Informed Consent for Operation
To:

Information was given as stated below on//(Day/Month/Year).

Aiiku Hospital
Doctor: Hideki Sakamoto MD
Witness:

Important notice: Our anesthesiologist requests removal of all makeups including manicuresand pedicures. Failure to do so may result in cancellation of the procedure.

1. The name of a disease (Condition/symptoms)

2. Necessity for operation (alternative therapy)

3. Name of operation and its details (planned date of operation:)

４．Possible side effects and complications associated with this operation, procedure, or treatment
・Anesthetic drugs and all other medicines may cause allergic responses that may lead to shock on very rareoccasions. We cannot foretell if a patient is allergic to a medicine, so we are prepared to deal with thoseconditions. Transient hives and gastritis or diarrhea caused by antibiotics are seen more frequently. If you
have a history of allergy to a medicine or a history of asthma, please inform us of the fact before treatment.
・In cases of excessive bleeding： ・Possibility of transfusion

・Possibility of use of blood preparations

・Possibility of intraperitoneal adhesion preventive treatment：

・Yes（

）

・No

・Laparotomy, as with other surgical operations, may generally be associated with the following complications
１．Intraoperative damage to other organs：Adjacent organs such as bowels, urinary tract, and bladder may bedamaged; in that case, repairing procedures will be given during operation,
but it may elongate bed rest after operation.
２．Postoperative bleeding：On rare occasions, bleeding, after cessation, may recur from a part of wound or severedvessels after closure of the wound. If the bleeding does not stop over time, the abdomenneeds to be reopened.
３．Postoperative infection：After operation, antibiotics are given to prevent bacterial infections inside and outside of
the abdomen. But infection may be caused by a bacterial species which happens to beresistant to the antibiotic given or on special occasions. In those cases, the medicine will beswitched to effective one and necessary treatment such as sterilization will be conducted.
４．Poor union of wound：In patients with diabetes, very thick subcutaneous fat, or postoperative infection, union ofwound may be poor. Those patients will take a little longer time before healing of the wound.
５．Intestinal palsy：If the digestive tract, which was immobilized by anesthesia during operation, does not recoverits motion well, it may take several days before the patient can take meals.
６．Intraperitoneal adhesion, bowel obstruction：Many people who underwent laparotomy have adhesion of theintestine or wound in the abdomen. Most of them remain free of
symptoms and harmless, but on rare occasions the intestine gets stuck in
the adhesion site to cause bowel obstruction. If conservative (medical)
management does not take effect, surgical treatment (operation) becomes
necessary.
７．Thrombosis, thrombotic embolism：Intrapelvic operation, in pregnant women or those patients who
have long been in bed or liable to thrombosis, may cause, during or
after operation, Thrombosis in a thick vein in loser extremities or
the pelvis that may cause thrombophlebitis or, on rate occasions,severe pulmonary embolism.

(Such adverse reactions or complications very rarely, about one out of several thousands cases, leadto critical condition, but the risk is not zero.)・Risk factors particular to you：
1)
2)
3)
4)
5)
6)
7)

Hemorrhage (rare)
Infection (rare)
Adhesions (not uncommon)
Recurrence (rare)
Emergency recovery open surgery (very rare)
Accidental adjacent/target organ injuries (very rare)
Perforation ( during D&C or endoscopic surgeries (very rare), this requires open repair

8) Blood clot formation after prolonged bed rest (uncommon)

I was given the above information and understood it. Thus I consent to have the operation.
Date:
Address:
Telephone No.:
Name of the patient:
Name of the attendant:(Relationship with the patient:)

Blood transfusion therapy

Record of informed consent
Aiiku Hospital, Maternal & Child Health Center

This document is to explain about transfusion therapy to the patient who needs or may come to need a transfusion(including patients whose autologous blood are pooled).
Transfusion therapy is a therapy to supplement blood components (red blood cells, platelets, protein components,
coagulation factors, etc.) when they decrease in number or function.
While blood transfusion has become remarkably safe recent years, it will be difficult to completely exclude side effects
or complications associated with it. Non-use of blood transfusion, on the other hand, may lead to a threat to life orserious residual disabilities. When we judge a blood transfusion necessary, we explain it to a patient and the family.
However, in case of emergency, the explanation will be performed after the transfusion therapy.

● You need transfusion therapy for the following reasons:・Massive bleeding (at delivery / operation /)・Decrease in coagulation factors ( massive bleeding / abnormal blood clotting due to hypertension disorders of pregnancy /congenital clotting factor deficiency /)・Thrombocytopenia ・Others● When blood transfusion is not given, it may lead to ()● Planned volume of blood transfusion and type of blood preparation to be used:
・Red blood cells
・Platelets

units

units ・Fresh frozen plasma
・Others (

units
)

units

● For each type of blood preparation, expected effects of blood transfusion and risk with non-use are as follows：
・Red blood cells
Red blood cells carry oxygen taken up at the lung all through the body. Depletion of red blood cells causes lackof oxygen and dysfunction of organs, and prolongation of such condition may leave disorders in the body system.
・Fresh frozen plasma
Plasma is the light yellow fluid which remains after cellular components such as red blood cells, leukocytes, andplatelets are removed from the blood. Plasma contains various proteins and blood coagulation factors in it. In
some pathological conditions, such as massive bleeding, blood coagulation factors are consumed excessively,
which makes bleeding less controllable. Fresh frozen plasma is given on such occasions or when such conditions
may arise.
・Platelets
Platelets cooperate with blood coagulation factors to close bleeding wounds or prevent leakage of blood byreinforcing the vascular wall. Lack of platelets due to massive bleeding or diseases such as thrombocytopenia
may cause bleeding without any injuries or less controllable bleeding from a wound. Platelet preparation is used
to treat such conditions. In patients who do not have sufficient platelets inherently, a platelet preparation will begiven in advance of the delivery.

● Side effects, complications, and risk associated with transfusion therapy*Figures in parentheses denote approximate incidences when blood from five donors is transfused (quoted from a report of the Informed Consent
Subcommittee, The Japan Society of Blood Transfusion)

・Post-transfusion infections

Hepatitis C and B (1/ 1,000,000)
HIV (＜1/ 10,000,000)
Other infections〔Yersinia, malaria, HTLV-1 virus, parvovirus, Creutzfeldt-Jakob
disease, and others〕 (from unknown incidence to ＜1/ 1,000,000)

In addition to hepatitis screening and HIV antigen/antibody screening conducted in blood donors, nucleic-acid
amplification testing to detect trace amounts of viruses have shortened the negative test period in the early phaseinfection (window period). As a result, the incidences of posttransfusion infections decreased fairly but it is
impossible to completely eliminate them. Infections with unknown pathogenic agents may also arise.
・Allogeneic response

Hives, fever (1/ 10 - 1/ 100)
Anaphylactic shock (1/ 10,000): with breathing difficulty, erythema, and blood pressure fall
Hemolysis (1/ 1,000 of mild cases to 1/ 10,000 of severe cases)※Immune reaction caused by anyone else's components taken into the body.
・Graft-versus-host disease〔GVHD〕
The complication has not been confirmed in Japan since 2000 as irradiated blood became widely used. It is acomplication in which any donor leukocytes contained in a transfusion preparation attack and destroy the patient's
body tissues. Irradiation inactivates those leukocytes. Fever, erythema, hepatic disorder, diarrhea, pancytopenia,
and bone marrow aplasia develop after one to two weeks, and the condition follows fatal course. Once developed,
there is no effective therapy for it at present.
Transfusion of blood from relatives is avoided because it
increases the risk of this complication.
・Transfusion-related acute lung injury〔TRALI〕 (309 cases, including suspected cases were reported since 2004 to2012 in Japan.)
It is breathing difficulty accompanied by lung edema which develops during or within 6 hours after bloodtransfusion. This condition is presumed to develop as antigen-antibody reaction, in which anti-leukocyte
antibodies in blood preparations damage the peripheral blood vessels of the lung, though the detailed mechanism is
unknown. Once developed, respiratory management with a respirator is necessary to control the condition.

● To avoid blood transfusion
When a bleeding necessitating blood transfusion is expected and there is sufficient time, the patient's own blood
may be withdrawn and pooled. By the own blood transfusion, the side effects and the complications mentioned in
the previous section are logically avoided. However, blood cannot be withdrawn in cases with, for example, anemia,
and the withdrawing during pregnancy would be harmful for both the mothers and the fetuses. The preserved
blood cannot be used in cases of bacterial contamination or clotting, which occur on rare occasions.

● Therapies, alternative to transfusion therapy
Usually alternative therapies, if available, are used before considering the blood transfusion therapy.
Examples of alternative therapies: Fluid replacement therapy, vasopressor therapy, anti-inflammatory treatment
with corticosteroid, iron preparation.

● Care after blood transfusion
Tests to see liver functions, anemia, and post-transfusion infections are conducted one and three months after
transfusion.

● Emergency response
Please understand that the minimum necessary volume of blood may be transfused at a doctor's discretion whenblood transfusion seems urgently necessary. In emergency situations, we do not have time enough to obtain priorconsent from the patient or the family. In such cases, your retrospective approval would be requested.

● Retention of Records and Disclosure of Information
Aiiku Hospital retains the records of your name and address, the preparation’s name and lot No. (Production
number), and the date of administration for twenty years. If any events should occur requiring action to prevent
occurrence or expansion of health hazards due to the use of blood transfusion, we may present the records to the
preparation’s manufacturer and/or Japanese administrative agencies.

Date:

Patient's signature

Plasma preparations therapy

Record of informed consent
Aiiku Hospital, Maternal & Child Health Center

Plasma preparations are products prepared from plasma component, blood residue after removal of cell components.
The preparations are used only when their benefits are thought to overweigh risks.

● Types of plasma preparations
・Dried and concentrated human anti-thrombin
Deficiency of anti-thrombin makes the body prone to develop clots to cause embolism or other disorders, thus
threatening life. Anti-thrombin preparations work to normalize the regulating mechanism of clot formation or
resolution.
・Fibrinogen preparations
In some conditions such as massive bleeding, sepsis, and systemic thromboembolism, the coagulation factors
are consumed extensively and the clotting system falls into malfunction.
The condition is called disseminatedintravascular coagulation (DIC).
Fibrinogen, which is one of the coagulation factors, usually decreases after
acute DIC develops.
In that condition, only fibrinogen preparations can resolve the bleeding tendency. Please
understand that the Japanese health insurance does not cover the fibrinogen preparations therapy in acute DIC
cases.
・Albumin preparations
The main function of albumin is to maintain the osmotic value level within the plasma and thus to prevent waterin plasma from permeating out of vessels. In some conditions such as massive bleeding, plasma protein level
drops to a low level, which brings in pulmonary edema, pleural effusion, and ascites.
Albumin preparations areused to improve those symptoms.
・Immunoglobulin preparations
Immunoglobulin preparations are known to have an effect of improving or preventing infections. They arealso effective in regulating immunity and improving Kawasaki disease, idiopathic thrombocytopenic purpura,
Guillain-Barre syndrome, and chronic inflammatory demyelinating polyradiculoneuropathy.
※Anti-D human immunoglobulin is used when blood type incompatibility is expected between the fetus with Rh(+) and the mother with Rh (-).
・Fibrinogen preparations (factor XIII with fibrinogen, fibrinogen combination products, etc.)
An adhesive made of coagulation factor in blood, which is applied to operative wound (not to be administeredintravenously). The agent prevents leakage of blood, fluid, or gas from the site of surgical suture or juncture.
・Other plasma preparations may be used to compensate for deficiencies in respective blood components and improvethe clinical condition (such as an adhesive patch to stop bleeding on the surface of an organ).

● Adverse effects
・Infection
The preparations are made from blood which has been checked for viruses and heat-treated to inactivate viruses.
No viral infections such as HIV infection or hepatitis due to those preparations have so far been confirmed.
However, as they are made from blood, possibility of infection cannot be completely excluded.
Also undeniable is a risk of infection with unknown pathogens such as abnormal prions --presumably causativeof the new type of Creutzfeldt-Jakob disease--which cannot be removed with the current technique.
Since it is difficult to completely inactivate or remove viruses such as human parvovirus B19 (pathogen forinfectious erythema), we will cautiously follow the course after administration.
・Allergic reaction
Hives, anaphylactic reaction, fever, decrease in blood pressure, difficulty in breathing, etc.

● Emergency procedures
On life-threatening occasions, we will place utmost priority on life saving. Please understand that informationin this leaflet may be given after administration of a plasma preparation in those cases.

● Possible risks associated with non-use of plasma preparations
・Pulmonary embolism (respiratory arrest) due to blood clot or embolism, multi organ failure;・Respiration failure due to pulmonary edema;・Excess strain on the cardiovascular system due to decreased circulating plasma volume; etc.
--All of the above conditions may threaten life.

● Retention of Records and Disclosure of Information
Aiiku Hospital retains the records of your name and address, the preparation’s name and lot No. (production
number), and the date of administration for twenty years. If any events should occur requiring action to prevent
occurrence or expansion of health hazards due to the use of blood transfusion, we may present the records to the
preparation’s manufacturer and/or Japanese administrative agencies.

Doctor who gave the information:

Hideki Sakamoto

Nurse/midwife in charge:
Date:

We have been fully informed about the necessity and risks of the transfusion and plasma preparations
therapies. We have understood and consent to the therapies, related treatments and tests.
Date:
Patient's signature(Family member's signature, patient's)

＜Aiiku Hospital has adopted the following plasma fraction preparations.＞To

Product nameBlood

Non-bloodbeDonation-

Donation-usedderivedderived□Neuart I.V. 1500 units□

Anthrobin P 1500 for Injection□

TachoSil Tissue Sealing sheet 9.5cm×4.8cm□

Fibrinogen HT I.V. 1g -BENESIS□(Antithrombin)(Antithrombin)

○

Japan

○

Japan

(Fibrinogen)(Fibrinogen)

Source○○fibrinogen）

US, Germany, Austria
Japan

○

Beriplast P Combi-Set Tissue adhesion (3mL) (Factor XIII with

US, Germany, Austria□

BOLHEAL (3mL) (Factor XIII with fibrinogen）

○

Japan

□

Albumin 5% I.V. 12.5g/250mL -BENESIS(Albumin)

○

Japan

□

Venoglobulin IH 5% I.V. 0.5g/10mL (Immunoglobulin)

○

Japan

□
□

Anti-DGLOBULIN

for

I.M.

injection

1000 「 NICHIYAKU 」○(Immunoglobulin)
Anti-HBs Human Immune Globulin I.M. 200 units/1mL “Nisseki”(Immunoglobulin)

US

○

Japan

○

Japan

○

Japan

□

Neuart I.V. 500 units□

Anthrobin P 500 for Injection□

Kogenate-FS BIO-SET 500 IU (Factor VIII: genetical recombination)

○

US

□

Fibrogammin P I.V. (Factor XIII)○US, Germany, Austria○

US, Germany, Austria□(Antithrombin)county(Antithrombin)

Beriplast P Combi-Set Tissue adhesion (1mL) (Factor XIII withfibrinogen）□

BOLHEAL (1mL) (Factor XIII with fibrinogen）

○

Japan

□

Venoglobulin IH 5% I.V. 2.5g/50mL (Immunoglobulin)

○

Japan

○

Japan

○

Japan

□
□

Anti-HBs Human Immune Globulin I.M. 1000 units/5mL “Nisseki”(Immunoglobulin)
Sekijuji albumin 20% I.V. 4g/20mL (Albumin)

Information and Consent Form about Anesthesia(for Surgery/Treatment)
Department of Anesthesiology, Aiiku Hospital

Method of anesthesia (planned)□ General anesthesia
General anesthesia is means with which the patient is made asleep with medication.
It includes various kinds including from mild one which causes vaguely sleepy feelingto deep one which causes deep sleep followed by complete mechanical ventilation.
Your anesthesiologist selects the safest method for each patient.
In cases of deep general anesthesia where breathing is completely controlled, air issent mechanically through an instrument (through which a tube is inserted into thetrachea or a mask is put into the mouth) inserted by the anesthesiologist to enable
ventilation, that is artificial respiration.
(Possible complications/adverse reactions）
Nausea/vomiting, Hoarse voice for a few days (following tube insertion through the trachea),
Tooth damage, Pneumonia, Pulmonary atelectasis (partial collapse of the lung),
Pneumothorax (perforation of the lung), Lung edema, Heart failure,
Malignant hyperpyrexia (unusually high fever, very rare)□ Spinal anesthesia
Spinal anesthesia is a means to temporarily immobilize the lower body, without
making the patient sleepy.
The procedure consists of insertion of a needle through the space of the backbone(lumbar spine) and injection of medicine(s) into the spinal subarachnoid space aroundthe spinal cord. Soon after injection, the lower body from the navel downward
becomes virtually immovable (it becomes movable again a few hours after the surgery).
The immovable part of the body feels no pain, though there is sensation of being
touched.
(Possible complications/adverse reactions）
Headache (it heals in about a week in most cases), Hypotension, Nausea/vomiting,Temporary decrease in sensation/muscle weakness in the lower extremity,
Nerve injury (on very rare occasions, paralysis may persist long),
Epidural hematoma (accumulation of blood), Epidural abscess (collection of pus)□ Epidural anesthesia
Epidural anesthesia is used in many cases to alleviate postoperative pain.
In some cases, operation may be performed only with epidural anesthesia (when theanesthesiologist judges that the procedure is safest).
For epidural anesthesia, a needle is inserted through the space of the backbone (spine)
and a very thin tube named catheter is inserted into the epidural space near the spinal
cord. Medicine(s) is injected through the catheter to eliminate the pain.
The catheter is left there for several days after operation. You can sleep on your backeven with the indwelling catheter.
(Possible complications/adverse reactions）
Headache (it heals in about a week in most cases), Hypotension, Nausea/vomiting,Temporary decrease in sensation/muscle weakness in the lower extremity,
Nerve injury (on very rare occasions, paralysis may persist long),
Epidural hematoma (accumulation of blood), Epidural abscess (collection of pus)

□ Other methods of anesthesia:
None planned

Finally,
If an unexpected complication/adverse reaction should develop in association with
anesthesia or allergy, we would provide the best possible therapy.

◎ I gave information as described above including advantages and possible adverse reactions

for respective methods.
Date of giving information://(hour):, By Dr. Hideki SAKAMOTO◎ I was given the above information, asked any questions, and understood what was told.

I thus give consent to receiving the anesthesia.
Date:

/

/

, Patient’s signature:

Signature of family member:

Relationship: