Detection Of Colonic Polyps In India: Diagnostic Colonoscopy

NCT04512729 | Unknown DMC

• 1 other identifier: DoCPI
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 1

Brief Summary

Colorectal carcinoma (CRC) is the third most common cancer in male and female worldwide. In India, it is the fourth most common cause of cancer in males and third most common cancer in female. Age, smoking, colonic adenomatous polyp, family history are traditional risk factor for CRC. The vast majority of CRC results from malignant transformation from adenoma, which is called as adenoma carcinoma sequence. These adenomatous polyps grows slowly over many years and malignant transformation eventually occurs over 10 years. So, the early detection and removal of polyp at early stage should benefit in preventing CRC.

Conditions

Colonic Polyp; Colonic Adenoma; Colonic Neoplasms

Outcome Measures

Primary Outcomes (1)

• Colonic Adenoma

  To evaluate prevalence of colonic polyps and adenomas in Indian Population

  1 year

Secondary Outcomes (1)

• Risk factors for Colonic adenoma

  1 year

Interventions

Colonoscopy DIAGNOSTIC_TEST

For all patients, either moderate sedation with intravenous midazolam or conscious sedation with intravenous propofol will be administered in a standard fashion prior to undergoing colonoscopy. The colonoscope will be inserted and cecum will be intubated. Photo documentation of the cecum will be performed. The colonic mucosa will be carefully visualized upon withdrawal of the colonoscope. The time spent in inspecting the mucosa during withdrawal of the colonoscope will be documented as the "withdrawal time". Meticulous technique will be employed during the withdrawal phase with special efforts to visualize portions of colonic mucosa on the proximal aspects of haustral folds, flexures and valves.All polyps detected will be documented: size, location, and morphology. Photo documentation of the polyps will be performed.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All subjects referred for the diagnostic colonoscopy will be enrolled. A member of the research team will approach each subject to discuss participation in the study, including background of the proposed study, inclusion and exclusion criteria, benefits and risks of the procedures and follow-up. If this is of interest to the subject, the informed consent form is discussed and presented. The subject must sign the consent form prior to enrollment. This form will have prior approval of the study site's Institutional Review Board (IRB). Failure to obtain informed consent renders the subject ineligible for the study

You may qualify if:

• Referral for diagnostic colonoscopy
• Ability to provide informed consent

You may not qualify if:

• Inability or not willing to give informed consent

Sponsors & Collaborators

• Asian Institute of Gastroenterology, India: lead

Study Sites (1)

D Nageshwar Reddy

Hyderabad, Telangana, 500082, India

RECRUITING

Related Publications (1)

• Jagtap N, Kalapala R, Rughwani H, Singh AP, Inavolu P, Ramchandani M, Lakhtakia S, Manohar Reddy P, Sekaran A, Tandan M, Nabi Z, Basha J, Gupta R, Memon SF, Venkat Rao G, Sharma P, Nageshwar Reddy D. Application of machine-learning model to optimize colonic adenoma detection in India. Indian J Gastroenterol. 2024 Oct;43(5):995-1001. doi: 10.1007/s12664-024-01530-4. Epub 2024 May 17.

  PMID: 38758433 DERIVED

MeSH Terms

Conditions

Colonic Polyps; Colonic Neoplasms

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Central Study Contacts

D Nageshwar Reddy, MD,DM

CONTACT

914023378888; aigindia@yahoo.co.in

Nitin Jagtap, MD, DNB

CONTACT

914023378888; docnits13@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 12, 2020
• First Posted: August 13, 2020
• Study Start: August 4, 2020
• Primary Completion: November 30, 2020
• Study Completion: December 30, 2020
• Last Updated: October 30, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)