Evaluation of the effect of probiotics in preventing lower rectal resection syndrome in patients with rectal cancer who have undergone lower anterior rectal resection
Determining the effectiveness of probiotics in relieving the symptoms of lower rectal resection syndrome
Design
A Double-blind Randomized, placebo-controlled clinical trial will perform on 180 patients.
To randomize, we will use a sequence of random numbers using SPSS.
Settings and conduct
This study is a clinical trial that is performed in Sina Hospital on patients who have undergone low anterior surgery and have an ileostomy. Patients are randomly divided into 2 groups of 90.
Participants/Inclusion and exclusion criteria
1- Age 18-57 years 2- Proven adenocarcinoma 3- With anterior resection indication,
4- Ability to fill out a questionnaire 5- Rectal cancers who underwent radiotherapy.
Intervention groups
The target groups include patients with rectal cancer who underwent anterior rectal resection and have an ileostomy. The intervention group will be patients who receive probiotics after surgery and the control group will be patients who will receive placebo.
Main outcome variables
Incidence of complications in patients, Duration of hospitalization, The duration of the novel having an ostomy, Death, Surgical method, The interval between surgery time and ileostomy closure, Total score, Symptoms score, Emotional score, Physical function score, Social function score, Medical treatment score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210704051784N1
Registration date:2021-10-26, 1400/08/04
Registration timing:prospective
Last update:2021-10-26, 1400/08/04
Update count:0
Registration date
2021-10-26, 1400/08/04
Registrant information
Name
Nima Afsharipur
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8867 8754
Email address
nimaa770@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-21, 1400/08/30
Expected recruitment end date
2022-07-20, 1401/04/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of probiotics in preventing lower rectal resection syndrome in patients with rectal cancer who have undergone lower anterior rectal resection
Public title
Evaluation of the effect of probiotics in preventing low anterior resection syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 18 years old to 57 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
180
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients who go under low anterior surgery and have ileostomy will randomly divided into 2 groups of 90. First, the patients will be explained how to do the job and 90 patients will be given probiotic pills daily and the other group will be given a placebo as a control group. Patients will be treated for 4 weeks. Block randomization method with a block size of 4 (marked with two As and two Bs randomly) will be used to randomize patients and assign them into two groups. Each A or B will be assigned to the specific number in the random number table. Only the treatment producing team including the specialist in pharmacology and the operator will be aware of the contents of each bottle (probiotic or placebo). The nursing team will attach the label of the bottles containing the random numbers. An experienced clinician will be responsible for doing the randomization in our study who generated the random allocation sequence and enrolled participants. Also, He/she will be responsible for the assignment of the participants to the intervention group. He/she will not have any role in participants’ treatment, analyzing the data, and writing the article of this trial and she is only responsible for blinding the study.
Placebo
Used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Keshavarz Boulevard, corner of Quds
City
Tehran
Province
Tehran
Postal code
1417613151
Approval date
2021-07-03, 1400/04/12
Ethics committee reference number
IR.TUMS.SINAHOSPITAL.REC.1400.041
Health conditions studied
1
Description of health condition studied
Patients with rectal cancer whose adenocarcinoma is pathologically proven and indicated for anterior resection.
ICD-10 code
C18.9
ICD-10 code description
Malignant neoplasm of colon, unspecified
Primary outcomes
1
Description
Level 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 outcomes
empty
Intervention groups
1
Description
Intervention group: Multilateral probiotics in the form of LactoCare capsules made by Zist-Takhmir Company will be given to patients every 12 hours (after lunch and after dinner) for 4 weeks. Participants will be given the necessary training before conducting this research.
Category
Treatment - Drugs
2
Description
Control group: Patients will be given 2 gr of powder (350 mg of xylooligosaccharides and 36 mg of fructooliosacaride as prebiotics without probiotic strain twice a day for 4 weeks. This product has been also made by Zist-Takhmir company. Participants will be given the necessary training before conducting this research.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Nima Afshari
Street address
Emam Khomeini Avenue
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8500
Email
hosp_sina@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Nima Afshari pour
Street address
Emam Khomeini Avenue
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8500
Email
nimaa770@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Nima Afshari pour
Position
resident
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Emam Khomeini Avenue
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8500
Email
nimaa770@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hadi Ahmadi Amoli
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Emam Khomeni Avenue
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8500
Email
ahmadam@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Nima Afshari pour
Position
resident
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Emam Khomeini Avenue
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8500
Email
nimaa770@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