Investigating the effect of hemoclips on the amount of delayed bleeding after polypectomy in patients with large lesions of the upper and lower gastrointestinal tract.
Design
Clinical trial with control group, with parallel groups, single-blind, randomized, phase 3 on 58 patients. Randomized permutation block was used for randomization.
Settings and conduct
The principal investigator will not be blinded to the groups. The main researcher randomly places the patients in one of the groups of embedding or not embedding clips. In order to blind the patients in this study, the laboratory technicians, the therapist who will be in charge of completing the questionnaire, and the researcher responsible for evaluating the results and the statistical analyst will be blinded to the treatment group of the patients and from the intervention and control groups. They will not know.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
People over 15 years of age
non-baseline lesions larger than 2 cm diagnosed
Exclusion criteria:
Patients with a history of anticoagulant use who are unable to stop it
patients with coagulation disorders
Intervention groups
intervention group:
People over 15 years of age with baseless lesions larger than 2 cm that are placed under clips.
Comparison group:
People over 15 years of age with baseless lesions larger than 2 cm that are
NOT placed under clips.
Main outcome variables
Bleeding within 30 days of a colonoscopy.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240707062350N1
Registration date:2024-08-10, 1403/05/20
Registration timing:registered_while_recruiting
Last update:2024-08-10, 1403/05/20
Update count:0
Registration date
2024-08-10, 1403/05/20
Registrant information
Name
mostafa sfini farahani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3280 0013
Email address
m.sfinif@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-20, 1403/01/01
Expected recruitment end date
2025-02-19, 1403/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of prophylactic hemoclips on the risk of delayed post-endoscopic mucosal resection bleed for large upper and lower gastrointestinal lesions
Public title
The effect of prophylactic clipping on the risk of delayed bleeding after resection of intestinal polyp
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People over 15 years of age
with non-baseline lesions larger than 2 cm diagnosed by endoscopy or colonoscopy .
Exclusion criteria:
Patients with a history of anticoagulant use who are unable to stop it.
patients with coagulation disorders (such as hemophilia, deficiency of other coagulation factors, thrombocytopenia, etc.) .
Patients who experience rapid bleeding during endoscopy or colonoscopy.
those who experience bowel perforation due to the depth of mucosectomy or insertion of clips to close the perforated lesion.
Age
From 15 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
58
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, permutation random block method will be used for randomization. For this purpose, blocks of 6 will be used. Six cards are selected, the letter h (hemoclips) is written on three cards and the letter c (control) is written on three cards. In order to hide the cards, they are placed inside the envelope and turned over several times so that the order is not clear. When each participant enters, a card is selected for him and the selected card is discarded. Then, in the same way, randomization will be done for other groups of 6 people to reach the desired sample size.
Blinding (investigator's opinion)
Double blinded
Blinding description
The principal investigator will not be blinded to the groups. The main researcher randomly places the patients in one of the groups of embedding or not embedding clips. In order to blind the patients in this study, the laboratory technicians, the therapist who will be in charge of completing the questionnaire, and the researcher responsible for evaluating the results and the statistical analyst will be blinded to the treatment group of the patients and from the intervention and control groups. They will not know.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Arak University of Medical Sciences
Street address
Block D Unit 17th Floor Ferdowsi Building Nahzat 1 Alley Shariati Street
City
Arak
Province
Markazi
Postal code
3819668226
Approval date
2024-07-13, 1403/04/23
Ethics committee reference number
IR.ARAKMU.REC.1403.085
Health conditions studied
1
Description of health condition studied
Polyp of colon
ICD-10 code
K63.5
ICD-10 code description
Polyp of colon
2
Description of health condition studied
Polyp of stomach and duodenum
ICD-10 code
K31.7
ICD-10 code description
Polyp of stomach and duodenum
Primary outcomes
1
Description
Bleeding within 30 days of a colonoscopy
Timepoint
The beginning of the study and one months later
Method of measurement
Clinical observation and questionnaire
Secondary outcomes
1
Description
Perforation of the gastrointestinal tract during intervention
Timepoint
during endoscopy
Method of measurement
endoscopy
2
Description
Endoscopic findings (wound or polyp or malignancy)
Timepoint
during endoscopy
Method of measurement
endoscopy
3
Description
Clinical findings during diagnosis (abdominal pain, rectal bleeding)
Timepoint
During and after endoscopy
Method of measurement
Physical examination
Intervention groups
1
Description
Intervention group: Insertion of clip: Vascular clip or hemoclip is a fast and efficient tool to control bleeding and close the vessels placed in a lesion or wound. This tool is also called a surgical clip or hemolock clip. Made of polymer - to close blood vessels during endoscopy - no interference with X-Ray, CT and MRI - no accessories manufactured by Med italia & G-Flex
Category
Treatment - Devices
2
Description
Control group: Not installing clips
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Endoscopy Department of Amirul Mominin Hospital and Prof. Qavamzadeh Arak's Subspecialty Clinic
Full name of responsible person
Dr. Ali Khani Dokht
Street address
Amirul Mominin Medical Training Center, next to the Medical School, Meydan Basij, Arak
City
arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3836 2105
Fax
+98 86 3417 3619
Email
m.sfinif@yahoo.com
Web page address
http://arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Alireza Amani
Street address
Alam El Hadi St-Shahid Shiroudi St.
City
arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 6055
Fax
+98 86 3313 3147
Email
info@arakmu.ac.ir
Web page address
https://www.arakmu.ac.ir/fa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Mustafa Esfini Farahani
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Unit 1, 7th Floor, Block D ,Ferdowsi Building ,Nahzat Alley ,Shariati St.
City
arak
Province
Markazi
Postal code
3819668226
Phone
+98 86 3280 0013
Email
m.sfinif@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mustafa Esfini Farahani
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Unit 1, 7th Floor, Block D, Ferdowsi Building, Nahzat Alley, Shariati St
City
arak
Province
Markazi
Postal code
3819668226
Phone
+98 86 3280 0013
Email
m.sfinif@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mustafa Esfini Farahani
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Unit 1, 7th Floor, Block D, Ferdowsi Building, Nahzat Alley, Shariati St
City
arak
Province
Markazi
Postal code
3819668226
Phone
+98 86 3280 0013
Email
m.sfinif@yahoo.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