Protocol summary
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Study aim
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Determining quality of life and chronic pelvic pain in 40-50-year-old women with endometriosis treated by laparoscopic hysterectomy and salpingoephrectomy compared to conservative laparoscopic surgery
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Design
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A non- randomized clinical trial with two groups of laparoscopic-hysterectomy and conservative laparoscopic surgery, with parallel groups, double-blind, phase 2 on 100 patients.
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Settings and conduct
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This study will be conducted in Hazrat Rasool Akram Hospital. The written consent form is signed and dated. Endometriosis patients undergoing laparoscopic surgery undergo two types of Hysterectomy and salpingovaphectomy and conservative laparoscopy. Study 2 is blinded.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
1. Age between 40 and 50 years Do not have surgery related to endometriosis 2. The patient's fertility is complete or she has no intention of fertility Have a 3. vas score above 8 before surgery
4. Failure to respond to three-month analgesic drug treatment
Exclusion criteria:
1. has an underlying disease (heart, blood pressure, depression, any other type of problem)
2. Age less than 40 years
3. Intends to be fertile, has a history of surgery related to endometriosis
4. Vas score is less than 8
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Intervention groups
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1. The group that undergoes hysterectomy and salpingovaphectomy
2. People who undergo conservative laparoscopic surgery for endometriosis.
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Main outcome variables
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Pain, quality of life and sexual function
General information
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Reason for update
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This study was initially designed as a randomized controlled trial, but randomization was not possible due to the ethical obligation to inform patients about the nature and consequences of radical surgery, including hysterectomy. As a result, patients chose their desired surgical approach after comprehensive counseling, which resulted in a practical and preference-based allocation. In addition, in the general information section of the design, it was mentioned from the beginning that randomization was not applicable in the investigator's opinion. Therefore, the randomization protocol was omitted in the abstract section.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20191123045476N5
Registration date:
2023-11-04, 1402/08/13
Registration timing:
registered_while_recruiting
Last update:
2025-09-23, 1404/07/01
Update count:
1
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Registration date
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2023-11-04, 1402/08/13
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-10-23, 1402/08/01
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Expected recruitment end date
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2024-06-04, 1403/03/15
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Investigating the quality of life and chronic pelvic pain in 40-50-year-old women with endometriosis treated by hysterectomy and laparoscopic salpingo-ferectomy compared to conservative laparoscopic surgery.
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Public title
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Investigating the quality of life and pain of endometriosis patients treated by hysterectomy and laparoscopy
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age between 40 and 50 years
Do not have surgery related to endometriosis
The patient's fertility is complete or she has no intention of fertility
Have a vas score above 8 before surgery
Failure to respond to three-month analgesic drug treatment
Exclusion criteria:
They have past medical such as hypertention , depretion , Diabet & ....
Age less than 40 years
Intends to be fertile
She has a history of surgery related to endometriosis
Vas score is less than 8
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Age
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From 40 years old to 50 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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- Investigator
- Data analyser
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Sample size
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Target sample size:
140
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Randomization (investigator's opinion)
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N/A
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Randomization description
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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In this study, the main researcher and the data analyst will be blinded to the assignment of the study groups; The patients are given a special code and the analyst does not know which group A and B are, and the main researcher is not involved in the selection of patients and does not know which group the patient who is undergoing surgery belongs to.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2022-11-15, 1401/08/24
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Ethics committee reference number
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IR.IUMS.FMD.REC.1401.428
Health conditions studied
1
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Description of health condition studied
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Endometriosis
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ICD-10 code
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N80.0
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ICD-10 code description
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Endometriosis of uterus
Primary outcomes
1
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Description
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Pain
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Timepoint
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3 month before surgery and 6 month & 12 month after surgery
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Method of measurement
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Visual Analogue Scale
Intervention groups
1
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Description
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First Intervention group: The group that undergoes hysterectomy and salpingovaphectomy
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Category
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Lifestyle
2
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Description
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Second Intervention group: People who undergo conservative laparoscopic surgery for endometriosis.
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Category
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Lifestyle
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Iran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Not applicable
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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After the article is published, confidential information such as patient and hospital details will be removed and other information will be provided to the researchers.
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When the data will become available and for how long
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After publishing the article
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To whom data/document is available
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Medical specialists
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Under which criteria data/document could be used
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Medical professionals can access the data for research purposes.
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From where data/document is obtainable
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Refer to the email of the responsible author (Samaneh Rokhgireh, email: s.rokhgireh@gmail.com )
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What processes are involved for a request to access data/document
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Official and academic email to the responsible author
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Comments
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