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1.
Gynecol Oncol Rep ; 55: 101489, 2024 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-39281843

RESUMO

Background: Number of organ transplant recipients continues to rise worldwide with increasing accessibility and growing advancements in transplant medicine. Transplant patients have at least a two-to-four fold higher risk of developing cancer compared to the general population. As the prevalence of transplant patients increases, a growing number of these patients are expected to present with concurrent conditions such as cancer, requiring more complex and interdisciplinary care. Case: A 44-year-old patient with an intraperitoneal pelvic renal transplant, found to have high-grade ovarian adenocarcinoma most likely arising from endometriosis, successfully underwent surgical staging, adjuvant chemotherapy, and subsequent pelvic radiation for recurrence. Her kidney function and graft viability were preserved throughout her treatment with careful monitoring. Conclusion: Management of reproductive tract cancers in kidney transplant recipients is complex. Current practices largely rely on evidence from observational studies and case reports for these cancers and more research is needed in this area.

2.
J Clin Med ; 13(15)2024 Aug 02.
Artigo em Inglês | MEDLINE | ID: mdl-39124796

RESUMO

Objectives: To determine the association between ovarian endometriomas and stage of endometriosis. Methods: A total of 222 women aged 18-55 years old, who underwent minimally invasive surgery between January 2016 and December 2021 for treatment of endometriosis were included in the study. Patients underwent laparoscopic and/or robotic treatment of endometriosis by a single surgeon (FRN) and were staged using the ASRM revised classification of endometriosis. Pre-operative imaging studies, and operative and pathology reports were reviewed for the presence of endometriomas and the final stage of endometriosis. Using univariate analyses for categorical variables and the two-sample t-test or Mann-Whitney test for continuous data, association between endometriomas, stage of endometriosis, type of endometrioma, and other patient parameters such as age, gravidity, parity, laterality of endometriomas, prior medical treatment, and indication for surgery was analyzed. Results: Of the 222 patients included in the study, 86 patients had endometrioma(s) and were found to have stage III-IV disease. All 36 patients with bilateral endometriomas and 70% of patients with unilateral endometriomas had stage IV disease. Conclusions: The presence of ovarian endometrioma(s) indicates a higher stage of disease, correlating most often with stage IV endometriosis. Understanding the association between endometriomas and anticipated stage of disease can aid in appropriate pre-operative planning and patient counseling.

3.
Life (Basel) ; 14(6)2024 May 30.
Artigo em Inglês | MEDLINE | ID: mdl-38929687

RESUMO

Endometriosis is a frequent, estrogen-dependent, chronic disease, characterized by the presence of endometrial glands and stroma outside of the uterine cavity. Although it is not considered a precursor of cancer, endometriosis is associated with ovarian cancer. In this review, we summarized the evidence that clear-cell and endometrioid ovarian carcinomas (endometriosis-associated ovarian carcinoma-EAOC) may arise in endometriosis. The most frequent genomic alterations in these carcinomas are mutations in the AT-rich interaction domain containing protein 1A (ARID1A) gene, a subunit of the SWI/SNF chromatin remodeling complex, and alterations in phosphatidylinositol 3-kinase (PI3K) which frequently coexist. Recent studies have also suggested the simultaneous role of the PTEN tumor-suppressor gene in the early malignant transformation of endometriosis and the contribution of deficient MMR (mismatch repair) protein status in the pathogenesis of EAOC. In addition to activating and inactivating mutations in cancer driver genes, the complex pathogenesis of EAOC involves multiple other mechanisms such as the modulation of cancer driver genes via the transcriptional and post-translational (miRNA) modulation of cancer driver genes and the interplay with the inflammatory tissue microenvironment. This knowledge is being translated into the clinical management of endometriosis and EAOC. This includes the identification of the new biomarkers predictive of the risk of endometriosis and cancer, and it will shape the precision oncology treatment of EAOC.

4.
Obstet Gynecol ; 143(6): 759-766, 2024 Jun 01.
Artigo em Inglês | MEDLINE | ID: mdl-38626453

RESUMO

Ovarian endometriomas affect many patients with endometriosis and have significant effects on quality of life, fertility, and risk of malignancy. Endometriomas range from small (1-3 cm), densely fibrotic cysts to large (20 cm or greater) cysts with varying degrees of fibrosis. Endometriomas are hypothesized to form from endometriotic invasion or metaplasia of functional cysts or alternatively from ovarian surface endometriosis that bleeds into the ovarian cortex. Different mechanisms of endometrioma formation may help explain the phenotypic variability observed among endometriomas. Laparoscopic surgery is the preferred first-line modality of diagnosis and treatment of endometriomas. Ovarian cystectomy is preferred over cyst ablation or sclerotherapy for enabling pathologic diagnosis, improving symptoms, preventing recurrence, and optimizing fertility outcomes. Cystectomy for small, densely adherent endometriomas is made challenging by dense fibrosis of the cyst capsule obliterating the plane with normal ovarian cortex, whereas cystectomy for large endometriomas can carry unique challenges as a result of adhesions between the cyst and pelvic structures. Preoperative and postoperative hormonal suppression can improve operative outcomes and decrease the risk of endometrioma recurrence. Whether the optimal management, fertility consequences, and malignant potential of endometriomas vary on the basis of size and phenotype remains to be fully explored.


Assuntos
Endometriose , Doenças Ovarianas , Humanos , Feminino , Endometriose/terapia , Endometriose/patologia , Endometriose/fisiopatologia , Endometriose/complicações , Endometriose/cirurgia , Doenças Ovarianas/cirurgia , Doenças Ovarianas/patologia , Doenças Ovarianas/terapia , Laparoscopia , Cistos Ovarianos/cirurgia , Cistos Ovarianos/terapia
5.
Obstet Gynecol ; 141(5): 1011-1013, 2023 05 01.
Artigo em Inglês | MEDLINE | ID: mdl-37023456

RESUMO

BACKGROUND: Congenital müllerian anomalies are found in 8.0% of women with infertility and up to 5.5% of women in a general population. Cervical diverticulum is a type of cervical malformation that can be congenital or acquired, with only select cases documented in the literature. Cervical diverticulum can be asymptomatic or present with abnormal uterine bleeding, pelvic pain, or infertility. Previously described management options are largely limited to observation or exploratory laparotomy. CASE: A 35-year-old woman, gravida 2 para 2, presented with persistent menorrhagia, pelvic pain, and abdominal bloating and was found to have an 8-cm right adnexal mass on pelvic ultrasonography. Magnetic resonance imaging showed a hemorrhagic cervical mass communicating with the uterine cavity. The mass was resected laparoscopically, and pathology revealed fibromuscular tissue with endocervical epithelium consistent with a cervical diverticulum. CONCLUSION: Isolated cervical diverticula are rare but should be considered in the differential diagnosis of adnexal masses. Laparoscopic surgery is a safe, minimally invasive approach for evaluation and repair of cervical diverticula.


Assuntos
Divertículo , Infertilidade , Laparoscopia , Humanos , Feminino , Adulto , Colo do Útero/cirurgia , Colo do Útero/patologia , Laparoscopia/métodos , Dor Pélvica , Infertilidade/cirurgia , Divertículo/diagnóstico por imagem , Divertículo/cirurgia
6.
CRSLS ; 10(1)2023.
Artigo em Inglês | MEDLINE | ID: mdl-37006378

RESUMO

Introduction: Cutaneous gluteal vaginal fistula is a rare but significant postoperative complication which may present years after sacrospinous ligament fixation (SSLF) surgery There is limited data on the management of cutaneous vaginal fistula following SSLF. Case description: This case report describes a 77-year-old who presents twenty years after SSLF with cutaneous gluteal vaginal abscess and fistula. She underwent successful management with CT-guided percutaneous drainage of gluteal abscess and placement of guiding cutaneous vaginal catheter, laparoscopic pelvic wall dissection and evaluation, and transvaginal localization and removal of the infected permanent suture. Discussion: Multi-disciplinary approach should be considered in the treatment of chronic fistula status post SSLF, including interventional radiology, urogynecology, and minimally invasive gynecologic surgery.


Assuntos
Prolapso de Órgão Pélvico , Fístula Vaginal , Feminino , Humanos , Idoso , Prolapso de Órgão Pélvico/cirurgia , Procedimentos Cirúrgicos em Ginecologia , Abscesso/diagnóstico por imagem , Ligamentos Articulares
8.
Am J Obstet Gynecol ; 228(6): 601-612, 2023 06.
Artigo em Inglês | MEDLINE | ID: mdl-36410423

RESUMO

Adnexal masses are identified in pregnant patients at a rate of 2 to 20 in 1000, approximately 2 to 20 times more frequently than in the age-matched general population. The most common types of adnexal masses in pregnancy requiring surgical management are dermoid cysts (32%), endometriomas (15%), functional cysts (12%), serous cystadenomas (11%), and mucinous cystadenomas (8%). Approximately 2% of adnexal masses in pregnancy are malignant. Although most adnexal masses in pregnancy can be safely observed and approximately 70% spontaneously resolve, a minority of cases warrant surgical intervention because of symptoms, risk of torsion, or suspicion of malignancy. Ultrasound is the mainstay of evaluation of adnexal masses in pregnancy because of accuracy, safety, and availability. Several ultrasound mass scoring systems, including the Sassone, Lerner, International Ovarian Tumor Analysis Simple Rules, and International Ovarian Tumor Analysis Assessment of Different NEoplasias in the adneXa scoring systems have been validated specifically in pregnant populations. Decisions regarding expectant vs surgical management of adnexal masses in pregnancy must balance the risks of torsion or malignancy with the likelihood of spontaneous resolution and the risks of surgery. Laparoscopic surgery is preferred over open surgery when possible because of consistently demonstrated shorter hospital length of stay and less postoperative pain and some data demonstrating shorter operative time, lower blood loss, and lower risks of fetal loss, preterm birth, and low birthweight. The best practices for laparoscopic surgery during pregnancy include left lateral decubitus positioning after the first trimester of pregnancy, port placement with respect to uterine size and pathology location, insufflation pressure of less than 12 to 15 mm Hg, intraoperative maternal capnography, pre- and postoperative fetal heart rate and contraction monitoring, and appropriate mechanical and chemical thromboprophylaxes. Although planning surgery for the second trimester of pregnancy generally affords time for mass resolution while optimizing visualization with regards to uterine size and pathology location, necessary surgery should not be delayed because of gestational age. When performed at a facility with appropriate obstetrical, anesthetic, and neonatal support, adnexal surgery in pregnancy generally results in excellent outcomes for pregnant patients and fetuses.


Assuntos
Doenças dos Anexos , Laparoscopia , Neoplasias Ovarianas , Nascimento Prematuro , Gravidez , Feminino , Humanos , Recém-Nascido , Doenças dos Anexos/diagnóstico por imagem , Doenças dos Anexos/cirurgia , Neoplasias Ovarianas/diagnóstico por imagem , Neoplasias Ovarianas/cirurgia , Prognóstico , Segundo Trimestre da Gravidez , Laparoscopia/métodos , Estudos Retrospectivos
9.
J Turk Ger Gynecol Assoc ; 23(4): 287-313, 2022 12 08.
Artigo em Inglês | MEDLINE | ID: mdl-36482657

RESUMO

In this review, we aim to evaluate the current literature on reproductive and oncologic outcomes after fertility-sparing surgery for early-stage cervical cancer (stage IA1-IB1). This is a systematic review of the existing literature using the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) checklist to report on fertility-sparing surgery and its outcomes in early-stage cervical cancer. Outcomes of interest were subsequent clinical pregnancy rate, reproductive outcomes, and cancer recurrence outcomes. Included in this systematic review were 68 studies encompassing 3,592 patients who underwent fertility-sparing surgery. Of these, reproductive outcomes were reported in 1096 pregnancies. The mean clinical pregnancy rate was 53.2%. Those who underwent vaginal radical trachelectomy had the highest clinical pregnancy rate (67.5%). The mean live birth rate was 67.8% in our study. Twenty-one percent of pregnancies after fertility-sparing surgery required assisted reproductive technology. The mean cancer recurrence rate was 3.2%, and the cancer death rate was 0.6% after a median follow-up period of 40.1 months with no statistically significant difference across surgical approaches. Offering fertility-sparing surgery in early-stage cervical cancer is reasonable. Highest clinical pregnancy rate is associated with vaginal radical trachelectomy. Moreover oncologic outcomes of minimally invasive approaches were comparable with abdominal approaches. We encourage detailed preoperative counseling and multidisciplinary approach to achieve best outcomes.

10.
JSLS ; 25(3)2021.
Artigo em Inglês | MEDLINE | ID: mdl-34456552

RESUMO

BACKGROUND AND OBJECTIVES: The rise in cesarean deliveries, has led to increase in maternal complications in subsequent pregnancies such as abnormal placental implantation, uterine rupture, hemorrhage and, less commonly, cesarean scar pregnancies (CSP). Our objective was to describe patient characteristics following a combined medical and surgical treatment approach to first trimester cesarean scar pregnancies. METHODS: This was a case series approved by the Institutional Review Board of cesarean scar pregnancies over a two-year period at a single academic institution. The study included five patients with diagnosed cesarean scar pregnancies opting for pregnancy termination with the desire for fertility preservation. Medical treatment involved intra-gestational sac injection of lidocaine followed by systemic injection of methotrexate. At a minimum of two months later, surgical resection of cesarean scar pregnancy and repair of the uterus was performed. RESULTS: Median patient age was 36 (range 34 - 42) years, with 4 (3 - 10) prior pregnancies and 2 (1 - 3) prior cesarean deliveries. 40% (2/5) were Hispanic, 20% (1/5) Caucasian, 20% (1/5) African-American, and 20% (1/5) South Asian. After medical intervention, patients waited on average 4.6 ± 2.3 months before surgery. No post-intervention complications or recurrences occurred. Two patients had a subsequent pregnancy. CONCLUSION: This case series demonstrates an ideal management of cesarean scar pregnancy using combined medical and surgical approach in treating current ectopic pregnancy and repairing the uterine defect successfully without recurrence.


Assuntos
Gravidez Ectópica , Procedimentos Cirúrgicos Robóticos , Adulto , Cesárea/efeitos adversos , Cicatriz/etiologia , Cicatriz/cirurgia , Feminino , Humanos , Placenta/patologia , Gravidez , Gravidez Ectópica/etiologia , Gravidez Ectópica/cirurgia
11.
Gynecol Oncol Rep ; 35: 100691, 2021 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-33521219

RESUMO

•Fertility treatment prior to definitive cancer therapy in stage IIB EOC.•Both fertility and oncologic outcomes were successful.•The role of Multidisciplinary team is critical.

12.
J Minim Invasive Gynecol ; 28(5): 942, 2021 05.
Artigo em Inglês | MEDLINE | ID: mdl-32882409

RESUMO

STUDY OBJECTIVE: To demonstrate intra- and postoperative steps in a successful management of a complicated vesico-[utero]/cervicovaginal fistula. DESIGN: Stepwise demonstration of the technique with narrated video footage. SETTING: A urogenital fistula in developed countries mostly occurs after gynecologic surgeries but rarely from obstetric complications. The main treatment of a urogenital fistula is either transvaginal or transabdominal surgical repair. We present a case of a 36-year-old woman, gravida 3 para 3-0-0-3, who developed a complicated large vesico-[utero]/cervicovaginal fistula after an emergent repeat cesarean section. Robotic repair was performed 2 months after the injury using the modified O'Connor method. Blood loss was minimal, and the patient was discharged from the hospital 1 day postoperatively. Follow-up showed complete healing of the fistula with no urine leakage, frequency of urination, or dyspareunia. The patient resumed normal bladder function and menstrual period up to 4 months after the repair procedure. INTERVENTIONS: The basic surgical principle of urogenital fistula repair is demonstrated: (1) development of vesicovaginal spaces by dissection of the bladder from the uterus and the vagina, (2) meticulous hemostasis, (3) adequate freshened of the fistula edges, (4) tension-free and watertight closure of the bladder. We also demonstrate some other techniques that have developed though our own practice: (1) facilitating bladder distention by temporarily blocking the fistula, (2) placement of a ureteral catheter to protect the ureters, (3) interposition with omental flap, (4) single layer through and through closure of a cystotomy with 2-0 V-Loc suture (Covidien, Irvington, NJ). CONCLUSION: Complicated urogenital fistulas may be repaired successfully using minimally invasive surgery using robotic assistance, enabling less blood loss, faster recovery, shorter hospital stay, and fewer complications, etc.


Assuntos
Fístula , Procedimentos Cirúrgicos Robóticos , Fístula Vesicovaginal , Adulto , Cesárea , Feminino , Humanos , Gravidez , Procedimentos Cirúrgicos Robóticos/efeitos adversos , Bexiga Urinária/cirurgia , Útero , Fístula Vesicovaginal/etiologia , Fístula Vesicovaginal/cirurgia
13.
Gynecol Oncol Rep ; 33: 100622, 2020 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-32885016

RESUMO

•Highly suspicious pelvic mass may require preoperative biopsy for diagnosis.•Neoadjuvant imatinib lowers EGIST tumor burden in extensive disease preoperatively.•EGIST resection aims at complete surgical resection and negative margins.•This case was managed with complete surgical resection and adjuvant imatinib.•Prognostic factors in EGIST are size, mitosis, location and genetic mutations.

14.
Fertil Steril ; 114(5): 1040-1048, 2020 11.
Artigo em Inglês | MEDLINE | ID: mdl-32826047

RESUMO

OBJECTIVE: To determine the incidence of fallopian tube endometriosis in patients undergoing laparoscopic surgery with a preoperative diagnosis of endometriosis, pelvic pain, infertility, or cystic adnexal mass. DESIGN: Retrospective cross-sectional study. SETTING: Gynecologic oncology and minimally invasive surgery practice. PATIENT(S): All patients who underwent surgery for endometriosis from July 2015 to June 2018 were included. Exclusion criteria were age ≥55 years, diagnosis of cancer, laparotomy, previous bilateral salpingectomy, and preoperative diagnosis other than endometriosis, pelvic pain, infertility, or cystic adnexal mass. INTERVENTION(S): Subjects were divided by those who did and those who did not have a salpingectomy at the time of surgery. MAIN OUTCOME MEASURE(S): Diagnosis of tubal endometriosis was based on macroscopic evidence of endometrial implants on the fallopian tube(s) noted within the operative report and microscopic evidence of endometriosis noted within the pathology report. RESULT(S): A total of 444 surgeries were performed and 185 met the study criteria. Among those, 153 (82.7%) had histologically diagnosed endometriosis within the abdominopelvic cavity. The incidence of tubal endometriosis was 11%-12% macroscopically and 42.5% microscopically after salpingectomy. Patients with tubal endometriosis were more likely to have severe disease. CONCLUSION(S): Among patients with endometriosis, the incidence of microscopic tubal endometriosis was significantly greater than that of macroscopic disease.


Assuntos
Endometriose/diagnóstico , Endometriose/cirurgia , Tubas Uterinas/patologia , Tubas Uterinas/cirurgia , Laparoscopia/métodos , Cirurgia Vídeoassistida/métodos , Adulto , Estudos Transversais , Feminino , Humanos , Pessoa de Meia-Idade , Estudos Retrospectivos
16.
Adv Exp Med Biol ; 1242: 59-72, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32406028

RESUMO

This chapter focuses on premalignant and malignant diseases of the endometrium (lining of the uterus). Endometrial carcinoma is the most common gynecologic cancer in the United States. Women have a 1 in 40 lifetime risk of being diagnosed with endometrial cancer, the fourth most common malignancy among women. An estimated 61,880 new diagnoses of uterine cancer and 12,160 deaths from the disease occurred in 2019 in the United States (American Cancer Society, Facts & Figures, https://www.cdc.gov/cancer/uterine/statistics/index.htm , 2019).


Assuntos
Neoplasias do Endométrio/patologia , Endométrio/patologia , Lesões Pré-Cancerosas , Neoplasias do Endométrio/epidemiologia , Feminino , Humanos , Estados Unidos/epidemiologia
17.
Adv Exp Med Biol ; 1242: 73-87, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32406029

RESUMO

Endometriosis is a gynecologic disease that affects over 10% of women of reproductive age causing pelvic pain, dysmenorrhea, and infertility, resulting in significant disability and reduced quality of life. Very recent genetic studies have suggested that endometriosis is a clonal disease in the epithelium and its development is independent of stroma, providing new insight into the genesis of endometriosis. The endometrioid tissue lining may also react by epithelial atypical hyperplasia and even neoplasia, in a manner somehow similar to that in the uterine cavity and under the same hormonal influences.


Assuntos
Endometriose , Neoplasias Ovarianas , Feminino , Humanos , Lesões Pré-Cancerosas , Qualidade de Vida
18.
Fertil Steril ; 113(4): 685-703, 2020 04.
Artigo em Inglês | MEDLINE | ID: mdl-32228873

RESUMO

This review sought to evaluate the current literature on reproductive and oncologic outcomes after fertility-sparing surgery for early stage cervical cancer (stage IA1-IB1) including cold-knife conization/simple trachelectomy, vaginal radical trachelectomy, abdominal radical trachelectomy, and laparoscopic radical trachelectomy with or without robotic assistance. A systematic review using the preferred reporting items for systematic reviews and meta-analysis (PRISMA) checklist to evaluate the current literature on fertility-sparing surgery for early stage cervical cancer and its subsequent clinical pregnancy rate, reproductive outcomes, and cancer recurrence was performed. Sixty-five studies were included encompassing 3,044 patients who underwent fertility-sparing surgery, including 1,047 pregnancies with reported reproductive outcomes. The mean clinical pregnancy rate of patients trying to conceive was 55.4%, with the highest clinical pregnancy rate after vaginal radical trachelectomy (67.5%). The mean live-birth rate was 67.9% in our study. Twenty percent of pregnancies after fertility-sparing surgery required assisted reproductive technology. The mean cancer recurrence rate was 3.2%, and the cancer death rate was 0.6% after a median follow-up period of 39.7 months with no statistically significant difference across surgical approaches. Fertility-sparing surgery is a reasonable alternative to traditional radical hysterectomy for early-stage cervical cancer in women desiring fertility preservation. Vaginal radical trachelectomy had the highest clinical pregnancy rate, and minimally invasive approaches to fertility-sparing surgery had equivalent oncologic outcomes compared with an abdominal approach. The results of our study allow for appropriate patient counseling preoperatively and highlight the importance of a multidisciplinary approach to achieve the best outcomes for each patient.


Assuntos
Preservação da Fertilidade/métodos , Reprodução/fisiologia , Neoplasias do Colo do Útero/cirurgia , Feminino , Preservação da Fertilidade/tendências , Humanos , Procedimentos Cirúrgicos Minimamente Invasivos/métodos , Procedimentos Cirúrgicos Minimamente Invasivos/tendências , Estadiamento de Neoplasias/métodos , Estadiamento de Neoplasias/tendências , Gravidez , Estudos Prospectivos , Estudos Retrospectivos , Resultado do Tratamento , Neoplasias do Colo do Útero/diagnóstico , Neoplasias do Colo do Útero/fisiopatologia
19.
JSLS ; 23(4)2019.
Artigo em Inglês | MEDLINE | ID: mdl-31624455

RESUMO

BACKGROUND: Endometriosis is a widely known benign disease, but 0.5%-1% of cases are associated with malignancy. It has been linked with ovarian neoplasms, particularly endometrioid and clear cell adenocarcinoma histology. Rhabdomyosarcomas are rarely associated with endometriosis. CASE: A 35-year-old patient underwent surgical management of endometriomas to optimize infertility treatment. She later developed abdominal pain with rapid recurrence of ovarian masses. This prompted additional surgery with biopsies diagnosing ovarian rhabdomyosarcoma. Retroactive review of pathologic specimens from her prior surgery demonstrated the neoplasm originated from her prior endometrioma. Focal areas suggested possible underlying ovarian adenosarcoma with stromal overgrowth. DISCUSSION: The incidence of rhabdomyosarcoma arising from endometriosis is exceedingly rare. The accuracy of diagnosing endometriosis and ruling out neoplasm requires coordinated efforts of a multidisciplinary team, involving radiologists, pathologists, oncologists, and gynecologic surgeons.


Assuntos
Transformação Celular Neoplásica , Endometriose/patologia , Neoplasias Ovarianas/patologia , Rabdomiossarcoma/patologia , Adulto , Feminino , Humanos
20.
Am J Obstet Gynecol ; 221(3): 230-232, 2019 09.
Artigo em Inglês | MEDLINE | ID: mdl-31121141

RESUMO

Randomized controlled trials of surgery are fundamentally different from randomized controlled trials of medications because it is difficult to blind or mask a surgical procedure or perform "sham" operations. An additional challenge is the variation in skills and surgical proficiency of participating centers and surgeons. Addressing heterogeneity in surgical proficiency remains of paramount importance, especially when randomized controlled trials involve a new or complex procedure such as minimally invasive radical surgery. In the presence of such heterogeneity, it is very cumbersome to evaluate objectively and monitor surgical skills so that most trials simply report associations that are averaged across surgeons and hospitals/centers. Such reporting is not transparent because the rates of complications and adverse outcomes are reported only as averages, and these averages may not apply to the individual participating surgeons or centers. These factors, coupled with the inherent nongeneralizability of findings from such randomized controlled trials, because of the strict inclusion and exclusion criteria for enrollment, may lead to conclusions that no longer apply to real life for individual surgeons or centers. Case in point is a recently published noninferiority randomized controlled trial that reported that minimally invasive radical hysterectomy was associated with lower rates of disease-free survival (86% vs 96.5% at 4.5 years) and overall survival (93.8% vs 99% at 3 years) than open abdominal radical hysterectomy in patients with cervical cancer. However, randomized controlled trials that involve 2 competing complex or new procedures may be affected by tremendous confounding because of variations in surgical proficiency and also nonstandardization for other confounding factors such as patient selection categories (ie, stage of cancer) and adjuvant postoperative therapies that may affect long-term survival. The purpose of this Viewpoint is not to provide an exhaustive review of the trial's shortcomings but to use it as an illustration to focus on 2 challenging areas that most randomized controlled trials of a new complex surgical procedure suffer from: (1) unadjusting or not correcting for surgical skill variability and (2) nontransparent reporting of averaged results. We provide suggestions to overcome these deficiencies through robust methods and statistical approaches.


Assuntos
Competência Clínica , Ensaios Clínicos Controlados Aleatórios como Assunto , Projetos de Pesquisa , Procedimentos Cirúrgicos em Ginecologia , Humanos
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