Retroflexion in the Entire Colon for the Detection of Colon-related Diseases

NCT03735953 | Unknown

• 1 other identifier: 20181030
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

Colorectal cancer is one of the common gastrointestinal malignancies, and the incidence of colorectal cancer in China increases by 3% to 4% annually . Colorectal adenoma is the most important precancerous lesion of colorectal cancer. Timely screening for colorectal adenoma and endoscopic resection is the most effective measure to prevent colorectal cancer .Removal of pre-malignant colon polyps during colonoscopy reduces colorectal cancer mortality by over 50%. However,Conventional colonoscopy endoscopy is a direct-view type, and the visual field is limited. About 10%-24% of the lesions may be missed. The ascending colon is more difficult because of the deep folds, and the rate of missed diagnosis is higher. Our goal is to determine if additional pre-cancerous colon polyps can be identified by looking at the total colon in retroflexion. During retroflexion the tip of the colonoscope is turned 180 degrees; allowing the doctor to view the backs of colonic folds. If additional polyps can be identified in this manner colonoscopy will become a more efficient method of screening for colon cancer. In order to evaluate how effective colon retroflexion is at detecting polyps in the total colon the investigators plan on performing a randomized, controlled trial. Patients undergoing screening or follow up colonoscopy will be invited to participate in the study. Those patients who agree to participate will be randomized into one of two groups once the colonoscope is fully inserted. Group one will have their colon examined for polyps with the endoscope looking forward (traditional form of examination) followed by repeat examination of the total colon with the colonoscope in retroflexion (looking backwards). In group two the colonoscopy will be completed in the usual manner. Polyps seen during each section of the exam will be recorded. The duration of each portion of colonoscopy will be recorded. After the procedure is completed the physician performing the colonoscopy will rate difficulty of the procedure and confidence with quality of the examination. Assess and record the degree of pain during and after the patient's examination.Pathology results for each polyp will be recorded once available. There will be no study related follow up after the pathology results are recorded.

Conditions

Colon Cancer Screening; Colon Polyps

Outcome Measures

Primary Outcomes (1)

• per-patient adenoma and polyp detection rate

  Patients were randomized to the exam of the proximal colon in forward or retroflexion view , and adenoma detection rates compared.

  1 day

Secondary Outcomes (3)

• Total procedure time

  1 day

• Rate of retroflexion-related adverse events.

  through study completion, an average of 1 year

• Patient's feeling

  In colonoscopy, at the end of the examination and 1 hour, 6 hours, 12 hours after the examination

Study Arms (2)

Retroflexion arm

EXPERIMENTAL

Retroflexion in the total colon and slow withdrawal to the rectum and record all visible colon polyps and other colon related diseases

Diagnostic Test: Retroflexion in the total colon

Forward view arm

NO INTERVENTION

Colonoscope is slowly withdrawn from the proximal colon to the the rectum have a forward view and record all visible colon polyps and other colon related diseases

Interventions

Retroflexion in the total colon DIAGNOSTIC_TEST

retroflexion in the cecum or proximal ascending colon and slow withdrawal to the rectum

Retroflexion arm

Eligibility Criteria

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

You may qualify if:

• Patients \>18 years of age undergoing colonoscopy for colorectal cancer screening or routine polyp surveillance

You may not qualify if:

• Failure to intubate the cecum during colonoscope insertion
• Prior right colon resection
• Known polyposis syndrome or polyposis identified at colonoscopy
• Inflammatory bowel disease
• Preparation of the colon is judged fair or poor using Boston Bowel Preparation Scale.
• Severe cardio-cerebral diseases
• Pregnant women, lactating women
• Acute lower gastrointestinal bleeding
• Preoperative use of antispasmodic sedative drugs

Sponsors & Collaborators

• Second Affiliated Hospital of Xi'an Jiaotong University: lead

Study Sites (1)

The second affiliated hospital of xi'an jiaotong university

Xi’an, Shanxi, 710004, China

Location

Related Publications (2)

• Cohen J, Grunwald D, Grossberg LB, Sawhney MS. The Effect of Right Colon Retroflexion on Adenoma Detection: A Systematic Review and Meta-analysis. J Clin Gastroenterol. 2017 Oct;51(9):818-824. doi: 10.1097/MCG.0000000000000695.

  PMID: 27683963 RESULT

• Kushnir VM, Oh YS, Hollander T, Chen CH, Sayuk GS, Davidson N, Mullady D, Murad FM, Sharabash NM, Ruettgers E, Dassopoulos T, Easler JJ, Gyawali CP, Edmundowicz SA, Early DS. Impact of retroflexion vs. second forward view examination of the right colon on adenoma detection: a comparison study. Am J Gastroenterol. 2015 Mar;110(3):415-22. doi: 10.1038/ajg.2015.21. Epub 2015 Mar 3.

  PMID: 25732415 RESULT

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Baicang Zou, MD

  Second Affiliated Hospital of Xi'an Jiaotong University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2018
• First Posted: November 8, 2018
• Study Start: October 1, 2018
• Primary Completion: September 30, 2019
• Study Completion: November 20, 2019
• Last Updated: November 8, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)