Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202112603690065 Date of Approval: 24/12/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Impact of a low-residue diet on bowel cleansing quality before colonoscopy: a prospective single blinded randomized controlled trial.
Official scientific title Impact of a low-residue diet on bowel cleansing quality before colonoscopy: a prospective single blinded randomized controlled trial.
Brief summary describing the background and objectives of the trial Low residue diet (LRD) has a similar quality of bowel preparation with clear liquid diet before colonoscopy, the optimal LRD duration is still controversial. In this study, we have compared the effect of different LRD regimens in a Mediterranean diet population on the quality of bowel preparation and patient tolerance.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Digestive System
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 15/12/2021
Actual trial start date
Anticipated date of last follow up 15/03/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 400
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group LRD Days before colonoscopy Without LRD 100 Placebo
Experimental Group LRD 1 Day 1 day LRD prior colonoscopy 100
Experimental Group LRD 3 days before colonoscopy 3 days prior colonoscopy 100
Experimental Group LRD 5 days 5 days prior colonoscopy 100
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All patients aged between 18 and 75 years who underwent colonoscopy were enrolled, including patients receiving colorectal cancer screening or patients with non-specific gastrointestinal symptoms. (1) Patients who were not cooperative during the examination; (2) patients who had digestive tract surgery; (3) patients with severe heart, brain, kidney, liver and other diseases and who could not tolerate colonoscopy; (4) patients with contraindications for colonoscopy, including digestive tract obstruction or perforation, severe intestinal infection or toxic megacolon, impaired consciousness and unstable vital signs; (5) failure to reach the caecum due to non-bowel-preparation issues (e.g., malignant lumen narrowing); (6) pregnant and lactating women; (7) stroke or dementia patients; (8) patients suffering from anxiety or depression; and (9) patients allergic to polyethylene glycol (PEG). Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 75 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 12/04/2021 Ethics Committee of the faculty of Medicine of Algiers
Ethics Committee Address
Street address City Postal code Country
BENAKNOUN Algiers 16000 Algeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome polyp/adenoma detection rate adherence to and level of satisfaction with the LRD, difficulty following the dietary recommendations, and willingness to repeat the same LRD in the future after colonoscopy
Primary Outcome bowel cleansing quality as evaluated using the Boston Bowel Preparation Scale (BBPS) after colonoscopy
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mohamed Seghir Nekkach KOUBA ALGIERS 16000 Algeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Hospital KOUBA ALGIERS 16000 Algeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mohamed seghir nekache hospital Kouba Algiers 16000 Algeria Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator KHELLAF AMALOU amalou_kh@yahoo.fr 00213661615850 Kouba
City Postal code Country Position/Affiliation
Algiers 16000 Algeria Professor in Gastroenterology
Role Name Email Phone Street address
Public Enquiries Khellaf AMALOU amalou_kh@yahoo.fr 00213661615850 Kouba
City Postal code Country Position/Affiliation
Algiers 16000 Algeria Professor in Gastroenterology
Role Name Email Phone Street address
Scientific Enquiries Khellaf AMALOU amalou_kh@yahoo.fr 00213661615850 Kouba
City Postal code Country Position/Affiliation
Algiers 16000 Algeria Professor in Gastroenterology
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All individual participant data collected during the trial, after deidentification including data that underlie the results (text, tables, figures, and appendices) will be reported in this study. Informed Consent Form Beginning 2 months and ending 5 years following article publication Proposals should be directed to amalou_kh@yahoo.fr. Researchers who provide a methodologically sound proposal may request access. The data can be used to achieve aims in the approved proposal.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Link To Protocol No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information