Evaluation of recurrence of adhesion after surgery.
Design
70 patients selected using random allocation software are divided into two groups with and without hanging the ovaries. In the software, the total sample size (70 people) and the number of groups (two groups) are entered into the software. .
Settings and conduct
Patients are first examined and history is taken and their personal and clinical information including age, height, weight, body mass index, and endometriosis risk factors are evaluated and recorded in the data collection form. The presence of dysmenorrhea and dyspareunia is also determined and recorded using the Visual Anxiety Scale (VAS). Ovarian hanging was performed randomly in 35 patients and not in 35 patients as a control group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women over 18 years with severe endometriosis according to ultrasound, informed consent and women with severe endometriosis need to protect the uterus and ovaries
Exclusion criteria: unsuccessful surgery; Patients with surgical complications, lack of follow-up and patient withdrawal from the study
Intervention groups
Patients with severe endometriosis who undergo ovarian hanging in one group and this is not done in the control group.
Main outcome variables
Existence of adhesion
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120201008897N10
Registration date:2022-05-23, 1401/03/02
Registration timing:registered_while_recruiting
Last update:2022-05-23, 1401/03/02
Update count:0
Registration date
2022-05-23, 1401/03/02
Registrant information
Name
Safoura Rouholamin
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1236 7001
Email address
s_rouholamin@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-22, 1401/03/01
Expected recruitment end date
2023-05-22, 1402/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of ovarian suspension in preventing post-operative ovarian adhesion in woman with sever endometriosis
Public title
The effect of ovarian suspension in Endometriosis surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Women over 18 years of age who are diagnosed with endometriosis + no sliding according to transvaginal ultrasound and history and physical condition
Women with severe endometriosis need bilateral dissection and need to protect the uterus and ovaries
Patient informed consent to enter the study
Exclusion criteria:
Inability to tolerate transvaginal ultrasound
Unsuccessful surgery
- Patients who suffer from surgical complications such as intestinal injury, unplanned oophorectomy or change to laparotomy
Lack of subsequent patient visits to determine the severity of menstrual pain and postoperative complications
The patient refuses to continue attending the study
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
The 70 patients selected were randomly assigned to two groups with and without ovarian suspension using randomized allocation software. In the mentioned software, the total number of sample size (70 people) and the number of groups (2 groups) are entered into the software. The software output includes a list that randomly distributes numbers 1 to 70 in two groups. Patients are distributed in two groups according to the time of referral in order to reach the required number of samples in each group.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is performed by Double blind method. Patients are unaware of the type of operation (without hanging the ovaries and hanging the ovaries); The outcome assessor (sonographer) is also unaware of whether or not the ovaries are suspend.
Placebo
Not used
Assignment
Factorial
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
Isfahan Hezar Jerib St. Isfahan University of Medical Sciences and Health Services
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-12-31, 1400/10/10
Ethics committee reference number
IR.MUI.MED.REC.1400.720
Health conditions studied
1
Description of health condition studied
severe endometriosis
ICD-10 code
N80.1
ICD-10 code description
Endometriosis of ovary
Primary outcomes
1
Description
check for adhesion
Timepoint
Before surgery and three months after surgery
Method of measurement
Transvaginal ultrasound
Secondary outcomes
1
Description
Severity of dysmenorrhea
Timepoint
Before surgery and three months after surgery
Method of measurement
Visual Analogue Scale
2
Description
Severe dyspareunia
Timepoint
Before surgery and three months after surgery
Method of measurement
Visual Analogue Scale
3
Description
Severe postoperative pain
Timepoint
Up to three days after surgery
Method of measurement
Visual Analogue Scale
4
Description
Severity of chronic pelvic pain
Timepoint
Before surgery and three months after surgery
Method of measurement
Visual Analogue Scale
Intervention groups
1
Description
Intervention group: Women with severe endometriosis, after the release of adhesions during the operation, the ovaries are hung on the anterior wall of the abdomen with vicryl thread and five days later, the ovaries are sutured and released into the abdomen; This period is equivalent to the period of peritoneal repair. Then, three months later, an ultrasound is performed to check for ovarian adhesions.
Category
Treatment - Surgery
2
Description
Control group: Control group: In women with severe endometriosis and release of adhesions during surgery and release of both ovaries, hanging of the ovaries during surgery is not performed and three months later, ovarian sliding examination is performed.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Shahid Beheshti hospital
Full name of responsible person
safoura rouholamin
Street address
Isfahan Hezar Jerib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Fax
Email
s_rouholamin@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
safoura rouholamin
Street address
Isfahan Hezar Jerib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
s_rouholamin@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
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
safoura rouholamin
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Isfahan Hezar Jerib Street
City
isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3663 9903
Email
s_rouholamin@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
safoura rouholamin
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Isfahan Hezar Jerib St., Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3663 9903
Email
s_rouholamin@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
safoura rouholamin
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Isfahan Hezar Jerib St., Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3663 9903
Email
s_rouholamin@med.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No; The data will not be shared separately, but the results of their analysis will be shared in the article