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Ontario Health Technology Assessment... 2023Robotic-assisted surgery has been used in Ontario hospitals for over a decade, but there is no public funding for the robotic systems or the disposables required to...
BACKGROUND
Robotic-assisted surgery has been used in Ontario hospitals for over a decade, but there is no public funding for the robotic systems or the disposables required to perform robotic-assisted surgeries ("robotics disposables"). We conducted a health technology assessment of robotic-assisted hysterectomy (RH) for the treatment of endometrial cancer in people with obesity. Our assessment included an evaluation of the effectiveness, safety, and cost-effectiveness of RH, as well as the 5-year budget impact for the Ontario Ministry of Health of publicly funding RH. It also looked at the experiences, preferences, and values of people with endometrial cancer and obesity, as well as those of health care professionals who provide surgical treatment for endometrial cancer.
METHODS
We performed a systematic literature search of the clinical evidence to identify systematic reviews and randomized controlled trials relevant to our research question. We reported the risk of bias from the included systematic review. We assessed the quality of the body of evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We performed a systematic economic literature search. We also analyzed the 5-year budget impact of publicly funding RH (including total, partial, and radical procedures) for people with endometrial cancer and obesity in Ontario. To contextualize the potential value of RH for people with endometrial cancer and obesity, we spoke with people with lived experience of endometrial cancer and obesity who had undergone minimally invasive surgery (either laparoscopic hysterectomy [LH] or RH), and we spoke with gynecological cancer surgeons who perform hysterectomy.
RESULTS
We included one systematic review in the clinical evidence review. An indirect comparison showed that conversion rates to open hysterectomy (OH) were similar for LH and RH in patients with a body mass index (BMI) ≥ 30 kg/m (6.5% vs. 5.5%, respectively) (GRADE: Very low). An indirect comparison within a subset of patients with a body mass index (BMI) ≥ 40 kg/m showed that a higher proportion of patients who underwent LH required conversion to OH compared with patients who underwent RH (7.0% vs. 3.8%, respectively) (GRADE: Very low). Rates of perioperative complications were similarly low for both LH and RH (≤ 3.5%) (GRADE: Very low). We identified two studies that met the inclusion criteria of our economic literature review. The included economic studies found RH to be more costly than OH or LH for endometrial cancer; however, because these studies were conducted in other countries, the results were not applicable to the Ontario context. Assuming a moderate increase in the volume of robotic-assisted surgeries, our reference case analysis showed that the 5-year budget impact of publicly funding RH for people with endometrial cancer and obesity would be $1.14 million. The budget impact analysis results were sensitive to surgical volume and the cost of robotics disposables. The people we spoke with who had lived experience of endometrial cancer and obesity, as well as gynecological cancer surgeons, spoke favourably of RH and its perceived benefits over OH and LH for people with endometrial cancer and obesity.
CONCLUSIONS
Compared with LH, RH is associated with fewer conversions to OH in patients with endometrial cancer and obesity (i.e., those with a BMI ≥ 40 kg/m). Rates of perioperative complications were similarly low for both LH and RH. The cost-effectiveness of RH for people with endometrial cancer and obesity is unknown. We estimate that the 5-year budget impact of publicly funding RH for people with endometrial cancer and obesity would be $1.14 million. People we spoke with who had lived experience of endometrial cancer and obesity reported favourably on their experiences with minimally invasive hysterectomy (either LH or RH) and emphasized the importance of the availability of safe surgical options for people with obesity. Gynecological surgeons perceived RH as a superior alternative to OH and LH for people with endometrial cancer and obesity.
Topics: Female; Humans; Robotic Surgical Procedures; Technology Assessment, Biomedical; Endometrial Neoplasms; Cost-Benefit Analysis; Laparoscopy; Hysterectomy
PubMed: 38026449
DOI: No ID Found -
International Journal of Gynecological... Nov 2023The objective of this systematic review was to evaluate the effect of different types of neoadjuvant chemotherapy regimens, in terms of optimal pathological response and...
OBJECTIVE
The objective of this systematic review was to evaluate the effect of different types of neoadjuvant chemotherapy regimens, in terms of optimal pathological response and oncological outcomes, in patients with locally advanced cervical cancer.
METHODS
A systematic search of the literature was performed. MEDLINE through PubMed and Embase databases were searched from inception to June 2023. The study was registered in PROSPERO (ID number CRD42023389806). All women with a pathological diagnosis of locally advanced cervical cancer (International Federation of Gynecology and Obstetrics (FIGO) 2009 classification stages IB2-IVA), any age or histology, who underwent intravenous neoadjuvant chemotherapy before radical surgery, and articles only in English language, were included. We conducted a meta-analysis for optimal pathological response after surgery and survival outcomes. The risk of bias was assessed using the Newcastle-Ottawa scale and the Risk of Bias 2 (RoB) tools. The review methods and results were reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines.
RESULTS
25 studies with a total number of 1984 patients fulfilled the eligibility criteria of our review and were included for data extraction and efficacy analysis. When compared with a two-drug regimen, the three-drug combination including cisplatin, paclitaxel, and ifosfamide or anthracyclines showed superior efficacy in terms of optimal pathological response with an odds ratio of 0.38 (95% CI 0.24 to 0.61, p<0.0001), with no difference in disease-free survival (hazard ratio (HR) 0.72, 95% CI 0.50 to 1.03, I=0%, p=0.07) and higher overall survival (HR 0.63, 95% CI 0.41 to 0.97, I=0%, p=0.03).
CONCLUSIONS
The three-drug combination of cisplatin, paclitaxel, and ifosfamide or anthracyclines showed a higher rate of complete or optimal partial response, with the triple regimens having an advantage over the platinum-based schedules in terms of overall survival. Neoadjuvant chemotherapy followed by radical surgery should not be considered a standard of care in locally advanced cervical cancer.
PubMed: 38011989
DOI: 10.1136/ijgc-2023-004863 -
International Journal of Gynecological... Nov 2023To evaluate the role of dose-dense neoadjuvant chemotherapy followed by radical hysterectomy in reducing adjuvant radiotherapy in International Federation of Gynecology...
OBJECTIVE
To evaluate the role of dose-dense neoadjuvant chemotherapy followed by radical hysterectomy in reducing adjuvant radiotherapy in International Federation of Gynecology and Obstetrics (FIGO) 2018 stage IB1-IB2/IIA1 cervical cancer with disrupted stromal ring and as an alternative to concurrent chemoradiotherapy in FIGO 2018 stages IB3/IIA2.
METHODS
This was a retrospective cohort study including patients with FIGO 2018 stage IB1-IIA2 cervical cancer undergoing dose-dense neoadjuvant chemotherapy at the European Institute of Oncology in Milan, Italy between July 2014 and December 2022. Weekly carboplatin (AUC2 or AUC2.7) plus paclitaxel (80 or 60 mg/m, respectively) was administered for six to nine cycles. Radiological response was assessed by Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 criteria. The optimal pathological response was defined as residual tumor ≤3 mm. Kaplan-Meier curves were used to estimate survival rates. A systematic literature review on dose-dense neoadjuvant chemotherapy before surgery for cervical cancer was also performed.
RESULTS
A total of 63 patients with a median age of 42.8 years (IQR 35.3-47.9) were included: 39.7% stage IB-IB2/IIA1 and 60.3% stage IB3/IIA2. The radiological response was as follows: 81% objective response rate (17.5% complete and 63.5% partial), 17.5% stable disease, and 1.6% progressive disease. The operability rate was 92.1%. The optimal pathological response rate was 27.6%. Adjuvant radiotherapy was administered in 25.8% of cases. The median follow-up for patients who underwent radical hysterectomy was 49.7 months (IQR 16.8-67.7). The 5-year progression-free survival and overall survival were 79% (95% CI 0.63 to 0.88) and 92% (95% CI 0.80 to 0.97), respectively. Fifteen studies including 697 patients met the eligibility criteria for the systematic review. The objective response rate, operability rate, and adjuvant radiotherapy rate across studies ranged between 52.6% and 100%, 64% and 100%, and 4% and 70.6%, respectively.
CONCLUSIONS
Dose-dense neoadjuvant chemotherapy before radical surgery could be a valid strategy to avoid radiotherapy in stage IB1-IIA2 cervical cancer, especially in young patients desiring to preserve overall quality of life. Prospective research is warranted to provide robust, high-quality evidence.
PubMed: 37949488
DOI: 10.1136/ijgc-2023-004928 -
European Journal of Obstetrics,... Sep 2023A Cesarean Scar Pregnancy (CSP) is a variant of uterine ectopic pregnancy defined by full or partial implantation of the gestational sac in the scar of a previous... (Review)
Review
A Cesarean Scar Pregnancy (CSP) is a variant of uterine ectopic pregnancy defined by full or partial implantation of the gestational sac in the scar of a previous cesarean section. The continuous increase of Cesarean Deliveries is causing a parallel increase in CSP and its complications. Considering its high morbidity, the most usual recommendation has been termination of pregnancy in the first trimester; however, several cases progress to viable births. The aim of this systematic review is to evaluate the outcome of CSP managed expectantly and understand whether sonographic signs could correlate to the outcomes. An online-based search of PubMed and Cochrane Library Databases was used to gather studies including women diagnosed with a CSP who were managed expectantly. The description of all cases was analysed by the authors in order to obtain information for each outcome. 47 studies of different types were retrieved, and the gestational outcome was available in 194 patients. Out of these, 39 patients (20,1%) had a miscarriage and 16 (8,3%) suffered foetal death. 50 patients (25,8%) had a term delivery and 81 (41,8%) patients had a preterm birth, out of which 27 (13,9%) delivered before 34 weeks of gestation. In 102 (52,6%) patients, a hysterectomy was performed. Placenta Accreta Spectrum (PAS) was a common disorder among CSP and was linked to a higher rate of complications such as foetal death, preterm birth, hysterectomy, haemorrhagic morbidity and surgical complications. Some of the analysed articles showed that sonographic signs with specific characteristics, such as type II and III CSP classification, Crossover Sign - 1, "In the niche" implantation and lower myometrial thickness could be related to worse outcomes of CSP. This article provides a good understanding of CSP as an entity that, although rare, presents with a high rate of relevant morbidity. It is also understood that pregnancies with confirmed PAS had an even higher rate of morbidity. Some sonographic signs were shown to predict the prognosis of these pregnancies and further investigation is necessary to validate one or more signs so they can be used for a more reliable counselling of women with CSP.
Topics: Pregnancy; Infant, Newborn; Humans; Female; Cesarean Section; Premature Birth; Cicatrix; Watchful Waiting; Pregnancy, Ectopic; Pregnancy Outcome; Placenta Accreta; Fetal Death; Retrospective Studies
PubMed: 37421745
DOI: 10.1016/j.ejogrb.2023.06.030 -
Journal of Personalized Medicine Nov 2022Uterine leiomyomas usually arise from the uterine body (95%), and rarely from the cervix (0.6%) or other urogenital sites. Lipoleiomyomas are benign, uncommon variants...
Uterine leiomyomas usually arise from the uterine body (95%), and rarely from the cervix (0.6%) or other urogenital sites. Lipoleiomyomas are benign, uncommon variants of leiomyomas (0.03-0.2%), histologically composed of smooth muscle cells and mature adipocytes; they usually occur in the uterine body and exceptionally in the cervix. We performed the first systematic literature review of cervical lipoleiomyomas (PRISMA guidelines), presenting five new cases. Including our series, thirty-one detailed cases were reported in the literature (mainly in Asia). The age range was 35-74 years, revealing a higher mean age than conventional cervical leiomyomas (46.5 vs. 39.4 years). Patients were usually multiparous (94%), typically complaining of vaginal bleeding (11/31, 36%), pelvic/abdominal pain (10/31, 32%), and/or urinary disturbances (6/31, 19%) 1 week to 10 months before presentation. Clinical examination revealed a pedunculated tumor (48%), or prolapse of ≥1 pelvic organs (16%). Twenty-four (77%) patients underwent total hysterectomy ± additional surgery; simple myomectomy/excision was performed in five (16%) cases. Only one (3%) of our cases recurred 2 years after partial excision; no evidence of disease was found 13 years after recurrence excision. Adipocytes occupied ≤50% of the tumor volume. Hyaline or myxoid changes and cartilaginous metaplasia were uncommon histological findings. Surgically challenging cases or pregnant patients may require expert gynecologists. Interventional radiology or conservative treatments were rarely proposed.
PubMed: 36579603
DOI: 10.3390/jpm12111852 -
Journal of Robotic Surgery Jun 2023As robotic-assisted surgery (RAS) expands to smaller centres, platforms are shared between specialities. Healthcare providers must consider case volume and mix required...
As robotic-assisted surgery (RAS) expands to smaller centres, platforms are shared between specialities. Healthcare providers must consider case volume and mix required to maintain quality and cost-effectiveness. This can be informed, in-part, by the volume-outcome relationship. We perform a systematic review to describe the volume-outcome relationship in intra-abdominal robotic-assisted surgery to report on suggested minimum volumes standards. A literature search of Medline, NICE Evidence Search, Health Technology Assessment Database and Cochrane Library using the terms: "robot*", "surgery", "volume" and "outcome" was performed. The included procedures were gynecological: hysterectomy, urological: partial and radical nephrectomy, cystectomy, prostatectomy, and general surgical: colectomy, esophagectomy. Hospital and surgeon volume measures and all reported outcomes were analysed. 41 studies, including 983,149 procedures, met the inclusion criteria. Study quality was assessed using the Newcastle-Ottawa Quality Assessment Scale and the retrieved data was synthesised in a narrative review. Significant volume-outcome relationships were described in relation to key outcome measures, including operative time, complications, positive margins, lymph node yield and cost. Annual surgeon and hospital volume thresholds were described. We concluded that in centres with an annual volume of fewer than 10 cases of a given procedure, having multiple surgeons performing these procedures led to worse outcomes and, therefore, opportunities should be sought to perform other complimentary robotic procedures or undertake joint cases.
Topics: Male; Humans; Robotic Surgical Procedures; Robotics; Prostatectomy; Outcome Assessment, Health Care; Hospitals
PubMed: 36315379
DOI: 10.1007/s11701-022-01461-2 -
Medicine Jul 2022This study aimed to systematically review the existing literature on epithelioid trophoblastic tumors (ETTs), the rarest type of gestational trophoblastic neoplasia.
BACKGROUND
This study aimed to systematically review the existing literature on epithelioid trophoblastic tumors (ETTs), the rarest type of gestational trophoblastic neoplasia.
METHODS
A systematic review according to PRISMA guidelines was performed, using ScienceDirect, Web of Science, and Scopus databases. The only filter used was the English language. Eligibility/inclusion criteria: retrospective observational studies (case reports, case series) including full case description of epithelioid trophoblastic tumor lesions.
RESULTS
Seventy studies were assessed for synthesis, including 147 cases. 66.7% of patients with ETT presented with irregular vaginal bleeding. Pretreatment β-hCG levels ranged up to 1000 mIU/mL in 58.5% patients. Of most patients, 42.2% had stage I disease, 10.9% stage II, 25.2% stage III, and 21.8% of patients had stage IV. The most common sites of metastatic disease were the lungs, followed by the liver and brain. After treatment, complete remission was achieved in 75.5% of patients, partial remission in 10.2% of patients, and 14.3% of patients died. On univariate and multivariate analyses, stage IV disease was an independent prognostic factor for overall and disease-free survival.
CONCLUSIONS
Hysterectomy and metastatic lesion resection are essential for controlling ETT. Investigational studies on molecules like EGFR, VEGF, PD-1, CD105, and LPCAT1 are potential therapeutic targets for metastatic ETT.
Topics: Female; Gestational Trophoblastic Disease; Humans; Hysterectomy; Pregnancy; Trophoblastic Neoplasms; Uterine Neoplasms
PubMed: 35905248
DOI: 10.1097/MD.0000000000029934 -
American Journal of Obstetrics and... Jun 2022Placenta percreta is described as the most severe grade of placenta accreta spectrum and accounts for a quarter of all cases of placenta accreta spectrum reported in the...
BACKGROUND
Placenta percreta is described as the most severe grade of placenta accreta spectrum and accounts for a quarter of all cases of placenta accreta spectrum reported in the literature.
OBJECTIVE
We investigated the hypothesis that placenta percreta, which has been described clinically as placental tissue invading through the full thickness of the uterus, is a heterogeneous category with most cases owing to primary or secondary uterine abnormality rather than an abnormally invasive form of placentation.
STUDY DESIGN
We have evaluated the agreement between the intraoperative findings using the International Federation of Gynecology and Obstetrics classification with the postoperative histopathology diagnosis in a prospective cohort of 101 consecutive singleton pregnancies presenting with a low-lying placenta or placenta previa, a history of at least 1 prior cesarean delivery and ultrasound signs suggestive of placenta accreta spectrum. Furthermore, a systematic literature review of case reports of placenta percreta, which included histopathologic findings and gross images, was performed.
RESULTS
Samples for histologic examination were available in 80 of 101 cases of the cohort, which were managed by hysterectomy or partial myometrial resection. Microscopic examination showed evidence of placenta accreta spectrum in 65 cases (creta, 9; increta, 56). Of 101 cases included in the cohort, 44 (43.5%) and 54 (53.5%) were graded as percreta by observer A and observer B, respectively. There was a moderate agreement between observers. Of note, 11 of 36 cases that showed no evidence of abnormal placental attachment at delivery and/or microscopic examination were classified as percreta by both observers. The systematic literature review identified 41 case reports of placenta percreta with microscopic images and presenting symptomatology, suggesting that most cases were the consequence of a uterine rupture. The microscopic descriptions were heterogeneous, and all descriptions demonstrated histology of placenta creta rather than percreta.
CONCLUSION
Our study supported the concept that placenta accreta is not an invasive disorder of placentation but the consequence of postoperative surgical remodeling or a preexisting uterine pathology and found no histologic evidence supporting the existence of a condition where the villous tissue penetrates the entire uterine wall, including the serosa and beyond.
Topics: Female; Humans; Placenta; Placenta Accreta; Placenta Previa; Pregnancy; Prospective Studies; Ultrasonography, Prenatal
PubMed: 34973177
DOI: 10.1016/j.ajog.2021.12.030 -
Annals of Surgery Mar 2021Describe clinical outcomes (eg, postoperative complications, survival) after robotic surgery compared to open or laparoscopic surgery.
OBJECTIVE
Describe clinical outcomes (eg, postoperative complications, survival) after robotic surgery compared to open or laparoscopic surgery.
BACKGROUND
Robotic surgery utilization has increased over the years across a wide range of surgical procedures. However, evidence supporting improved clinical outcomes after robotic surgery is limited.
METHODS
We systematically searched MEDLINE, EMBASE, and the Cochrane Central Register of systematic reviews from inception to January 2019 for systematic reviews describing postoperative outcomes after robotic surgery. We qualitatively described patient outcomes of commonly performed robotic procedures: radical prostatectomy, hysterectomy, lobectomy, thymectomy, rectal resection, partial nephrectomy, distal gastrectomy, Roux-en-Y gastric bypass, hepatectomy, distal pancreatectomy, and cholecystectomy.
RESULTS
One hundred fifty-four systematic reviews included 336 studies and 18 randomized controlled trials reporting on patient outcomes after robotic compared to laparoscopic or open procedures. Data from the randomized controlled trials demonstrate that robotic-assisted radical prostatectomy offered fewer biochemical recurrence and improvement in quality of recovery and pain scores only up to 6 weeks postoperatively compared to open radical prostatectomy. When compared to laparoscopic prostatectomy, robotic surgery offered improved urinary and sexual functions. Robotic surgery for endometrial cancer had fewer conversion to open compared to laparoscopic. Otherwise, robotic surgery outcomes were similar to conventional surgical approaches for other procedures except for radical hysterectomy where minimally invasive approaches may result in patient harm compared to open approach.
CONCLUSION
Robotic surgery has been widely incorporated into practise despite limited supporting evidence. More rigorous research focused on patient-important benefits is needed before further expansion of robotic surgery.
Topics: Humans; Laparoscopy; Laparotomy; Postoperative Complications; Robotic Surgical Procedures; Survival Rate
PubMed: 32398482
DOI: 10.1097/SLA.0000000000003915 -
International Urogynecology Journal Jul 2017Obliterative procedures for the treatment of pelvic organ prolapse have been reported to have a recurrence rate up to 10%. We present (1) a case report of a patient with... (Review)
Review
INTRODUCTION AND HYPOTHESIS
Obliterative procedures for the treatment of pelvic organ prolapse have been reported to have a recurrence rate up to 10%. We present (1) a case report of a patient with prolapse after LeFort colpocleisis and how it was managed in our department, and (2) a review of the literature regarding the types of recurrence after LeFort colpocleisis, their rate and their treatment.
METHODS
A 77-year-old woman was treated in our department for recurrence of prolapse through the right lateral channel 6 months after LeFort colpocleisis. A systematic review of the literature up to 2016 was performed through MEDLINE, Web of Science and the Cochrane Library.
RESULTS
The patient underwent a modified repeat colpocleisis and 6 months later was doing well with no signs of recurrence. We found 28 eligible studies including 1,810 patients, and the rate of recurrence after LeFort colpocleisis was 4.2% (76/1,810) leaving the majority of patients very satisfied. Information about the management of recurrence of prolapse after LeFort colpocleisis was provided in 17 studies including 33 patients with a 60-month follow-up. It appears that there are three major categories of recurrent prolapse after LeFort partial colpocleisis: (1) patients with a total breakdown of colpocleisis (57.6%), (2) patients with "channel prolapse" (15.2%), and (3) patients with prolapse at sites not involved in the primary partial colpocleisis (27.3%). The most frequent treatments were total colpocleisis/colpectomy (27.3%), perineorrhaphy and posterior repair (9.1%) and hysterectomy (9.1%). Almost 50% of these patients opted not to have surgical treatment.
CONCLUSIONS
The rate of prolapse recurrence after LeFort colpocleisis is estimated to be 4.2%. The management of recurrences after LeFort colpocleisis depends on the time and type of recurrence. The repeat modified LeFort colpocleisis is a viable option in patients with channel prolapse; if no uterus exists, colpectomy appears to be the best option.
Topics: Aged; Female; Gynecologic Surgical Procedures; Humans; Pelvic Organ Prolapse; Recurrence
PubMed: 28025678
DOI: 10.1007/s00192-016-3236-9