Screening for Colorectal Cancer in Average and High Risk Population

EARLY_PHASE1CompletedINTERVENTIONAL
Enrollment

537

Participants

Timeline

Start Date

April 1, 2015

Primary Completion Date

May 30, 2017

Study Completion Date

October 30, 2017

Conditions
Colorectal NeoplasmsColorectal CancerAdenomatous Polyp of Colon
Interventions
DIAGNOSTIC_TEST

FIT

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

PROCEDURE

Precolonoscopy cleansing regimen

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.

PROCEDURE

Conventional Colonoscopy

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.

DIAGNOSTIC_TEST

Histopathological examinations of screen-detected lesions

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.

DRUG

Tribenoside 400 mg + lidocaine 40 mg suppositories

Treatment of hemorrhoids was initiated with tribenoside 400 mg + lidocaine 40 mg suppositories, once daily for up to 2 weeks.

DRUG

Diltiazem hydrochloride 2%/Nitroglycerin rectal ointment

Treatment of anal fissure was initiated with Diltiazem hydrochloride 2%/Nitroglycerin rectal ointment applied every 12 hours, for up to six weeks.

Trial Locations (1)

10045

Lewai S Abdulaziz, Baghdad

All Listed Sponsors
collaborator

Research & Development Directorate, Ministry of Higher Education, Iraq

UNKNOWN

collaborator

Al-Kindy College of Medicine

OTHER

lead

Lewai Sharki Abdulaziz, MSc PhD

OTHER

NCT04017845 - Screening for Colorectal Cancer in Average and High Risk Population | Biotech Hunter | Biotech Hunter