Effect of vitamin A injection on healing of anastomosis in patients with gastrointestinal cancer

Effect of vitamin A injection on healing of anastomosis in patients with gastrointestinal cancer

Factorial Clinical Trial Triple blind , Randomized, Sample Size: 140 (70 persons in each group), Trial Phase: 3, How to Randomize by Using Randomization Lists Set by a biostatistician .

In this randomized,Triple blind clinical trial, 140 patients with gastrointestinal cancers (gastric, colon and rectal cancers) undergoing gastrointestinal surgery and anastomosis at Dr. Rahnemoon and Shahid Sadoughi hospitals، Will be selected. Eligible patients will be randomly divided into intervention and control groups (The first group received 50000 international units of vitamin A injection , daily for 3 days after surgery and the second group received placebo). Randomization Lists, will be used to randomly assign the two groups to the intervention and control groups, according to the priority of their surgical history. The clinical symptoms of patients in both groups will be monitored by a specialist physician up to 5 days after surgery, including fever, biliary secretion, leukocytosis, peritonitis, and the need for reoperation. In this study, participants, as well as the researcher, outcome assessor, and data analyst, will be blinded .

Inclusion criteria : People with one of the types of gastrointestinal cancers, including gastric, colon and rectum that undergo gastrointestinal surgery and anastomosis. Exclusion criteria : Malnutrition ، History of Alcohol Use ، History of corticosteroids Use ، Multiple blood transfusions In operation ، Emergency surgery ، Surgery following recurrence the disease

Intervention group: Intramuscular injection of 50,000 international units of Vitamin A Control group: Intramuscular injection of 1ml injectable sterile normal saline

Anastomosis Leakage

Persons who will be admitted to the treatment centers that qualify for inclusion will be given priority by the date of surgery of these patients, using a Randomization Lists, set by the Biostatistician, Code A or B, and They will be randomly divided into intervention and control groups.

Vitamin A ampoules or injectable sterile normal saline will be administered by a qualified surgical resident in accordance with the Randomization Lists set by the biostatistician. The resident will not be a researcher, outcome assessor, or data analyst in the study. Nurse who dose not participate in the study will inject vitamin A ampoules or normal saline, so that the vitamin A ampoule or normal saline will be drawn into the syringe before presenting to the patient's bedside and will be injected intramuscularly by the said nurse . Therefore, participants, as well as the researcher, outcome assessor, and data analyst, will be blinded by the lack of knowledge of vitamin A or placebo injections.