Investigating the effect of high dose vitamin C on preventing anastomotic leakage after colon anastomosis surgery

Investigating the effect of high dose ascorbic acid on preventing anastomotic leakage after colon anastomosis surgery: a randomized clinical trial study

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20230828059288N1

Enrollment

Registered

2023-08-30

Start date

2023-09-11

Completion date

Unknown

Last updated

2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anastomotic leakage. Other intraoperative and postprocedural complications and disorders of digestive system

Interventions

Intervention 1: 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. Intervention 2: Control group: Injection of 10 mg

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Colon anastomosis surgery candidate Age range 18-80

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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.;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.;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.;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.;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.;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.	—

Measure

Time frame

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.;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.;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.;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.;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.;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.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactFarid Zare Ganjaroodi

Qazvin University of Medical Sciences

Faridz1991@gmail.com+98 28 3379 0620

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026