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Comparing Maximal and Half-maximal Suction Pressure Applied During Water Exchange in Colonoscopy

NCT ID: NCT01948284

Last Updated: 2013-09-23

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

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2014-02-28

Brief Summary

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This prospective, randomize, controlled trial will compared maximal to half-maximal suction pressure applied during water exchange in patients undergoing minimally sedated colonoscopy. We test the hypothesis that maximal suction pressure is more efficient and causes shorter insertion time.

Detailed Description

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Conditions

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Minimally Sedated Patient Undergoing Colonoscopy

Keywords

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cecal intubation time water exchange pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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maximal suction pressure

The pressure level of the suction unit (DF 601, Hanlien, Taipei, Taiwan) will be set at the maximal (-70 cm Hg).

Group Type ACTIVE_COMPARATOR

maximal pressure

Intervention Type PROCEDURE

The pressure level of the suction unit (DF 601, Hanlien, Taipei, Taiwan) will be set at the maximal (-70 cm Hg).

Suction Unit

Intervention Type DEVICE

half-maximal pressure

The pressure level of the suction unit will be set at the half-maximal (-35 cm Hg).

Group Type ACTIVE_COMPARATOR

half-maximal pressure

Intervention Type PROCEDURE

the pressure level of the suction unit (DF 601, Hanlien, Taipei, Taiwan) will be set at the half-maximal (-35 cm Hg).

Suction Unit

Intervention Type DEVICE

Interventions

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half-maximal pressure

the pressure level of the suction unit (DF 601, Hanlien, Taipei, Taiwan) will be set at the half-maximal (-35 cm Hg).

Intervention Type PROCEDURE

maximal pressure

The pressure level of the suction unit (DF 601, Hanlien, Taipei, Taiwan) will be set at the maximal (-70 cm Hg).

Intervention Type PROCEDURE

Suction Unit

Intervention Type DEVICE

Other Intervention Names

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suction unit (DF 601, Hanlien, Taipei, Taiwan)

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing minimally sedated colonoscopy performed by YHH

Exclusion Criteria

* known history of obstructive lesions of the colon,
* allergy to meperidine,
* massive ascites,
* past history of partial colectomy, or
* refusal to provide written informed consent.
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Felix Leung, MD, Sepulveda Ambulatory Care Center, VAGLAHS

UNKNOWN

Sponsor Role collaborator

Dalin Tzu Chi General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yu-Hsi hsieh

Chief of Gastrointestinal Endoscopic Suite

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Buddhist Dalin Tzu Chi General Hospital

Chiayi City, Taiwan, Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Yu-Hsi Hsieh, MD

Role: CONTACT

Phone: 886-5-2648000

Email: [email protected]

Facility Contacts

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Yu-Hsi Hsieh, MD

Role: primary

References

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Leung FW, Amato A, Ell C, Friedland S, Harker JO, Hsieh YH, Leung JW, Mann SK, Paggi S, Pohl J, Radaelli F, Ramirez FC, Siao-Salera R, Terruzzi V. Water-aided colonoscopy: a systematic review. Gastrointest Endosc. 2012 Sep;76(3):657-66. doi: 10.1016/j.gie.2012.04.467.

Reference Type BACKGROUND
PMID: 22898423 (View on PubMed)

Leung J, Mann S, Siao-Salera R, Ransibrahmanakul K, Lim B, Canete W, Samson L, Gutierrez R, Leung FW. A randomized, controlled trial to confirm the beneficial effects of the water method on U.S. veterans undergoing colonoscopy with the option of on-demand sedation. Gastrointest Endosc. 2011 Jan;73(1):103-10. doi: 10.1016/j.gie.2010.09.020.

Reference Type BACKGROUND
PMID: 21184876 (View on PubMed)

Leung JW, Mann SK, Siao-Salera R, Ransibrahmanakul K, Lim B, Cabrera H, Canete W, Barredo P, Gutierrez R, Leung FW. A randomized, controlled comparison of warm water infusion in lieu of air insufflation versus air insufflation for aiding colonoscopy insertion in sedated patients undergoing colorectal cancer screening and surveillance. Gastrointest Endosc. 2009 Sep;70(3):505-10. doi: 10.1016/j.gie.2008.12.253. Epub 2009 Jun 24.

Reference Type BACKGROUND
PMID: 19555938 (View on PubMed)

Wasan SK, Schroy PC 3rd. Water-assisted unsedated colonoscopy: does the end justify the means? Gastrointest Endosc. 2009 Mar;69(3 Pt 1):551-3. doi: 10.1016/j.gie.2008.10.045. No abstract available.

Reference Type BACKGROUND
PMID: 19231498 (View on PubMed)

Other Identifiers

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DalinTzuChi-Hsieh-2013-2

Identifier Type: -

Identifier Source: org_study_id