Consent Form OG5 – Patient agreement to investigation or treatment
Name of proposed procedure:
LAPAROSCOPY FOR BILATERAL TUBAL OCCLUSION
A. Statement of health professional:
I have explained the procedure to the patient. In particular, I have explained:
1. The intended benefits: (tick where applicable)
To intentionally occlude both the fallopian tubes using either rings, clips or any other methods including complete or partial removal of the tubes to permanently prevent further pregnancies.
2. Possible serious risks:
§ Damage to the bowel, bladder and major blood vessels – in approximately 3 in 1000 procedures
§ Uterine perforation
3. Possible frequently occurring risks:
§ Bruising
§ Delayed wound healing
§ Shoulder tip pain
§ Incisional hernia
4. Any extra emergency procedures which may become necessary during the operation:
§ Laparotomy – 3 to 4 per 1000 procedures
§ Repair of damage to bladder, bowel, uterus or major blood vessels
§ Other procedures (please specify)______
The overall risk of complications from laparoscopic tubal occlusion is approximately 2 to 5 in 1000 procedures.
Failure to gain entry into the abdominal cavity will require a laparotomy.
I have explained that in women with previous abdominal surgery (example: Caesarean section), with medical conditions or who are obese, the risks mentioned above may be increased.
All operations carry some risk of death. The risk in an operation such is this is estimated at 3 to 8 women in every 100,000 procedures.
I have also discussed the following issues with the patient;
· Surgical tubal occlusion is associated with a lifetime failure rate of approximately 5 in 1000 procedures
· If she does conceive despite the occlusion, there is a risk of a resulting pregnancy occurring outside the womb (ectopic pregnancy)
· Despite all reasonable assessment, a patient undergoing the procedure may already be pregnant at the time of the procedure
· Other contraceptive options including the option of no treatment
Signed: ______Date: ______Time: ______
Name (print): ______Designation: ______
B. Statement of interpreter (where appropriate)
I have interpreted the information above to the patient to the best of my ability and in a way which I believe she can understand.
Signed: ______Name :______Date: ______Time: ______
C. Statement of patient
Please read this form carefully. You must also read the front page carefully which describes the benefits and risks of the proposed treatment. If you have any questions, please ask as we are here to help you. You have the right to change your mind at any time, including after you have signed this form.
1. I have read the previous sheet and understood the benefits YES NO
and risks of the proposed treatment, including the risk of failure
and the possibility of a resulting pregnancy occurring outside the womb
2. I agree to the procedure described YES NO
3. I understand that you cannot give me a guarantee that a particular YES NO
person will perform the procedure. The person will, however, have
appropriate experience
4. I understand that any procedure in addition to those described on YES NO
this form will only be carried out if it is necessary to save my life
or to prevent serious harm to my health
5. I have been told about additional procedures which may become YES NO
necessary during my treatment
6. I have been given a patient information leaflet YES NO
7. I have listed below procedures which I do not wish to be carried YES NO
out without further discussion
______
______
Signed: ______Name: ______Date: ______Time: ______
D. Witness
A witness should sign below if he/she has witnessed the patient’s signature above.
Signed: ______Name: ______Date: ______Time: ______
Relationship to patient: ______Designation: ______
E. Confirmation of consent
This section to be completed when the patient admitted for a procedure has signed the form in advance.
On behalf of the team treating this patient, I have confirmed with the patient that she has no further questions and wishes the procedure to go ahead.
Signed: ______Name: ______Date: ______Time: ______