NCT02220530

Brief Summary

This study aims to assess the impact of the use of sedation on the overall quality of the colonoscopy, therefore addressing each and every one of its dimensions, namely: scientific and technical quality, perceived quality and safety.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
7,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2013

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

August 20, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

August 20, 2014

Status Verified

August 1, 2014

Enrollment Period

1 year

First QC Date

April 7, 2013

Last Update Submit

August 18, 2014

Conditions

Ambulatory Patients Referred for a First-time Colonoscopy

Keywords

Sedation.Colonoscopy quality.Scientific and technical quality.Perceived quality (patient's satisfaction).Safety

Outcome Measures

Primary Outcomes (7)

  • Percentage of colonoscopies completed up to the cecum.

    Colonoscopy in which the cecum is reached per hundred colonoscopy performed

    During colonoscopy

  • Time required to reach the cecum

    Time used to complete colonoscopy (in minutes)

    During colonoscopy

  • Endoscopic withdrawal time

    Time used (in minutes) to endoscopic withdrawal.

    During colonoscopy

  • Adenomas resected

    Number of adenomas resected

    During colonoscopy

  • Perceived quality (patients satisfaction).

    ASGE (American Society of Gastrointestinal Endoscopy) endoscopy satisfaction survery score (GHAA 9-me).

    Thirty days after colonoscopy

  • Early complications.

    Complications occurring during the procedure and recovery phase.

    During colonoscopy.

  • Late complications.

    Complications occurring in the 30 days after the procedure).

    Thirty days after colonoscopy

Study Arms (2)

Sedation group

Colonoscopies performed with conscious sedation with iv midazolam and fentanyl

Drug: Conscious sedation with iv midazolam and fentanyl.

Control group

Colonoscopies performed without sedation.

Interventions

Conscious sedation with iv midazolam and fentanyl.DRUG

Sedation group: Conscious sedation with iv midazolam and fentanyl dosed according to age, weight and baseline conditions of the patients.

Also known as: Control group: Colonoscopies performed without sedation.
Sedation group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Prospective case-control study. The study will include . Patients will be excluded when they have had previous colonoscopies, have an anesthetic risk above ASA III, allergy to the drugs used or if they are undergoing antiplatelet or anticoagulant therapy contraindicated for the procedure

You may qualify if:

  • Consecutive ambulatory patients referred to our Endoscopy Unit for a first-time colonoscopy.

You may not qualify if:

  • Patients with previous colonoscopies.
  • Patients with anesthetic risk above ASA III,
  • Patients with allergy to the drugs used.
  • Patients undergoing antiplatelet or anticoagulant therapy.
  • Pregnant woman.
  • Patients unable to understand the questionnaires.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Htal. Universitario Ntra. Sra. de Candelaria

Santa Cruz de Tenerife, Santa Cruz de Tenerife, 38010, Spain

Location

Related Publications (15)

  • Gellad ZF, Weiss DG, Ahnen DJ, Lieberman DA, Jackson GL, Provenzale D. Colonoscopy withdrawal time and risk of neoplasia at 5 years: results from VA Cooperative Studies Program 380. Am J Gastroenterol. 2010 Aug;105(8):1746-52. doi: 10.1038/ajg.2010.107. Epub 2010 Mar 16.

    PMID: 20234348BACKGROUND

  • Bannert C, Reinhart K, Dunkler D, Trauner M, Renner F, Knoflach P, Ferlitsch A, Weiss W, Ferlitsch M. Sedation in screening colonoscopy: impact on quality indicators and complications. Am J Gastroenterol. 2012 Dec;107(12):1837-48. doi: 10.1038/ajg.2012.347. Epub 2012 Nov 13.

    PMID: 23147522BACKGROUND

  • Rex DK, Petrini JL, Baron TH, Chak A, Cohen J, Deal SE, Hoffman B, Jacobson BC, Mergener K, Petersen BT, Safdi MA, Faigel DO, Pike IM; ASGE/ACG Taskforce on Quality in Endoscopy. Quality indicators for colonoscopy. Am J Gastroenterol. 2006 Apr;101(4):873-85. doi: 10.1111/j.1572-0241.2006.00673.x. No abstract available.

    PMID: 16635231BACKGROUND

  • Rex DK. Quality in colonoscopy: cecal intubation first, then what? Am J Gastroenterol. 2006 Apr;101(4):732-4. doi: 10.1111/j.1572-0241.2006.00483.x.

    PMID: 16635220BACKGROUND

  • Baudet JS, Aguirre-Jaime A. The sedation increases the acceptance of repeat colonoscopies. Eur J Gastroenterol Hepatol. 2012 Jul;24(7):775-80. doi: 10.1097/MEG.0b013e32835376a2.

    PMID: 22522140BACKGROUND

  • Sanchez Del Rio A, Baudet JS, Naranjo Rodriguez A, Campo Fernandez de Los Rios R, Salces Franco I, Aparicio Tormo JR, Sanchez Munoz D, Llach J, Hervas Molina A, Parra-Blanco A, Diaz Acosta JA; los miembros del Grupo de Calidad en Endoscopia de la Asociacion Espanola de Gastroenterologia. [Development and validation of quality standards for colonoscopy]. Med Clin (Barc). 2010 Jan 30;134(2):49-56. doi: 10.1016/j.medcli.2009.07.047. Epub 2009 Nov 14. Spanish.

    PMID: 19913837BACKGROUND

  • Baudet JS, Borque P, Borja E, Alarcon-Fernandez O, Sanchez-del-Rio A, Campo R, Aviles J. Use of sedation in gastrointestinal endoscopy: a nationwide survey in Spain. Eur J Gastroenterol Hepatol. 2009 Aug;21(8):882-8. doi: 10.1097/MEG.0b013e328314b7ca.

    PMID: 19352194BACKGROUND

  • Baudet JS, Diaz-Bethencourt D, Aviles J, Aguirre-Jaime A. Minor adverse events of colonoscopy on ambulatory patients: the impact of moderate sedation. Eur J Gastroenterol Hepatol. 2009 Jun;21(6):656-61. doi: 10.1097/MEG.0b013e328314b7e3.

    PMID: 19300274BACKGROUND

  • Del Rio AS, Baudet JS, Fernandez OA, Morales I, Socas Mdel R. Evaluation of patient satisfaction in gastrointestinal endoscopy. Eur J Gastroenterol Hepatol. 2007 Oct;19(10):896-900. doi: 10.1097/MEG.0b013e3281532bae.

    PMID: 17873615BACKGROUND

  • Sanchez del Rio A, Alarcon Fernandez O, Baudet JS, Sainz Menendez Z, Socas Mendez M. Reliability of the Spanish version of a brief questionnaire on patient satisfaction with gastrointestinal endoscopy. Rev Esp Enferm Dig. 2005 Aug;97(8):554-61. doi: 10.4321/s1130-01082005000800003. English, Spanish.

    PMID: 16266222BACKGROUND

  • Kahi CJ, Ballard D, Shah AS, Mears R, Johnson CS. Impact of a quarterly report card on colonoscopy quality measures. Gastrointest Endosc. 2013 Jun;77(6):925-31. doi: 10.1016/j.gie.2013.01.012. Epub 2013 Mar 6.

    PMID: 23472996BACKGROUND

  • Valori R, Rey JF, Atkin WS, Bretthauer M, Senore C, Hoff G, Kuipers EJ, Altenhofen L, Lambert R, Minoli G; International Agency for Research on Cancer. European guidelines for quality assurance in colorectal cancer screening and diagnosis. First Edition--Quality assurance in endoscopy in colorectal cancer screening and diagnosis. Endoscopy. 2012 Sep;44 Suppl 3:SE88-105. doi: 10.1055/s-0032-1309795. Epub 2012 Sep 25.

    PMID: 23012124BACKGROUND

  • Williams JE, Holub JL, Faigel DO. Polypectomy rate is a valid quality measure for colonoscopy: results from a national endoscopy database. Gastrointest Endosc. 2012 Mar;75(3):576-82. doi: 10.1016/j.gie.2011.12.012.

    PMID: 22341104BACKGROUND

  • Lee TJ, Rutter MD, Blanks RG, Moss SM, Goddard AF, Chilton A, Nickerson C, McNally RJ, Patnick J, Rees CJ. Colonoscopy quality measures: experience from the NHS Bowel Cancer Screening Programme. Gut. 2012 Jul;61(7):1050-7. doi: 10.1136/gutjnl-2011-300651. Epub 2011 Sep 22.

    PMID: 21940723BACKGROUND

  • Imperiali G, Minoli G, Meucci GM, Spinzi G, Strocchi E, Terruzzi V, Radaelli F. Effectiveness of a continuous quality improvement program on colonoscopy practice. Endoscopy. 2007 Apr;39(4):314-8. doi: 10.1055/s-2006-945196. Epub 2007 Feb 1.

    PMID: 17273959BACKGROUND

MeSH Terms

Interventions

Conscious SedationMidazolamFentanyl

Intervention Hierarchy (Ancestors)

Anesthesia and AnalgesiaBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPiperidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Juan Salvador Baudet, M. D.

    Hospital San Juan de Dios Tenerife

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
30 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

April 7, 2013

First Posted

August 20, 2014

Study Start

October 1, 2014

Primary Completion

October 1, 2015

Study Completion

November 1, 2015

Last Updated

August 20, 2014

Record last verified: 2014-08

Locations

ES(1)