Investigating the effect of high dose ascorbic acid on preventing anastomotic leakage after colon anastomosis surgery: a randomized clinical trial study
Determining the effect of high-dose ascorbic acid on anastomotic leakage after colon anastomosis surgery
Design
A clinical trial with a control group, with parallel groups, double-blind, on 88 patients, Randomized by the method of Balanced Block Randomization
Settings and conduct
This study is a double-blind randomized clinical trial, which is conducted in patients referred to independent educational-therapeutic centers of Qazvin province in 1402 who are candidates for colon anastomosis surgery according to the surgeon's order. 12 hours after the surgery for five days a single dose of vitamin C (1000mg) will be injected daily to a group and a placebo (distilled water) with the same volume will be injected to the control group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Candidates for colon anastomosis surgery; Age range 18-80 years
Non-inclusion criteria: Patients with diabetes; Ischemic heart disease; Malnutrition (low nutritional standards including albumin<3.4 g/dl); Obese patients; Use of steroidal and non-steroidal anti-inflammatories; Immune system deficiency diseases; History of previous abdominal surgery; Emergency surgery; Patients undergoing chemotherapy; Taking any type of vitamin for at least the last three months; Allergy to vitamin C.
Intervention groups
The intervention group of 10 mg vitamin C is injected in a single dose (1000 mg) daily، The control group is injected with the same amount of distilled water.
Main outcome variables
Active secretions from the drain site, Recovery time
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230828059288N1
Registration date:2023-08-30, 1402/06/08
Registration timing:prospective
Last update:2023-08-30, 1402/06/08
Update count:0
Registration date
2023-08-30, 1402/06/08
Registrant information
Name
Farid Zare Ganjaroodi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3379 0620
Email address
faridz1991@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-11, 1402/06/20
Expected recruitment end date
2024-09-10, 1403/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of high dose ascorbic acid on preventing anastomotic leakage after colon anastomosis surgery: a randomized clinical trial study
Public title
Investigating the effect of high dose vitamin C on preventing anastomotic leakage after colon anastomosis surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Colon anastomosis surgery candidate
Age range 18-80
Exclusion criteria:
Having diabetes
Heart ischemic disease
Malnutrition (low nutritional standards, including albumin < 3.4 g/dl)
Obese patients
Steroidal and non-steroidal anti-inflammatories consumption
Pregnancy
Patients undergoing chemotherapy
History of previous abdominal surgery
Immune system diseases
Vitamin C allergy
Taking any type of vitamin supplement at least 3 years ago
Age
From 18 years old to 80 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
The method of random allocation in this study is Balanced Block Randomization. 6 blocks AABB- ABAB_ ABBA- BBAA- BABA_ BAAB are numbered based on 1 to 6 and numbers 1 to 6 are selected from the table of random numbers and placed together. Then they are replaced with numbered blocks
Blinding (investigator's opinion)
Double blinded
Blinding description
The surgical resident receives the drugs which are coded in closed envelopes and injects them into the patients. Coding is done by one of the colleagues of the project and the doctor, surgical resident, and patient are blinded
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Qazvin University of Medical Sciences
Street address
Research and Technology deputy, 1st Branch, Maudet Alley, Shahid Beheshti Blvd, Qazvin
City
Qazvin
Province
Qazvin
Postal code
3415613911
Approval date
2023-08-12, 1402/05/21
Ethics committee reference number
IR.QUMS.REC.1402.111
Health conditions studied
1
Description of health condition studied
Anastomotic leakage
ICD-10 code
K91.8
ICD-10 code description
Other intraoperative and postprocedural complications and disorders of digestive system
Primary outcomes
1
Description
Active secretions from the drain site
Timepoint
From the time of the end of the surgery to ten days after that
Method of measurement
Clinical examination by a doctor
2
Description
Leukocytosis (More than 11,000 white blood cells in one microliter of blood
Timepoint
From the time of the end of the surgery to ten days after that
Method of measurement
CBC test
3
Description
Fistula (an abnormal passageway between adjacent organs or tissues or leading to the outside of the body)
Timepoint
From the time of the end of the surgery to ten days after that
Method of measurement
Clinical examination by a doctor
4
Description
Malaise (disordered, weak and lethargic appearance, reduced alertness and lack of mastery and awareness of the surrounding environment and restlessness)
Timepoint
From the time of the end of the surgery to ten days after that
Method of measurement
Clinical examination by a doctor
5
Description
Fever (body temperature 38 degrees Celsius or higher)
Timepoint
From the time of the end of the surgery to ten days after that
Method of measurement
thermometer
6
Description
Recovery time (the number of days the patient is eligible to be discharged from the hospital)
Timepoint
From the time of the end of the surgery to ten days after that
Method of measurement
Clinical examination by a doctor
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Injection of 10 mg of ascorbic acid with a concentration of 1000 as a single dose and daily starting 12 hours after colorectal anastomosis surgery for five days; product in the form of two ampoules of vitamin C with a concentration of 500 mg and a volume of 5 ml It is prepared from Osweh Pharmaceutical Company
Category
Prevention
2
Description
Control group: Injection of 10 mg of distilled water
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Velayat hospital
Full name of responsible person
Farid Zare Ganjarody
Street address
22 Bahman Blvd, Tavon Square, Elahiye Quay, Minodar Town
City
Qazvin
Province
Qazvin
Postal code
3471976161
Phone
+98 28 3379 0620
Email
Clinical_research@qums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Seyed Mahidi Mirhashemi
Street address
Mavaddat Alley ,Research and Technology deputy, Shahid Beheshti Blvd, Qazvin
City
Qazvin
Province
Qazvin
Postal code
34199-15315
Phone
+98 28 3333 6001
Email
researchdpt@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Farid Zare Ganjaroodi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
22 Bahman Blvd, Tavon Square, Elahiye Quay, Minodar Town
City
Qazvin
Province
Qazvin
Postal code
3471976161
Phone
+98 28 3379 0620
Fax
Email
Faridz1991@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Farid Zare Ganjaroodi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
22 Bahman Blvd, Tavon Square, Elahiye Quay, Minodar Town
City
Qazvin
Province
Qazvin
Postal code
3471976161
Phone
+98 28 3379 0620
Fax
Email
Faridz1991@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Farid Zare Ganjaroodi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
22 Bahman Blvd, Tavon Square, Elahiye Quay, Minodar Town
City
Qazvin
Province
Qazvin
Postal code
347196161
Phone
+98 28 3379 0620
Fax
Email
Faridz1991@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