Zahra Asgari
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7788 8755
Email address
asgariza@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-22, 1397/03/01
Expected recruitment end date
2018-11-22, 1397/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the features of the uterine scar after Laparoscopy vs laparoscopy-assisted myomectomy, using color Doppler ultrasound imaging
Public title
Uterine scar after Laparoscopy vs laparoscopy-assisted myomectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Reproductive ages (20 - 45 years old)
Patient's desire to maintain the uterus
Type 2 to 6 myomas
The maximum number of myomas: 1
Size of Myoma: less than 10 cm
Exclusion criteria:
Changes in favor of sarcoma in MRI
Laparoscopy contraindication
History of myomectomy or Classic Cesarean section
Age
From 20 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
92
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Sonographer responsible for the assessment of uterine scar will be unaware of the type of surgery performed in patients. Also, the statistical analyzer will be unaware of the type of intervention performed in 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 Tehran University of Medical Sciences
Street address
Research and Technology Dept, Sixth Floor of Central University Building, Corner of Quds Street, Keshavarz Blvd, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2018-05-03, 1397/02/13
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1397.084
Health conditions studied
1
Description of health condition studied
Leiomyoma of uterus
ICD-10 code
D25
ICD-10 code description
Leiomyoma of uterus
Primary outcomes
1
Description
myometrial thickness at the site of the uterine scar and intact myometrium
Timepoint
3 Months after myomectomy
Method of measurement
Samsung WS80A Ultrasound Machine (both vaginal and abdominal probes)
2
Description
blood flow at the site of the uterine scar and intact myometrium
Timepoint
3 Months after myomectomy
Method of measurement
doppler ultrasound
3
Description
Hematoma size
Timepoint
3 Months after myomectomy
Method of measurement
Samsung WS80A Ultrasound Machine (both vaginal and abdominal probes)
Secondary outcomes
1
Description
Operative time
Timepoint
at the time of operation
Method of measurement
Timer
2
Description
Hemoglobin concentration
Timepoint
Pre and post operation
Method of measurement
CBC Test
3
Description
Blood transfusion
Timepoint
During or post operation
Method of measurement
check list
4
Description
length of hospital stay
Timepoint
Time inter wall between operation and discharge
Method of measurement
check list
Intervention groups
1
Description
Intervention group 1: Myomectomy site will be sutured with vicryl 1-0 continuously in two or three layers according to defects depth, and, the serosa will be sutured with vicril 2-0 laparoscopically.
Category
Treatment - Surgery
2
Description
Intervention group 2: After opening the abdominal wall about 4 cm and introducing the retractor (Alexis) the myometrium and serosa will be sutured in the same manner and with the same material as the first group.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Arash Women's Hospital
Full name of responsible person
Dr.Zahra Asgari
Street address
Eastern 162th St.,Baghdarnia st.,Resalat Highway, Tehranpars, Tehran ,Iran.
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7788 3283
Fax
Email
Dr.zahra.asgari@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr.Mohammad Ali Sahraeian
Street address
Research and Technology Dept, Sixth Floor of Central University Building, Corner of Quds Street, Keshavarz Blvd, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3698
Fax
+98 21 8163 3611
Email
rmo@tums.ac.ir
Web page address
http://vcr.tums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Zahra Asgari
Position
assistant proffesor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Eastern 162th St.,Baghdarnia st.,Resalat Highway, Tehranpars, Tehran ,Iran.
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7788 8755
Fax
+98 21 7788 8751
Email
asgariza@sina.tums.ac.ir
Web page address
http://arash.tums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Zahra Asgari
Position
assistant proffesor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Eastern 162th St.,Baghdarnia st.,Resalat Highway, Tehranpars, Tehran ,Iran.
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7788 8755
Fax
+98 21 7788 8751
Email
asgariza@sina.tums.ac.ir
Web page address
http://arash.tums.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Salehi
Position
Laparoscopy Fellowship
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Eastern 162th St.,Baghdarnia st.,Resalat Highway, Tehranpars, Tehran ,Iran.
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7788 3283
Email
fateme.s@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available