From the Guidelines
Informed consent for a colonoscopy should be obtained during a face-to-face discussion between the endoscopist and the patient, covering the procedure's purpose, benefits, risks, alternatives, and what to expect before, during, and after the examination. The consent process should explain that colonoscopy involves inserting a flexible tube with a camera through the rectum to examine the large intestine, often to screen for colorectal cancer or investigate symptoms like bleeding or pain. Patients should be informed about common risks including bleeding (occurring in about 1 in 1000 cases), perforation (about 1 in 1500 cases), missed lesions (up to 6% for significant polyps), and rare complications from sedation 1. The consent should cover preparation requirements, typically involving a clear liquid diet for 24 hours and consuming a bowel preparation solution like polyethylene glycol (GoLYTELY, MoviPrep), sodium picosulfate, or magnesium citrate the day before. Patients should understand they'll need someone to drive them home after the procedure due to sedation effects, and that they may experience mild cramping or bloating afterward.
The consent process should allow time for questions and confirm the patient's understanding before proceeding, with the endoscopist being ultimately responsible for ensuring that the consent process is appropriate for the procedure being undertaken 1. It is also recommended that information leaflets should be available in languages common to the local population and should be reviewed by lay people 1. For surveillance procedures, consent can be obtained in advance, but it is necessary to check whether the patient’s condition or medication has changed significantly before any surveillance procedure, and to confirm that the patient still wishes to proceed 1.
Key points to consider in the consent process include:
- The procedure's purpose and benefits
- Risks and alternatives
- Preparation requirements
- Sedation effects and need for a driver
- Potential complications and their management
- The patient's understanding and questions
- The endoscopist's responsibility for the consent process
- The need for confirmation of consent before proceeding with the procedure, especially in cases where new information becomes available or the patient's condition has changed 1.
From the FDA Drug Label
The sodium picosulfate, magnesium oxide and anhydrous citric acid regimen of one packet administered as two doses demonstrated successful colon cleansing in both the 9 to 12 year age group and the 13 to 16 year age group. The FDA drug label does not answer the question about colonoscopy consent.
From the Research
Colonoscopy Consent
- The process of obtaining informed consent for colonoscopy has been studied to improve patient knowledge and satisfaction 2, 3, 4.
- A study in 2014 found that patients received suboptimal levels of information about colonoscopy compared to their preferences, and suggested that a combination of written information, diagrams, and graphs, followed by a discussion, would be most effective in gaining informed consent 2.
- The use of video tools to supplement traditional consent has been shown to improve patient knowledge retention and satisfaction with the informed consent process 3, 4.
- A randomized controlled study in 2022 found that patients who received informed consent supplemented by a video tool had higher recall of key aspects of informed consent and higher satisfaction with the process, with no impact on procedural times 3.
- Another study in 2023 found that an informed consent video prior to colonoscopy resulted in similar overall patient satisfaction, but patients were more likely to report sufficient time to talk with their physician, and physicians reported higher satisfaction with consent efficiency 4.
Patient Education and Satisfaction
- Patient education is a crucial aspect of the colonoscopy consent process, and studies have shown that patients prefer different methods of communication, such as leaflets or verbal information from a doctor or nurse 2.
- The use of visual aids, such as pie graphs and pictographs, has been shown to be effective in explaining the risks of colonoscopy to patients 2.
- Patient satisfaction with the informed consent process is an important outcome, and studies have shown that the use of video tools and other supplemental materials can improve patient satisfaction 3, 4.
Clinical Considerations
- The management of anticoagulants and antiplatelet agents during colonoscopy is an important consideration, and studies have shown that the risk of postpolypectomy bleeding is increased in patients who continue to take these medications 5.
- The use of bowel preparation regimens is also an important consideration, and studies have shown that adequate cleansing is essential for thorough visualization of the colon and successful detection of colon polyps 6.