Ambulatory Patients Referred for a First-time ColonoscopyNCT02220530
Sedation Effect on the Global Quality Colonoscopy
An observational study of Ambulatory Patients Referred for a First-time Colonoscopy, run by Hospital San Juan de Dios Tenerife at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Ambulatory Patients Referred for a First-time Colonoscopy
- What is being tested?
- Conscious sedation with iv midazolam and fentanyl.
- Type of treatment
- Injection or infusion
- How many people
- 7,000 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2014to Nov 2015
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- Consecutive ambulatory patients referred to our Endoscopy Unit for a first-time colonoscopy.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Htal. Universitario Ntra. Sra. de Candelaria
Santa Cruz de Tenerife, Santa Cruz de Tenerife, 38010
About this study
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.
Read the detailed description
In recent decades there has been a notable increase in the use of a range of gastrointestinal endoscopy procedures - colonoscopy particularly -, more so in recent years with the implementation of colorectal cancer screening programs.
Colonoscopy can cause discomfort and even pain. In order to reduce these effects and facilitate the procedure, patients are usually administered iv sedation.
Numerous studies have assessed the impact of sedation on patient discomfort and anxiety, on the undesirable effects of the colonoscopy, and even on certain aspects relating to its scientific and technical quality. There have not, however, been any studies evaluating the effects of sedation on the overall quality of the procedure.
The overall quality of every medical act can be defined according to four dimensions: accessibility, or how easily the patient can obtain the assistance required without physical or bureaucratic barriers; scientific and technical quality, or the provision of the best possible assistance with the most up-to-date knowledge and technical resources; perceived quality, or the patient's degree of satisfaction with the care provided; and safety, or the absence of undesirable side effects. Doctors have typically assessed the quality of a procedure based on its scientific and technical quality and its safety. The investigators have strived to conduct good, complication-free techniques based on cutting-edge scientific knowledge, but have often overlooked the other dimensions.
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. Since sedation during the procedure has no impact on accessibility, the study will not assess this dimension.
Subjects and Methods:
Prospective case-control study. The study will include consecutive ambulatory patients referred to our Endoscopy Unit for a first-time colonoscopy. Patients will be excluded when they have had previous colonoscopies, have an anesthetic risk above ASA III (American Society of Anesthesia classifications) allergy to the drugs used or if they are undergoing antiplatelet or anticoagulant therapy contraindicated for the procedure, pregnant woman and patients unable to understand the questionnaires.
Prior to inclusion demographic data, clinical background and indication for the colonoscopy will be collected on each patient.
Thereafter patients will be randomly assigned to colonoscopy without sedation or with conscious sedation with iv midazolam and fentanyl dosed according to age, weight and baseline conditions.
The procedures will be conducted by four endoscopists with ample experience in endoscopy and sedation (over 7000 colonoscopies each).
- Data collected during the endoscopy will include:
- The degree of cleanliness of the colon according to the Boston scale; defined as the adequate preparation of at least 2 points in each region of the colon);
- Whether or not colonoscopy is completed up to the cecum;
- Time needed for insertion up to the cecum and for withdrawal;
- The complications that might arise during the procedure and recovery period (early complications). To this end, patients' oxygen saturation and heart rate will be continuously monitored from the beginning of the procedure until their discharged and their blood pressure will be taken every 5 minutes. Non-sedated patients will be discharged from the Unit immediately after the procedure, and sedated patients when they reach a score of 9 or 10 on the Aldrete scale.
- Adenomas resected, based on pathology reports. All of the biopsies will be examined by a pathologist specialized in gastrointestinal pathology.
- Thirty days after the Endoscopy, patients will be interviewed by telephone by staff with no involvement in the study (call center) and asked to respond to two questionnaires.
- The ASGE (American Society of Gastrointestinal Endoscopy) endoscopy satisfaction survey (GHAA 9-me), previously translated into Spanish and validated by our team.
- A survey on complications suffered in the 30 days following the procedure (late complications), previously used in earlier studies.
- Assessment of quality criteria:
- Six indicators will be used to assess the scientific and technical quality of each procedure. The first three will assess their technical aspects: percentage of colonoscopies completed up to the cecum; time required to reach the cecum; and withdrawal time. The remaining three are results indicators: percentage of patients with adenomas; total number of adenomas per patient; and total number of advanced adenomas. These indicators were previously validated in our setting. Since the use or not of sedation during the procedure does not affect the cleanliness of the colon, this indicator will be used as a control variable.
- Perceived quality will be assessed using the ASGE (American Society of Gastrointestinal Endoscopy) satisfaction survey, previously translated into Spanish and adapted and validated. Total scores, scores for the procedure (item 7 on the survey) and the number of patients rating the procedure "excellent" will be analyzed.
- Safety will be assessed following the same method used in previous research, analyzing early complications (those occurring during the procedure and recovery phase) and late complications (those occurring in the 30 days after the procedure).
Statistical Analyses:
Results will be expressed as mean ± standard deviation. Comparisons between groups will be performed using the Chi-squared test for ordinal variables and Student's t-test for quantitative variables. Results with a p value <0.05 will be considered statistically significant. Logistic regression will be used to determine the impact of sedation on the quality indicators studied.
- Being tested
- Conscious sedation with iv midazolam and fentanyl.
- Keywords
- Sedation., Colonoscopy quality., Scientific and technical quality., Perceived quality (patient's satisfaction)., Safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conscious sedation with iv midazolam and fentanyl.Drug
Also called Control group: Colonoscopies performed without sedation.
Sedation group: Conscious sedation with iv midazolam and fentanyl dosed according to age, weight and baseline conditions of the patients.
| Study group | Role | What they receive |
|---|---|---|
| Sedation group | Colonoscopies performed with conscious sedation with iv midazolam and fentanyl Receives: Drug: Conscious sedation with iv midazolam and fentanyl. | |
| Control group | Colonoscopies performed without sedation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of colonoscopies completed up to the cecum.
Colonoscopy in which the cecum is reached per hundred colonoscopy performed
Measured: During colonoscopy
Time required to reach the cecum
Time used to complete colonoscopy (in minutes)
Measured: During colonoscopy
Endoscopic withdrawal time
Time used (in minutes) to endoscopic withdrawal.
Measured: During colonoscopy
Adenomas resected
Number of adenomas resected
Measured: During colonoscopy
Perceived quality (patients satisfaction).
ASGE (American Society of Gastrointestinal Endoscopy) endoscopy satisfaction survery score (GHAA 9-me).
Measured: Thirty days after colonoscopy
Early complications.
Complications occurring during the procedure and recovery phase.
Measured: During colonoscopy.
Late complications.
Complications occurring in the 30 days after the procedure).
Measured: Thirty days after colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2014 (estimated)
- Study startOct 2014
- Primary completionOct 2015 (estimated)
- Study completionNov 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Ambulatory Patients Referred for a First-time ColonoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 7,000 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Hospital San Juan de Dios Tenerife
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan Salvador Baudet, Hospital San Juan de Dios Tenerife
- Investigators
- Juan Salvador Baudet, M. D., Principal investigator, Hospital San Juan de Dios Tenerife
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02220530
- Sponsor's protocol ID
- HSJD-1
- Status last verified
- Aug 2014
- First submitted
- 7 Apr 2013
- Last updated
- 20 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 20234348Bannert 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.
PubMed 23147522Rex 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.
PubMed 16635231Rex 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.
PubMed 16635220Baudet 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.
PubMed 22522140Sanchez 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.
PubMed 19913837Baudet 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.
PubMed 19352194Baudet 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.
PubMed 19300274Del 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.
PubMed 17873615Sanchez 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.
PubMed 16266222Kahi 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.
PubMed 23472996Valori 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.
PubMed 23012124Williams 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.
PubMed 22341104Lee 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.
PubMed 21940723Imperiali 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.
PubMed 17273959
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sedation Effect on the Global Quality Colonoscopy
- ClinicalTrials.gov ID
- NCT02220530
- Acronym / sponsor ID
- HSJD-1
- Keywords
- Sedation., Colonoscopy quality., Scientific and technical quality., Perceived quality (patient's satisfaction)., Safety
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 7,000 participants (estimated)
- Lead sponsor
- Hospital San Juan de Dios TenerifeUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Nov 2015 (estimated)
- First posted
- 20 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In recent decades there has been a notable increase in the use of a range of gastrointestinal endoscopy procedures - colonoscopy particularly -, more so in recent years with the implementation of colorectal cancer screening programs.
Colonoscopy can cause discomfort and even pain. In order to reduce these effects and facilitate the procedure, patients are usually administered iv sedation.
Numerous studies have assessed the impact of sedation on patient discomfort and anxiety, on the undesirable effects of the colonoscopy, and even on certain aspects relating to its scientific and technical quality. There have not, however, been any studies evaluating the effects of sedation on the overall quality of the procedure.
The overall quality of every medical act can be defined according to four dimensions: accessibility, or how easily the patient can obtain the assistance required without physical or bureaucratic barriers; scientific and technical quality, or the provision of the best possible assistance with the most up-to-date knowledge and technical resources; perceived quality, or the patient's degree of satisfaction with the care provided; and safety, or the absence of undesirable side effects. Doctors have typically assessed the quality of a procedure based on its scientific and technical quality and its safety. The investigators have strived to conduct good, complication-free techniques based on cutting-edge scientific knowledge, but have often overlooked the other dimensions.
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. Since sedation during the procedure has no impact on accessibility, the study will not assess this dimension.
Subjects and Methods:
Prospective case-control study. The study will include consecutive ambulatory patients referred to our Endoscopy Unit for a first-time colonoscopy. Patients will be excluded when they have had previous colonoscopies, have an anesthetic risk above ASA III (American Society of Anesthesia classifications) allergy to the drugs used or if they are undergoing antiplatelet or anticoagulant therapy contraindicated for the procedure, pregnant woman and patients unable to understand the questionnaires.
Prior to inclusion demographic data, clinical background and indication for the colonoscopy will be collected on each patient.
Thereafter patients will be randomly assigned to colonoscopy without sedation or with conscious sedation with iv midazolam and fentanyl dosed according to age, weight and baseline conditions.
The procedures will be conducted by four endoscopists with ample experience in endoscopy and sedation (over 7000 colonoscopies each).
- Data collected during the endoscopy will include:
- The degree of cleanliness of the colon according to the Boston scale; defined as the adequate preparation of at least 2 points in each region of the colon);
- Whether or not colonoscopy is completed up to the cecum;
- Time needed for insertion up to the cecum and for withdrawal;
- The complications that might arise during the procedure and recovery period (early complications). To this end, patients' oxygen saturation and heart rate will be continuously monitored from the beginning of the procedure until their discharged and their blood pressure will be taken every 5 minutes. Non-sedated patients will be discharged from the Unit immediately after the procedure, and sedated patients when they reach a score of 9 or 10 on the Aldrete scale.
- Adenomas resected, based on pathology reports. All of the biopsies will be examined by a pathologist specialized in gastrointestinal pathology.
- Thirty days after the Endoscopy, patients will be interviewed by telephone by staff with no involvement in the study (call center) and asked to respond to two questionnaires.
- The ASGE (American Society of Gastrointestinal Endoscopy) endoscopy satisfaction survey (GHAA 9-me), previously translated into Spanish and validated by our team.
- A survey on complications suffered in the 30 days following the procedure (late complications), previously used in earlier studies.
- Assessment of quality criteria:
- Six indicators will be used to assess the scientific and technical quality of each procedure. The first three will assess their technical aspects: percentage of colonoscopies completed up to the cecum; time required to reach the cecum; and withdrawal time. The remaining three are results indicators: percentage of patients with adenomas; total number of adenomas per patient; and total number of advanced adenomas. These indicators were previously validated in our setting. Since the use or not of sedation during the procedure does not affect the cleanliness of the colon, this indicator will be used as a control variable.
- Perceived quality will be assessed using the ASGE (American Society of Gastrointestinal Endoscopy) satisfaction survey, previously translated into Spanish and adapted and validated. Total scores, scores for the procedure (item 7 on the survey) and the number of patients rating the procedure "excellent" will be analyzed.
- Safety will be assessed following the same method used in previous research, analyzing early complications (those occurring during the procedure and recovery phase) and late complications (those occurring in the 30 days after the procedure).
Statistical Analyses:
Results will be expressed as mean ± standard deviation. Comparisons between groups will be performed using the Chi-squared test for ordinal variables and Student's t-test for quantitative variables. Results with a p value <0.05 will be considered statistically significant. Logistic regression will be used to determine the impact of sedation on the quality indicators studied.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sedation group | – | Drug: Conscious sedation with iv midazolam and fentanyl.Colonoscopies performed with conscious sedation with iv midazolam and fentanyl |
| Control group | – | –Colonoscopies performed without sedation. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Consecutive ambulatory patients referred to our Endoscopy Unit for a first-time colonoscopy.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conscious sedation with iv midazolam and fentanyl.Also: Control group: Colonoscopies performed without sedation.Sedation group: Conscious sedation with iv midazolam and fentanyl dosed according to age, weight and baseline conditions of the patients. | Drug | Sedation group |
Primary outcome
Percentage of colonoscopies completed up to the cecum.
Time frame: During colonoscopy
Colonoscopy in which the cecum is reached per hundred colonoscopy performed
Time required to reach the cecum
Time frame: During colonoscopy
Time used to complete colonoscopy (in minutes)
Endoscopic withdrawal time
Time frame: During colonoscopy
Time used (in minutes) to endoscopic withdrawal.
Adenomas resected
Time frame: During colonoscopy
Number of adenomas resected
Perceived quality (patients satisfaction).
Time frame: Thirty days after colonoscopy
ASGE (American Society of Gastrointestinal Endoscopy) endoscopy satisfaction survery score (GHAA 9-me).
Early complications.
Time frame: During colonoscopy.
Complications occurring during the procedure and recovery phase.
Late complications.
Time frame: Thirty days after colonoscopy
Complications occurring in the 30 days after the procedure).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2014.
- Background: PubMed 20234348Gellad 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.
- Background: PubMed 23147522Bannert 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.
- Background: PubMed 16635231Rex 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.
- Background: PubMed 16635220Rex 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.
- Background: PubMed 22522140Baudet 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.
- Background: PubMed 19913837Sanchez 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.
- Background: PubMed 19352194Baudet 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.
- Background: PubMed 19300274Baudet 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.
- Background: PubMed 17873615Del 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.
- Background: PubMed 16266222Sanchez 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.
- Background: PubMed 23472996Kahi 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.
- Background: PubMed 23012124Valori 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan Salvador Baudet, M. D. principal investigator
Hospital San Juan de Dios Tenerife
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ambulatory Patients Referred for a First-time Colonoscopy, run by Hospital San Juan de Dios Tenerife at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of colonoscopies completed up to the cecum. (time frame: During colonoscopy). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02220530, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2014.