Ambulatory Patients Referred for a First-time Colonoscopy Clinical Trial
Official title:
Sedation Effect on the Global Quality Colonoscopy
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.
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.
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Observational Model: Case Control, Time Perspective: Prospective