Intubation Techniques on Colonoscopy Quality (SINOCOLO2013)

NCT ID: NCT01919463

Last Updated: 2015-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2016-02-29

Brief Summary

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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

Detailed Description

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Conditions

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Colorectal Adenoma Colorectal Polyp

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Control Group

Colonoscopy is completed without abdominal compression by GI assistants. Live image of magnetic endoscopic imaging system is shown to investigators for study but not to the colonoscopist for facilitating the intubation process.

Group Type NO_INTERVENTION

No interventions assigned to this group

Experimental Group 2 (Monitoring)

Colonoscopy is completed with abdominal compression by GI assistants. Live image of magnetic endoscopic imaging system is shown to investigators for study but not to the colonoscopist for facilitating the intubation process. The colonoscopist directs GI assistants to conduct compression by his subjective judgement.

Group Type EXPERIMENTAL

Abdominal Compression

Intervention Type BEHAVIORAL

Abdominal Compression is conducted by GI assistants during intubation process to facilitate the process. It can be conducted at different ares of the abdomen with different force.

Experimental Group 1 (Guiding)

Colonoscopy is completed with abdominal compression by GI assistants. Live image of magnetic endoscopic imaging system is shown both to investigators for study and to the colonoscopist for facilitating the intubation process. The colonoscopist directs GI assistants to conduct compression according to the guidance of magnetic endoscopic imaging system.

Group Type EXPERIMENTAL

Abdominal Compression

Intervention Type BEHAVIORAL

Abdominal Compression is conducted by GI assistants during intubation process to facilitate the process. It can be conducted at different ares of the abdomen with different force.

Guidance of Magnetic Endoscopic Imaging (MEI) System

Intervention Type DEVICE

Live image of MEI can show the form of the colonoscope inside the body. Live image is show to colonoscopist for facilitating the intubation process.

Interventions

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Abdominal Compression

Abdominal Compression is conducted by GI assistants during intubation process to facilitate the process. It can be conducted at different ares of the abdomen with different force.

Intervention Type BEHAVIORAL

Guidance of Magnetic Endoscopic Imaging (MEI) System

Live image of MEI can show the form of the colonoscope inside the body. Live image is show to colonoscopist for facilitating the intubation process.

Intervention Type DEVICE

Other Intervention Names

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MEI System (Olympas, Tokyo, Japan)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Changhai Hospital

OTHER

Sponsor Role lead

Responsible Party

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En-Da Yu

Surgical Professor, Vice Director of Department of Colorectal Surgery and Center of GI Endoscopy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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En-Da Yu, M.D.

Role: PRINCIPAL_INVESTIGATOR

Changhai Hospital, Shanghai, China

Locations

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Changhai Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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En-Da Yu, M.D.

Role: CONTACT

08615921509177

Facility Contacts

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En-Da Yu, M.D.

Role: primary

08615921509177

References

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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.

Reference Type BACKGROUND
PMID: 10882954 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21481862 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16528645 (View on PubMed)

Other Identifiers

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SINOCOLO2013

Identifier Type: -

Identifier Source: org_study_id

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