Comparison the efficacy of vasopressin injection for adhisionolysis of bowel DIE (deep infilterating endometriosis)in laparoscopic surgery for severe endometriosis
Comparison the efficacy of vasopressin injection for adhisionolysis of bowel DIE in laparoscopic surgery for severe endometriosis
Design
This is a double blind phase 3 randomized clinical trial which patients and physician are blinded regarding groups. Vasopressin (case group) or saline(control group)will be injected in posterior of uterus ,then ease of adhisionolysis, Bleeding,and surgical complications will be recorded
Settings and conduct
All patients with endometriosis of bowel randomly will be allocated in case(vasopressin)or control (normal salin)group for injection to the posterior uterine wall during laparoscopy in Yas hospital, then the ease of adhisionolysis, bleeding,and complications will be recorded.
Participants/Inclusion and exclusion criteria
Age 20-50
Stage 3-4 endometriosis according to ASRM
Severe adhesion in pelvis
Exclusion criteria
Hypersensitivity to vasopressin
Endocrine disease
Intervention groups
Intervention group: In intervention group 50 patients will allocated and diluted injection vasopressin in 200 cc normal salin will injected in low posterior wall of uterus. Bleeding, ease of adhesion dissection, surgical complications will be recorded.
Main outcome variables
Time of surgery,Bleeding,bowel injury, ease of dissection will be evaluated after surgery by questionnaire
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20091012002576N27
Registration date:2023-01-27, 1401/11/07
Registration timing:prospective
Last update:2023-01-27, 1401/11/07
Update count:0
Registration date
2023-01-27, 1401/11/07
Registrant information
Name
Fatemeh Davari Tanha
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8831 3955
Email address
fdavaritanha@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-30, 1401/11/10
Expected recruitment end date
2023-08-01, 1402/05/10
Actual recruitment start date
2023-01-30, 1401/11/10
Actual recruitment end date
2023-08-01, 1402/05/10
Trial completion date
2023-08-01, 1402/05/10
Scientific title
Comparison the efficacy of vasopressin injection for adhisionolysis of bowel DIE (deep infilterating endometriosis)in laparoscopic surgery for severe endometriosis
Public title
Efficacy of vasopressin for adhisionolysis of bowel DIE in laparoscopy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 20-50
Stage 3-4 endometriosis according to ASRM
Severe adhesion in pelvis
Exclusion criteria:
Hypersensitivity to vasopressin
Endocrine disease
Age
From 20 years old to 50 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
100
Actual sample size reached:
100
Randomization (investigator's opinion)
Randomized
Randomization description
After randomization 100 patients randomly will assigned in intervention group who wii received diluted injection vasopressin in 200 cc normal salin in low posterior wall of uterus, or control group who received injection of normal salin in the site of adhesion. Bleeding, ease of adhesion dissection, surgical complications will be recorded. 50 letters A and 50 letters B are written on special papers that are not marked inside. Then all of them are placed in a bag and for each patient, after obtaining informed consent, a paper is removed randomly and without replacement, and based on the letter written on it, the desired intervention is performed for the patients. In addition, interventions A (case group) or B (control group) are determined by a lot.
Blinding (investigator's opinion)
Double blinded
Blinding description
This is a double blind intervention which patients and physician are blinded regarding groups. Patients and care providers are blinded regarding the case and control groups with using saline that is the same as vasopressin regarding the appearance.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Tehran University of medical sciences
Street address
Deputy of research, sixth floor of central building of Tehran University of medical sciences, Ghods Avenue, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1597815978
Approval date
2023-01-23, 1401/11/03
Ethics committee reference number
IR.TUMS.MEdICINE.REC.1401.703
Health conditions studied
1
Description of health condition studied
Severe endometriosis
ICD-10 code
ICD-10 code description
N97.8
Primary outcomes
1
Description
Time of surgery,Bleeding,bowel injury, ease of dissection
Intervention group: In intervention group 50 patients will allocated and diluted injection vasopressin in 200 cc normal salin will injected in low posterior wall of uterus. Bleeding, ease of adhesion dissection, surgical complications will be recorded.
Category
Treatment - Surgery
2
Description
Control group: 5o patients randomly will assigned in control group who received injection of normal salin in the site of adhesion. Bleeding, ease of adhesion dissection, surgical complications will be recorded.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Yes hospital
Full name of responsible person
Fatemeh Davari Tanha
Street address
Yas hospital, North Ostad Nejatollahi Avenue, Karim khan Zand Blvd.
City
Tehran
Province
Tehran
Postal code
1597815978
Phone
+98 21 4216 0000
Email
Fatedavtanha@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Davari Tanha
Street address
Yas hospital, North Ostad Nejatollahi Avenue, Karim khan Zand
City
Tehran
Province
Tehran
Postal code
1597815978
Phone
+98 21 4216 0000
Email
Fatedavtanha@gmail.com
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
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
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Davari Tanha
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yas hospital, North Ostad Nejatollahi Avenue, Karim khan Zand Blvd.
City
Tehran
Province
Tehran
Postal code
1598718311
Phone
+98 21 8831 3955
Fax
+98 21 8831 3955
Email
fdavaritanha@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Davari Tanha
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yas hospital, North Ostad Nejatollahi Avenue, Karim khan Zand Blvd.
City
Tehran
Province
Tehran
Postal code
1598718311
Phone
+98 21 8831 3955
Fax
Email
fdavaritanha@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Davari Tanha
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yas hospital, North Ostad Nejatollahi Avenue, Karim khan Zand Blvd.
City
Tehran
Province
Tehran
Postal code
1598718311
Phone
+98 21 8831 3955
Fax
Email
fatedavari@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be 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 available by mail
When the data will become available and for how long
SPSS data after publishing data till 3 years
To whom data/document is available
Academic Researchers
Under which criteria data/document could be used
For scientific purpose
From where data/document is obtainable
Mail to:fatedavtanha @gmail.com
What processes are involved for a request to access data/document