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Evaluation of the effect of probiotics in preventing low anterior resection syndrome

Not Applicable
Conditions
Patients with rectal cancer whose adenocarcinoma is pathologically proven and indicated for anterior resection..
Malignant neoplasm of colon, unspecified
C18.9
Registration Number
IRCT20210704051784N1
Lead Sponsor
Tehran University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
180
Inclusion Criteria

Age 18 to 57 years
Indicated removal of the anterior part of the lower rectum
Confirmed adenocarcinoma
Ability to fill out a questionnaire
Patients with Rectal cancers whom undergone radiotherapy

Exclusion Criteria

Use antibiotics or probiotics a week before
Systemic evidence of obstruction in preoperative endoscopy
Urinary and fecal incontinence
Metastatic cancer
Advanced cardiovascular and cerebral disease
Pregnant and lactating mothers
Irritable Bowel Syndrome
History of chemotherapy or radiotherapy
Symptoms of infection or immunodeficiency disease
Abnormal creatinine
Abnormal liver enzymes
Uncontrolled hypertension or diabetes
Patients with celiac disease or probiotic intolerance

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
evel of Quality of Life. Timepoint: The questionnaire will be completed by the patients of both groups once before starting the drug treatment and after that by the patient every week. Method of measurement: The Gastrointestinal Quality of Life Questionnaire consists of 36 different items that include general and specific symptoms, physical and mental functioning, and social dysfunction related to gastrointestinal diseases. Each item has a score from 0 to 4. The score of this questionnaire is from 0 to 144, of which 0 is the worst possible case and 144 is the best possible case. The Anterior Resect Syndrome Questionnaire examines 5 important questions, including 1. Incontinence for stool 2. Incontinence for liquid stool 3. Frequency 4. Clustering 5. Urgency. The score of this questionnaire is from 0 to 42, according to which if the patient scores 0 to 20, he does not have anterior resection syndrome. A score of 21 to 29 indicates a mild form of the syndrome, and a score of 30 to 42 indicates a severe form.
Secondary Outcome Measures
NameTimeMethod
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