Enhanced recovery in gynecologic surgery Kalogera, Eleftheria; Bakkum-Gamez, Jamie N; Jankowski, Christopher J ...
Obstetrics and gynecology (New York. 1953),
08/2013, Letnik:
122, Številka:
2 Pt 1
Journal Article
Recenzirano
Odprti dostop
To investigate the effects of enhanced recovery (a multimodal perioperative care enhancement protocol) in patients undergoing gynecologic surgery.
Consecutive patients managed under an enhanced ...recovery pathway and undergoing cytoreduction, surgical staging, or pelvic organ prolapse surgery between June 20, 2011, and December 20, 2011, were compared with consecutive historical controls (March to December 2010) matched by procedure. Wilcoxon rank-sum, χ, and Fisher's exact tests were used for comparisons. Direct medical costs incurred in the first 30 days were obtained from the Olmsted County Healthcare Expenditure and Utilization Database and standardized to 2011 Medicare dollars.
A total of 241 enhanced recovery women in the case group (81 cytoreduction, 84 staging, and 76 vaginal surgery) were compared with women in the control groups. In the cytoreductive group, patient-controlled anesthesia use decreased from 98.7% to 33.3% and overall opioid use decreased by 80% in the first 48 hours with no change in pain scores. Enhanced recovery resulted in a 4-day reduction in hospital stay with stable readmission rates (25.9% of women in the case group compared with 17.9% of women in the control group) and 30-day cost savings of more than $7,600 per patient (18.8% reduction). No differences were observed in rate (63% compared with 71.8%) or severity of postoperative complications (grade 3 or more: 21% compared with 20.5%). Similar, albeit less dramatic, improvements were observed in the other two cohorts. Ninety-five percent of patients rated satisfaction with perioperative care as excellent or very good.
Implementation of enhanced recovery was associated with acceptable pain management with reduced opioids, reduced length of stay with stable readmission and morbidity rates, good patient satisfaction, and substantial cost reductions.
II.
The Society of Gynecologic Surgeons Systematic Review Group performed a systematic review of both randomized and observational studies to compare robotic vs nonrobotic surgical approaches ...(laparoscopic, abdominal, and vaginal) for treatment of both benign and malignant gynecologic indications to compare surgical and patient-centered outcomes, costs, and adverse events associated with the various surgical approaches. MEDLINE and the Cochrane Central Register of Controlled Trials were searched from inception to May 15, 2012, for English-language studies with terms related to robotic surgery and gynecology. Studies of any design that included at least 30 women who had undergone robotic-assisted laparoscopic gynecologic surgery were included for review. The literature yielded 1213 citations, of which 97 full-text articles were reviewed. Forty-four studies (30 comparative and 14 noncomparative) met eligibility criteria. Study data were extracted into structured electronic forms and reconciled by a second, independent reviewer. Our analysis revealed that, compared with open surgery, robotic surgery consistently confers shorter hospital stay. The proficiency plateau seems to be lower for robotic surgery than for conventional laparoscopy. Of the various gynecologic applications, there seems to be evidence that renders robotic techniques advantageous over traditional open surgery for management of endometrial cancer. However, insofar as superiority, conflicting data are obtained when comparing robotics vs laparoscopic techniques. Therefore, the specific method of minimally invasive surgery, whether conventional laparoscopy or robotic surgery, should be tailored to patient selection, surgeon ability, and equipment availability.
To analyze inaccuracies in the news media reporting of the 2019 US Food and Drug Administration (FDA) ban on surgical mesh for transvaginal repair of pelvic organ prolapse (POP).
We queried the ...NexisUni media database for English-language news articles about “transvaginal mesh” or “FDA” published before and after the ban. Content analysis was based on discussion of the ban, indications for surgical mesh, and assessment of bias. We characterized public interest in transvaginal mesh using Google Trends.
Of 290 news articles reviewed, 42 articles were included for analysis. Public interest in transvaginal mesh increased 4-fold after the FDA announcement. While 15 articles (38%) accurately reported that mesh was used in both POP and incontinence repairs, a plurality (18, 43%) only described using mesh for POP. The majority (30, 71%) of articles did not specify that the FDA ban applied to only transvaginal repair of POP and not to incontinence. Despite multiple professional societies affirming the use of mesh for incontinence, only 2 (5%) articles cited these evidence-based recommendations. About half of the articles had an overtly biased tone; articles with an anti-mesh bias were significantly less likely to identify the mesh indications relevant to the ban (P <.01).
Seventy percent of news reports about the 2019 FDA ban on transvaginal mesh for POP failed to distinguish between the clinical indications for mesh impacted by the ban. The findings raise concern about patient perceptions of and future access to mesh surgery, regardless of indication.
Enhanced Recovery After Surgery (ERAS) programs are mechanisms for achieving value-based improvements in surgery. This report provides a detailed analysis of the impact of an ERAS program on patient ...outcomes as well as quality and safety measures during implementation on a gynecologic oncology service at a major academic medical center.
A retrospective review of gynecologic oncology patients undergoing elective laparotomy during the implementation phase of an ERAS program (January 2016 through December 2016) was performed. Patient demographics, surgical variables, postoperative outcomes, and adherence to core safety measures, including antimicrobial and venous thromboembolism (VTE) prophylaxis, were compared to a historical patient cohort (January 2015 through December 2015). Statistical analyses were performed using t-tests, Wilcoxon rank sum tests, and Chi squared tests.
The inaugural 109 ERAS program participants were compared to a historical patient cohort (n=158). There was no difference in BMI, race, malignancy, or complexity of procedure between cohorts. ERAS patients required less narcotics (70.7 vs 127.4, p=0.007, oral morphine equivalents) and PCA use (32.1% vs. 50.6%, p=0.002). Despite this substantial reduction in narcotics, ERAS patients did not report more pain and in fact reported significantly less pain by postoperative day 3. There were no differences in length of stay (5days), complication rates (13.8% vs. 20.3%, p=0.17) or 30-day readmission rates (9.5 vs 11.9%, p=0.54) between ERAS and historical patients, respectively. Compliance with antimicrobial prophylaxis was 97.2%. However, 33.9% of ERAS patients received substandard preoperative VTE prophylaxis.
ERAS program implementation resulted in reductions in narcotic requirements and PCA use without changes in length of stay or readmission rates. Compliance should be diligently audited during the implementation phase of ERAS programs, with special attention to adherence to pre-existing core safety measures.
•Enhanced recovery after surgery programs in open gynecologic surgery result in decreased inpatient narcotic utilization.•Enhanced recovery after surgery programs in open gynecologic surgery result in fewer patient controlled analgesia devices.•Auditing during the implementation of ERAS for compliance with protocol and core safety measures is imperative.
Background
Laparoscopy is a common procedure in many surgical specialties. Complications arising from laparoscopy are often related to initial entry into the abdomen. Life‐threatening complications ...include injury to viscera (e.g. bowel, bladder) or to vasculature (e.g. major abdominal and anterior abdominal wall vessels). No clear consensus has been reached as to the optimal method of laparoscopic entry into the peritoneal cavity.
Objectives
To evaluate the benefits and risks of different laparoscopic entry techniques in gynaecological and non‐gynaecological surgery.
Search methods
We searched the Cochrane Gynaecology and Fertility (CGF) Group trials register, CENTRAL, MEDLINE, Embase, PsycINFO, and trials registers in January 2018. We also checked the references of articles retrieved.
Selection criteria
We included randomised controlled trials (RCTs) that compared one laparoscopic entry technique versus another. Primary outcomes were major complications including mortality, vascular injury of major vessels and abdominal wall vessels, visceral injury of bladder or bowel, gas embolism, solid organ injury, and failed entry (inability to access the peritoneal cavity). Secondary outcomes were extraperitoneal insufflation, trocar site bleeding, trocar site infection, incisional hernia, omentum injury, and uterine bleeding.
Data collection and analysis
Two review authors independently selected studies, assessed risk of bias, and extracted data. We expressed findings as Peto odds ratios (Peto ORs) with 95% confidence intervals (CIs). We assessed statistical heterogeneity using the I² statistic. We assessed the overall quality of evidence for the main comparisons using GRADE methods.
Main results
The review included 57 RCTs including four multi‐arm trials, with a total of 9865 participants, and evaluated 25 different laparoscopic entry techniques. Most studies selected low‐risk patients, and many studies excluded patients with high body mass index (BMI) and previous abdominal surgery. Researchers did not find evidence of differences in major vascular or visceral complications, as would be anticipated given that event rates were very low and sample sizes were far too small to identify plausible differences in rare but serious adverse events.
Open‐entry versus closed‐entry
Ten RCTs investigating Veress needle entry reported vascular injury as an outcome. There was a total of 1086 participants and 10 events of vascular injury were reported. Four RCTs looking at open entry technique reported vascular injury as an outcome. There was a total of 376 participants and 0 events of vascular injury were reported. This was not a direct comparison. In the direct comparison of Veress needle and Open‐entry technique, there was insufficient evidence to determine whether there was a difference in rates of vascular injury (Peto OR 0.14, 95% CI 0.00 to 6.82; 4 RCTs; n = 915; I² = N/A, very low‐quality evidence). Evidence was insufficient to show whether there were differences between groups for visceral injury (Peto OR 0.61, 95% CI 0.06 to 6.08; 4 RCTs; n = 915: I² = 0%; very low‐quality evidence), or failed entry (Peto OR 0.45, 95% CI 0.14 to 1.42; 3 RCTs; n = 865; I² = 63%; very low‐quality evidence). Two studies reported mortality with no events in either group. No studies reported gas embolism or solid organ injury.
Direct trocar versus Veress needle entry
Trial results show a reduction in failed entry into the abdomen with the use of a direct trocar in comparison with Veress needle entry (OR 0.24, 95% CI 0.17 to 0.34; 8 RCTs; N = 3185; I² = 45%; moderate‐quality evidence). Evidence was insufficient to show whether there were differences between groups in rates of vascular injury (Peto OR 0.59, 95% CI 0.18 to 1.96; 6 RCTs; n = 1603; I² = 75%; very low‐quality evidence), visceral injury (Peto OR 2.02, 95% CI 0.21 to 19.42; 5 RCTs; n = 1519; I² = 25%; very low‐quality evidence), or solid organ injury (Peto OR 0.58, 95% Cl 0.06 to 5.65; 3 RCTs; n = 1079; I² = 61%; very low‐quality evidence). Four studies reported mortality with no events in either group. Two studies reported gas embolism, with no events in either group.
Direct vision entry versus Veress needle entry
Evidence was insufficient to show whether there were differences between groups in rates of vascular injury (Peto OR 0.39, 95% CI 0.05 to 2.85; 1 RCT; n = 186; very low‐quality evidence) or visceral injury (Peto OR 0.15, 95% CI 0.01 to 2.34; 2 RCTs; n = 380; I² = N/A; very low‐quality evidence). Trials did not report our other primary outcomes.
Direct vision entry versus open entry
Evidence was insufficient to show whether there were differences between groups in rates of visceral injury (Peto OR 0.13, 95% CI 0.00 to 6.50; 2 RCTs; n = 392; I² = N/A; very low‐quality evidence), solid organ injury (Peto OR 6.16, 95% CI 0.12 to 316.67; 1 RCT; n = 60; very low‐quality evidence), or failed entry (Peto OR 0.40, 95% CI 0.04 to 4.09; 1 RCT; n = 60; very low‐quality evidence). Two studies reported vascular injury with no events in either arm. Trials did not report our other primary outcomes.
Radially expanding (STEP) trocars versus non‐expanding trocars
Evidence was insufficient to show whether there were differences between groups in rates of vascular injury (Peto OR 0.24, 95% Cl 0.05 to 1.21; 2 RCTs; n = 331; I² = 0%; very low‐quality evidence), visceral injury (Peto OR 0.13, 95% CI 0.00 to 6.37; 2 RCTs; n = 331; very low‐quality evidence), or solid organ injury (Peto OR 1.05, 95% CI 0.07 to 16.91; 1 RCT; n = 244; very low‐quality evidence). Trials did not report our other primary outcomes.
Other studies compared a wide variety of other laparoscopic entry techniques, but all evidence was of very low quality and evidence was insufficient to support the use of one technique over another.
Authors' conclusions
Overall, evidence was insufficient to support the use of one laparoscopic entry technique over another. Researchers noted an advantage of direct trocar entry over Veress needle entry for failed entry. Most evidence was of very low quality; the main limitations were imprecision (due to small sample sizes and very low event rates) and risk of bias associated with poor reporting of study methods.
Abstract Objective The objective of this study was to evaluate the ability of the American College of Surgeons (ACS) National Surgical Quality Improvement Program (NSQIP) surgical risk calculator to ...predict complications in gynecologic oncology patients undergoing laparotomy. Methods A chart review of patients who underwent laparotomy on the gynecologic oncology service at a single academic hospital from January 2009 to December 2013 was performed. Preoperative variables were abstracted and NSQIP surgical risk scores were calculated. The risk of any complication, serious complication, death, urinary tract infection, venous thromboembolism, cardiac event, renal complication, pneumonia and surgical site infection were correlated with actual patient outcomes using logistic regression. The c-statistic and Brier score were used to calculate the prediction capability of the risk calculator. Results Of the 1094 patients reviewed, the majority were < 65 years old (70.9%), independent (95.2%), ASA class 1–2 (67.3%), and overweight or obese (76.1%). Higher calculated risk scores were associated with an increased risk of the actual complication occurring for all events (p < 0.05). The calculator performed best for predicting death (c-statistic = 0.851, Brier = 0.008), renal failure (c-statistic = 0.752, Brier = 0.015) and cardiac complications (c-statistic = 0.708, Brier = 0.011). The calculator did not accurately predict most complications. Conclusions The NSQIP surgical risk calculator adequately predicts specific serious complications, such as postoperative death and cardiac complications. However, the overall performance of the calculator was worse for gynecologic oncology patients than reported in general surgery patients. A tailored prediction model may be needed for this patient population.
This is the first updated Enhanced Recovery After Surgery (ERAS) Society guideline presenting a consensus for optimal perioperative care in gynecologic/oncology surgery.
A database search of ...publications using Embase and PubMed was performed. Studies on each item within the ERAS gynecologic/oncology protocol were selected with emphasis on meta-analyses, randomized controlled trials, and large prospective cohort studies. These studies were then reviewed and graded according to the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) system.
All recommendations on ERAS protocol items are based on best available evidence. The level of evidence for each item is presented accordingly.
The updated evidence base and recommendation for items within the ERAS gynecologic/oncology perioperative care pathway are presented by the ERAS® Society in this consensus review.
Objective In the last decade, many new surgical treatments have been developed to achieve less-invasive approaches to prolapse management. However, limited data exist on how the patterns of care for ...women with pelvic organ prolapse (POP) may have changed over the last decade, and whether mesh implantation techniques have influenced the type of specific compartment repair performed. We used a national data set to analyze the temporal trends in patterns of care for women with POP. Study Design Data were obtained from Public Use Files from the Centers for Medicare and Medicaid Services for a 5% random sample of national beneficiaries with an International Classification of Diseases, Ninth Revision, Clinical Modification diagnosis of POP from 1999 through 2009. Current Procedural Terminology, 4th Edition and International Classification of Diseases, Ninth Revision, Clinical Modification procedure codes were used to evaluate nonsurgical and surgical management trends for this cohort. Types of surgery were categorized by prolapse compartment and combinations of repairs. After 2005, when applicable codes became available, mesh or graft repairs were also analyzed. Results Over the study time period, the number of women with a diagnosis of POP in any 1 year in our 5% sample of Medicare beneficiaries remained relatively stable (range, 21,245–23,268 per year). Rates of pessary insertion were also consistent at 11-13% over the study period. Of the women with a prolapse diagnosis, 14-15% underwent surgical repair, and there was little change over time in surgical management patterns based on compartment. Most commonly, multiple compartments were repaired simultaneously. There was a rapid increase in mesh use such that in 2009, 41% of all women who underwent surgery (5.8% of the total cohort) had mesh or graft inserted in their repair. Hysterectomy rates for prolapse decreased over time. Rates of vault suspension at the time of hysterectomy for prolapse were low; however, they showed a relative increase over time (22% in 1999 to 26% in 2009). Conclusion Patterns and rates of prolapse repairs remained relatively unchanged from 1999 through 2009, with an exception of a rapid rise in mesh use. These data suggest that the majority of mesh techniques were used for augmentation purposes only, but did not result in an increase in apical repairs performed in the United States. There remains a disappointingly low rate of vault suspension repairs concomitantly at time of hysterectomy for POP.
Introduction and hypothesis
Prolapse of the vaginal apex can be treated using multiple surgical modalities. We describe national trends and patient characteristics associated with the surgical ...approach and compare perioperative outcomes of abdominal versus vaginal repair of apical pelvic organ prolapse (POP).
Methods
The 2006–2012 National Surgical Quality Improvement Program Database was queried for abdominal sacrocolpopexy (ASC) and vaginal apical suspensions. Patients were stratified by whether or not concomitant hysterectomy (CH) was performed or whether or not they were post-hysterectomy (PH). Multivariate logistic regressions were adjusted for confounding variables.
Results
A total of 6,147 patients underwent apical POP repair: 33.9% (2,085) ASCs, 66.1% (4,062) vaginal suspensions. 60.0% (3,689) underwent CH. In all cohorts, older patients were less likely to have ASC (CH: OR 0.48, CI 0.28–0.83,
p
= 0.008 for age ≥ 60; PH: OR 0.28, CI 0.18–0.43,
p
< 0.001). Over time, the proportion of all vaginal and abdominal repairs remained relatively stable. Use of minimally invasive ASC, however, increased over the study period (trend
p
< 0.001), and use of mesh for vaginal suspensions decreased (
p
< 0.001). ASC had a longer median operative time (PH 174 vs 95 min,
p
< 0.001; CH 192 vs 127 min,
p
< 0.001). Complication rates were the same for vaginal repairs and ASC, overall and when sub-stratified by hysterectomy status.
Conclusions
Nationally, most apical POP repairs are performed via a vaginal route. Older age was predictive of the vaginal route for both CH and PH groups. ASCs had longer operative times. There has been increased utilization of minimally invasive ASC and decreased use of mesh-augmented vaginal suspensions over time.
Although women with endometrial cancer generally have a favourable prognosis, those with high-risk disease features are at increased risk of recurrence. The PORTEC-3 trial was initiated to ...investigate the benefit of adjuvant chemotherapy during and after radiotherapy (chemoradiotherapy) versus pelvic radiotherapy alone for women with high-risk endometrial cancer.
PORTEC-3 was an open-label, international, randomised, phase 3 trial involving 103 centres in six clinical trials collaborating in the Gynaecological Cancer Intergroup. Eligible women had high-risk endometrial cancer with FIGO 2009 stage I, endometrioid-type grade 3 with deep myometrial invasion or lymph-vascular space invasion (or both), endometrioid-type stage II or III, or stage I to III with serous or clear cell histology. Women were randomly assigned (1:1) to receive radiotherapy alone (48·6 Gy in 1·8 Gy fractions given on 5 days per week) or radiotherapy and chemotherapy (consisting of two cycles of cisplatin 50 mg/m2 given during radiotherapy, followed by four cycles of carboplatin AUC5 and paclitaxel 175 mg/m2) using a biased-coin minimisation procedure with stratification for participating centre, lymphadenectomy, stage of cancer, and histological type. The co-primary endpoints were overall survival and failure-free survival. We used the Kaplan-Meier method, log-rank test, and Cox regression analysis for final analysis by intention to treat and adjusted for stratification factors. The study was closed on Dec 20, 2013, after achieving complete accrual; follow-up is ongoing. PORTEC-3 is registered with ISRCTN, number ISRCTN14387080, and ClinicalTrials.gov, number NCT00411138.
686 women were enrolled between Nov 23, 2006, and Dec 20, 2013. 660 eligible patients were included in the final analysis, of whom 330 were assigned to chemoradiotherapy and 330 were assigned to radiotherapy. Median follow-up was 60·2 months (IQR 48·1–73·1). 5-year overall survival was 81·8% (95% CI 77·5–86·2) with chemoradiotherapy versus 76·7% (72·1–81·6) with radiotherapy (adjusted hazard ratio HR 0·76, 95% CI 0·54–1·06; p=0·11); 5-year failure-free survival was 75·5% (95% CI 70·3–79·9) versus 68·6% (63·1–73·4; HR 0·71, 95% CI 0·53–0·95; p=0·022). Grade 3 or worse adverse events during treatment occurred in 198 (60%) of 330 who received chemoradiotherapy versus 41 (12%) of 330 patients who received radiotherapy (p<0·0001). Neuropathy (grade 2 or worse) persisted significantly more often after chemoradiotherapy than after radiotherapy (20 8% women vs one 1% at 3 years; p<0·0001). Most deaths were due to endometrial cancer; in four patients (two in each group), the cause of death was uncertain. One death in the radiotherapy group was due to either disease progression or late treatment complications; three deaths (two in the chemoradiotherapy group and one in the radiotherapy group) were due to either intercurrent disease or late treatment-related toxicity.
Adjuvant chemotherapy given during and after radiotherapy for high-risk endometrial cancer did not improve 5-year overall survival, although it did increase failure-free survival. Women with high-risk endometrial cancer should be individually counselled about this combined treatment. Continued follow-up is needed to evaluate long-term survival.
Dutch Cancer Society, Cancer Research UK, National Health and Medical Research Council Project Grant and Cancer Australia, L'Agenzia Italiana del Farmaco, and Canadian Cancer Society Research Institute.
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