Sedation Effect on the Global Quality Colonoscopy

August 18, 2014 updated by: Juan Salvador Baudet, Hospital San Juan de Dios Tenerife
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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).

  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.

Study Type

Observational

Enrollment (Anticipated)

7000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Santa Cruz de Tenerife, Spain, 38010
        • Htal. Universitario Ntra. Sra. de Candelaria

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Sedation group
Colonoscopies performed with conscious sedation with iv midazolam and fentanyl
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.
Other Names:
  • Control group: Colonoscopies performed without sedation.
Control group
Colonoscopies performed without sedation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of colonoscopies completed up to the cecum.
Time Frame: During colonoscopy
Colonoscopy in which the cecum is reached per hundred colonoscopy performed
During colonoscopy
Time required to reach the cecum
Time Frame: During colonoscopy
Time used to complete colonoscopy (in minutes)
During colonoscopy
Endoscopic withdrawal time
Time Frame: During colonoscopy
Time used (in minutes) to endoscopic withdrawal.
During colonoscopy
Adenomas resected
Time Frame: During colonoscopy
Number of adenomas resected
During colonoscopy
Perceived quality (patients satisfaction).
Time Frame: Thirty days after colonoscopy
ASGE (American Society of Gastrointestinal Endoscopy) endoscopy satisfaction survery score (GHAA 9-me).
Thirty days after colonoscopy
Early complications.
Time Frame: During colonoscopy.
Complications occurring during the procedure and recovery phase.
During colonoscopy.
Late complications.
Time Frame: Thirty days after colonoscopy
Complications occurring in the 30 days after the procedure).
Thirty days after colonoscopy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital San Juan de Dios Tenerife

Investigators

  • Principal Investigator: Juan Salvador Baudet, M. D., Hospital San Juan de Dios Tenerife

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Anticipated)

October 1, 2015

Study Completion (Anticipated)

November 1, 2015

Study Registration Dates

First Submitted

April 7, 2013

First Submitted That Met QC Criteria

August 18, 2014

First Posted (Estimate)

August 20, 2014

Study Record Updates

Last Update Posted (Estimate)

August 20, 2014

Last Update Submitted That Met QC Criteria

August 18, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSJD-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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