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Investigating the effect of anti-adhesion substances in reducing adhesions after laparoscopic endometriosis surgery

Protocol summary

Study aim
Determining the effect of anti-adhesion substances in reducing adhesions after laparoscopic endometriosis surgery
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 60 patients. For randomization, the block randomization method will be used using: www.sealedenvelope.com.
Settings and conduct
This study will be done at Avicenna fertility center and Kamali hospital in karaj city. Patients with advanced endometriosis who underwent surgery during surgery after releasing the adhesion, the material is placed in the places where the adhesion have been opened (intervention group). No intervention is performed for the control group. And between 3 and 6 months after surgery, they undergo ultrasound and the amount of adhesion is determined by ultrasound and compared between the two groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients referred to Avicenna endometriosis clinic and Kamali hospital in Karaj who are diagnosed with severe endometriosis (stage 3 and 4) according to clinical and sonographic criteria; Women in the age group of 15 to 45 years; Women diagnosed with infertility; Women with chronic cyclic pelvic pain associated with menstruation.Exclusion criteria :Pregnant or lactating women, Having Laparoscopy contraindications (coagulopathy, cirrhosis, unclear anatomy, heart, lung disease)
Intervention groups
Intervention group: During laparoscopic surgery for endometriosis, after releasing the adhesions and shaving the intestine, the anti-adhesion material (interguard oxidized regenerated cellulose, Samyang biofarm company, Made in Hungary) is placed placed in the parts where the adhesion is opened. Control group: No intervention.
Main outcome variables
Abdominal and pelvic adhesion using ultrasound, 3-6 months after surgery

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221121056562N1
Registration date: 2023-01-25, 1401/11/05
Registration timing: prospective

Last update: 2023-01-25, 1401/11/05
Update count: 0
Registration date
2023-01-25, 1401/11/05
Registrant information
Name
Shiva Mahmooudzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2237 1991
Email address
shiva.kani91@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-19, 1401/11/30
Expected recruitment end date
2024-02-04, 1402/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of anti-adhesion substances in reducing adhesions after laparoscopic endometriosis surgery
Public title
Investigating the effect of anti-adhesion substances in reducing adhesion after laparoscopic endometriosis surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Women in the age group of 15 to 45 years Women diagnosed with infertility Women with chronic cyclic pelvic pain associated with menstruation Patients who are diagnosed with severe endometriosis (stage 3 and 4) according to clinical and ultrasound criteria.
Exclusion criteria:
Pregnancy Lactating lady Laparoscopy contraindications (coagulopathy - cirrhosis - unclear anatomy - heart - lung disease)
Age
From 15 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Our sample size is 60 people, with 30 people in each group. We will use the block randomization method by using: www.sealedenvelope.com. The number of blocks considered is 4.
Blinding (investigator's opinion)
Double blinded
Blinding description
The statistician will be unaware of the intervention method. Participants are unaware of the type of intervention. Injections are performed by a surgeon as a result of the surgeon and assistant surgeon are aware of the type of intervention. The person who records the final result of the study is unaware of the type of intervention.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Alborz University of Medical Sciences
Street address
Ethics committee unit; Vice Chancellor for Research; No.20; Saffarian alley; 45 Metri Golshahr street
City
Tehran
Province
Tehran
Postal code
3149779453
Approval date
2022-11-02, 1401/08/11
Ethics committee reference number
IR.ABZUMS.REC .1401. 199

Health conditions studied

1

Description of health condition studied
Endometriosis
ICD-10 code
N80
ICD-10 code description
Endometriosis

Primary outcomes

1

Description
Abdominal adhesions
Timepoint
Three to six months after surgery
Method of measurement
Sonography , According to the scoring system Enzian

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: During laparoscopic surgery for endometriosis, after releasing the adhesions and shaving the intestine, the anti-adhesion material (interguard oxidized regenerated cellulose, 7.5-10 cm ,Samyang biofarm company, Made in Hungary) is placed placed in the parts where the adhesion is opened. Its amount is determined based on the extent of adhesion during surgery
Category
Prevention

2

Description
Control group: During laparoscopic endometriosis surgery, no intervention is performed
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Kamali Hospital
Full name of responsible person
Shiva Mahmoodzadeh
Street address
Kamali hospital; Kamali alley; Shohada square; Shahid Beheshti street
City
Karaj
Province
Alborz
Postal code
3145746486
Phone
+98 26 3240 2161
Email
kamali@abzumbs.ac.ir

2

Recruitment center
Name of recruitment center
Avicenna Fertility Center
Full name of responsible person
Shiva mahmoodzadeh
Street address
No. 97, Dr. Shariati St
City
Tehran
Province
Tehran
Postal code
1941913114
Phone
+98 21 23519
Email
info@avicennaclinic.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Mohammad Nourisepehr
Street address
Vice Chancellor for Research; No.20; Saffarian alley; 45 Metri Golshahr street
City
Karaj
Province
Alborz
Postal code
3198764653
Phone
+98 26 3464 3705
Email
Research@abzums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Karaj 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
Karaj University of Medical Sciences
Full name of responsible person
Shiva Mahmooudzadeh
Position
Resident of Obsetetrics and gynecology
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Kamali hospital; Kamali alley; Shohada square; Shahid Beheshti street
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3222 2021
Email
shiva.kani91@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Shiva Mahmooudzadeh
Position
Resident of Obsetetrics and gynecology
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Kamali hospital; Kamali alley; Shohada square; Shahid Beheshti street
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3222 2021
Email
shiva.kani91@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Shiva Mahmooudzadeh
Position
Resident of Obsetetrics and gynecology
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Kamali hospital; Kamali alley; Shohada square; Shahid Beheshti street
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3222 2021
Email
shiva.kani91@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
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