Sedation Effect on the Global Quality Colonoscopy

Ambulatory Patients Referred for a First-time Colonoscopy Clinical Trial

Official title:

Sedation Effect on the Global Quality Colonoscopy

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02220530
• Other study ID #: HSJD-1
• Status: Enrolling by invitation
• Phase: N/A
• First received: April 7, 2013
• Last updated: August 18, 2014
• Start date: October 2014
• Est. completion date: November 2015

Study information

• Verified date: August 2014
• Source: Hospital San Juan de Dios Tenerife
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health and Consumption
• Study type: Observational [Patient Registry]

Clinical 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.

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).

1. Data collected during the endoscopy will include:

1. 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);

2. Whether or not colonoscopy is completed up to the cecum;

3. Time needed for insertion up to the cecum and for withdrawal;

4. 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.

5. Adenomas resected, based on pathology reports. All of the biopsies will be examined by a pathologist specialized in gastrointestinal pathology.

2. 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.

1. The ASGE (American Society of Gastrointestinal Endoscopy) endoscopy satisfaction survey (GHAA 9-me), previously translated into Spanish and validated by our team.

2. A survey on complications suffered in the 30 days following the procedure (late complications), previously used in earlier studies.

3. Assessment of quality criteria:

1. 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.

2. 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.

3. 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 7000
• Est. completion date: November 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Ambulatory Patients Referred for a First-time Colonoscopy

Intervention

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

Locations

Country	Name	City	State
Spain	Htal. Universitario Ntra. Sra. de Candelaria	Santa Cruz de Tenerife

Sponsors (1)

Lead Sponsor	Collaborator
Hospital San Juan de Dios Tenerife

Country where clinical trial is conducted

Spain, 

References & Publications (15)

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. — View Citation

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. — View Citation

Baudet JS, Borque P, Borja E, Alarcón-Fernández O, Sánchez-del-Río A, Campo R, Avilés 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. — View Citation

Baudet JS, Diaz-Bethencourt D, Avilés 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. — View Citation

Del Río AS, Baudet JS, Fernández OA, Morales I, Socas Mdel R. Evaluation of patient satisfaction in gastrointestinal endoscopy. Eur J Gastroenterol Hepatol. 2007 Oct;19(10):896-900. — View Citation

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. — View Citation

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. Epub 2007 Feb 1. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Rex DK. Quality in colonoscopy: cecal intubation first, then what? Am J Gastroenterol. 2006 Apr;101(4):732-4. — View Citation

Sánchez del Río A, Alarcón Fernández O, Baudet JS, Sainz Menéndez Z, Socas Méndez 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. English, Spanish. — View Citation

Sánchez Del Río A, Baudet JS, Naranjo Rodríguez A, Campo Fernández de Los Ríos R, Salces Franco I, Aparicio Tormo JR, Sánchez Muñoz D, Llach J, Hervás Molina A, Parra-Blanco A, Díaz Acosta JA; los miembros del Grupo de Calidad en Endoscopia de la Asociación Española de Gastroenterología. [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. — View Citation

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. Epub 2012 Sep 25. — View Citation

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of colonoscopies completed up to the cecum.	Colonoscopy in which the cecum is reached per hundred colonoscopy performed	During colonoscopy	No
Primary	Time required to reach the cecum	Time used to complete colonoscopy (in minutes)	During colonoscopy	No
Primary	Endoscopic withdrawal time	Time used (in minutes) to endoscopic withdrawal.	During colonoscopy	No
Primary	Adenomas resected	Number of adenomas resected	During colonoscopy	No
Primary	Perceived quality (patients satisfaction).	ASGE (American Society of Gastrointestinal Endoscopy) endoscopy satisfaction survery score (GHAA 9-me).	Thirty days after colonoscopy	No
Primary	Early complications.	Complications occurring during the procedure and recovery phase.	During colonoscopy.	No
Primary	Late complications.	Complications occurring in the 30 days after the procedure).	Thirty days after colonoscopy	No