Developing standardized informed consent for hysterectomy and vulva cancer surgery.

Informed consent involves explaining the procedure to the patient and their guardian and obtaining their consent. Although informed consent is a fundamental component of patient care, it remains unstandardized in Korea. And various institutions use documents that differ in content and format. Improvements in economic standards, the growth and specialization of medical institutions, expanded health insurance coverage, and increased awareness of civil rights have emphasized the “patient’s right to self-determination” [ 1 2 ]. However, this has often led to discrepancies where patient expectations are not met due to inconsistent attention from medical personnel, resulting in dissatisfaction with treatment outcomes and increased legal disputes. Another growing issue is the need for more systematic English-language informed consent, essential for the increasing number of foreign patients seeking treatment in Korea. The Korean Society of Gynecologic Oncology (KSGO) has focused on developing informed consent forms for gynecological cancer surgeries in response to these challenges [ 3 ]. Standardizing informed consent poses significant difficulties due to the complexity and variability of medical procedures, patient demographics, and institutional policies. For instance, hysterectomy is a common gynecological procedure in South Korea, and in 2021 about 159.5 hysterectomies were performed per 100,000 women [ 4 ]. Despite its prevalence, there is lack of uniform content and structure of consent forms, which can vary widely across institutions. These discrepancies often arise from differences in individual physician preferences, resource availability, and institutional priorities. Vulvar cancer is a relatively rare, accounting for only 3%–5% of gynecologic malignancies, its incidence has been slowly rising, particularly in older populations [ 5 6 ]. Surgical management may involve wide local excision, partial or total vulvectomy, and inguinofemoral lymph node evaluation or sentinel lymph node biopsy [ 7 ]. However, vulvar cancer surgery is particularly demanding due to the high postoperative morbidity rates including wound breakdown, lymphedema, infection, and long-term quality-of-life issues [ 8 9 ]. The procedure often requires precise surgical techniques to achieve oncological safety while preserving as much normal anatomic structures as possible. These challenges highlight the need for detailed communication between physicians and patients, ensuring patients fully understand the risks, potential complications, and alternative treatments options. To address these difficulties, we developed new informed consent forms for laparoscopic-robotic hysterectomy and vulvar cancer surgery. This initiative aims to enhance patient comprehension and mitigate legal risks associated with inadequate or unclear communication during the informed consent process.

The KSGO formed an audit committee (director: Kwang-Beom Lee, secretary: Jae Man Bae) of gynecological oncologists. The committee members included Min-Sun Kyung, Myounghwan Kim, Mi-Kyung Kim, Min Jong Song, Soohyun Oh. Heon Jong Yoo, Geonwoo Lee, Dae-Hyung Lee, Sang-Hun Lee, and Ha Kyun Chang. Article 24-2 (Explanation Regarding Medical Acts) of the Korean Medical Service Act mandates that a physician explain significant risks associated with surgeries, blood transfusions, or general anesthesia to patients or their legal representatives and obtain written consent, except in emergencies where delays could endanger the patient or cause serious harm. The information that must be included in consent is as follows: 1) Diagnosis of symptoms that have occurred or may occur in the patient. 2) The necessity, method, and details of the surgery; 3) The name of the physician, dentist, or Korean medicine doctor providing the explanation, as well as the primary physician, dentist, or Korean medicine doctor participating in the surgery; 4) Typical aftereffects or side effects expected from the surgery; and 5) Matters the patient must comply with before and after the surgery [ 10 ]. During the first meeting on April 6, 2023, the committee members decided to develop an informed consent form for laparoscopic hysterectomy and vulvar cancer surgery based on existing gynecologic surgery informed consent and secured consent forms from various hospitals. After the second meeting on April 28, 2023, a draft consent form for vulvar cancer surgery, which included the original 16 basic items, was presented at the third meeting on June 27, 2023 ( Table 1 ). At the fourth meeting on July 26, 2023, we decided to further revise the document address complications, the definition of the surgery, and illustrations. The final version was formalized during the fifth meeting on September 21, 2023. A similar process was followed for laparoscopic hysterectomy. In the third meeting, the title of the consent form was changed to ‘Laparoscopic-Robotic Hysterectomy Consent Form,’ and partial hysterectomy was added. Uterine prolapse and postpartum hemorrhage were included as indications for surgery. At the fourth meeting, explanations of the indications were omitted; only brief titles were retained and the postpartum hemorrhage section was removed. At the fifth meeting, a distinction was made between complete and partial oophorectomies within the scope of surgery, and the options for ovarian and fallopian tube preservation were deleted.

This includes the patient’s identification number, full name, date of birth, age, and sex. It consists of the operating surgeon’s diagnosis, the name of operation, approach, extent of the procedure, expected surgery date, and the surgeon’s name and specialty. The patient’s health status includes any history of disease or injury; allergy; idiosyncrasies; diabetes; hypertension or hypotension; drug abuse; airway disorder; smoking; bleeding disorder; cardiovascular, pulmonary, or renal disease; or other problems. Data on the current medications and test results were collected. The indications, purposes, and benefits of surgery were specified. We identified risk factors that could compromise the safety of surgery and delay recovery post-surgery. These risk factors include age >70 years, prolonged operations, extensive surgery, limited physical activity, malnourishment, and chronic diseases such as hypertension, diabetes, or immunological disorders. We explained alternative treatments and their possible outcomes. The potential for disease progression, a poor quality of life, and even death was outlined for patients who choose not to receive treatment. The overall process and extent of the surgery are presented with the figures. The possibilities of a change in the surgical approach or extent are described. The approximate duration of the surgery, including preparation and stabilization times in the recovery room, was explained. We clarify that the operating surgeon may be changed due to the patient’s condition or institutional circumstances. In such cases, the reason will be explained to the patient or guardian, and written consent will be obtained before or immediately after surgery. Each consent form categorized potential complications and their management following surgery. Common precautions required immediately after surgery such as those encouraging coughing or deep breathing, as well as those regarding eating, ambulation, and showering, were clearly specified in the consent form. Furthermore, the situations requiring a visit to the hospital were also explained. Consent should be requested for the following: administering anesthesia, blood transfusions, marking the surgical site, performing frozen sectioning and pathological examinations, the possibility of special examinations, and the use of their biological material for research (human-derived materials research). This blank space can be used to provide additional explanations for surgery-related questions. The physician’s explanation should clarify the benefits and potential complications of the surgery, possible changes to the approach and extent of the surgery, and any changes to the operating surgeon. Physicians should also obtain patient consent regarding the possibility of medical students observing or participating in the operation for educational purposes. It is essential to ensure that the patient understands the explanations, accurately informs the physician about their condition, and agrees to cooperate during the surgery. The patient’s signature should be obtained; however, if a guardian signs on their behalf, the reason for this must be specified. (1) In “Surgery information,” we classify the surgical approach into laparoscopic, robotic, or a combination of laparoscopic and robotic methods. The extent of the surgery was defined as follows: whether total or subtotal hysterectomy was performed, whether the ovaries were completely or partially removed, and whether the fallopian tubes were removed. (2) The indications or purpose of the surgery includes the following conditions: 1) leiomyomas or adenomyosis; 2) abnormal uterine bleeding; 3) intractable dysmenorrhea; 4) pelvic pain; 5) cervical intraepithelial neoplasia; 6) endometrial hyperplasia; 7) pelvic inflammatory disease; 8) endometriosis; 9) pelvic organ prolapse; 10) conditions where hysterectomy is necessary to complete treatment; and 11) others [ 11 12 ]. (3) The possibility of changing the surgical approach is described if it is difficult to safely perform minimally invasive surgery due to other concomitant gynecologic diseases, large tumors, abdominal adhesions from previous surgeries, or suspected malignancies before surgery. Additionally, the occurrence of severe bleeding or the presence of significant adhesions, that raise concerns regarding damage to adjacent organs, during surgery, may result in the procedure being converted to a laparotomy. If malignancy is strongly suspected based on surgical findings, a diagnostic laparotomy, including salpingo-oophorectomy and lymphadenectomy, may be performed. (4) The potential complications and management following surgery are included and categorized as follows: 1) complications related to laparoscopy; 2) adjacent organ injury; 3) bleeding; 4) pain; 5) thromboembolism; 6) bowel obstruction; 7) surgical wound and other infections; 8) urinary disorders; 9) fistula with adjacent organs; 10) reduced motor and sensory function [ 13 14 ]. (5) We explain the risk of developing vaginal or vulvar cancer after total hysterectomy and recommend that selected patients continue receiving Pap smears [ 15 16 ]. (1) In “Surgery information,” the extent of the surgery is divided into excision of the primary lesion, laterality, inguinofemoral lymphadenectomy, and skin grafting. Excision of the primary lesion is classified into local excision, wide excision, partial vulvectomy, total vulvectomy, radical vulvectomy, and excision of recurrent tumors [ 7 17 ]. Inguinofemoral lymphadenectomy features sentinel lymph node biopsy, ipsilateral lymphadenectomy, and bilateral lymphadenectomy owing to sentinel lymph node biopsies being recommended as an alternative to full lymph node dissections in early-stage vulvar cancer [ 18 19 ]. (2) Radiotherapy is suggested as the alternative treatment and the possible outcomes and complications of receiving radiotherapy are presented. Furthermore, the possibility of requiring additional radiotherapy is explained after surgery [ 20 ]. (3) We explained the extent of vulvar cancer surgery based on the location of the primary tumor, the necessity of inguinal lymph node dissection, the type of disease, and patient preferences. Surgical approaches are described as the excision of the primary lesion, an inguinofemoral lymphadenectomy, and the possibility of a skin graft [ 7 20 ]. Cooperation with other departments is required if metastasis to adjacent organs, such as the gastrointestinal or urinary system, is evident or if such organs are injured during surgery. (4) In “Risk, complications, and management after surgery,” wound dehiscence and infection are emphasized due to their high incidence. Herein, we describe the management of wound complications, including the use of antibiotics, re-suturing, debridement, and drainage. In addition, we discuss the risk of lymphedema or lymphocele after surgery and the possibility of persistent symptoms or recurrence. Patients may not be allowed to ambulate to prevent wound dehiscence, thereby increasing the risk of thromboembolism [ 21 22 ]. The final versions of the informed consent forms are provided in Appendices 1 and 2 , while the Korean versions are available in the supplementary materials ( Documents S1 and S2 ).

The KSGO has developed a comprehensive consent form for laparoscopic-robotic hysterectomy and vulvar cancer surgery to enhance communication between physicians and patients. This document ensures that patients are well informed about their diagnoses, procedures, and associated risks, thereby improving overall satisfaction and minimizing potential legal disputes. While comprehensive information is increasingly emphasized in medical practice, this informed consent form is designed to complement, not replace, the physician’s duty to provide a thorough explanation of the procedure. Additionally, as the healthcare system increasingly serves diverse populations, including foreign patients, these standardized forms will facilitate explicit communication across language barriers. In the future, there is a continued need to develop informed consent forms related to other cancer treatments, such as chemotherapy.