1. Home
  2. Approved trials
  3. » فارسی

Comparison of two bowel preparation regimens for colonoscopy: high-dose polyethylene glycol versus low-dose polyethylene glycol combined with senna

Protocol summary

Study aim
Comparison between two bowel preparation regimens for colonoscopy: high-dose polyethylene glycol (PEG) and low-dose polyethylene glycol combined with senna
Design
A Controlled clinical trial with parallel groups, single-blind, randomized with permuted blocks on 362 patients.
Settings and conduct
Patients referred to the Taleghani Hospital Gastroenterology Clinic, who have inclusion criteria and no exclusion criteria will be placed in one of two control or intervention groups and will undergo colonoscopy by two endoscopists unaware of the patient's diet.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: More than 18 year-olds, written consent, Indications for colorectal cancer screening, positive fecal occult blood , iron deficiency anemia in men or postmenopausal women, Lower gastrointestinal symptoms, involuntary weight loss, Abnormal abdominal imaging. Exclusion Criteria: Hypersensitivity to PEG or senna, Taking laxatives within one week before colonoscopy, Previous colonic surgery, Known or suspected bowel obstruction, Prior history of colonoscopy.
Intervention groups
Intervention group: Half of the agents will be administrated at 4 pm the day before and the second half in the morning of the colonoscopy up to 5 hr before the procedure. 3 sachets of polyethylene glycol powder (210 g) (Sepidaj Pharmaceutical Company) with senna solution (120 ml) (Iran Darok Company) will be administrated in two divided doses. Control group: at the same time, 6 sachets of polyethylene glycol powder (420 g) will be administrated in divided doses.
Main outcome variables
Bowel preparation scale (Boston Bowel Preparation Scale), adverse effects of colon cleansers agents (nausea, vomiting, abdominal pain, bloating, headache, vertigo, sleeplessness)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20211101052935N1
Registration date: 2022-05-13, 1401/02/23
Registration timing: retrospective

Last update: 2022-05-13, 1401/02/23
Update count: 0
Registration date
2022-05-13, 1401/02/23
Registrant information
Name
Mohsen Rajabnia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2303 1799
Email address
dr.rajabnia@outlook.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-28, 1399/12/10
Expected recruitment end date
2022-03-01, 1400/12/10
Actual recruitment start date
2021-02-28, 1399/12/10
Actual recruitment end date
2021-11-01, 1400/08/10
Trial completion date
2021-11-01, 1400/08/10
Scientific title
Comparison of two bowel preparation regimens for colonoscopy: high-dose polyethylene glycol versus low-dose polyethylene glycol combined with senna
Public title
Investigating the effect of senna on preparation for colonoscopy
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
People more than 18 year-old. Giving a written consent. Indications for colorectal cancer screening, include: average-risk screening, increased-risk screening (patients with one or more first degree relative[s] with colorectal cancer [CRC] or colorectal adenomas, hereditary CRC syndromes), positive fecal occult blood test, documented iron deficiency anemia in men or postmenopausal women. Lower gastrointestinal symptoms such as unexplained chronic clinically significant diarrhea, or unexplained involuntary weight loss. Abnormal abdominal imaging such as abnormalities detected on barium enema, abdominal computed tomography and etc.
Exclusion criteria:
Hypersensitivity to polyethylene glycol or senna Taking laxatives within one week prior to colonoscopy Previous colonic resection surgery Known or suspected bowel obstruction Prior history of colonoscopy
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 362
Actual sample size reached: 402
Randomization (investigator's opinion)
Randomized
Randomization description
Based on sample size of study, 100 blocks with a size of 4 (such as AABB, ABAB, etc.) in a randomly varied order, will be used for random allocation. Random blocks will be provided by GraphPad software. The blocks will be placed one after the other in sequence, from the first to the 100th of them (equivalent to the first to the 400th patient). For example, if the blocks that will be provided by the software are AABB, BBAA, ABAB, respectively, the order of patients’ bowel preparation regimens will be AABBABABBBAA. The order of the blocks (100 provided blocks, it means arranging 400 bowel preparation regimens for 400 patients) will be reposed to the clinic secretary. Patients who will be candidates for colonoscopy, do not meet the exclusion criteria, and declare their informed consent to enter the study, will receive a preparation regimen based on the provided blocks A or B, respectively.
Blinding (investigator's opinion)
Single blinded
Blinding description
The endoscopist does not know which class of medications had been used by the patient for preparation. Therefore, he/she reports the patient's preparation in the colonoscopy report, regardless of the preparation regimen.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Gastroenterology and Liver Diseases Research Institute, Shahid Beheshti University of Medical Scienc
Street address
Gastroenterology and Liver Diseases Research Institute, No 1, Ayatollah Taleghani Hospital, Shahid Arabi Ave., Yaman St., Shahid Chamran Highway, Tehran.
City
Tehran
Province
Tehran
Postal code
1985711151
Approval date
2021-02-24, 1399/12/06
Ethics committee reference number
IR.SBMU.RIGLD.REC.1399.064

Health conditions studied

1

Description of health condition studied
colonoscopy preparation
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Quality of colon preparation
Timepoint
During colonoscopy (within first 24 hours after use regimens)
Method of measurement
Endoscopist report based on BBPS (Boston Bowel Preparation Scale)

Secondary outcomes

1

Description
Adverse effects of preparation regimens
Timepoint
While taking the drug until colonoscopy
Method of measurement
patients report

Intervention groups

1

Description
Control group: In this study, all patients will undergo colonoscopy in the afternoon and we will use a split-dose preparation, i.e., administering half of the colon cleansing agent in the evening (4 pm) before colonoscopy and the remaining in the morning (Five hours before the procedure). Patients in the control group will receive 6 sachets of polyethylene glycol powder (420 g) (Sepidaj Pharmaceutical Company), at 4 pm on the prior day of colonoscopy to 5 hours before the procedure.
Category
Other

2

Description
Intervention group: In this study, all patients will undergo colonoscopy in the afternoon and we will use a split-dose preparation, i.e., administering half of the colon cleansing agent in the evening (4 pm) before colonoscopy and the remaining in the morning (Five hours before the procedure). Patients in the intervention group will receive 3 sachets of polyethylene glycol powder (210 g) (Sepidaj Pharmaceutical Company), along with senna solution (120 ml) (Iran Darok Company) in two divided doses of 60 ml. The first dose will be given at 4 pm on the prior day of the colonoscopy and the second dose on the morning of the procedure (five hours before the procedure).
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Taleghani hospital-Tehran
Full name of responsible person
Mohsen Rajabnia
Street address
Gastroenterology and Liver Diseases Research Institute, No 1, Ayatollah Taleghani Hospital, Shahid Arabi Ave., Yaman St., Shahid Chamran Highway, Tehran.
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2243 2560
Email
dr.rajabnia@outlook.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammadreza Zali
Street address
Gastroenterology and Liver Diseases Research Institute, No 1, Ayatollah Taleghani Hospital, Shahid Arabi Ave., Yaman St., Shahid Chamran Highway, Tehran.
City
تهران
Province
Tehran
Postal code
1985711151
Phone
+98 21 2243 2560
Email
nnzali@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
50
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

2

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Vice-chancellor in research affairs, No 1, Shahid Beheshti university of medical sciences, Shahid Arabi Ave., Yaman St., Shahid Chamran Highway, Tehran.
City
Tehran
Province
Tehran
Postal code
19839-63113
Phone
+98 21 2243 9770
Email
zarghi@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
50
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohsen Rajabnia
Position
Adult gastroenterology and hepatology subspecialist assistant
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Gastroenterology and Liver Diseases Research Institute, No 1, Ayatollah Taleghani Hospital, Shahid Arabi Ave., Yaman St., Shahid Chamran Highway, Tehran.
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2243 2560
Email
dr.rajabnia@outlook.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Amir Sadeghi
Position
associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Gastroenterology and Liver Diseases Research Institute, No 1, Ayatollah Taleghani Hospital, Shahid Arabi Ave., Yaman St., Shahid Chamran Highway, Tehran.
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2243 2560
Email
amirsadeghimd@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohsen Rajabnia
Position
Gastroenterology and hepatology subspecialist assistant
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Gastroenterology and Liver Diseases Research Institute, No 1, Ayatollah Taleghani Hospital, Shahid Arabi Ave., Yaman St., Shahid Chamran Highway, Tehran.
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2243 2560
Email
dr.rajabnia@outlook.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No further information available.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Loading...