Evaluation of the effect of synbiotic on complications after gastrointestinal surgery - randomized clinical trial

Evaluation of the effect of synbiotics on complications after gastrointestinal surgery

All patients referred to the surgical ward of Shahid Mohammadi Hospital in Bandar Abbas who need gastrointestinal surgery are divided into two intervention groups (receiving synbiotics) and the control group (receiving placebo) using a random number table. Complications of surgery in them will be examined until the day of discharge.

Patients undergoing gastrointestinal surgery will be divided into two groups, the case and the control. All patients will receive medication or placebo for another week 7 days before surgery and as soon as oral feeding begins. The drug will be prescribed 2 times a day after meals (until oral and intravenous antibiotics are taken at least 2 hours apart). The placebo group will also receive the placebo as instructed above.

Inclusion criteria: patient satisfaction, need for elective gastrointestinal surgery for any reason; Existence of proper nutritional status for surgery. Exclusion criteria: Patient dissatisfaction to enter the study, patient with underlying diseases such as diabetes, coagulation disorders, congenital or acquired immunodeficiency, liver cirrhosis, renal failure, acute pancreatitis

The intervention group is patients receiving the synbiotic drugs and the control group is patients receiving placebo.

postoperative ileus, number of days after hospitalization, time to start oral feeding, postoperative infection / abdominal abscess/ulcer infection, postoperative pneumonia Surgery, Anastomotic leak, Heart failure / Kidney failure / Liver dysfunction, Nausea and vomiting, pain and indigestion, Fever, Mortality 30 days after surgery, SIRS

Before assigning groups to individuals eligible to participate in the study, informed consent is completed for grouping individuals. the person who has no role in admitting patients and assigning patients to random codes preparing random sequences using online tools (https://www.sealedenvelope.com/) and by permuted block randomization method. Individualized random allocation is done in blocks with sizes 2 and 4, and without stratification. eligibility criteria are monitored by the person responsible for admitting patients. Codes in a random sequence are assigned to patients by the treatment team without knowing that each code is in the intervention or placebo group. Patient codes are then matched to randomly generated sequence information for interventions. (randomization concealment is done by the treatment team without informing the person responsible for admitting patients and the person who prepared the random sequence.)

In this study, all participants are aware of participating in this study and enter the study with their consent. All participants are unaware of which group of this study they are in and after grouping patients in the groups, Patients receive synbiotic in the treatment group and receive a placebo in the control group. The lead researcher, health care personnel, data collection officials are aware of the grouping of patients. Those who prepare the draft of the article are unaware of the groupings if they do not cooperate in the above cases. The outcome assessor physician will be unaware of the patient's allocation.