This is a non-randomized clinical trial (quasi-experimental) that aims to compare the results of the peritoneal washing and peri-operative outcomes in laparoscopic myomectomy with morcellation versus laparotomy myomectomy without morcellation in patients whom referred to Arash Hospital for myomectomy. We include all woman who meet the established criteria for myomectomy in Arash Hospital. Subjects should be aged between 18 and 45 years old without known or suspected history of cancers and have Normal menstrual cycle. in the case of abnormal uterine bleeding , an endometrial biopsy will be performed. in the laparoscopic myomectomy group, patients who have a history of uterine, ovary or colon cancer in her own or her first degree relatives diagnosed under the age of 50 years, will be excluded. All participants in laparoscopy group will provide written informed consent recommended by FDA panel outlining the risks of morcellation and of unsuspected malignant myoma (In this case, the malignancy can be diffused and the prognosis will be significantly worsened) . Sample size: 144 (72 in the laparoscopic (interventional) group and 72 in the laparotomy group (control) ) in the laparoscopic group abdominal washing will be done in two steps. First step after myomectomy and suturing the myoma bed, and the second step after the morcellation will be done. In the laparotomy group, washings step will be performed one time after the end of the myomectomy and closing the bed, the uterus is returned to the pelvis. Pathological assessment for detecting The presence of spindle cells in peritoneal washings will perform by using cell block technique. Peri-operative outcomes including the duration of surgery, pre and postoperative hemoglobin levels, hospitalization time and re-admission will be compared between two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201707156640N2
Registration date:2017-08-04, 1396/05/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-08-04, 1396/05/13
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
Tehran University Of Medical Sciences
Expected recruitment start date
2017-07-23, 1396/05/01
Expected recruitment end date
2018-07-23, 1397/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of outcomes after laparoscopic myomectoy with morcellation versus laparatomy myomectoy without morcellation
Public title
comparison of outcomes after laparoscopic myomectoy with morcellation versus laparatomy myomectoy without morcellation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria:
subjects should be aged between 18 and 45 years old without known or suspected history of cancers and have Normal menstrual cycle
Exclusion criteria: ( in laparoscopy group ) : a history of uterine, ovary or colon cancer in her own or her first degree relatives diagnosed under the age of 50 years
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
144
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
Tehran Province, Tehran, District 6, Pour Sina St
City
Tehran
Postal code
Approval date
2017-06-24, 1396/04/03
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1396.2714
Health conditions studied
1
Description of health condition studied
Leiomyoma of uterus
ICD-10 code
D25
ICD-10 code description
benign neoplasms of uterus with morphology code M889 and behaviour code /0 fibromyoma of uterus
Primary outcomes
1
Description
duration of surgery
Timepoint
during intervention
Method of measurement
Hours and minutes
2
Description
result of pertoneal washing pathological assessment
Timepoint
after intervention
Method of measurement
presence of spindle cells
3
Description
Blood loss
Timepoint
pre and post operative
Method of measurement
Hemoglobin level
4
Description
Hospitalization time
Timepoint
after intervention
Method of measurement
Check list
5
Description
complications during operation
Timepoint
during intervention
Method of measurement
Bowel, bladder or ureter injury or hysterectomy ( checklist )
Secondary outcomes
1
Description
readmission for myomectomy
Timepoint
after intervention
Method of measurement
check list
Intervention groups
1
Description
laparoscopic myomectomy
Category
Treatment - Surgery
2
Description
laparotomy myomectomy
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Arash Women Hospital
Full name of responsible person
Dr.Maryam Hashemi
Street address
Arash Women 's Hospital, Rashid Ave, Resalat Highway, Tehranparse
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences , Deputy of Research
Full name of responsible person
Dr. Akbar Fotohi
Street address
Qods St, Keshavarz Blvd
City
Tehran
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 , Deputy of Research
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
Arash Women 's Hospital
Full name of responsible person
Dr . Maryam Hashemi
Position
laparoscopy fellowship Student
Other areas of specialty/work
Street address
Arash Women 's Hospital, Rashid Ave, Resalat Highway
City
Tehran
Postal code
Phone
+98 21 7771 9922
Fax
Email
nfaridi@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arash Women 's Hospital
Full name of responsible person
Dr. Zahra Asgari
Position
Associate Professor
Other areas of specialty/work
Street address
Arash Women 's Hospital, Rashid Ave, Resalat Highway,
City
Tehran
Postal code
Phone
00219877719922
Fax
Email
asgariza@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arash Women 's Hospital, Rashid Ave, Resalat Highway,
Full name of responsible person
Arezoo Maleki Hajiagha
Position
MS , Employee of research development center
Other areas of specialty/work
Street address
Arash Women 's Hospital, Rashid Ave, Resalat Highway
City
Tehran
Postal code
Phone
00
Fax
Email
arezoomaleki.h@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)