Disclosure and Informed Consent

Disclosure should be taken very seriously. It is generally known that the great majority of lawsuits brought by patients against physicians stem from inadequate disclosure rather than treatment errors. Despite its relatively high tolerance and low complication risks, upper GI endoscopy is still an invasive examination. The patient should sign a consent form confirming that the physician has fully explained the nature and risks of the procedure, and the consent form should accurately reflect the information that the patient has received.

General Policies

► Disclosure is provided by a physician.

► Disclosure should be given at least 24 hours prior to the examination.

► Disclosure is given verbally and in writing (aided by a standard information sheet).

► The consent form should reflect the information that has been disclosed.

► The patient willingly consents to the procedure in writing. Exceptions

► Disclosure may be waived for patients who are not verbally responsive.

► Disclosure may be waived in emergencies and for incompetent patients.

Content of Disclosure

Adequate disclosure should include the reasons for performing the examination and the details of the procedure itself, patient-associated risks and special circumstances, the risks of the examination and of medications used during the procedure, and patient instructions before and after the examination.

General information about the procedure

► Reason for the examination

► Nature and conduct of the examination

► Alternatives

► Possible consequences of refusing the procedure

► Risks and discomfort

Patient

► Patient risk factors

► Prior illnesses

► Bleeding tendency

► Dental status

► Prior surgery

► Medications that are taken regularly

Patient instructions before and after the procedure

► Nothing by mouth for 12 hours before the examination.

► No solid foods for 30 minutes after the examination.

► Allow for aftereffects of sedation (no driving, no hazardous work activities for 24 hours).

► Report any complications (pain, bleeding, fever).

Risks and complications

► Complication rate of diagnostic endoscopy

- Overall complication rate < 0.1%

► Cardiac complications

- Ischemia, arrhythmias

► Pulmonary complications

- Hypoxia, aspiration

► Bleeding and perforation

► Complications from medications used during the procedure

- Pharyngeal anesthesia: allergy, aspiration

- Sedation: respiratory depression, hypotension

► Complications of therapeutic endoscopy (sclerotherapy of esophageal varices, bougie or balloon dilation of the esophagus, pol-ypectomy)

- Bleeding, perforation, mediastinitis, fistulation, pleural effusion

► Complications of percutaneous endoscopic gastrostomy (PEG) placement and percutaneous endoscopic jejunostomy (PEJ) placement

- Local infection, peritonitis, bleeding, sepsis

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