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Completed

NCT Number: NCT01467609

PillCam Colon Capsule Endoscopy for Ulcerative Colitis

Pillcam colon capsule (PCC) endoscopy is a novel strategy tool to inspect colon mucosa. The aim of the present study is to evaluate if PCC endoscopy is able to precisely investigate patients with ulcerative colitis and reach high consistency to conventional colonoscopy.

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

About this study

Symptomatic patients with confirmed ulcerative colitis (UC) were enrolled in this prospective single-center study. No sooner had patients gone through Pillcam colon capsule (PCC) endoscopy solution than they got conventional colonoscopy which is recognized as the "gold standard" examination technique. The extent of mucosal damage and inflammatory lesions during both modalities were recorded for comparison. In addition, the regimen of bowel preparation, completion rate, colonic cleanliness, compliance or adverse events were analyzed.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients (aged 18-70)
  • Ulcerative Colitis history
  • Suffering from symptoms such as hematochezia, diarrhea or abdominal pain

Exclusion criteria

  • Patients with a high risk for capsule retention (such as intestinal diverticula, acute abdominal pain without regular defecation indicating intestinal obstruction or a history of abdominal operation or intestinal reconstructed operation),
  • Patients allergic to sodium phosphate or polyethylene glycol (PEG) solution,
  • Patients with a history of Crohn's disease
  • Patients with serious systematic diseases such as congestive heart failure, renal failure or severe liver disease.

Treatment and study plan

Primary outcomes

  1. Evaluate the accuracy of PCC endoscopy in the survey of ulcerative colitis compared with conventional compared with conventional

    the severity of patients investigated by PCC endoscopy and conventional colonoscopy the extent of evolved lesions extent investigated by PCC endoscopy and conventional colonoscopy the safety of PCC endoscopy course (eg: adverse events during bowel preparation and the course; the completion rate)

Secondary outcomes

  1. the gastrointestinal transit time (transit time from ingestion to excretion), cecum arrival time (transit time from ingestion to the cecum), and colon residence time (transit time from the arrival in the cecum to excretion)

  2. clinical data such as age, gender,chief complaint

  3. the Mayo score of each case

  4. the quality of colonic preparation

    4 grades contain excellent, good, fair and poor

Sponsors and collaborators

Lead sponsor

Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

PillCam Colon Capsule Endoscopy Versus Conventional Colonoscopy for the Detection of the Severity and Extent of Ulcerative Colitis

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Nov 8, 2011
Registry last updated
Nov 8, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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