Informed Consent for Colonoscopy
according to § 28 of the law 372/2011 on health services
Patient: ...................................................................................................
Name: ....................................................................................................
Date of Birth: .........................................................................................
Health Insurance Company: ...................................................................
The endoscopic examination of the large bowel and the distal part of the small bowel (Colonoscopy)
Dear Madam, Sir, based on an assessment of your problem, and performed examinations, colonoscopy, i.e. the screening of the lower part of the digestive tract has been indicated. This examination helps to diagnose diseases of the large bowel and in some cases parts of the small bowel as well.
What is colonoscopy? Colonoscopy is an endoscopic examination which allows direct visualization of the inside of the large bowel with a colonoscope. This is a flexible tube with a light and camera attached which the physician will pass through the rectum into the large intestine. The examination takes 30-50 minutes on average, in some cases, especially in the medical (therapeutic) performance even more.
Colonoscopy is an invasive procedure, this is why your explicit and informed consent is necessary. You must be informed and understand the nature of this performance as well as possible risks before you sign the consent. The physician will explain all details. Keep asking your physician until you know and understand all about the procedure, its indication, and its benefits. The informed consent will be part of your medical documentation.
Preparation for the examination: The diet – see the diet instructions.
It is necessary to stop using products containing iron ( Ferronat, Sorbifer durules,etc) 7 days before the examination.
Follow a low residue diet for 5 days before the procedure.
The afternoon before the colonoscopy drink the laxative solution prepared according to the instructions. We advise drinking a lot of liquid together with the laxative solution.
Medication: Patients should skip aspirin and aspirin-like products such as Anopyrin, Acylpyrin, Clopidogrel (Plavix, Trombex) and similar medications for up to 1 week. Patients who use medicines which influence blood clotting such as Warfarin (Lawarin), Prasugrel (Efient) and other anticoagulants such as Pradaxa, Arixtra, Xarelto, must inform the physician about these. It is necessary to skip Warfarin for at least 1 week before the procedure and if indicated, replace it with low-molecular-weight Heparin. Please contact and ask your General Practitioner. Before the examination it is necessary to perform a blood test (CBS,coagulation test, PTT, Quick). Please inform the nurse or the physician about any possible allergic reactions to drugs, and serious illnesses which you are being treated for. The information about possible glaucoma in also important.
Examination in analgosedation - see the informed consent
The procedure: After this preparation the physician will insert a colonoscope into your anus and will slowly guide it through your rectum into your colon until it reaches the opening to the small intestine. The scope pumps air into your digestive tract in order to give a better view ofyour intestinal issues. Alternatively, abdominal support from external hand pressure can often "straighten" the endoscope to allow the scope to move forward. You may be moved several times on the table to adjust the scope for better viewing. Another closer visual inspection of the lining of the large intestine is performed upon the withdrawal as well as possible therapeutic interventions may be performed. After the procedure your pulse, blood pressure and pulse oximetry will be monitored.
Diagnostic and therapeutic interventions during the examination
Biopsy – removal of small mucous samples with special pincers for histology or microbiological examination. This is painless.
Polypectomy – removal of polyps with a polypectomic loop and eloctrokoagulation device.
Endoscopic mucosal resection (EMR) – is an endoscopic procedure to remove lesions, polyps and small tumours. This is performed using loops and special instruments to cut off the lesions.
Clipping – the application of special clips to treat mucosal perforation or haemostasis.
Complications: No doctor can guarantee any risks when performing theexamination. However, this procedure, as well as other endoscopic examinations, is of low risk.
The possible risks and complications may be:
Allergic reaction to medications given at the time of the procedure, respiratory and cardiac problems
endoscopic complications: the most serious complication is the perforation of the colon, bleeding, eventually bacteraemia and sepsis (infection in the blood). These complications may need hospitalization, other treatment or eventually a surgery. The risk is higher with a therapeutic intervention (biopsy, polypectomy, EMR, etc.) or with an acute examination (this includes cases of acute bleeding into the colon, connected with theremoval offoreign objects, etc). They may show bleeding from the colon andabdominal pain.
Alternative procedures: X-ray (irrirography, CT colonoscopy) with the use of contrast agent
After the colonoscopy: Do not eat and drink after the examination for 2 hours. Ifyou were given sedatives or anaesthesia, you are not allowed to drive or operate machines for 8 hours.
The doctor's statement: I certify that I have explained the nature, purpose, benefits, risks, complications and alternatives to the proposed procedure to the patient and/or their legal representative. I have given the opportunity to ask any questions and all the questions have been answered. Thepatient and/or their legal representative has expressed understanding of what I have explained and agrees to the procedure.
In Ostrava Date ………….................
Gastroenterologist's Signature .....................................................
The patient's (legal representative's) consent: By signing below I confirm that the nature of the colonoscopy, its indications, alternative means of diagnosis or treatmenthave been explained to me. I have also been informed of the potential risks involved and their possible consequences. I have read the information sheet regarding this procedure and have had the opportunity to discuss the above with my physician and she has answered all my questions to my satisfaction. I understand this information and hereby agree to the examination, therapeutic treatment (see above) including other necessary therapeutic interventions.
As a legal representative I certify that the person represented by me has been informed and instructed clearly about the procedure. I certify that I have informed the physician about all known facts which could complicate the peaceful process of the treatment procedure (especially about medications being used and associated diseases).
In Ostrava Date............................
Signature of Patient / Legal Representative / Witness * ...........................
*Delete as required
Informed Consent for Gastroscopy
according to § 28 of the law 372/2011 on health services
Patient: ….....................................................................................
Name: ...........................................................................................
Date of birth: ................................................................................
Health Insurance Company: ..........................................................
ENDOSCOPIC EXAMINATION OF THE UPPER DIGESTIVE TRACT (oesophago-gastro-duodenoscopy).
Dear Madam, Sir, based on an assessment of your problem, and performed examinations, gastroscopy - an examination of upper digestive tracthas been indicated.
What is gastroscopy? This is an endoscopic examination of your oesophagus, stomach and the first part of your bowel called duodenum The test is done using a narrow, flexible, tube-like telescope called an endoscope. The endoscope is passed through the mouth and into the oesophagus and down towards the stomach and duodenum.The examination takes 10-15 minutes on average, in some cases, especially in the medical (therapeutic) performance even more.
Gastroscopy is an invasive procedure, this is why your explicit and informed consent is necessary. You must be informed and understand the nature of this performance as well as possible risks before you sign the consent. The physician will explain all details. Keep asking your physician until you know and understand all about the procedure, andits indication, and its benefits. The informed consent will be part of your medical documentation.
Preparation for the examination: Diet- do not eat or drink for at least 8 hours before the examination.
Medication: Patients who use medicines which influence blood clotting such as Warfarin (Lawarin), Clopidogrel (Plavix, Trombex) Prasugrel (Efient) and other anticoagulants such as Pradaxa, Arixtra, Xarelto, must inform the physician about these. Please inform the nurse or the physician about any possible allergic reactions to drugs, and serious illnesses which you are being treated for. The information about possible glaucoma in also important.
Anaesthetics – Before the procedure, your throat will be numbed with a local anaesthetic spray. When sedation is used, it is not full anaesthetic and you will be still conscious and aware. Ifyou were given sedatives or anaesthesia, you are not allowed to drive or operate machines for 8 hours.
The procedure: After this preparation the physician will place the endoscope in the back of your mouth and ask you to swallow the first part of the tube. It will then be guided down your oesophagus and into your stomach and duodenum. Breath calmly during the procedure, do not swallow the excess saliva, drain it into the prepared pulp. Air will be pumped through the tube and into the stomach to make it expand and the stomach lining easier to see. When this happens, you may briefly feel a sensation of fullness or nausea.
Complications: No doctor can guarantee any risks when performing theexamination. However, this procedure, as well as other endoscopic examinations, is of low risk.
The possible risks and complications may be:
allergic reaction to medications given at the time of the procedure, respiratory and cardiac problems
Endoscopic complications: the most serious complication is the perforation of the digestive tract, bleeding, eventually bacteraemia and sepsis (infection in the blood). These complications may need hospitalization, other treatment or eventually a surgery. The risk is higher with a therapeutic intervention (biopsy, polypectomy, etc.) or with an acute examination (this includes cases of acute bleeding into the digestive tract, connected with theremoval offoreign objects, etc). They may show bleeding from the digestive tract andabdominal pain.
Alternative procedures: X-ray with the use of contrast agent
After the gastroscopy: Do not eat and drink after the examination for 30 minutes. Ifyou were given sedatives or anaesthesia, you are not allowed to drive or operate machines for 8 hours.
The doctor`s statement: I certify that I have explained the nature, purpose, benefits, risks, complications and alternatives to the proposed procedure to the patient and/or their legal representative. I have given the opportunity to ask any questions and all the questions have been answered. Thepatient and/or their legal representative has expressed understanding of what I have explained and agrees to the procedure.
In Ostrava Date ………….................
Gastroenterologist`s Signature .....................................................
The patient`s (legal representative`s) consent: By signing below I confirm that the nature of the gastroscopy, its indications, alternative means of diagnosis or treatmenthave been explained to me. I have also been informed of the potential risks involved and their possible consequences. I have read the information sheet regarding this procedure and have had the opportunity to discuss the above with my physician and she has answered all my questions to my satisfaction. I understand this information and hereby agree to the examination, therapeutic treatment (see above) including other necessary therapeutic interventions.
As a legal representative I certify that the person represented by me has been informed and instructed clearly about the procedure. I certify that I have informed the physician about all known facts which could complicate the peaceful process of the treatment procedure (especially about medications being used and associated diseases).
In OstravaDate............................
Signature of Patient / Legal Representative / Witness * ...........................
*Delete as required