The comparison of pelvic pain recurrence within 6 and 12 months after treatment of endometriotic lesions with excisional surgery approach versus ablation therapy
Design
Two arm parallel-group randomized trial using Random Allocation software on 60 patients without blindness postoperative care and outcome assessment
Settings and conduct
The patients with endometriosis grades 1 and 2 who are a candidate for surgical treatment And refer to the Educational and Treatment Centers of Alzahra and Shahid Beheshti will be randomly allocated to excisional or ablation treatments of endometriosis using Random Allocation Software. Blinding will not be performed. The patients will be evaluated in terms of recurrence in pelvic pain within 6 and 12 months postoperatively.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
-Age above 18 years and less than 40 years
- Endometriosis grades I and II in laparoscopy
-Lacking hormone therapy within the previous three months
-Willingness for participation in the study
-Chronic pelvic pain for more than 6 months
-Normal abdominopelvic, uterine and ovarian ultrasonographic imaging
-No medical history of diabetes or hypertension
Exclusion criteria:
-Lacking gross endometriosis evidence in laparoscopy
-Endometriosis grades III and IV in laparoscopy
Intervention groups
Excisional surgery of lesions: Excision of the endometriotic peritoneum by scissors using butterfly method
Ablation: Cautery of the endometriotic parts without peritoneal excision
Main outcome variables
Pain score related to dysmenorrhea; to dyspareunia; Dysschesia; non-menstruation time
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200518047489N1
Registration date:2020-06-02, 1399/03/13
Registration timing:registered_while_recruiting
Last update:2020-06-02, 1399/03/13
Update count:0
Registration date
2020-06-02, 1399/03/13
Registrant information
Name
Forough Momeni
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3444 7707
Email address
forough.momeni@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-21, 1399/03/01
Expected recruitment end date
2021-05-22, 1400/03/01
Actual recruitment start date
2019-09-23, 1398/07/01
Actual recruitment end date
2020-09-22, 1399/07/01
Trial completion date
2020-09-22, 1399/07/01
Scientific title
The comparison of excision versus ablation in the surgical procedures of superficial endometriosis related to chronic pelvic pain
Public title
Investigation of excisional surgery versus ablation for the treatment of chronic pelvic pain in endometriosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age above 18 years and less than 40 years
Lacking hormone therapy within the previous three months
Willingness for participation in the study
Chronic pelvic pain for more than 6 months
Normal abdominopelvic, uterine and ovarian ultrasonographic imaging
No medical history of diabetes or hypertension
Exclusion criteria:
Lacking gross endometriosis evidence in laparoscopy
Endometriosis grades III and IV in laparoscopy
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Each of the patients is provided with a particular number using Random Allocation software if the number is odd, the patient will be allocated to the excisional surgery and if even, they will be allocated to the ablation therapy.
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 Isfahan University of Medical Sciences
Street address
Hezarjarib Avenue
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-03-16, 1398/12/26
Ethics committee reference number
IR.MUI.MED.REC.1398.732
Health conditions studied
1
Description of health condition studied
Endometriosis
ICD-10 code
N80
ICD-10 code description
Endometriosis
Primary outcomes
1
Description
Pain score due to dysmenorrhea
Timepoint
At baseline, within 6 months and within 12 months
Method of measurement
Visual analogue scale questionnaire
2
Description
Dysparonia
Timepoint
At baseline, within 6 months and within 12 months
Method of measurement
Visual analogue scale questionnaire
3
Description
Dyschezia
Timepoint
At baseline, within 6 months and within 12 months
Method of measurement
Visual analogue scale questionnaire
4
Description
Pain in non-menstrual time
Timepoint
At baseline, within 6 months and within 12 months
Method of measurement
Visual analogue scale questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Excisional surgery: The excision of endometriotic peritoneum based on butterfly method using scissors
Category
Treatment - Surgery
2
Description
Ablation therapy: Cautery of the endometriotic lesions without the excision of affected peritoneum
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Forough Momeni
Street address
Shohaday-e-Sofeh Avenue
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
forough.momeni@gmail.com
2
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Forough Momeni
Street address
Shahid Motahhari Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3236 7001
Email
forough.momeni@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mojgan Mortazavi
Street address
Hezar Jarib Avenue
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
mortazavi@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Forough Momeni
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Hezar jarib Avenue
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3444 7707
Fax
Email
forough.momeni@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Forough Momeni
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Hezar jarib Avenue
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3444 7707
Fax
Email
forough.momeni@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Forough Momeni
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Hezar jarib Avenue
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3444 7707
Fax
Email
forough.momeni@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The data are accessible if the professor permits
When the data will become available and for how long
Following the publication of the paper, the data are accessible if the professor permits
To whom data/document is available
the people who have a proposal related to the published article
Under which criteria data/document could be used
For the publication of a new article related to this study
From where data/document is obtainable
To the professor
What processes are involved for a request to access data/document