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1.
Eur J Cancer ; 211: 114310, 2024 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-39270379

RESUMO

AIM: The aim of this study was to assess whether the use of sentinel lymph node (SLN) in addition to lymphadenectomy was associated with survival benefit in patients with early-stage cervical cancer. METHODS: International, multicenter, retrospective study. INCLUSION CRITERIA: cervical cancer treated between 01/2007 and 12/2016 by surgery only; squamous cell carcinoma, adenocarcinoma, adenosquamous carcinoma, FIGO 2009 stage IB1-IIA2, negative surgical margins, and laparotomy approach. Patients undergoing neo-adjuvant and/or adjuvant treatment and/or with positive para-aortic lymph nodes, were excluded. Women with positive pelvic nodes who refused adjuvant treatment, were included. Lymph node assessment was performed by SLN (with ultrastaging protocol) plus pelvic lymphadenectomy ('SLN' group) or pelvic lymphadenectomy alone ('non-SLN' group). RESULTS: 1083 patients were included: 300 (27.7 %) in SLN and 783 (72.3 %) in non-SLN group. 77 (7.1 %) patients had recurrence (N = 11, 3.7 % SLN versus N = 66, 8.4 % non-SLN, p = 0.005) and 34 (3.1 %) (N = 4, 1.3 % SLN versus N = 30, 3.8 % non-SLN, p = 0.033) died. SLN group had better 5-year disease-free survival (DFS) (96.0 %,95 %CI:93.5-98.5 versus 92.0 %,95 %CI:90.0-94.0; p = 0.024). No 5-year overall survival (OS) difference was shown (98.4 %,95 %CI:96.8-99.9 versus 96.8 %,95 %CI:95.4-98.2; p = 0.160). SLN biopsy and lower stage were independent factors associated with improved DFS (HR:0.505,95 %CI:0.266-0.959, p = 0.037 and HR:2.703,95 %CI:1.389-5.261, p = 0.003, respectively). Incidence of pelvic central recurrences was higher in the non-SLN group (1.7 % versus 4.5 %, p = 0.039). CONCLUSION: Adding SLN biopsy to pelvic lymphadenectomy was associated with lower recurrence and death rate and improved 5-year DFS. This might be explained by the lower rate of missed nodal metastasis thanks to the use of SLN ultrastaging. SLN biopsy should be recommended in patients with early-stage cervical cancer.


Assuntos
Excisão de Linfonodo , Linfonodo Sentinela , Neoplasias do Colo do Útero , Humanos , Feminino , Neoplasias do Colo do Útero/patologia , Neoplasias do Colo do Útero/cirurgia , Neoplasias do Colo do Útero/mortalidade , Excisão de Linfonodo/métodos , Pessoa de Meia-Idade , Estudos Retrospectivos , Linfonodo Sentinela/patologia , Linfonodo Sentinela/cirurgia , Adulto , Idoso , Estadiamento de Neoplasias , Biópsia de Linfonodo Sentinela/métodos , Metástase Linfática , Carcinoma de Células Escamosas/cirurgia , Carcinoma de Células Escamosas/patologia , Carcinoma de Células Escamosas/mortalidade
3.
Am J Obstet Gynecol ; 2024 Aug 14.
Artigo em Inglês | MEDLINE | ID: mdl-39151769

RESUMO

BACKGROUND: The Laparoscopic Approach to Cervical Cancer study results revolutionized our understanding of the best surgical management for this disease. After its publication, the guidelines state that the standard and recommended approach for radical hysterectomy is an open abdominal approach. Nevertheless, the effect of the Laparoscopic Approach to Cervical Cancer trial on real-world changes in the surgical approach to radical hysterectomy remains elusive. OBJECTIVE: This study aimed to investigate the trends and routes of radical hysterectomy and to evaluate postoperative complication rates before and after the Laparoscopic Approach to Cervical Cancer trial (2018). STUDY DESIGN: The National Surgical Quality Improvement Program registry was used to examine radical hysterectomy for cervical cancer performed between 2012 and 2022. This study excluded vaginal radical hysterectomies and simple hysterectomies. The primary outcome measures were the trends in the route of surgery (minimally invasive surgery vs laparotomy) and surgical complication rates, stratified by periods before and after the publication of the Laparoscopic Approach to Cervical Cancer trial in 2018 (2012-2017 vs 2019-2022). The secondary outcome measure was major complications associated specifically with the different routes of surgery. RESULTS: Of the 3611 patients included, 2080 (57.6%) underwent laparotomy, and 1531 (42.4%) underwent minimally invasive radical hysterectomy. There was a significant increase in the minimally invasive surgery approach from 2012 to 2017 (45.6% in minimally invasive surgery in 2012 to 75.3% in minimally invasive surgery in 2017; P<.01) and a significant decrease in minimally invasive surgery from 2018 to 2022 (50.4% in minimally invasive surgery in 2018 to 11.4% in minimally invasive surgery in 2022; P<.001). The rate of minor complications was lower in the period before the Laparoscopic Approach to Cervical Cancer trial than after the trial (317 [16.9%] vs 288 [21.3%], respectively; P=.002). The major complication rates were similar before and after the Laparoscopic Approach to Cervical Cancer trial (139 [7.4%] vs 78 [5.8%], respectively; P=.26). The rates of blood transfusions and superficial surgical site infections were lower in the period before the Laparoscopic Approach to Cervical Cancer trial than in the period after the trial (137 [7.3%] vs 133 [9.8%] [P=.012] and 20 [1.1%] vs 53 [3.9%] [P<.001], respectively). In a comparison of minimally invasive surgery vs laparotomy radical hysterectomy during the entire study period, patients in the minimally invasive surgery group had lower rates of minor complications than in those in the laparotomy group (190 [12.4%] vs 472 [22.7%], respectively; P<.001), and the rates of major complications were similar in both groups (100 [6.5%] in the minimally invasive surgery group vs 139 [6.7%] in the laparotomy group; P=.89). In a specific complications analysis, the rates of blood transfusion and superficial surgical site infections were lower in the minimally invasive surgery group than in the laparotomy group (2.4% vs 12.7% and 0.6% vs 3.4%, respectively; P<.001; for both comparisons), and the rate of deep incisional surgical site infections was lower in the minimally invasive surgery group than in the laparotomy group (0.2% vs 0.7%, respectively; P=.048). In the multiple logistic regression analysis, the route of radical hysterectomy was not independently associated with the occurrence of major complications (adjusted odds ratio, 1.02; 95% confidence interval, 0.63-1.65). CONCLUSION: Although the proportion of minimally invasive radical hysterectomies decreased abruptly after the Laparoscopic Approach to Cervical Cancer trial, there was no change in the rate of major postoperative complications. In addition, the hysterectomy route was not associated with major postoperative complications.

5.
Int J Gynecol Cancer ; 2024 Aug 24.
Artigo em Inglês | MEDLINE | ID: mdl-39181697

RESUMO

In March 2024, 12 European Network of Young Gynae Oncologists-International Journal of Gynaecological Cancer (ENYGO-IJGC) Editorial Fellows conducted 10 interviews with senior opinion leaders on original and controversial topics in the field of gynecologic oncology presented during the 25th European Society of Gynaecological Oncology (ESGO) Congress in Barcelona, Spain. This article provides a summary and overview of the content of these discussions summarizing key points presented at the meeting. These selected interviews were chosen by consensus by the ENYGO-IJGC Editorial Fellows based on novelty and relevance to the field of gynecologic oncology.

6.
Int J Gynecol Cancer ; 2024 Aug 07.
Artigo em Inglês | MEDLINE | ID: mdl-39117381

RESUMO

Cervical cancer is a major global health issue, ranking as the fourth most common cancer in women worldwide. Depending on stage, histology, and patient factors, the standard management of cervical cancer is a combination of treatment approaches, including (fertility- or non-fertility-sparing) surgery, radiotherapy, platinum-based chemotherapy, and novel systemic therapies such as bevacizumab, immune checkpoint inhibitors, and antibody-drug conjugates. While ambitious global initiatives seek to eliminate cervical cancer as a public health problem, the management of cervical cancer continues to evolve with major advances in imaging modalities, surgical approaches, identification of histopathological risk factors, radiotherapy techniques, and biomarker-driven personalized therapies. In particular, the introduction of immune checkpoint inhibitors has dramatically altered the treatment of cervical cancer, leading to significant survival benefits in both locally advanced and metastatic/recurrent settings. As the landscape of cervical cancer therapies continues to evolve, the aim of the present review is to provide a comprehensive discussion of the current state and the latest practice-changing updates in cervical cancer.

7.
Int J Gynecol Cancer ; 2024 Aug 28.
Artigo em Inglês | MEDLINE | ID: mdl-39209433

RESUMO

After the publication of the Laparoscopic Approach to Cervical Cancer (LACC) trial, open surgery has become the standard approach for radical hysterectomy in early stage cervical cancer. Recent studies assessed the role of a non-radical approach in low risk cervical cancer and showed no survival difference compared with radical hysterectomy. However, there is a gap in knowledge regarding the oncologic outcomes of minimally invasive simple hysterectomy in low risk cervical cancer. This review offers an overview of the current evidence on the role of the minimally invasive approach in low risk cervical cancer and raises the need for a new clinical trial in this setting.

8.
Int J Gynecol Cancer ; 2024 Jul 23.
Artigo em Inglês | MEDLINE | ID: mdl-39043573

RESUMO

Observational and cohort studies using large databases have made important contributions to gynecologic oncology. Knowledge of the advantages and potential limitations of commonly used databases benefits both readers and reviewers. In this review, researchers familiar with National Cancer Database (NCDB), Surveillance, Epidemiology, and End Results Program (SEER), SEER-Medicare, MarketScan, Healthcare Cost and Utilization Project (HCUP), National Surgical Quality Improvement Program (NSQIP), and Premier, describe each database, its included data, access, management, storage, highlights, and limitations. A better understanding of these commonly used datasets can help readers, reviewers, and researchers to more effectively interpret and apply study results, evaluate new research studies, and develop compelling and practice-changing research.

9.
Artigo em Inglês | MEDLINE | ID: mdl-38992749

RESUMO

STUDY OBJECTIVE: To characterize robotic surgery publications in gynecologic oncology, and to identify factors associated with high citation metrics. DESIGN: A cross-sectional study SETTING: Original articles on robotic surgery in gynecologic oncology. PATIENTS: No patients involved. INTERVENTIONS: Robotic surgeries in gynecologic oncology. MEASUREMENTS AND MAIN RESULTS: We performed PubMed Medical Subject Headings search for original articles on robotic surgery in gynecologic oncology. We analyzed citation scores and income level of country of publication, as well as factors associated with high citation metrics. Overall, 566 studies during 2005 to 2023 were included. Of those 292, 51.6% were from North America, and 182 32.2% from Europe. The leading tumor site studied was endometrial cancer (57.4%). The majority (87.6%) of studies were retrospective and 13 (2.3%) were randomized controlled trials. Most studies (94.2%) originated in high-income countries. Articles from middle-income countries had lower citations per year as compared to high-income countries (median 1.6 vs 2.5, p =.002) and were published in lower-impact factor journals (median 2.6 vs 4.3, p < .001) when compared with high-income countries. Cervical cancer studies had higher representation in middle-income countries than in high-income countries (48.5% vs 18.4%, p < .001). In a multivariable regression analysis, journal's impact factor [aOR 95% CI 1.26 (1.12-1.40)], cervical cancer topic [aOR 95% CI 3.0 (1.58-5.91)], and North American publications [aOR 95% CI 2.07 (1.08-3.97)] were independently associated with higher number of citations per year. CONCLUSION: The majority of robotic surgery research in gynecologic oncology is retrospective and from high-income countries. Middle-income countries are not as frequently cited and are predominantly in lower-impact factor journals.

11.
Int J Gynecol Cancer ; 34(9): 1445-1453, 2024 Sep 02.
Artigo em Inglês | MEDLINE | ID: mdl-38876786

RESUMO

Surgical site infection rates are among 5-35% in all gynecologic oncology procedures. Such infections lead to increased patient morbidity, reduction in quality of life, higher likelihood of readmissions, and reinterventions, which contribute directly to mortality and increase in health-related costs. Some of these are potentially preventable by applying evidence-based strategies in the peri-operative patient setting. The objective of this review is to provide recommendations for the individual components that most commonly comprise the surgical site infection prevention bundles that could be implemented in gynecologic oncology procedures. We searched articles from relevant publications with specific topics related to each surgical site infection intervention chosen to be reviewed. Studies on each topic were selected with an emphasis on meta-analyses, systematic reviews, randomized control studies, non-randomized controlled studies, reviews, clinical practice guidelines, and case series. Data synthesis was done through content and thematic analysis to identify key themes in the included studies. This review intends to serve as the most up-to-date frame of evidence-based peri-operative care in our specialty and could serve as the first initiative to introduce an enhanced recovery after surgery (ERAS) program.


Assuntos
Recuperação Pós-Cirúrgica Melhorada , Neoplasias dos Genitais Femininos , Procedimentos Cirúrgicos em Ginecologia , Infecção da Ferida Cirúrgica , Humanos , Infecção da Ferida Cirúrgica/prevenção & controle , Feminino , Recuperação Pós-Cirúrgica Melhorada/normas , Neoplasias dos Genitais Femininos/cirurgia , Procedimentos Cirúrgicos em Ginecologia/métodos , Procedimentos Cirúrgicos em Ginecologia/normas , Procedimentos Cirúrgicos em Ginecologia/efeitos adversos
12.
Int J Gynecol Cancer ; 34(8): 1273-1282, 2024 Aug 05.
Artigo em Inglês | MEDLINE | ID: mdl-38858104

RESUMO

In the last decade, we have witnessed important advances in novel therapeutics in the management of gynecologic cancers. These studies have built on the findings from preexisting data and have provided incremental contributions leading to changes that have not only impacted the accuracy of cancer detection and its metastatic components but also led to improvements in oncologic outcomes and quality of life. Key landmark trials have changed the standard of care in cervix, uterine, and ovarian cancer. A number of these have been controversial and have generated significant debate among gynecologic oncologists. The main objective of this review was to provide an overview on each of these trials as a reference for immediate and consolidated access to the study aims, methodology, results, and conclusion.


Assuntos
Neoplasias dos Genitais Femininos , Humanos , Feminino , Neoplasias dos Genitais Femininos/cirurgia , Ensaios Clínicos como Assunto , Procedimentos Cirúrgicos em Ginecologia/métodos
13.
J Clin Oncol ; 42(23): 2741-2746, 2024 Aug 10.
Artigo em Inglês | MEDLINE | ID: mdl-38810208

RESUMO

Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported.The aim of this study was to compare overall survival between open and minimally invasive radical hysterectomy with participants followed for 4.5 years. The primary objective was to evaluate whether minimally invasive surgery was noninferior in disease-free survival (DFS) to abdominal radical hysterectomy. Secondary outcomes included overall survival. Sample size was based on DFS of 90% at 4.5 years and 7.2% noninferiority margin for minimally invasive surgery. A total of 631 patients were enrolled: 319 assigned to minimally invasive and 312 to open surgery. Of these, 289 (90.6%) patients underwent minimally invasive surgery and 274 (87.8%) patients open surgery. At 4.5 years, DFS was 85.0% in the minimally invasive group and 96% in the open group (difference of -11.1; 95% CI, -15.8 to -6.3; P = .95 for noninferiority). Minimally invasive surgery was associated with lower rate of DFS compared with open surgery (hazard ratio [HR], 3.91 [95% CI, 2.02 to 7.58]; P < .001). Rate of overall survival at 4.5 years was 90.6% versus 96.2% for the minimally invasive and open surgery groups, respectively (HR for death of any cause = 2.71 [95% CI, 1.32 to 5.59]; P = .007). Given higher recurrence rate and worse overall survival with minimally invasive surgery, an open approach should be standard of care.


Assuntos
Histerectomia , Procedimentos Cirúrgicos Minimamente Invasivos , Estadiamento de Neoplasias , Neoplasias do Colo do Útero , Humanos , Feminino , Histerectomia/métodos , Histerectomia/mortalidade , Pessoa de Meia-Idade , Neoplasias do Colo do Útero/cirurgia , Neoplasias do Colo do Útero/mortalidade , Neoplasias do Colo do Útero/patologia , Procedimentos Cirúrgicos Minimamente Invasivos/métodos , Procedimentos Cirúrgicos Minimamente Invasivos/mortalidade , Adulto , Intervalo Livre de Doença , Idoso
14.
Int J Gynecol Cancer ; 34(5): 669-674, 2024 May 06.
Artigo em Inglês | MEDLINE | ID: mdl-38627032

RESUMO

OBJECTIVE: To determine if reviewer experience impacts the ability to discriminate between human-written and ChatGPT-written abstracts. METHODS: Thirty reviewers (10 seniors, 10 juniors, and 10 residents) were asked to differentiate between 10 ChatGPT-written and 10 human-written (fabricated) abstracts. For the study, 10 gynecologic oncology abstracts were fabricated by the authors. For each human-written abstract we generated a ChatGPT matching abstract by using the same title and the fabricated results of each of the human generated abstracts. A web-based questionnaire was used to gather demographic data and to record the reviewers' evaluation of the 20 abstracts. Comparative statistics and multivariable regression were used to identify factors associated with a higher correct identification rate. RESULTS: The 30 reviewers discriminated 20 abstracts, giving a total of 600 abstract evaluations. The reviewers were able to correctly identify 300/600 (50%) of the abstracts: 139/300 (46.3%) of the ChatGPT-generated abstracts and 161/300 (53.7%) of the human-written abstracts (p=0.07). Human-written abstracts had a higher rate of correct identification (median (IQR) 56.7% (49.2-64.1%) vs 45.0% (43.2-48.3%), p=0.023). Senior reviewers had a higher correct identification rate (60%) than junior reviewers and residents (45% each; p=0.043 and p=0.002, respectively). In a linear regression model including the experience level of the reviewers, familiarity with artificial intelligence (AI) and the country in which the majority of medical training was achieved (English speaking vs non-English speaking), the experience of the reviewer (ß=10.2 (95% CI 1.8 to 18.7)) and familiarity with AI (ß=7.78 (95% CI 0.6 to 15.0)) were independently associated with the correct identification rate (p=0.019 and p=0.035, respectively). In a correlation analysis the number of publications by the reviewer was positively correlated with the correct identification rate (r28)=0.61, p<0.001. CONCLUSION: A total of 46.3% of abstracts written by ChatGPT were detected by reviewers. The correct identification rate increased with reviewer and publication experience.


Assuntos
Indexação e Redação de Resumos , Humanos , Indexação e Redação de Resumos/normas , Feminino , Revisão da Pesquisa por Pares , Redação/normas , Ginecologia , Inquéritos e Questionários , Editoração/estatística & dados numéricos
17.
Int J Gynecol Cancer ; 34(4): 504-509, 2024 Apr 01.
Artigo em Inglês | MEDLINE | ID: mdl-38378695

RESUMO

OBJECTIVE: The purpose of this study was to establish a consensus on the surgical technique for sentinel lymph node (SLN) dissection in cervical cancer. METHODS: A 26 question survey was emailed to international expert gynecological oncology surgeons. A two-step modified Delphi method was used to establish consensus. After a first round of online survey, the questions were amended and a second round, along with semistructured interviews was performed. Consensus was defined using a 70% cut-off for agreement. RESULTS: Twenty-five of 38 (65.8%) experts responded to the first and second rounds of the online survey. Agreement ≥70% was reached for 13 (50.0%) questions in the first round and for 15 (57.7%) in the final round. Consensus agreement identified 15 recommended, three optional, and five not recommended steps. Experts agreed on the following recommended procedures: use of indocyanine green as a tracer; superficial (with or without deep) injection at 3 and 9 o'clock; injection at the margins of uninvolved mucosa avoiding vaginal fornices; grasping the cervix with forceps only in part of the cervix is free of tumor; use of a minimally invasive approach for SLN biopsy in the case of simple trachelectomy/conization; identification of the ureter, obliterated umbilical artery, and external iliac vessels before SLN excision; commencing the dissection at the level of the uterine artery and continuing laterally; and completing dissection in one hemi-pelvis before proceeding to the contralateral side. Consensus was also reached in recommending against injection at 6 and 12 o'clock, and injection directly into the tumor in cases of the tumor completely replacing the cervix; against removal of nodes through port without protective maneuvers; absence of an ultrastaging protocol; and against modifying tracer concentration at the time of re-injection after mapping failure. CONCLUSION: Recommended, optional, and not recommended steps of SLN dissection in cervical cancer have been identified based on consensus among international experts. These represent a surgical guide that may be used by surgeons in clinical trials and for quality assurance in routine practice.


Assuntos
Neoplasias do Colo do Útero , Feminino , Humanos , Neoplasias do Colo do Útero/cirurgia , Neoplasias do Colo do Útero/patologia , Metástase Linfática/patologia , Consenso , Excisão de Linfonodo/métodos , Biópsia de Linfonodo Sentinela/métodos , Verde de Indocianina , Linfonodos/patologia
18.
Am J Obstet Gynecol ; 230(6): 663.e1-663.e13, 2024 06.
Artigo em Inglês | MEDLINE | ID: mdl-38365097

RESUMO

BACKGROUND: Cervical cancer incidence among premenopausal women is rising, and fertility-sparing surgery serves as an important option for this young population. There is a lack of evidence on what tumor size cutoff should be used to define candidacy for fertility-sparing surgery. OBJECTIVE: We sought to describe how the association between fertility-sparing surgery (compared with standard surgery) and life expectancy varies by tumor size among patients with cervical cancers measuring ≤4 cm in largest diameter. Our secondary objective was to quantify the probability of undergoing adjuvant radiotherapy among patients who underwent fertility-sparing surgery as a function of tumor size. STUDY DESIGN: We identified patients in the National Cancer Database aged ≤45 years, diagnosed with stage I cervical cancer with tumors ≤4 cm between 2006 and 2018, who received no preoperative radiation or chemotherapy, and who underwent either fertility-sparing surgery (cone or trachelectomy, either simple or radical) or standard surgery (simple or radical hysterectomy) as their primary treatment. Propensity-score matching was performed to compare patients who underwent fertility-sparing surgery with those who underwent standard surgery. A flexible parametric model was employed to quantify the difference in life expectancy within 5 years of diagnosis (restricted mean survival time) based on tumor size among patients who underwent fertility-sparing and those who underwent standard surgery. In addition, among those who underwent fertility-sparing surgery, a logistic regression model was used to explore the relationship between tumor size and the probability of receiving adjuvant radiation. RESULTS: A total of 11,946 patients met the inclusion criteria of whom 904 (7.6%) underwent fertility-sparing surgery. After propensity-score matching, 897 patients who underwent fertility-sparing surgery were matched 1:1 with those who underwent standard surgery. Although the 5-year life expectancy was similar among patients who had fertility sparing surgery and those who had standard surgery regardless of tumor sizes, the estimates of life-expectancy differences associated with fertility-sparing surgery were more precise among patients with smaller tumors (1-cm tumor: restricted mean survival time difference, -0.10 months; 95% confidence interval, -0.67 to 0.47) than among those with larger tumors (4-cm tumor: restricted mean survival time difference, -0.11 months; 95% confidence interval, -3.79 to 3.57). The probability of receiving adjuvant radiation increased with tumor size, ranging from 5.6% (95% confidence interval, 3.9-7.9) for a 1-cm tumor to 37% (95% confidence interval, 24.3-51.8) for a 4-cm tumor. CONCLUSION: Within 5 years of diagnosis, young patients with stage I cancers measuring ≤4 cm had similar survival outcomes after either fertility-sparing surgery or standard surgery. However, because few patients with tumors >2 cm underwent fertility-sparing surgery, a clinically important survival difference could not be excluded in this population.


Assuntos
Preservação da Fertilidade , Histerectomia , Expectativa de Vida , Estadiamento de Neoplasias , Traquelectomia , Carga Tumoral , Neoplasias do Colo do Útero , Humanos , Feminino , Neoplasias do Colo do Útero/cirurgia , Neoplasias do Colo do Útero/patologia , Neoplasias do Colo do Útero/mortalidade , Preservação da Fertilidade/métodos , Adulto , Histerectomia/métodos , Traquelectomia/métodos , Radioterapia Adjuvante , Conização/métodos , Pontuação de Propensão , Pessoa de Meia-Idade
19.
Nat Med ; 30(1): 61-75, 2024 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-38242979

RESUMO

The next generation of surgical robotics is poised to disrupt healthcare systems worldwide, requiring new frameworks for evaluation. However, evaluation during a surgical robot's development is challenging due to their complex evolving nature, potential for wider system disruption and integration with complementary technologies like artificial intelligence. Comparative clinical studies require attention to intervention context, learning curves and standardized outcomes. Long-term monitoring needs to transition toward collaborative, transparent and inclusive consortiums for real-world data collection. Here, the Idea, Development, Exploration, Assessment and Long-term monitoring (IDEAL) Robotics Colloquium proposes recommendations for evaluation during development, comparative study and clinical monitoring of surgical robots-providing practical recommendations for developers, clinicians, patients and healthcare systems. Multiple perspectives are considered, including economics, surgical training, human factors, ethics, patient perspectives and sustainability. Further work is needed on standardized metrics, health economic assessment models and global applicability of recommendations.


Assuntos
Inteligência Artificial , Procedimentos Cirúrgicos Robóticos , Humanos , Robótica
20.
Am J Obstet Gynecol ; 230(2): 241.e1-241.e18, 2024 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-37827271

RESUMO

BACKGROUND: There are few prospective studies in the gynecologic surgical literature that compared patient-reported outcomes between open and minimally invasive hysterectomies within enhanced recovery after surgery pathways. OBJECTIVE: This study aimed to compare prospectively collected perioperative patient-reported symptom burden and interference measures in open compared with minimally invasive hysterectomy cohorts within enhanced recovery after surgery pathways. STUDY DESIGN: We compared patient-reported symptom burden and functional interference in 646 patients who underwent a hysterectomy (254 underwent open surgery and 392 underwent minimally invasive surgery) for benign and malignant indications under enhanced recovery after surgery protocols. Outcomes were prospectively measured using the validated MD Anderson Symptom Inventory, which was administered perioperatively up to 8 weeks after surgery. Cohorts were compared using Fisher exact and chi-squared tests, adjusted longitudinal generalized linear mixed modeling, and Kaplan Meier curves to model return to no or mild symptoms. RESULTS: The open cohort had significantly worse preoperative physical functional interference (P=.001). At the time of hospital discharge postoperatively, the open cohort reported significantly higher mean symptom severity scores and more moderate or severe scores for overall (P<.001) and abdominal pain (P<.001), fatigue (P=.001), lack of appetite (P<.001), bloating (P=.041), and constipation (P<.001) when compared with the minimally invasive cohort. The open cohort also had significantly higher interference in physical functioning (score 5.0 vs 2.7; P<.001) than the minimally invasive cohort at the time of discharge with no differences in affective interference between the 2 groups. In mixed modeling analysis of the first 7 postoperative days, both cohorts reported improved symptom burden and functional interference over time with generally slower recovery in the open cohort. From 1 to 8 postoperative weeks, the open cohort had worse mean scores for all evaluated symptoms and interference measures except for pain with urination, although scores indicated mild symptomatic burden and interference in both cohorts. The time to return to no or mild symptoms was significantly longer in the open cohort for overall pain (14 vs 4 days; P<.001), fatigue (8 vs 4 days; P<.001), disturbed sleep (2 vs 2 days; P<.001), and appetite (1.5 vs 1 days; P<.001) but was significantly longer in the minimally invasive cohort for abdominal pain (42 vs 28 days; P<.001) and bloating (42 vs 8 days; P<.001). The median time to return to no or mild functional interference was longer in the open than in the minimally invasive hysterectomy cohort for physical functioning (36 vs 32 days; P<.001) with no difference in compositive affective functioning (5 vs 5 days; P=.07) between the groups. CONCLUSION: Open hysterectomy was associated with increased symptom burden in the immediate postoperative period and longer time to return to no or mild symptom burden and interference with physical functioning. However, all patient-reported measures improved within days to weeks of both open and minimally invasive surgery and differences were not always clinically significant.


Assuntos
Histerectomia , Medidas de Resultados Relatados pelo Paciente , Humanos , Feminino , Estudos Prospectivos , Histerectomia/métodos , Dor Abdominal , Fadiga/epidemiologia , Procedimentos Cirúrgicos Minimamente Invasivos
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