Clinical trial NCT01919463: Intubation Techniques on Colonoscopy Quality (SINOCOLO2013)
Official title: Intubation Techniques on Colonoscopy Quality: A Single Center Randomized Control Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Adenoma
Colorectal Polyp
Keywords: Colonoscopy
Lower Gastrointestinal Tract
Magnetic Endoscopic Imaging
Abdominal Compression
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2013-08-09
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary aim of this study is

- to explore the usefulness of abdominal compression on intubation.

Other aims include

1. to investigate the effectiveness and the efficacy of different manners of abdominal compression and to analysis the reasons of their success and failure
2. to get the knowledge of the formation of colon loops and its frequency
3. to clarify the impact of intubation with loops on adenoma detection rate


Eligibility criteria: Inclusion Criteria:

* Patients who undergo colonoscopy examination for screening, surveillance, diagnosis or treatment

Exclusion Criteria:

* Pregnant female patients
* Patients who have history of colorectal cancer, colorectal polyposis, inflammatory bowel disease or heredity colorectal neoplasm syndrome such as familiar adenomatous polyposis, Lynch Syndrome and so on
* Patients who had previous abdominal surgery
* Patients who are known to have colonic stricture or obstructing tumor from the results of radiography (X ray, CT scan or barium enema)
* Patients who are presenting acute surgical conditions such as severe colitis, megacolon and active gastrointestinal bleeding
* Patients who have inadequate bowel preparation
* Patients who reject to participate in this study

Primary outcomes:
measure: Mean Intubation Time (MIT)
timeFrame: At the end of the procedure, up to 1 hour
Secondary outcomes:
measure: Cecal Intubation Rate (CIR)
timeFrame: At the end of the procedure, up to 1 hour
measure: Pain Score (PS)
timeFrame: During the procedure, up to 1 hour
measure: Severe Adverse Event Rate (SAER)
timeFrame: The day of the procedure, 24 hours
measure: Adenoma Detection Rate (ADR)
timeFrame: At the end of the procedure, up to 1 hour
measure: Polyp Detection Rate (PDR)
timeFrame: At the end of the procedure, up to 1 hour
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital
state: Shanghai
Study officials:
affiliation: Changhai Hospital, Shanghai, China
name: En-Da Yu, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shah SG, Saunders BP, Brooker JC, Williams CB. Magnetic imaging of colonoscopy: an audit of looping, accuracy and ancillary maneuvers. Gastrointest Endosc. 2000 Jul;52(1):1-8. doi: 10.1067/mge.2000.107296.
citation: Holme O, Hoie O, Matre J, Stallemo A, Garborg K, Hasund A, Wiig H, Hoff G, Bretthauer M. Magnetic endoscopic imaging versus standard colonoscopy in a routine colonoscopy setting: a randomized, controlled trial. Gastrointest Endosc. 2011 Jun;73(6):1215-22. doi: 10.1016/j.gie.2011.01.054. Epub 2011 Apr 8.
citation: Cheung HY, Chung CC, Kwok SY, Tsang WW, Li MK. Improvement in colonoscopy performance with adjunctive magnetic endoscope imaging: a randomized controlled trial. Endoscopy. 2006 Mar;38(3):214-7. doi: 10.1055/s-2005-921172.