Background: Leiomyomata is the most frequent gynecological neoplasm. One of the major complications of myomectomy is intrauterine adhesion (synechiae).
Objective: To evaluate and compare the rate and severity of synechiae formation after myomectomy by laparotomy and laparoscopy.
Design: non-randomized interventional trial
Materials and Methods:
Participants:
All married fertile women who had undergone myomectomy (type 3-6 interamural and subserosal fibroids) via laparotomy and laparoscopy in Tehran’s Arash Hospital.
The exclusion criteria: receiving GnRH analogous, a history of uterine surgery, the presence of systemic conditions which increase the occurrence rate of synechiae such as genital tuberculosis, endometritis or post-operative fever of unknown origin, no desire to includr in the survey, patients for whom laparoscopy was contra-indicated due to the myoma size or other parameters.
Intervention: Three months after the operation, hysteroscopy was performed in all patients.
Essential variants: The occurrence rate and severity of intrauterine synechiae, and its relationship with type, number and location of myomas in both groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014123020486N1
Registration date:2015-02-15, 1393/11/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-02-15, 1393/11/26
Registrant information
Name
Leili Hafizi
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3802 2608
Email address
hafizil@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Deputy of Tehran University of Medical Sciences
Expected recruitment start date
2013-07-06, 1392/04/15
Expected recruitment end date
2015-07-06, 1394/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Intrauterine synechiae after myomectomy; laparotomy versus laparoscopy
Public title
Evaluation intrauterine adhesion after uterine myoma surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: all of the married fertile women who had undergone myomectomy; having intra-mural and sub-serosal fibroids; types 3-6 (according to FIGO classification).
Exclusion criteria: receiving GnRH analogous; a history of uterine surgery; the presence of systemic conditions which increase the occurrence rate of synechiae such as genital tuberculosis, endometritis or post-operative fever of unknown origin; no desire to includr in the survey; patients for whom laparoscopy was contra-indicated due to the myoma size or other parameters.
Age
From 16 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
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
Tehran University of Medical Sciences
Street address
Centeral Organization of Tehran University of Medical Sciences, Across from Ghoda Street, Keshavarz Boulevard, Tehran
City
Tehran
Postal code
Approval date
2013-07-02, 1392/04/11
Ethics committee reference number
92-01-39-22191
Health conditions studied
1
Description of health condition studied
intrauterine synechia
ICD-10 code
N85.5
ICD-10 code description
Other specified noninflammatory disorders of uterus
Primary outcomes
1
Description
Intrauterine synechia
Timepoint
3 months after myomectomy
Method of measurement
According to the modified classification of the European Society of Gynecological Endoscopy (ESGE)
Secondary outcomes
1
Description
Evaluation relationship between type, size and location of myoma with frequency and severity of intrauterine adhesion
Timepoint
3 months after myomectomy
Method of measurement
Based on FIGO classification
Intervention groups
1
Description
All patients in intervention group underwent myomectomy by laparoscopy method. Surgeries were performed in the follicular phase of menstrual cycle (except for those with metrorrhagia).
Surgery was performed under generalized anesthesia. Hysteroscopy was initially performed in order to determine the type of myoma and detect the intra-uterine pathology; if there was any, the patient would excluded of the survey. The myomectomy surgical technique was similar by control group (laparotomy). For uterine suturing, the 1 and 0 vicryl suture was used. In the case of endometrial opening, 3 layers and in other cases 2 layers were used.
Category
Treatment - Surgery
2
Description
All patients in control group underwent myomectomy by laparotomy method. Surgeries were performed in the follicular phase of menstrual cycle (except for those with metrorrhagia). Surgery was performed under generalized anesthesia. Hysteroscopy was initially performed in order to determine the type of myoma and detect the intra-uterine pathology; if there was any, the patient would excluded of the survey. The myomectomy surgical technique was similar by intervention group (laparoscopy). For uterine suturing, the 1 and 0 vicryl suture was used. In the case of endometrial opening, 3 layers and in other cases 2 layers were used.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Arash Women's Hospital
Full name of responsible person
Zahra Asgari
Street address
Baghdarnia Street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Deputy of Tehran University of Medical Sciences
Full name of responsible person
Nahid Mostofi
Street address
Sixth floor, Centeral Organization of Tehran University of Medical Sciences, Across from Ghoda Street, Keshavarz Boulevard, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy of Tehran University of Medical Sciences