Clinical trial NCT04017845: Screening for Colorectal Cancer in Average and High Risk Population
Official title: Screening for Colorectal Cancer in Average and High Risk Iraqi Population: A Pilot Study
Conditions: Colorectal Neoplasms
Colorectal Cancer
Adenomatous Polyp of Colon
Summary: The existing evidence from epidemiological studies and randomized controlled trials has consistently assures the cost effectiveness and the influential role of screening in reducing incidence rates and deaths caused by Colorectal Cancer (CRC). Population based organized screening programmes, which should be considered an obligation that is not to be postponed, require valuable information that can be reliably extrapolated from well-designed pilot study conducted prior to programme implementation.
The main objectives of the current pilot CRC screening project, named after "Al-Kindy College of Medicine", was to evaluate and explore the specific aspects of the intended population-based organized CRC screening programme, including: barriers affecting adherence to the programme, performance indicators of the proposed screening programme, the target population in which CRC screening is a legitimate healthcare priority, quality assurance of screening tests and colonoscopy services, and to propose an algorithm that will provide a clinically and logistically acceptable positivity rate.
Interventions:
description: Screenees were supplied with two fecal collection devices and asked to collect two specimens from two consecutive Different Bowel Movement Samples (DBMS) or, in case of infrequent bowel movements, from the Same Bowel Movement Sample (SBMS).Instruction stressed that after collection the device must be stored in refrigerator and transported in an iced pack within no more than 48h from sampling. After checking for sampling appropriateness, the received samples were analyzed by the FOB Gold/SENTiFOB method (Sentinel Diagnostics SpA, Milan, Italy), according to the previously validated procedural platform
name: FIT
other_name: FOB Gold/SENTiFOB (Sentinel Diagnostics SpA, Milan, Italy)
Fecal Immunochemical Test (FIT)
Fecal occult blood tests (FOBT)
type: Diagnostic Test
description: Laxative stimulant two days prior to the cleansing regimen involves the intake of one 10 mg tablet of bisacodyl (Dulcolax, Sanofi,UK) at 18:00 for two consecutive nights.The evening before colonoscopy cleansing started with 2 doses (at 16:00 and 20:00) of one sachet Sodium picosulphate preparations (PICOPREP, Ferring Pharmaceutical Co., Ltd., Zhongshan, China), dissolved in150 mL of cold water, followed with five 240 mL portions of clear liquids within 3 h. The third dose is taken in the morning about 5 h prior to colonoscopy, followed with at least three 240 mL portions of clear liquids no later than 2 h before colonoscopy.
name: Precolonoscopy cleansing regimen
other_name: PICOPREP- Adjuvant Bisacodyl Regimen
type: Procedure
description: With the colonoscopists completely blinded regarding the FIT results, conventional colonoscopy examinations were conducted in the Endoscopy Unit of Al-Kindy Polyclinic. According to the five levels of competency proposed by the European guidelines, this unit is assigned as level 2, with the possibility of removing polypoid and sessile lesions <25 mm, providing there is good access. For flat lesions, larger sessile and polypoid lesions, and smaller lesions with more difficult access, the lesions were documented appropriately with the patients referred to higher competent units in order to be safely and expertly removed.
name: Conventional Colonoscopy
other_name: Optical Colonoscopy
type: Procedure
description: Adenomas were classified according to the modified revised Vienna classification for the European Guidelines. Advanced adenoma was defined as the presence of one of the following features: >10 mm diameter, tubulovillous or villous structure, and high-grade neoplasia. Polypoid adenocarcinomas were reported according to the TNM classification, while colorectal cancer associated with flat and/or depressed lesions were reported as non-polypoid lesions, and further classified by the Paris classification. Pathologic results of hyperplastic polyps, sessile serrated lesions or post inflammatory polyps were considered normal findings.
name: Histopathological examinations of screen-detected lesions
other_name: Histological examinations of Lesion Biopsies and Resections
type: Diagnostic Test
description: Treatment of hemorrhoids was initiated with tribenoside 400 mg + lidocaine 40 mg suppositories, once daily for up to 2 weeks.
name: Tribenoside 400 mg + lidocaine 40 mg suppositories
other_name: PROCTO-GLYVENOL
type: Drug
description: Treatment of anal fissure was initiated with Diltiazem hydrochloride 2%/Nitroglycerin rectal ointment applied every 12 hours, for up to six weeks.
name: Diltiazem hydrochloride 2%/Nitroglycerin rectal ointment
other_name: Topical calcium channel blockers/nitrates
type: Drug
Study arms:
design_group_description: Precolonoscopy cleansing regimen and referral to conventional colonoscopy is based on Positive FIT (level ≥75ng/ml) in any of the two collected samples. Histopathological examinations of screen-detected lesions are reported and lesion with the worst prognosis is indicated as the final colonoscopic outcome used for evaluation purposes. Screenees with intermediate and high risk polyp were referred to a follow-up surveillance programme.Treatments were initiated with Diltiazem hydrochloride 2%/Nitroglycerin rectal ointment for anal fissure, and tribenoside 400 mg + lidocaine 40 mg suppositories for hemorrhoids. Positive FIT results in participants who were identified with no adenomas, advance adenomas, or adenocarcinomas are considered False-positive FIT (FP-FIT) results.
design_group_title: Household-Open Invitation (HOI)
design_group_type: Active Comparator
design_group_description: Precolonoscopy cleansing regimen and referral to conventional colonoscopy is based on Positive FIT (level ≥75ng/ml) in any of the two collected samples. Histopathological examinations of screen-detected lesions are reported and lesion with the worst prognosis is indicated as the final colonoscopic outcome used for evaluation purposes. Screenees with intermediate and high risk polyp were referred to a follow-up surveillance programme.Treatments were initiated with Diltiazem hydrochloride 2%/Nitroglycerin rectal ointment for anal fissure, and tribenoside 400 mg + lidocaine 40 mg suppositories for hemorrhoids. Positive FIT results in participants who were identified with no adenomas, advance adenomas, or adenocarcinomas are considered False-positive FIT (FP-FIT) results.
design_group_title: Recommendation By Physician (RBP)
design_group_type: Active Comparator
Sponsor: Al-Kindy College of Medicine
Collaborators: Al-Kindy College of Medicine
Drug name mappings:
name: 利多卡因/三苄糖苷
lang: CN
name: Lidocaine/Tribenoside
lang: EN
name: トリベノシド/リドカイン
lang: JP
name: 盐酸地尔硫卓
lang: CN
name: Ditiazem Hydrochloride
lang: EN
name: ジルチアゼム塩酸塩
lang: JP
name: 三硝酸酯
lang: CN
name: Trinitrate
lang: EN
name: ニトログリセリン
lang: JP