Informed Consent for Capsule Endoscopy

Procedure Name

Form Sections

Section 1info grid

Facility / Clinic Name

Ordering Gastroenterologist

Patient Full Legal Name

Date of Birth

Medical Record Number (MRN)

Date of Capsule Ingestion

Capsule System Used

Section 2text block

Section 3list block

Section 4list block

Section 5text block

Section 6list block

Section 7text block

Section 8text block

Section 9text block

Section 10text block

Section 11text block

Section 12text block

Section 13signature block

Patient / LAR Signature

Ordering Gastroenterologist Signature

Witness Signature

Date and Time of Consent

Informed Consent for Capsule Endoscopy

Patient and Procedure Information

Facility / Clinic Name

Ordering Gastroenterologist

Patient Full Legal Name

Date of Birth

Medical Record Number (MRN)

Date of Capsule Ingestion

Capsule System Used

Nature and Purpose of the Procedure

Capsule endoscopy is a diagnostic study to visualize the lining of the small intestine, which cannot be easily reached by standard upper endoscopy or colonoscopy. You will swallow a small, pill-sized capsule containing a light source and a tiny video camera. As the capsule travel naturally through your digestive tract, it takes thousands of high-resolution images and transmits them to a recording device worn on a belt around your waist. The study is used to find sources of unexplained bleeding, check for Crohn's disease, or evaluate small bowel tumors. The capsule is disposable and will pass naturally in your bowel movements within 24 to 72 hours. You do not need to retrieve the capsule unless instructed. You will return the recording device to the clinic at the end of the day.

MRI Safety Exclusion Screening

I understand that until the capsule has passed completely out of my body, I must NOT undergo an MRI (Magnetic Resonance Imaging) scan. The powerful magnetic field of an MRI can cause the capsule to move or heat up, leading to serious internal injury or bowel perforation.

I agree to verify that the capsule has passed before scheduling any MRI scans in the next 14 days.

I understand that if I am unsure if the capsule has passed, an X-ray may be ordered to confirm it is gone.

Material Risks and Potential Complications

Capsule retention: the most common risk of this procedure. The capsule can get stuck in a narrowed area (stricture) of the bowel caused by inflammation, scar tissue, or a tumor. This occurs in less than 2 percent of patients. While often causing no symptoms, retention can require surgical removal or endoscopic retrieval of the capsule.

Bowel obstruction: if the capsule completely blocks a narrowed area, it can cause a bowel obstruction. Symptoms include severe abdominal pain, nausea, vomiting, and bloating. This is a medical emergency that requires immediate care.

Difficulty swallowing: some patients find it hard to swallow the capsule. If needed, the physician can place the capsule directly into the small bowel using an endoscope.

Technical failure: rarely, the capsule may fail to transmit images, the recorder battery may run out early, or the capsule may pass too quickly, requiring the study to be repeated.

Patient Compliance and Prep Guidelines

To ensure a clear study, the patient agrees to: (1) Follow the recommended liquid diet and fasting instructions starting the day before ingestion. (2) Swallow the capsule with water only while standing. (3) Do not eat or drink anything for 2 hours after swallowing the capsule. (4) You may have clear liquids after 2 hours and a light meal after 4 hours. (5) Avoid heavy physical activity, bending, or stretching during the 8-hour study. (6) Check the blue light on the recording device periodically to confirm it is flashing. (7) Return the recording device to the clinic at the scheduled time.

Alternatives to Capsule Endoscopy

Radiology studies: CT enterography or MR enterography can image the small bowel but do not show the surface lining in detail.

Single or double balloon enteroscopy: an advanced endoscopic procedure that can reach the small bowel. It is invasive, requires sedation, but allows biopsies.

No study: monitoring symptoms and checking blood counts without direct small bowel visualization.

Warning Signs and Post-Ingestion Care

Contact the clinic immediately if you experience: (1) Severe or worsening abdominal pain, (2) Nausea or vomiting, (3) Difficulty swallowing, (4) Fever. If you develop these symptoms before the capsule has passed, do not eat or drink anything until evaluated.

Right to Refuse

You have the right to refuse this study. The gastroenterologist will explain the implications, such as leaving a source of small bowel bleeding or inflammation undiagnosed.

Patient Understanding and Questions

I confirm that I have read this document and understand the capsule endoscopy study, its risks (including capsule retention and MRI restrictions), and its prep requirements. All my questions have been answered.

Language Access

If English is not your primary language, a qualified interpreter is available at no cost. Please inform staff before signing.

Copy of Consent Acknowledgment

I acknowledge that I have been offered a copy of this signed consent form.

Patient Authorization

I voluntarily consent to undergo a capsule endoscopy study. I confirm I have followed the prep instructions and agree to the safety restrictions, including avoiding MRI scans until the capsule has passed.

Signatures and Verification

Patient / LAR Signature

Ordering Gastroenterologist Signature

Witness Signature

Date and Time of Consent

Document ID: CC-PENDING

CONSENTCOLLECT