Is Robotic-Assisted Surgery Safe in the Elderly Population? An Analysis of Gynecologic Procedures in Patients ≥ 65 Years Old.

BACKGROUND: The elderly population is expanding worldwide but is underrepresented in clinical trials. We sought to assess the safety of robotic gynecologic surgery in an elderly cohort and to identify factors associated with unfavorable outcomes. METHODS: All patients ≥ 65 years who underwent a robotically assisted procedure at a single institution between May 2007 to December 2016 were divided into three age groups: 65-74 (Group 1); 75-84 (Group 2); ≥ 85 (Group 3). Perioperative outcomes were recorded in patients who did not require conversion to laparotomy. We compared clinical variables among groups and performed multivariate logistic regression to detect variables associated with major complications (≥ Grade 3) or 90-day mortality. RESULTS: We retrospectively identified 982 cases: 685 in Group 1; 249 in Group 2; 48 in Group 3. Median age = 71 years. Median BMI = 28.9. Malignancy was documented in 72.8% of cases; the majority were endometrial cancer (61.8%). Thirty-four patients (3.5%) were readmitted within 30 days. Seventy-seven (7.8%) had a postoperative complication, and 23 (2.3%) had a major complication. Ninety-day mortality was 0.5%. There was significant difference between groups with respect to body mass index (P = 0.026), ECOG PS (P ≤ 0.001), > 5 comorbidities (P = 0.005), hospital stay (P < 0.001), major complications (P = 0.001), and 90-day mortality (P < 0.001). On multivariable logistic regression, age ≥ 85 years was associated with major complications. Body mass index, age ≥ 85 years, and major complications were significantly associated with 90-day mortality. CONCLUSIONS: Robotic-assisted surgery appears to be safe in an elderly cohort. The incidence of overall and major complications is consistent with those reported in the literature. Patients ≥ 85 years old appear to be at higher risk of unfavorable outcomes.

Near-infrared fluorescence for detection of sentinel lymph nodes in women with cervical and uterine cancers (FILM): a randomised, phase 3, multicentre, non-inferiority trial.

BACKGROUND: Accurate identification of sentinel lymph nodes in patients with cancer improves detection of metastatic disease and decreases surgical morbidity. We sought to establish whether indocyanine green fluorescent dye is non-inferior to isosulfan blue dye in detecting sentinel lymph nodes in women with cervical and uterine cancers. METHODS: In this non-inferiority, within-patient comparison study, patients aged 18 years or older with clinical stage I endometrial or cervical cancer undergoing curative surgery were randomly assigned 1:1 to lymphatic mapping with isosulfan blue dye (visualised by white light) followed by indocyanine green (visualised by near-infrared imaging), or indocyanine green followed by isosulfan blue dye. Permuted block randomisation with stratification by study site was done with a computerised random number generator. All participants were masked to their randomisation assignment until after the procedure; however, investigators were not masked to the procedure used. Laparoscopic surgery with the PINPOINT near-infrared fluorescence imaging system (Stryker, Kalamazoo, MI, USA) was used in all cases. The primary outcome was efficacy of intraoperative indocyanine green with near-infrared fluorescence imaging versus that of isosulfan blue dye in the identification of lymph nodes, defined as the number of lymph nodes identified by indocyanine green and isosulfan blue dye, respectively (and confirmed as lymphoid tissue by histology), divided by the number of lymph nodes identified intraoperatively and excised. The study had a 5% non-inferiority margin needed to show non-inferiority of the frequency of lymph node detection with indocyanine green to that with isosulfan blue dye with 80% power at a 5% two-sided significance level. Analyses were done in both per-protocol and modified intention-to-treat populations. The trial was registered with ClinicalTrials.gov, number NCT02209532, and is completed and closed. FINDINGS: Between Dec 21, 2015, and June 19, 2017, 180 patients were enrolled and randomly assigned to the two groups (90 to each group); 176 patients received the intervention and were evaluable (modified intention-to-treat population). 13 patients with major protocol violations were subsequently excluded from the per-protocol population. 517 sentinel nodes were identified in the per-protocol population (n=163), of which 478 (92%) were confirmed to be lymph nodes on pathological processing: 219 (92%) of 238 nodes that were both blue and green, all seven nodes that were blue only, and 252 (95%) of 265 nodes that were green only (p=0·33). Seven sentinel lymph nodes were neither blue nor green but were removed for appearing suspicious or enlarged on visual examination. In total, 471 (97%) of 485 lymph nodes were identified with the green dye and 226 (47%) with the blue dye (difference 50%, 95% CI 39-62; p<0·0001). In the modified intention-to-treat population (n=176), 545 nodes were identified, of which 513 (94%) were confirmed to be lymph nodes on pathological processing: 229 (92%) of 248 nodes that were both blue and green, all nine nodes that were blue only, and 266 (95%) of 279 nodes that were green only (p=0·30). Nine sentinal lymph nodes were neither blue nor green but were removed for appearing suspicious or enlarged on visual examination. 495 (96%) of 513 nodes were identified with the green dye and 238 (46%) with the blue dye (50%, 39-61; p<0·0001). INTERPRETATION: Indocyanine green dye with near-infrared fluorescence imaging identified more sentinel nodes than isosulfan blue dye in women with cervical and uterine cancers, with no difference in the pathological confirmation of nodal tissue between the two mapping substances. FUNDING: Novadaq.

Fellowship learning curve associated with completing a robotic assisted total laparoscopic hysterectomy.

OBJECTIVE: To describe the learning curve associated with training fellows in completing robotic assisted total laparoscopic hysterectomies. METHODS: All patients scheduled to undergo a robotic procedure at our institution from 5/15/07 to 5/22/12 were identified. Fellow participation per procedure was documented. The learning curve of fellows for the time to complete a hysterectomy (from initiation of developing the retroperitoneal space to the completion of the colpotomy) was analyzed. RESULTS: Of the 1754 planned robotic cases, 1626 were completed robotically and 128 were converted to laparotomy. Fifty-seven fellows participated in 99.7% of the cases. Eleven gynecologic oncology fellows completed at least 1 robotic assisted total laparoscopic hysterectomy. From 7/7/08 to 5/21/12, 981 hysterectomies were completed robotically, 254 of these (25.9%) by the 11 fellows. Prior to completing a hysterectomy, the median number of hysterectomies in which a fellow participated was 16 (range, 11-40). Median amount of time for a fellow to complete a hysterectomy decreased from 60 min in 2009 (N=27 cases) to 31 min in 2011 (N=148 cases). Based on the recorded completion times in which the 11 fellows completed a hysterectomy, it required ~33 cases per fellow to be able to perform the hysterectomy and overcome the learning curve. CONCLUSIONS: The learning curve associated with hysterectomy requires completion of ~33 cases by the fellow after an initial median experience of 16 cases. Our data suggest that a minimum of 50 total cases is required during fellowship to complete a robotic hysterectomy.

Postoperative outcomes among patients undergoing thoracostomy tube placement at time of diaphragm peritonectomy or resection during primary cytoreductive surgery for ovarian cancer.

OBJECTIVE: Primary cytoreductive surgery in patients with stage IIIC-IV epithelial ovarian cancer frequently includes diaphragm peritonectomy or resection, which can lead to symptomatic pleural effusions when the resection specimen is ≥ 10 cm. Our objective was to evaluate whether the placement of an intraoperative thoracostomy tube decreased the incidence of symptomatic pleural effusions in these cases. METHODS: We identified 156 patients who underwent primary debulking surgery involving diaphragm peritonectomy or resection for stage III-IV ovarian cancer from 1/01-12/09. Using standard statistical tests, the incidence of symptomatic pleural effusions and other variables were compared between patients who did and did not have intraoperative chest tubes placed. RESULTS: Forty-nine patients had a resected diaphragm specimen ≥ 10 cm in largest dimension; 28 (57%) did not undergo chest tube placement (NCT group) while 21 (43%) did (CT group). Mediastinal lymph node dissection (0% vs 19%, P = 0.028) and liver resections (11% vs 38%, P = 0.037) were higher in the CT group. Postoperatively, 57% of the NCT group developed a moderate or large pleural effusion compared to 19% of the CT group (P = 0.007). Thirteen patients (46%) in the NCT group developed respiratory symptoms requiring either placement of a postoperative chest tube or thoracentesis compared to 3 patients (14%) in the CT group (P = 0.018). CONCLUSIONS: Diaphragm peritonectomy or resection can often lead to moderate or large pleural effusions that may become symptomatic. In these patients, intraoperative chest tube placement may be considered to decrease the incidence of symptomatic effusions and the need for postoperative chest tube placement or thoracentesis.

Feasibility of adjuvant chemotherapy after pelvic exenteration for gynecologic malignancies.

OBJECTIVE: It is well documented that recurrence after pelvic exenteration remains high (up to 50%), and patients may require a prolonged period of recuperation following this aggressive surgery. We conducted a retrospective review to evaluate the feasibility of administering adjuvant chemotherapy after pelvic exenteration for gynecologic malignancies. METHODS: We reviewed the medical records of patients with any gynecologic cancer who underwent exenterative surgery between January 2005 and February 2011 at our institution. Patients were referred for postexenteration adjuvant chemotherapy based on surgeon's discretion and/or presence of high-risk features: positive margins, positive lymph nodes, and/or lymphovascular space invasion. Suitability for chemotherapy was assessed by a gynecologic medical oncologist. Regimens consisted of 4 to 6 cycles of platinum-based doublet chemotherapy. Chemotherapy-related toxicities were assessed using the Common Terminology Criteria for Adverse Events version 4. RESULTS: We identified 42 patients who underwent pelvic exenteration during the study period. Eleven (26%) were referred for adjuvant chemotherapy. Three (27%) of the 11 patients did not receive chemotherapy because of delayed postoperative recovery or physician choice. Seven (88%) of the remaining 8 patients completed all scheduled chemotherapy. Grade 2 toxicities or greater were documented in 6 patients (75%), the most common being neutropenia, neuropathy, and fatigue. Median follow-up time was 25 months (range, 6-56 months). The 3-year progression-free and overall survival rates of the 8 patients who received chemotherapy were 58% (95% confidence interval, 18%-84%) and 54% (95% confidence interval, 13%- 83%), respectively. CONCLUSIONS: The administration of adjuvant chemotherapy is feasible for a select group of patients after pelvic exenteration for gynecologic malignancies. Our results need to be interpreted with caution because of the small and heterogeneous cohort of patients included.

Radical surgery with individualized postoperative radiation for stage IB cervical cancer: oncologic outcomes and severe complications.

OBJECTIVE: The objective of this study was to compare morbidity and outcome following radical surgery with or without adjuvant radiation therapy (RT) in the treatment of stages IB1-IB2 cervical carcinoma. METHODS: We retrospectively identified 222 patients with stages IB1-IB2 cervical carcinoma treated initially with radical hysterectomy or radical trachelectomy with or without adjuvant RT from February 2000 to November 2009. All grade 3 or higher complications-those requiring interventional radiology, endoscopic evaluation, or operative intervention-were documented. RESULTS: One hundred fifty-eight patients (71%) underwent radical hysterectomy; 64 (29%) underwent radical trachelectomy. One hundred fifty-three patients (69%) underwent surgery alone; 69 (31%) received adjuvant radiation with or without chemosensitization. There was a statistically significant difference in the rate of total grades 1 to 5 late complications between the surgery-alone and surgery + RT groups (12% vs 32%, respectively; P < 0.001); however, the rate of grade 3 or higher complications was similar (5% vs 4%, respectively; P = 0.999). The progression-free and overall survival rates of the entire cohort were both 95%. The 5-year progression-free survival rates for the surgery-alone and surgery + RT groups were 93% and 90% (P = 0.172). The overall survival rates were 96% and 91%, respectively (P = 0.332). CONCLUSIONS: The majority of women with stages IB1-IB2 cervical cancer undergoing radical surgery do not require adjuvant RT, have excellent oncologic outcome, and have low severe complication rates. Nearly one third of our patients required postoperative radiation, with no statistically significant increase in severe complication rate and with similar oncologic outcomes compared with the surgery-only cohort. These data support the continued practice of radical surgery with individualized postoperative radiation for these patients.

Sweet's syndrome: a cutaneous harbinger of ovarian carcinoma.

Sweet's syndrome, or acute febrile neutrophilic dermatosis, is a condition characterized by fever, neutrophilia, erythematous skin lesions, and a dermal infiltrate consisting predominantly of mature neutrophils on histology. Sweet's syndrome is a reactive phenomenon and should be considered a cutaneous marker of systemic disease, including underlying malignancy. We present a case of a 56-year-old woman who presented with vague abdominal symptoms and a tender, erythematous rash on her extremities. Biopsy of her skin lesions revealed Sweet's syndrome. A work-up for malignancy eventually demonstrated a pelvic mass and carcinomatosis, and a diagnosis of advanced-stage papillary serous ovarian carcinoma was subsequently made. In postmenopausal women who present with Sweet's syndrome, a comprehensive evaluation for malignancy is indicated. In women with a known diagnosis of cancer, Sweet's syndrome may manifest in the detection of persistent or recurrent disease.

Incidence of venous thromboembolism after minimally invasive surgery in patients with newly diagnosed endometrial cancer.

OBJECTIVE: To estimate the incidence of postoperative venous thromboembolism among patients undergoing minimally invasive surgery for endometrial cancer, and to characterize risk factors associated with the development of venous thromboembolism. METHODS: Patients with newly diagnosed endometrial cancer who were scheduled to undergo a planned minimally invasive surgery procedure from May 1, 2007 to December 31, 2010 were identified. The incidence of symptomatic postoperative venous thromboembolism was estimated in the patients who did not require conversion to laparotomy. Various clinicopathologic variables were tested for an association with the development of a postoperative venous thromboembolism using standard statistical tests. RESULTS: A total of 573 cases were identified. Postoperative low molecular weight heparin was administered to 125 (22%) patients during their immediate postoperative hospital stay. All patients had sequential compression devices placed intraoperatively. Seven (1.2%) patients had development of a symptomatic venous thromboembolism. The factors associated with development of a postoperative venous thromboembolism were: body mass index (BMI) (P=.005); estimated blood loss (P=.03); and operative time (P=.01). A high-risk group was determined to be patients with BMIs of 40 or higher and an operative time of 180 minutes or more. In this group, the incidence of venous thromboembolism was 9.5% (4 of 42) compared with 0.6% (3 of 531) in all others (P=.001). CONCLUSION: The incidence of venous thromboembolism in patients with newly diagnosed endometrial cancer undergoing minimally invasive surgery is very low. There appears to be no clear justification for the routine use of a heparin for perioperative thromboprophylaxis in the majority of these patients. Thromboprophylaxis with heparin, however, may be a consideration in morbidly obese patients (BMI of 40 or higher) after a procedure that lasts 3 hours or more. LEVEL OF EVIDENCE: II.

The effect of sleep disturbance on quality of life in women with ovarian cancer.

OBJECTIVE: To estimate the prevalence of sleep disturbances, and to determine if there is an association between sleep disturbances with quality of life (QOL), depression or clinical demographic variables. METHODS: Patients diagnosed with ovarian, fallopian tube or primary peritoneal cancer during the last 5years completed questionnaires regarding sleep patterns and disturbances [Pittsburgh Sleep Quality Index (PSQI)], depression [Beck Depression inventory (BDI)], and QOL [The Functional Assessment of Cancer Therapy-Ovarian (FACT-O), fatigue module (-F)]. Data were analyzed by Student's t-test or Pearson correlation coefficient to determine if there were differences between PSQI score with QOL, depression or clinical demographic variables. RESULTS: 86/275 (31% response) of patients returned the surveys. Mean age was 58.1 (SD=14.6) years and 70% had advanced disease at diagnosis. Thirty-six percent had current disease of which 81% were receiving chemotherapy. Sixty-seven percent of patients had a PSQI score≥5 corresponding to overall poor sleep quality and 46% of patients reported using sleep medication at least once during the prior month. PSQI score was significantly inversely correlated with all QOL domains (physical: r=-.599, p<.001, functional: r=-.692, p<.001, social: r=-.212, p<.001, emotional: r=-.379, p<.001, fatigue; r=-.655 p<.001) and with depression (r=.539, p<.001). PSQI was not correlated with age, time since diagnosis, number of previous chemotherapy regimens. PSQI score did not differ by current disease or chemotherapy status. CONCLUSIONS: Sleep disturbances reduce QOL, a prognostic indicator for survival, in ovarian cancer patients. These patients should undergo routine screening and would benefit from interventions that aim to promote restful sleep.

Recognition and management of major vessel injury during laparoscopy.

Laparoscopy is one of the most commonly performed procedures in the United States. Injury to a major retroperitoneal vessel occurs in 0.3% to 1.0% of procedures, most commonly during laparoscopic entry while placing the Veress needle or primary trocar. Fatal outcome can be related to massive gas embolism or exsanguination. Recommended treatment for gas embolism can range from supportive measures to external chest compression and insertion of a central line to withdraw gas from the right side of the heart. Recommended treatment of major vessel injury with massive hemorrhage consists of rapid laparotomy and control of hemorrhage using direct pressure until a surgeon experienced in vascular procedures arrives. When a major vessel injury occurs in a surgical facility distant from a medical center and without an available surgeon with vascular experience, based on the trauma literature, we recommend temporary control of blood loss using abdominal packing and closure (i.e., "damage control surgery") and judicious resuscitation (i.e., "damage control resuscitation") before transportation to a medical center.

Ectopic pregnancy: role of laparoscopic treatment.

Ectopic pregnancy is a common condition with the immediate risk of life-threatening hemorrhage and subsequent risks of infertility and recurrence. Despite remarkable advances in diagnosis and treatment, ectopic pregnancies account for 9% of all maternal deaths. Early diagnosis has led to the development of innovative surgical and nonsurgical options. The choice of treatment, including expectant, medical, and surgical approaches, depends on ectopic location, symptoms, gestational age, and future fertility desires. Goals are to make the diagnosis of ectopic pregnancy early and provide the most effective and least invasive procedure while sparing future fertility when desired.

Reproductive outcome after transplantation of ovarian tissue: a systematic review.

BACKGROUND: Despite interest in ovarian tissue transplantation (OTT) as a promising procedure for fertility preservation, to date, no precise data are available about its effectiveness. We systematically reviewed reproductive function after OTT for fertility preservation in women at high risk of premature ovarian failure (POF). METHODS: We searched the MEDLINE, EMBASE, Cochrane Systematic Reviews, CENTRAL, Web of Science and Scopus databases for studies on the reproductive outcomes after OTT in humans up to June 2007. Women with follicle-stimulating hormone (FSH) >30 IU/l at the time of OTT were included in a meta-analysis of individual-patient data to evaluate the time to re-establishment of ovarian function (ROF). Secondary outcomes included short-term (<12 months) and long-term (>12 months) ovarian function (OVF) and pregnancy after OTT. RESULTS: We identified 25 reports including 46 unique cases. OTT was performed to treat POF in 27 women, to prevent POF in 15, to treat infertility in 2 and accidentally in 1. In 23 women with FSH >30 at the time of OTT, OVF was re-established with a median time to ROF of 120 days (range 60-244). Within 6 months after ROF, four women had recurrent ovarian failure. There are insufficient data to evaluate the long-term OVF (>12 months). Fresh grafts had an increased likelihood of return of OVF and a decreased likelihood for recurrent ovarian failure compared with cryopreserved grafts [HR of 2.44 (95% CI 0.92, 6.49) and 0.47 (95% CI 0.18, 1.12), respectively]. In 25 women who sought pregnancy, eight women had nine pregnancies at 12 months, giving a cumulative pregnancy rate of 37% (95% CI 19, 60). CONCLUSIONS: Transplantation of ovarian tissue can re-establish OVF after POF; however, the efficacy of OTT using cryopreserved tissues is not yet equivalent to that of fresh grafts. A controlled multicenter trial with sufficient follow-up would provide valid evidence of the potential benefit of this procedure.

Radius of curvature and asphericity of the anterior and posterior surface of human cadaver crystalline lenses.

The purpose of this study was to measure the shape of the anterior and posterior surface of human cadaver lenses in situ using a corneal topography system. Measurements were performed on 13 pairs of eyes using the PAR Corneal Topography System (PAR-CTS). The age of the donors ranged from 46 to 93 years, with an average age of 76.4 years. Anterior lens topography was measured after excision of the cornea and iris. Posterior lens topography was measured after sectioning the posterior segment and adherent vitreous. The PAR-CTS files providing raw surface height were exported for analysis. In each surface, 18 meridians separated by 10 degrees were fitted using conic sections to obtain values of the apical radius of curvature (R) and shape factor (p). The average apical radius of curvature and asphericity were R=10.15+/-1.39mm and p=4.27+/-1.39 for the anterior surface and R=-6.25+/-0.79mm and p=-0.64+/-1.85 for the posterior surface. A significant variation of the radius of curvature and shape factor as a function of the meridian angle (lens astigmatism) was found in some lenses. Contrary to previous findings, the anterior lens surface was found to steepen toward the periphery.