to investigate the efficacy of fibrin glue in prevention of seroma formation in gastric cancer with D 2 dissection
Design
Phase 3 of a randomized clinical trial with a control group, single-blind
Settings and conduct
Patients with gastric cancer admitted to the cancer department of Imam Khomeini Hospital in Tehran are studied
Participants/Inclusion and exclusion criteria
all Patients with gastric cancer who are candidates for gastrectomy and are hospitalized within 1399
Exclusion criteria:
1. Patients with previous history of surgery,
2. patients who are unwilling to participate in the study,
3. patients with any established local allergy to fibrin glue,
4. patients with metastasis
Intervention groups
In this single-blind randomized clinical trial study, patients with gastric cancer who are candidates for gastrectomy are randomly divided into two groups. In 1. After lymphatic D2 dissection, .5 ml of fibrin glue will be injected into the dissected area in the intervention group.
2. The control group will not receive any injection after D2 dissection.
Seroma formation in the two groups is examined and compared within 24 hours after dissection and until patients are discharged.The method of measuring seroma formation will be measuring the discharge of the drain inserted during surgery in all patients.
Main outcome variables
Seroma formation
General information
Reason for update
Acronym
TFD2
IRCT registration information
IRCT registration number:IRCT20200710048071N1
Registration date:2020-08-16, 1399/05/26
Registration timing:registered_while_recruiting
Last update:2020-08-16, 1399/05/26
Update count:0
Registration date
2020-08-16, 1399/05/26
Registrant information
Name
Ehsanollah Rahimi movaghar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2265 9074
Email address
ehsanrm81@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-30, 1399/04/10
Expected recruitment end date
2021-02-28, 1399/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of fibrine glue on seroma formation after lymph nodes D2 dissection in gastric cancer surgery
Public title
Efficacy of fibrine glue on seroma formation after lymph nodes D2 dissection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with gastric cancer are candidates for gastrectomy,hospitalized in 1399
Exclusion criteria:
Patients with a history of surgery, patients with dissatisfaction with the study, patients with any local allergy to fibrin glue, patients in the metastatic stage of cancer
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is generated using random block generation. The block size includes 4 and 2 block. 15 blocks with size of 4 and 10 blocks with size of 2 will be generated using a computer program. The blocks will be allocated using random numbers and the allocation was concealed from the patients.
Blinding (investigator's opinion)
Single blinded
Blinding description
The study will be one-sided blind so that patients will be completely unaware of the randomization protocol and allocation
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committe Imam Khomeini hospital complex-Tehran university of medical sciences
Street address
No.62 Rahimi st,Valiasr blvd,Tehran
City
Tehran
Province
Tehran
Postal code
1586899567
Approval date
2020-06-30, 1399/04/10
Ethics committee reference number
IR.TUMS.IKHC.REC.1399.106
Health conditions studied
1
Description of health condition studied
Gastric cancer
ICD-10 code
C16
ICD-10 code description
Malignant neoplasm of stomach
Primary outcomes
1
Description
Seroma formation
Timepoint
Measurement of drainage (seroma) on a daily basis until discharge of patients
Method of measurement
Drain rate (ml / 24 hours)
Secondary outcomes
1
Description
Number of days hospitalized
Timepoint
Duration of hospitalization
Method of measurement
Days of hospitalization
Intervention groups
1
Description
Intervention group:In this group, after D2 lymphatic dissection, 0.5 ml of fibrine glue (IFABOND, Peters Surgical,Bobigny,France) is injected into the dissected area, and seroma formation is measured within 24-hours after dissection until the patient's discharge. Measurement method is based on the amount of discharge in the surgical drain of the patient placed during the surgery.
Category
Treatment - Drugs
2
Description
Control group: In this group, after D2 lymphatic dissection, not the fibrin glue nor any tissue adhesive is injected into the dissected area. similar to the intervention group the examiner measured the amount of discharge in the surgical drain.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini hospital/Tehran university of medical sciences
Full name of responsible person
Habibollah Mahmoodzadeh
Street address
No.62 Rahimi st.Valiasr Ave,Tehran
City
Tehran
Province
Tehran
Postal code
1586899567
Phone
+98 21 2265 9074
Email
ehsanrm81@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Sahraeian
Street address
Ghods Street, Keshavrz Blvrd,
City
Tehran
Province
Tehran
Postal code
3439123900
Phone
+98 21 8163 3698
Email
vcr@tums.ac.ir
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
Ehsanollah Rahimi Movaghar
Position
Fellowship Assistant of cancer surgery
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
No62.Rahimi St.Valiasr Ave.Tehran
City
Tehran
Province
Tehran
Postal code
1586899567
Phone
+98 21 2265 9074
Email
ehsanrm81@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ehsanollah Rahimi Movaghar
Position
Fellowship assistant of cancer surgery
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
No62.Rahimi St.Valiasr Ave.Tehran
City
Tehran
Province
Tehran
Postal code
1586899567
Phone
+98 21 2265 9074
Email
ehsanrm81@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ehsanollah Rahimi Movaghar
Position
Fellowship assistant of cancer surgery
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
No62.Rahimi St.Valiasr Ave.Tehran
City
Tehran
Province
Tehran
Postal code
1586899567
Phone
+98 21 2265 9074
Email
ehsanrm81@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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
All research data except the patient profile can be published
When the data will become available and for how long
6 months after printing the results
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
To continue research on this topic
From where data/document is obtainable
To the main and scientific person in charge of research
What processes are involved for a request to access data/document
The email sent will be checked and the requested content will be answered if it is correct