Cost analysis of the enhanced recovery after surgery protocol applied in advanced ovarian cancer: A secondary outcome of the PROFAST trial.

INTRODUCTION: A randomised trial implementing Enhanced Recovery After Surgery (ERAS) for high complexity advanced ovarian cancer (AOC) surgery (PROFAST) demonstrated a reduction of median length of stay and hospital readmissions when compared to patients managed conventionally. One secondary objective was to determine if an ERAS pathway in the perioperative management of advanced ovarian cancer patients led to cost savings. MATERIAL AND METHODS: Secondary objective of a prospective randomised trial of patients with suspected or diagnosed advanced ovarian cancer allocated to conventional or ERAS perioperative management, carried out at a referral centre from June 2014 to March 2018. Treatment was determined by a computer-generated random allocation system. METHODS: Gross counting was employed to estimate the cost of hospitalisation in wards, intensive care unit (ICU) and surgical care, while micro-costing was used to obtain image and laboratory test costs. Mean costs between trial arms were considered. Sensitivity analyses were performed. RESULTS: Ninety-nine patients (n = 50 ERAS group, n = 49 Conventional group) were included. Mean costs per patient were 10,719€ in the ERAS group and 11,028€ in the conventional group, leading to an average saving of 309€ per patient. These results were based on 96 patients, excluding 3 extreme outliers mainly related with very high ICU costs. Savings, which were significant for hospital ward costs (-33% total; 759€ per patient in first hospitalisation, and 914€ per partient/day of readmission) were found as robust in the sensitivity analysis. CONCLUSIONS: Implementation of an ERAS pathway leads to cost savings when compared to conventional management after AOC surgery.

Indications and practice of diverting ileostomy after colorectal resection and anastomosis in ovarian cancer cytoreduction.

OBJECTIVE: To determine the factors related with diverting ileostomy performance after colorectal resection and anastomosis, in advanced ovarian cancer cytoreductive surgery. METHODS: We have previously demonstrated the risk factors associated with anastomotic leak after colorectal anastomosis: Advanced age at surgery, low serum albumin level, additional bowel resections, manual anastomosis and distance of the anastomosis from the anal verge. However, use of diverting ileostomy is strongly variable and depends on individual surgeon preferences and training. Eight hospitals participated in this retrospective study. Data of 695 patients operated for ovarian cancer with primary colorectal anastomosis were included (January 2010-June 2018). Fourteen pre-/intraoperatively defined variables were identified and analysed as justification factors for use of diverting ileostomy. RESULTS: The rate of diverting ileostomy in the entire cohort was 19.13% (133/695; range within individual centers 4.6-24.32%). Previous treatment with bevacizumab [OR 2.8 (1.3-6.1); p=0.01]; additional bowel resections [OR 3.0 (1.8-5.1); p<0.001]; extended operating time [OR 1.005 (1.003-1.006); p<0.001] and intra-operative red blood transfusion [OR 2.7 (1.4-5.3); p<0.001] were found to be independently associated with diverting ileostomy performance. Assuming a 7% AL rate cut-off, up to 51.8% of DI presented an AL risk below 7% and might have been spared. CONCLUSIONS: The risk factors that drive the gynecologic oncology surgeons to perform a diverting ileostomy, seem to differ from the actual risk factors that we have identified to be associated with postoperative anastomotic leak. Broader awareness of the risk factors that contribute to a higher perioperative risk profile, will facilitate a better risk stratification process and possibly avoid unnecessary stoma formation in ovarian cancer patients.

Evaluation of the intraoperative human papillomavirus test as a marker of early cure at 12 months after electrosurgical excision procedure in women with cervical high-grade squamous intraepithelial lesion: a prospective cohort study.

OBJECTIVE: To evaluate if the intraoperative human papillomavirus (IOP-HPV) test has the same prognostic value as the HPV test performed at 6 months after treatment of high-grade squamous intraepithelial lesion (HSIL) to predict treatment failure. DESIGN: Prospective cohort study. SETTING: Barcelona, Spain. POPULATION: A cohort of 216 women diagnosed with HSIL and treated with loop electrosurgical excision procedure (LEEP). METHODS: After LEEP, an HPV test was performed using the Hybrid Capture 2 system. If this was positive, genotyping was performed with the CLART HPV2 technique. The IOP-HPV test was compared with HPV test at 6 months and with surgical margins. MAIN OUTCOME MEASURE: Treatment failure. RESULTS: Recurrence rate of HSIL was 6%. There was a strong association between a positive IOP-HPV test, a positive 6-month HPV test, positive HPV 16 genotype, positive surgical margins and HSIL recurrence. Sensitivity, specificity, and positive and negative predictive values of the IOP-HPV test were 85.7, 80.8,24.0 and 98.8% and of the HPV test at 6 months were 76.9, 75.8, 17.2 and 98.0%. CONCLUSION: Intraoperative HPV test accurately predicts treatment failure in women with cervical intraepithelial neoplasia grade 2/3. This new approach may allow early identification of patients with recurrent disease, which will not delay the treatment. Genotyping could be useful in detecting high-risk patients. TWEETABLE ABSTRACT: IOP-HPV test accurately predicts treatment failure in women with CIN 2/3.

Oncologic impact of micrometastases or isolated tumor cells in sentinel lymph nodes of patients with endometrial cancer: a meta-analysis.

PURPOSE: There is a gap in knowledge regarding the impact of micrometastases (MIC) and isolated tumor cells (ITCs) found in the sentinel lymph nodes of patients with endometrial cancer. Here, we present a meta-analysis of the published literature on the rate of MIC and ITCs after lymphatic mapping and determine trends in postoperative management. METHODS: Literature search of Medline and PubMed was done using the terms: micrometastases, isolated tumor cells, endometrial cancer, and sentinel lymph node. Inclusion criteria were: English-language manuscripts, retrospectives, or prospective studies published between January 1999 and June 2019. We removed manuscripts on sentinel node mapping that did not specify information on micrometastases or isolated tumor cells, non-English-language articles, no data about oncologic outcomes, and articles limited to ten cases or less. RESULTS: A total of 45 manuscripts were reviewed, and 8 studies met inclusion criteria. We found that the total number of patients with MIC/ITCs was 286 (187 and 99, respectively). The 72% of patients detected with MIC/ITCs in sentinel nodes received adjuvant therapies. The MIC/ITCs group has a higher relative risk of recurrence of 1.34 (1.07, 1.67) than the negative group, even if the adjuvant therapy was given. CONCLUSION: We noted that there is an increased relative risk of recurrence in patients with low-volume metastases, even after receiving adjuvant therapy. Whether adjuvant therapy is indicated remains a topic of debate because there are other uterine factors implicated in the prognosis. Multi-institutional tumor registries may help shed light on this important question.

Risk factors for anastomotic leakage after colorectal resection in ovarian cancer surgery: A multi-centre study.

OBJECTIVE: To determine pre-/intraoperative risk factors for anastomotic leak after modified posterior pelvic exenteration (MPE) or colorectal resection in ovarian cancer and to create a practical instrument for predicting anastomotic leak risk. BACKGROUND: In advanced ovarian cancer surgery, there is rather limited published evidence, drawn from a small sample, providing information about risk factors for anastomotic leak. METHODS: Eight hospitals participated in this retrospective study. Data on 695 patients operated for ovarian cancer with primary anastomosis were included (January 2010-June 2018). Twelve pre-/intraoperative variables were analysed as potential independent risk factors for anastomotic leak. A predictive model was created to stablish the risk of anastomotic leak for a given patient. RESULTS: The anastomotic leak rate was 6.6% (46/695; range 1.7%-12.5%). A total of 457 patients were included in the final multivariate analysis. The following variables were found to be independently associated with anastomotic leakage: age at surgery (OR 1.046, 95% CI 1.013-1.080, p = 0.005), serum albumin level (OR 0.621, 95% CI 0.407-0.948, p = 0.027), one or more additional small bowel resections (OR 3.544, 95% CI 1.228-10.23, p = 0.019), manual anastomosis (OR 8.356, 95% CI 1.777-39.301, p = 0.007) and distance of the anastomosis from the anal verge (OR 0.839, 95% CI 0.726-0.971, p = 0.018). CONCLUSIONS: Due to the low incidence of AL in ovarian cancer patients, a restrictive stoma policy based on the presence of risk factors should be the actual recommendation. Hand-sewn anastomosis should be avoided.

Comparison of robotic-assisted vs conventional laparoscopy for extraperitoneal paraaortic lymphadenectomy.

OBJECTIVE: To evaluate the perioperative outcomes of robotic-assisted extraperitoneal paraaortic lymphadenectomy for locally advanced cervical cancer and to compare to a previous series of patients from our institution undergoing the same procedure by conventional laparoscopy. METHODS: 17 patients with locally advanced cervical cancer (FIGO stages IB2, IIA2 and IIB-IVA) underwent pretherapeutic extraperitoneal paraaortic lymphadenectomy by robotic-assisted laparoscopy. Perioperative outcomes including age, BMI, FIGO stage, operating time, blood loss, complications and length of hospital stay were compared to a series of 83 patients from our institution undergoing the same procedure by conventional laparoscopy. RESULTS: The median values for operating time and hospital days for the robotic-assisted and conventional laparoscopy groups were 150 vs. 150 min and 2 vs 2 days, respectively. In the robotic group, blood loss was lower (90 vs 20 ml, p<0.05) and more aortic nodes were removed (14 vs 17 nodes, p<0.05). Docking time was 7 min (range 3-15). There were no intraoperative complications. There were no differences for postoperative complications (17.6% vs 8.4%). CONCLUSION: Robotic-assisted and conventional laparoscopy provide similar perioperative outcomes other than lower blood loss and higher number of aortic nodes removed (both without clinical impact) in robotic patients for the performance of extraperitoneal paraaortic lymphadenectomy in patients with locally advanced cervical cancer. We believe that robotic surgery is an additional tool to perform the same surgical procedure. HIGHLIGHTS: Robotic-assisted and conventional laparoscopic extraperitoneal paraaortic lymphadenectomy provide similar perioperative outcomes.

Location of aortic node metastases in locally advanced cervical cancer.

BACKGROUND: To assess the location of aortic node metastasis in patients with locally advanced cervical cancer undergoing extraperitoneal aortic lymphadenectomy to define the extent of the aortic lymphadenectomy. MATERIAL AND METHODS: Between August 2001 and December 2010, 100 consecutive patients with primary locally advanced cervical cancer underwent extraperitoneal laparoscopic aortic and common iliac lymphadenectomy. The location of aortic node metastases, inframesenteric or infrarenal was noted. RESULTS: The mean number±standard deviation (SD) of aortic nodes removed was 15.9 ± 7.8 (range 4-62). The mean number ± SD of inframesenteric (including common iliac) nodes removed was 8.8 ± 4.5 (range 2-41) and the mean number ± SD of infrarenal nodes removed was 7.8 ± 4.1 (range 2-21). Positive aortic nodes were observed in 16 patients, and in 5 (31.2%) of them the infrarenal nodes were the only nodes involved, with negative inframesenteric nodes. CONCLUSION: Inframesenteric aortic nodes are negative in the presence of positive infrarenal nodes in about one third of patients with locally advanced cervical cancer and aortic metastases.

Gammagrafía abdominal con leucocitos marcados en la isquemia intestinal / Abdominal scintigraphy using labelled leukocytes in intestinal ischaemia

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[Perforation risk in esophageal endoscopic mucosal resection with ligation: an experimental study with two ligator models]. / Riesgo de perforación en la mucosectomía esofágica con banda: estudio experimental con dos modelos de ligadores.

OBJECTIVE: endoscopic mucosal resection with ligation (EMRL) is considered an efficient, safe method for the treatment of some esophageal, gastric and colorectal tumors. We conducted this study using a porcine model in order to compare the safety of esophageal EMRL with two multiband ligation systems, since many centers only use these ligator models in EMRL (commercialized for varix ligation). METHODS: eight pigs were used, which were submitted to 23 esophageal resections without previous injection. Ten resections were conducted using the Six Shooter Saeed model, and 13 resections used the Speedband Superview Super 7 model. The technique was also compared by making random cuts either above or below the band. RESULTS: five perforations occurred, all of them using the Speedband model. This represents 38.5% of total in the Speedband model group. No perforation occurred when using the Six Shooter model (p = 0.046). On the contrary, no significant differences were found regarding frequency of perforation when cutting above or below the band. CONCLUSIONS: esophageal EMRL using the Speedband model without previous injection leads to perforation in a high percentage of cases in an experimental animal model. Further studies are required to find out whether a previous injection may increase the safety of this technique with this ligator model.

Incidence of tumoral pathology according to study using capsule endoscopy for patients with obscure gastrointestinal bleeding.

BACKGROUND: Capsule endoscopy has involved a significant advance in techniques for imaging of the small bowel. Its most frequent indication is for studying patients with obscure gastrointestinal bleeding (OGIB). Small bowel tumors are infrequent, representing only 1% to 3% of all malignant gastrointestinal tumors. This study aimed to assess retrospectively the occurrence and characteristics of tumoral pathology diagnosed by means of capsule endoscopy in patients with OGIB. METHODS: A retrospective review analyzed the first 320 patients submitted to capsule endoscopy because of OGIB (166 with obscure overt bleeding and 154 with obscure occult bleeding) at a single center. The patients with a tumor diagnosis were analyzed in terms of incidence, characteristics, and treatment of OGIB pathology. RESULTS: Tumor incidence was of 7.18% (23/320), with 65.2% of the cases supported with histologic confirmation (15/23). Obscure overt bleeding was the most frequent form of presentation, with the jejunum as the most frequent location (65.2%). For 16 patients, an intervention was conducted with a healing intent. Capsule endoscopy allowed the diagnosis of two cecal adenocarcinomas missed by colonoscopy. CONCLUSIONS: Small bowel tumors are not an infrequent cause of OGIB. Capsule endoscopy, even if it does not allow determination of the benign or malignant nature or the histologic type of the tumor, is a useful tool for the diagnosis and early management of these tumors.

[Paravertebral pyomyositis in childhood following closed injury]. / Piomiositis paravertebral infantil en relación con traumatismo cerrado.

Pyomyositis is an acute bacterial infection that affects striated muscle and is generally accompanied by the formation of an abscess. In most cases, the microorganism involved is Staphylococcus aureus. Clinical findings are characterized by pain, swelling and muscular edema, together with variable general symptoms. Complications include arthritis, osteomyelitis and even septic shock with a mortality of 1.8%. We report the case of an 8-year-old boy who sustained a closed lumbar injury on banging his shoulder while he was playing on a trampoline and who developed paravertebral pyomyositis complicated by sepsis. S. aureus was isolated in the blood culture. The boy subsequently developed a perivertebral abscess and finally contiguous osteomyelitis in the L3 spinous process. The patient received treatment with vancomycin and metronidazole for 6 weeks followed by cloxacillin therapy for 2 weeks (a total of 8 weeks of intravenous antibiotic therapy). Physical examination 3 months after discharge revealed no abnormalities. The possibility of pyomyositis should be borne in mind, especially in children with fever, localized muscular pain and a history of accidental or sports injuries. Early diagnosis and treatment are important to reduce the risk of possibly fatal complications.

Usefulness of endoscopic ultrasonography in the preoperative diagnosis of submucosal digestive tumours.

INTRODUCTION: The preoperative diagnosis of submucosal lesions in the gut may be complicated. Conventional endoscopy does not allow to clearly establishing a diagnosis, and does not adequately assess lesion size. Furthermore, endoscopic biopsy is usually not diagnostic. Cytology as performed by means of fine-needle puncture does not have enough sensitivity and specificity to be considered the gold standard in the diagnosis of these lesions. We will now assess the usefulness of endoscopic ultrasonography in the study of submucosal digestive tumors. MATERIALS AND METHODS: We have prospectively collected ultrasonographic studies from all the patients with submucosal tumors who were treated surgically. We assessed the sensitivity and specificity of this technique in the diagnosis of malignancy in said lesions, alongside factors that predict malignant behavior with the highest reliability. We also valued the reliability of ultrasound endoscopy in the assessment of lesion size and the wall layer where lesions are located. The results of histological studies were considered the gold standard. RESULTS: The average size of lesions as measured by ultrasound endoscopy was 37.42 mm, with no significant differences in surgical piece: 38.98 (p = 0.143). However, conventional endoscopy underestimates the size of lesions. Endoscopic ultrasonography was able to adequately establish the origin layer of lesions in all cases. Sensitivity, specificity, positive predictive value, and negative predictive value of ultrasound endoscopy in the diagnosis of malignancy were 89.5, 90.9, 89.5, and 90.9%, respectively. In the univariate analysis, the ultrasonographic characteristics associated with a diagnosis of malignancy included presence of ulceration (p = 0.043), size above 4 cm (p = 0.049), irregular edges of lesion (p = 0.0001), a heterogeneous ultrasonographic pattern (p = 0.002), and the presence of cystic areas above 2 mm (p = 0.012). In the multivariate analysis, the last three factors were considered independent predictive factors for malignancy. CONCLUSIONS: Endoscopic ultrasonography has a great sensitivity and specificity in the diagnosis of malignancy regarding submucosal lesions. The irregularity of lesion borders, a heterogeneous ultrasonographic pattern, and the presence of cystic areas above 2 mm in size were considered independent predictive factors for malignancy.

Endoscopic resection of gastrointestinal submucosal tumors assisted by endoscopic ultrasonography.

BACKGROUND: The resection and histologic examination of the lesions is generally considered the treatment of choice in order to achieve diagnosis in gastrointestinal submucosal tumors. Moreover, the degree of malignancy of the tumor depends on certain features that can only be studied on the entire resected piece. METHODS: We revised the cases of patients who underwent endoscopic resection of gastrointestinal submucosal tumors in the period from 1997 through 2002. RESULTS: Fifty submucosal lesions were resected in 45 patients (64.4% men). Patient mean age was 55.31 years. Of the lesions, 52% were gastric tumors and 88% were located in the second layer. Mean size was 12.34 mm, and 54% were smaller than 10 mm. Resection with submucosal injection of saline solution and diluted adrenaline was performed on 46% of the lesions, and standard resection using polypectomy snare on 48%. Ligation was used in three cases. Resection was successful in 98% and major complications were observed in 4% (two cases of bleeding, endoscopically resolved). CONCLUSIONS: The endoscopic resection of submucosal tumors is a safe and efficient technique: It has few associated complications and allows diagnosis in all the cases and cure of the lesion in the great majority of cases.

The value of abdominal ultrasound in the diagnosis of colon cancer.

INTRODUCTION: Colon cancer is one of the main causes of cancer death. Diagnosis requires the examination of the entire large bowel by means of radiological or endoscopic techniques. Many patients suspect of colon cancer are referred for colonoscopy but nevertheless this suspicion is not confirmed after endoscopic examination. The objective of this study is the evaluation of the reliability of abdominal ultrasound in the diagnosis of these tumors. MATERIAL AND METHOD: We selected patients suspect of colon cancer referred to the endoscopy unit for a colonoscopy. An abdominal ultrasound was carried out on all patients prior to the endoscopy. Considering the endoscopic examination as a gold standard, the sensibility, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the ultrasonography were evaluated. Likewise, a series of analytical and clinical parameters were evaluated, in an attempt to establish associated factors of a colon cancer. The statistical analysis was carried out by means of the statistical package SPSS 12.0 for Windows. RESULTS: 145 patients were included in the study (56.6% males) with an average 66.72 years of age (22-89). A cancer was diagnosed in 42 cases (28.9%). In the diagnosis of colon cancer, abdominal ultrasound presents a sensitivity of 79.06%, a specificity of 92.15%, a PPV and a NPV of 80.9% and of 91.2%, respectively. Excluding from the analysis lesions of the rectal ampulla, which cannot be adequately evaluated by means of ultrasound, the figures for sensitivity, specificity, PPV and NPV increase to 91.8, 92.1, 80.9 and 96.9% respectively. The univariate analysis showed that an age over 65 years and the presence of microcytosis are associated to a greater risk of colon cancer while after multivariate analysis only the presence of microcytosis resulted to be an independent predictive factor of cancer. CONCLUSIONS: Abdominal ultrasound presents high sensitivity, specificity, PPV and NPV in the diagnosis of colon cancer. The combination of an ultrasonography and a rectoscopy permits us to rule out the presence of a colorectal carcinoma. In patients with microcytosis of 65 years and over, if there is strong clinical suspicion, a negative ultrasound may not be sufficient to rule out a colorectal neoplasia.