FIGO best practice guidance in surgical consent

Obtaining medical consent preoperatively is one of the key steps in preparing for surgery, and is an important step in informed decision making with the patient. According to good medical practice guidelines, doctors are required to have the knowledge and skills to treat patients as well as inform them, respect their wishes, and establish trust between themselves and their patients. Valid consent includes elements of competence, disclosure, understanding, and voluntariness. Documentation of these elements is also very important. The International Federation of Gynecology and Obstetrics (FIGO) Education Communication and Advocacy Consortium (ECAC) has realized that the quality of consent varies considerably across the world and has developed simple guidelines regarding consent and procedure‐specific checklists for the most common obstetric and gynecological procedures.


K E Y W O R D S
cesarean section, consent, delivery, gynecology, hysterectomy, hysteroscopy, laparoscopy, myomectomy, obstetrics, surgery

| INTRODUC TI ON
Obtaining medical consent preoperatively is one of the key steps in preparing for surgery.As part of good medical practice guidance, doctors are required to have the knowledge and skills to treat patients as well as inform them, respect their wishes, and establish trust between themselves and their patients. 1Once these grounds are established, it is necessary to obtain informed consent prior to surgery.Obtaining valid informed consent is not only a signature on a form before the surgery, but a process whereby the patient is thoroughly informed about the procedure by their surgeon: about the benefits, risks, and alternatives, discussing the patient's concerns and wishes, and the patient providing informed and deliberate consent for the proposed treatment. 1,2taining medical consent is part of informed decision making with the patient that requires sufficient time, information, and clarity.Which surgery is needed to treat a disease and how that surgery is performed does not differ from one center to another.Therefore, the preoperative discussion between the surgeon and the patient should also not differ.
The International Federation of Gynecology and Obstetrics (FIGO) is dedicated to the improvement of women's health and rights and to the reduction of disparities in health care available to women and newborns, as well as to advancing the science and practice of obstetrics and gynecology.FIGO Education Communication and Advocacy Consortium (ECAC) has realized that the quality of consent varies considerably throughout the world.
Therefore, FIGO ECAC decided to develop simple guidance regarding consent and procedure-specific checklists for the most common obstetric and gynecological procedures together with the World Association of Trainees in Obstetrics and Gynecology (WATOG).
To standardize medical care, it is important to understand what constitutes good consent, and FIGO has endorsed this guidance for the most common obstetric and gynecological procedures.

| Capacity/competence
It must be demonstrated that the patient has the ability to understand the information provided, analyze/process that information, and make a decision that is in her best interest, based on the provided information.
Patients must have attained the legal age of competency and possess the mental capacity to give informed consent.
In the case of a minor, or when it has been established that a patient does not possess the mental capacity to give informed consent due to a serious condition or if unconscious or comatose, consent can be given by a surrogate or substitute decision maker, usually a parent, spouse, or offspring.
The patient must have the capacity to make a healthcare decision.It is important to ensure that: • they understand that they are ill and require treatment • they understand their treatment options and the general risks and benefits of each • they have the capacity to make sense of the information presented and can process it rationally to reach a decision that furthers their healthcare goals • they have the capacity to communicate their wishes.Incapacitated patients do not lose their right of consent.Instead, it is transferred to an authorized surrogate decision maker to exercise on their behalf.
Coercion can arise from individuals who may not be present in the room, but who have a relationship of power over the patient.If we have reason to suspect this, we can ask a general question, such as "Do you feel safe and free to give consent?Are you feeling pressure from anyone to have this operation?".

| Disclosure
Patients should be provided with accurate, necessary, and relevant information to enable them make an informed and autonomous decision, taking into account their concerns and wishes.Information should be provided in clear, unambiguous, and simple language that is easily understood by the patient.In case of language differences or barriers, a professional medical interpreter/translation service should be employed.
Information provided should include the diagnosis, the name and description of the proposed procedure/intervention, the intended benefits of the procedure, the possible complications/ risks, any extra procedures that may become necessary during the procedure, alternative treatments (including no treatment and non-operative care in case of consent for surgery)-including the benefits and risks of the alternatives, and the options and risks of anesthesia.
Even though it is often impracticable to discuss every potential risk or complication with the patient, the most likely and/or serious risks must be explained.To make a rational healthcare decision, reasonable people need to know their choices and the general benefits and harms of each choice.Physicians should communicate the risks of treatment to the extent that they are common or serious.Risks should be expressed as percentages (e.g.10%) or frequencies (e.g. 10 in every 100 people).The latter with a corresponding verbal descriptor better conveys information on risk, such as "very common" corresponds to 1/1-1/10, and "very rare" is less than 1/10 000.The patient should be allowed to discuss the mode of anesthesia and its risks in detail with the anesthetist before the planned procedure.

| Understanding
Comprehension of the information provided must be confirmed by asking the patient to recap or summarize what has been disclosed to her, and to allow sufficient time to ask questions and clarifications.
After a recap of disclosed information by the patient, any identified gaps in the patient's understanding must be addressed by repeating the misunderstood parts of the information.

| Voluntariness
Patients should be allowed to use the information disclosed to intentionally and voluntarily make a decision, without coercion or inducement.The consent process should not be a one-off event occurring immediately before the planned procedure.It should ideally, except in emergencies, involve multiple sessions and encounters, so that the patient has ample time to further discuss and reflect on the disclosed information before making a decision.Until the planned procedure has commenced, the patient reserves the right to withdraw her consent and this should be respected.
The patient must consent freely: • Patients should not be coerced into accepting treatment by a physician.
• Making a strong treatment recommendation is persuasion, not coercion.Coercion is the use of threats that a reasonable person would not be expected to resist.
It is appropriate to document a refusal of surgery when that choice carries considerable risk.

| D O CU M E NTATI O N
All of the above discussions should be fully documented in the patient's records.The patient's consent is completed by the patient signing a "consent form", which is included in her medical records.This form is often standardized in a hospital or region, and it is usually generic and not specific to obstetrics and gynecology.Hence, it is necessary to augment it with any additional relevant information.The consent form should be countersigned by the personnel administering and witnessing the consent process.If the patient has objected to the use of a particular instrument or any procedures aside from the one planned, this should be documented in the signed consent form.

| CHALLENG E S AND S ITUATIONS DO C TOR S S HOULD AVOID WHEN OBTAINING INFORMED CONS ENT
Surgery produces anxiety in patients, and some display this stress more than others.Hearing their surgeon iterate a long list of things that can go wrong is frightening.Another challenge is the language barrier when a friend or family member translates the surgeon's explanations into brief sentences, with the patient receiving a fraction of the information provided.A hospital interpreter can be a valuable resource.
Informed consent requires surgeons to make reasonable attempts to answer the patient's questions.With all the information available on the Internet, patients may wish to engage in an intensive, detailed discussion, and the surgeon must be patient while facilitating their understanding of the wealth of data they have acquired. 1,2oper documentation is the only objective measurement of what the information was communicated to the patient and provides legal protection for the surgeon.The following is an example of proper documentation of an informed consent discussion: 2 The patient was advised that laparoscopic hysterectomy was indicated to prevent further episodes of bleeding due to fibroids.The nature of the surgery and the risk of conversion to open laparotomy for unexpected bleeding, infection, or injury to an organ during the operation was discussed with the patient and her husband.We talked about the postoperative course and potential complications, including wound infection and herniation.I advised them of common risks for all surgery, such as pneumonia and venous thrombosis.She understood and wished to proceed with surgery.
The planned date of surgery is after 2 weeks.
The dialogue and documentation of informed consent for surgery have evolved from a brief chat and a quick signature into a major and sometimes complex component of surgical practice.We can anticipate more changes in the future in response to patient expectations regarding communication and information.
The challenge now is that there is so much information to convey, it is easy to miss an item or overlook one area or complication, and this may lead to inadequate or incomplete consent.FIGO has developed a standardized checklist that acts as an aide memoire to assist the consent process and to improve the documentation ultimately leading to better patient care and transfer of information.

| CON S ENT CHECKLIS TS
Downloadable and printable FIGO consent checklists for common obstetric and gynecological procedures are included below, and also as supplementary material to this article.Individual forms can be downloaded from the 'Additional information' section at the foot of this online article, and are free to use and reproduce.

A checklist of consent guidelines was established as follows:
Checklist headings

DIAGNOSTIC HYSTEROSCOPY
A hysteroscopy is the examination of the inside of the vagina, cervix, and uterus under general anesthesia using a narrow telescope with a light and camera at the end.

Intended benefits
• To identify the cause of symptoms, infertility, anomalies, bleeding, abnormal smear, biopsy, etc.As this is a diagnostic procedure, it will not alter symptoms unless additional procedures are anticipated.

Possible additional procedures
• Laparoscopy and/or laparotomy in case of suspected damage, perforation, bleeding, etc. • To carry out tubal occlusion for sterilization (a procedure where a micro-insert is placed into each of the fallopian tubes).

Alternative measures
• Conservative management (management of heavy menstrual bleeding or other conditions without an invasive procedure).

Possible additional procedures
• Blood transfusion • In the event of perforation, a laparotomy or laparoscopy can be performed • In cases of failure to control bleeding, a hysterectomy can be performed (rare).

Intended benefits
• To find the cause of symptoms-the procedure is diagnostic and will not treat symptoms unless required.

Alternative measures
• Conservative management (if possible without an invasive procedure).

Frequent risks
Note: All risks are increased in those who are obese (BMI >30 kg/m 2 ), have had previous abdominal surgery, or have pre-existing medical conditions.
• Failure to identify disease

• Bruising
• Pain or discomfort across the shoulders due to the collection of gas used during the operation to distend your abdomen.

Serious risks
• Injury to adjacent organs or blood vessels in the pelvis, such as the bladder, bowel, or womb (0.3%) • Infection requiring antibiotics • Failure to gain entry to the abdominal cavity • Uterine perforation • The overall risk of complications is 2/1000 (0.02%) • 1 in 12 000 women (0.008%) die as a result of complications.

Possible additional procedures
• Proceeding from laparoscopy to laparotomy • Repairs of any injured organs • Blood transfusion if profuse bleeding occurs • More extensive surgery to treat an injury; this may require making a cut to open the abdomen, known as a laparotomy.This may be necessary at the time of the operation, or may require a second operation at a later date.

I hereby confirm that I have been fully informed about this pro-
cedure.I understand and I am aware of all the risks and benefits.
• Name and signature (patient) and date

________________________________________________________
• Name and signature (Medical Officer) and date

FU R T H E R R E A D I N G
1. Royal College of Obstetricians and Gynecologists.Diagnostic laparoscopy.Consent advice no.2.2017.
Patient ID

OPERATIVE LAPAROSCOPY-REMOVAL OF ENDOMETRIOMA
An operative laparoscopy involves the insertion of a laparoscope through a sub-umbilical incision, and abdominal incisions for trocars.
The pelvis is temporarily inflated with gas.The endometrioma is removed using different techniques (stripping, coagulating, laser vaporization, etc.).

• Elimination of endometriotic tissue • To carry out adhesiolysis (division of adhesions)
• To collect tissue for histological assessment • To preserve the maximum amount of normal ovarian tissue • To improve pain.

Serious risks
• Damage to the bowel, bladder, uterus, or major blood vessels, which would require immediate repair by laparoscopy or laparotomy (uncommon, 2 in 1000) • Failure to gain entry to the abdominal cavity and to complete the intended procedure • Hernia at the site of entry (uncommon, 1 in 100) • Death as a result of complications (3-8 in 100 000).

Possible additional procedures
• Laparotomy • Repair of damage to the bowel, bladder, uterus, or blood vessels • Blood transfusion • Two-or three-step approach for large endometriomas.
I hereby confirm that I have been fully informed about this procedure.I understand and I am aware of all the risks and benefits.
• Name and signature (patient) and date

________________________________________________________
• Name and signature (Medical Officer) and date

TOTAL LAPAROSCOPIC HYSTERECTOMY
A total laparoscopic hysterectomy is the removal of the uterus with or without the cervix.It is a total hysterectomy, where both the uterus and cervix (neck of the womb) are removed.

Intended benefits
• Menstruation will be stopped by total hysterectomy.However, the effect on pelvic pain and premenstrual symptoms is not guaranteed, and the likelihood of this effect should be discussed.

Alternative measures
• Vaginal hysterectomy or laparoscopically assisted vaginal hysterectomy • Subtotal hysterectomy, where just the uterus is removed and the cervix is not • Total abdominal hysterectomy.
I hereby confirm that I have been fully informed about this procedure.I understand and I am aware of all the risks and benefits.
• Name and signature (patient) and date

________________________________________________________
• Name and signature (Medical Officer) and date

FU R T H E R R E A D I N G TOTAL ABDOMINAL HYSTERECTOMY
Hysterectomy is the removal of the uterus.A transverse incision is made at the lower abdomen (suprapubic/midline) and the uterus and cervix are removed.

Intended benefits
• Hysterectomy is frequently performed to treat benign uterine pathology; however, it may be an option in the case of cervix dysplasia and in some stages of cervical cancer • To control abnormal uterine bleeding.

Frequent risks
Factors that contribute to a higher risk are: age over 40 years, systemic arterial hypertension, diabetes mellitus, asthma, allergies, obesity, malnutrition, anemia, and heart, lung, neurological, hematological, or varicose diseases.

Serious risks
• Injuries to nearby organs, such as the bladder, ureters, and bowel, for which repair will be needed (<1%) • Vesicovaginal and intestinal fistulae (abnormal connections between the bladder and vagina or intestine and vagina) (<1%) • Eventrations and postoperative eviscerations, descent or prolapse of the vaginal cuff (<1%) • Venous thromboembolism can still occur, even with prophylaxis • Death should be considered a major complication of the surgical procedure-the main causes are pulmonary embolism, venous thrombosis, and cardiac disease (rare, 32 in 100 000 cases).

Possible additional procedures
• Blood transfusion • Removal of one or both ovaries in case of ovarian pathology (hysterectomy with bilateral salpingo-oophorectomy) • In some cases, it is not possible to remove the entire uterus, therefore a subtotal abdominal hysterectomy should be performed (removal of the uterus without the cervix).
I hereby confirm that I have been fully informed about this procedure.I understand and I am aware of all the risks and benefits.
• Name and signature (patient) and date

________________________________________________________
• Name and signature (Medical Officer) and date

VAGINAL HYSTERECTOMY AND VAGINAL REPAIR
The vaginal hysterectomy and vaginal repair procedure involves removal of the uterus.With pelvic floor repair, it can include vaginal wall(s) reconstruction and/or urinary bladder and bowel placement to the correct anatomical position.

Intended benefits
• To improve or resolve symptoms of uterine prolapse (pressure in the vagina or lower abdomen); to resolve the feeling that "something will fall out" • Absence of periods, loss of fertility potential • Faster recovery and fewer days of hospitalization (minimally invasive).

Alternative measures
• Conservative treatment, such as physiotherapy or pessary placement • Abdominal (with transverse incision to the lower abdomen) or laparoscopic (endoscopic) approach in hysterectomy.

Frequent risks
Risks are increased in women with pre-existing medical conditions (cardiovascular disease, neurological disorders), in women who had previous surgeries, or those who have tissue resulting from a BMI >30 kg/m 2 .

Possible additional procedures
• Blood transfusion(s) (2%) • Laparotomy (conversion to abdominal surgery with an incision from the lower abdomen) if serious injuries of visceral organs occur.Patient ID

I hereby confirm that
additional procedures • Name, signatures, and date Consent checklists for the following procedures can be found below: • Diagnostic hysteroscopy • Operative hysteroscopy • Diagnostic laparoscopy • Operative laparoscopy -removal of endometrioma • Total laparoscopic hysterectomy • Total abdominal hysterectomy • Vaginal hysterectomy and vaginal repair • Open/abdominal myomectomy • Elective cesarean delivery • Cesarean delivery for placenta previa • Vaginal twin delivery • Operative vaginal delivery • Vaginal breech delivery.

•
Antibiotics to reduce infections • Analgesia to reduce pain • Blood transfusion (rare).I hereby confirm that I have been fully informed about this procedure.I understand and I am aware of all the risks and benefits.• Name and signature (patient) and date ________________________________________________________ • Name and signature (Medical Officer) and date ________________________________________________________ FU R T H E R R E A D I N G1.American College of Obstetricians and Gynecologists.Committee Opinion.The use of hysteroscopy for the diagnosis and treatment of intrauterine pathology.Accessed September 7, 2023.https:// www.acog.org/clinical/clini cal-guida nce/commi ttee-opini on/artic les/2020/03/the-use-of-hyste rosco py-for-the-diagn osis-and-treat ment-of-intra uteri ne-patho logy 2. Vitale SG, Della Corte L, Ciebiera M, et al.Hysteroscopic endometrial ablation: from indications to instrumentation and techniques-A call to action.Diagnostics (Basel).2023;13(3):339.doi:10.3390/diagnostics130303393. Bradley LD.Overview of Hysteroscopy.UpToDate.Waltham, MA: UpToDate Inc. Accessed April 14, 2023.http://www.uptodate.com/onlin e/conte nt/topic.do?topic Key=gyn_surg/13448 &view=print 4. ACOG Committee Opinion No. 800: the use of hysteroscopy for the diagnosis and treatment of intrauterine pathology.Obstet Gynecol.2020;135(3):e138-e148.Patient IDOPERATIVE HYSTEROSCOPYAn operative hysteroscopy is a technique for the treatment of certain processes affecting the uterus, such as abnormal uterine bleeding or others.A hysteroscope (a thin camera) is inserted into the vagina and through the cervix to examine the inside of the uterus.The uterus is filled with fluid to make it possible to see inside and perform surgery.The surgeon will remove a structure that may be causing symptoms or perform a biopsy to aid the diagnostic process.Intended benefits• To obtain a biopsy• To treat symptoms by removing structures in the endometrial cavity, e.g.polyp(s), fibroid(s), septum, adhesion(s), and retained products of conception• To carry out endometrial ablation (an operation used to treat heavy periods, using a device to apply heat to the womb lining) the insertion of a laparoscope via a sub-umbilical incision.The pelvis is temporarily inflated with gas.The pelvis is imaged through the laparoscope.The procedure may require a suprapubic incision.Discussion and consent is required for any additional anticipated procedures, e.g.hydrotubation (trans-cervical flushing of fluid through the fallopian tubes), biopsy, aspiration of a cyst, treating endometriosis, or division of adhesions.

••
I have been fully informed about this procedure.I understand and I am aware of all the risks and benefits.Name and signature (patient) and date ________________________________________________________ Name and signature (Medical Officer) and date ________________________________________________________ FU R T H E R R E A D I N G 1. Royal College of Obstetricians and Gynecologists.Presenting Information on Risk.Clinical Governance Advice No. 7. London: RCOG.2008.www.rcog.org.uk/womens-health/clini cal-guida nce/ prese nting-infor mation-risk 2. Royal College of Obstetricians and Gynecologists.Vaginal surgery for prolapse.Consent Advice No. 5. London: RCOG.2009.www.rcog.org.uk/guidance/browse-all-guida nce/conse nt-advic e/vagin al-surge ry-for-prola pse-conse nt-advice-no-5