Uterine myometrial thickness at the site of myomectomy scar after laparoscopic myomectomy compared to conventional open myomectomy
Design
clinical trial on 90 patients، no blinded
Settings and conduct
This study will be performed on 90 patients with uterine myomas type 2-5 with different clinical symptoms who are referred to Alzahra Hospital in Tabriz and undergo laparoscopic or laparoscopic myomectomy due to the need for surgery. Vicryl suture is used for suturing and the uterine wall is sutured in two layers.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All women who undergo surgery due to having uterine type 2-5 myomas and with various clinical clinical symptoms such as abnormal uterine hemorrhage, pain, rapid growth of myoma and compressive effects on adjacent offal. Exclusion criteria: patient dissatisfaction, single myomas greater than 8 cm and multiples greater than 5 cm, multiple myomas more than three, subserosal myomas, type 2-0 myomas, history of previous surgeries more than once, previous myomectomy history, malignancy in endometrial samples.
Intervention groups
A total of 90 patients of women with uterine myoma who need surgery for various reasons such as unbearable abdominal pain, medically resistant uterine bleeding, compressive effects on adjacent viscera, infertility or any other reason need surgery. Vicryl suture is used for suturing and the uterine wall is sutured in two layers.
Main outcome variables
Blood hemoglobin levels، Adequacy of sutures in myomectomy ،bleeding during surgery, Length of hospital stay ،Scar thickness of uterine myometer
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211103052950N3
Registration date:2022-04-24, 1401/02/04
Registration timing:registered_while_recruiting
Last update:2022-04-24, 1401/02/04
Update count:0
Registration date
2022-04-24, 1401/02/04
Registrant information
Name
Fatemeh Tabatabaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3326 2754
Email address
drtabatabaeigyn@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-21, 1401/02/01
Expected recruitment end date
2023-04-21, 1402/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Uterine myometrial thickness at the site of myomectomy scar after laparoscopic myomectomy compared to conventional open myomectomy
Public title
Uterine myometrial thickness at the site of myomectomy scar
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All women in need of surgery due to uterine type 2-5 myomas
Exclusion criteria:
Patient dissatisfaction ,
Single myomas larger than 8 cm
Multiples myomas more than three in number
Multiples myomas larger than 5 cm
Type 2-0 myomas
More than one previous surgeries
Previous myomectomy
The presence of malignancy in endometrial samples.
Sub-serous myomas
Age
From 15 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Of Tabriz University Of Medical Sciences
Street address
Third Floor, Central Building Number 2, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Approval date
2022-04-01, 1401/01/12
Ethics committee reference number
IR.TBZMED.REC.1401.003
Health conditions studied
1
Description of health condition studied
Uterine myoma
ICD-10 code
2E86.0
ICD-10 code description
Fibromyoma of uterus
Primary outcomes
1
Description
Uterine myometrial thickness at the site of myomectomy scar
Timepoint
Four months after surgery - Eight months after surgery
Method of measurement
ultrasonographic study
Secondary outcomes
1
Description
Comparison of during of hospital stay in laparoscopic and laparotomy myectomy
Timepoint
During hospitalization after surgery
Method of measurement
according to hours of hospitalization
2
Description
Comparison of intraoperative bleeding in laparoscopic and laparotomy myectomy
Timepoint
during the hospitalization
Method of measurement
Differential hemoglobin levels before and after surgery
3
Description
Comparison of duration of operation in laparoscopic and laparotomy myomectomy
Timepoint
during the surgery
Method of measurement
Surgery time in minutes
4
Description
Comparison of the time required to achieve proper vascularity (similar to other parts of the myometrium) and the minimum myometrial thickness of 2 mm at the site of myomectomy scar in two methods of laparoscopy and laparotomy
Timepoint
4 months and 8 months after surgery
Method of measurement
sonography
5
Description
Comparison of the number of endometrial openings during myomectomy with laparoscopic and laparotomy