Importance of Enhanced Recovery After Surgery (ERAS) Protocol Compliance for Length of Stay in Ovarian Cancer Surgery.

OBJECTIVES: Enhanced Recovery After Surgery (ERAS) programs include multiple perioperative care elements, which when implemented together are designed to improve recovery after surgery with subsequent reduction in hospital length of stay (LOS). The aim of this study is to examine the impact of ERAS protocol compliance on LOS in patients undergoing advanced ovarian cancer surgery within the context of a randomized clinical trial. METHODS: Patients were enrolled in a prospective, consecutive, interventional randomized clinical trial between June 2014 and March 2018. Women with either suspected or confirmed advanced ovarian cancer with International Federation of Gynecology and Obstetrics (FIGO) stages IIB-IVA and recurrent ovarian cancer, who underwent cytoreduction surgery, were randomly assigned to either a conventional management (CM) protocol or an ERAS protocol. Demographic items, preoperative clinical data, and surgical characteristics of patients were recorded, as were LOS and ERAS protocol compliance. Negative binomial regression was used to model the relation between length of stay and ERAS protocol compliance. RESULTS: We included 49 patients in the CM group and 50 patients in the ERAS group. The overall rate of ERAS compliance was 92%. We observed that increasing ERAS protocol compliance was associated with shorter median LOS, and in patients who underwent higher complex surgeries, the length of stay reduction was greater. CONCLUSION: This study identifies a correlation between increasing ERAS protocol compliance and decreasing LOS in ovarian cancer surgery. This finding underlines the necessity to implement as many ERAS protocol elements as possible to achieve optimal clinical outcome improvements.

M-TRAP: Safety and performance of metastatic tumor cell trap device in advanced ovarian cancer patients.

OBJECTIVE: Despite radical surgery and chemotherapy, most patients with ovarian cancer die due to disease progression. M-Trap is an implantable medical device designed to capture peritoneal disseminated tumor cells with the aim to focalize the disease. This trial analyzed the safety and performance of the device. METHODS: This first-in-human prospective, multi-center, non-blinded, single-arm study enrolled 23 women with high-grade serous advanced ovarian cancer. After primary or interval debulking surgery, 3 M-Trap devices were placed in the peritoneum of the abdominal cavity. 18-months post-implantation or at disease progression, devices were initially removed by laparoscopy. The primary safety endpoint was freedom from device and procedure-related major adverse events (MAEs) through 6-months post-implantation compared to an historical control. The primary performance endpoint was histopathologic evidence of tumor cells capture. RESULTS: Only one major adverse event was attributable to the device. 18 women were free of device and procedure related MAEs (78.3%). However, the primary safety endpoint was not achieved (p = 0.131), primarily attributable to the greater surgical complexity of the M-Trap patient population. 62% of recurrent patients demonstrated tumor cell capture in at least one device with a minimal tumor cell infiltration. No other long-term device-related adverse events were reported. The secondary performance endpoint demonstrated a lack of disease focalization. CONCLUSIONS: The M-Trap technology failed to meet its primary safety objective, although when adjusted for surgical complexity, the study approved it. Likewise, the devices did not demonstrate the anticipated benefits in terms of tumor cell capture and disease focalization in recurrent ovarian cancer.

PROFAST: A randomised trial implementing enhanced recovery after surgery for highcomplexity advanced ovarian cancer surgery.

BACKGROUND: Enhanced recovery after surgery (ERAS) programs include multiple perioperative elements designed to achieve early recovery after surgery and a shorter length of stay (LOS) in hospital. The PROFAST trial aimed to expand the evidence base for implementing ERAS in advanced gynaecologic oncology surgery. METHODS: This prospective, interventional randomised clinical trial enrolled women undergoing surgery for either suspected or diagnosed advanced ovarian cancer, at a reference hospital in gynaecologic oncology in Barcelona (Spain) and who were treated after either an ERAS protocol or conventional management (CM) protocol. All enrolled women who underwent cytoreductive surgery were included in the primary analysis. The primary outcome was reduction in LOS, and secondary outcomes were incidence and type of intraoperative and postoperative complications, rate of readmission and mortality within a 30-d follow-up period. This trial is registered at ClinicalTrials.gov, number NCT02172638. FINDINGS: From June 2014 to March 2018, 110 women were recruited, of which eleven were excluded. The ERAS group comprised 50 patients, and the CM group, 49 patients. Both groups were comparable with respect to baseline characteristics and complexity of the cytoreductive surgery, with an overall medium/high Aletti surgical complexity score of 7.4. Overall compliance to the ERAS protocol was 92%. As compared with the patients in the CM group, patients in the ERAS group had a decreased median of LOS of two days (7 versus 9 days; p = 0.0099) and a decreased rate of readmission (6% versus 20%, p = 0.0334). No further significant differences were detected with respect to incidence of intraoperative or postoperative complications, severe (Clavien-Dindo grade IIIB-IV) complications, Comprehensive Complication Index, reoperation during primary stay, or mortality. INTERPRETATION: Patients with advanced ovarian cancer in the ERAS program had a decreased LOS and decreased rate of readmission as compared with those in CM, with no increased morbidity or mortality. This study provides important evidence for the benefits of ERAS management even for gynaecologic surgeries of medium/high complexity and suggests that ERAS should be a standard practice for cytoreductive surgeries for peritoneal carcinomatosis.

A giant superinfected uterine angioleiomyoma with distant septic metastases: an extremely rare presentation of a benign process and a systematic review of the literature.

PURPOSE: Uterine angioleiomyoma is a rare type of leiomyoma variant and there are few cases reported in the literature. The definitive diagnosis is usually obtained only after the histopathologic examination because there are no specific imaging criteria for this disease. The objective of this article is to review published cases about this clinical condition. METHODS: We report a case of giant angioleiomyoma superinfected by S. agalactiae with the development of latero-cervical distant metastasis in a premenopausal woman. Firstly, the case herein reported was orientated as an endometrial stroma sarcoma in the peri-operative histologic examination by frozen sections. It was treated with laparotomic total hysterectomy, bilateral salpingo-oophorectomy, inframesocolic omentectomy and pelvic and paraaortic lymph node dissection. Postoperative definitive anatomopathological analyses using a proper immunohistochemical panel revealed a case of uterine angioleiomyoma. We also review other case reports published about this clinical condition. RESULTS: We present the first case reported in the literature, in our knowledge, of a giant angioleiomyoma superinfected by S. agalactiae with the development of distant septic metastases. Immunohistochemistry permitted the definitive diagnosis of angioleiomyoma. Treatments previously reported are hysterectomy or tumor resection and any patient recurred. CONCLUSIONS: The definitive diagnosis is usually obtained after the definitive histopathologic examination since the use of immunohistochemical study has an important role in this regard. Complete surgical removal of the lesion is the treatment of choice, with no recurrent cases reported to date.

Nerve-sparing versus non-nerve-sparing radical hysterectomy: surgical and long-term oncological outcomes.

OBJECTIVES: There are controversies regarding the long-term oncological safety of preservation of pelvic innervation during radical hysterectomy (RH). This study aimed to analyze the feasibility and safety of nerve-sparing radical hysterectomy (NSRH) for cervical cancer compared with non-NSRH following 17 years of experience in a tertiary cancer referral center. MATERIALS AND METHODS: Between May 1999 and June 2016, all patients who underwent RH for cervical cancer were followed-up prospectively. Comparison analyses regarding surgical outcomes, complications, overall survival (OS), disease-free survival (DFS), and cancer-specific survival (CSS) were performed between patients treated with NSRH and non-NSRH. RESULTS: A total of 188 patients were included (113 non-NSRH and 75 NSRH). The median follow-up was 112 months. Estimated blood loss and hospital stay were all significantly lower in the NSRH group. Overall intraoperative complication rate (p = 0.02) and need for transfusion (p = 0.016) were lower in the NSRH group. There were no differences in the median operation time, OS, DFS, CSS, or recurrence rates between the NSRH and non-NSRH group. CONCLUSIONS: Our study provides a wide perspective on the developments of nerve-sparing procedures for the management of women with early-stage cervical cancer. Our results suggest that NSRH is a feasible and safe procedure, with reduced morbidity outcomes.

Radical Hysterectomy: Efficacy and Safety in the Dawn of Minimally Invasive Techniques.

STUDY OBJECTIVE: To analyze the effect that the introduction of minimally invasive procedures has had on surgical and oncologic outcomes when compared with conventional open radical hysterectomy (ORH) in a national reference cancer after 17 years of experience in radical hysterectomy. DESIGN: A prospective controlled study (Canadian Task Force classification II-2). SETTING: A university teaching hospital. PATIENTS: All patients who underwent radical hysterectomy as primary treatment for cervical cancer in our institution between May 1999 and June 2016, with a total of 188 patients. INTERVENTIONS: Patients underwent ORH or minimally invasive surgery (MIS) (i.e., laparoscopic or robotically assisted radical hysterectomy). MEASUREMENTS AND MAIN RESULTS: Seventy-six patients underwent ORH, 90 laparoscopic radical hysterectomy, and 22 robotically assisted radical hysterectomy. Blood loss and hospital stay were inferior in the MIS group (p <.0001). The laparotomic group presented shorter operation times (p = .0001). With a median follow-up of 112.4 months, a total of 156 patients (83%) were alive and free of disease at the time of the data analysis. Overall survival was higher in the MIS group when compared with the ORH group (91 vs 78.9, p = .026). There were no differences regarding recurrence rates between the surgical approaches. CONCLUSION: With 1 of the largest follow-up periods in the literature, this study provides added evidence that MIS could become the preferable surgical approach for early-stage cervical cancer since it appears to reduce morbidity without affecting oncologic results.

Impact of Laparoscopy to Assess Resectability in Stage IIIC Epithelial Ovarian, Tubal and Peritoneal Cancer Patients.

AIMS: To evaluate overall survival (OS) and progression-free survival (PFS) in patients with stage IIIC epithelial ovarian, tubal and peritoneal cancer (EOC) who underwent a laparoscopy to assess surgical resectability prior to Primary Debulking Surgery (PDS) or Interval Debulking Surgery (IDS). METHODS: Retrospective cohort study that included all women with stage IIIC EOC treated at our center between 2000 and 2010. Patients were classified in groups: PDS, neoadjuvant chemotherapy (NACT) with IDS, NACT without IDS; and then sub-classified based on residual tumor (RT). A laparoscopy to assess resectability was performed before PDS and IDS. RESULTS: Among 111 patients included, 66 underwent PDS, and 45 were treated with NACT, 80% of them receiving subsequent IDS. OS was 75.6 months in the PDS group, and 52.8 months for IDS group (p = 0.100); the PFS was 30 months and 19.2 months respectively (p = 0.049). Median OS was 104.4 and 52.8 months for patients with optimal cytoreduction (RT = 0) in the PDS and IDS group respectively (p < 0.05). Laparoscopy did not modify the preoperative consideration for PDS; however, 9 laparotomies were avoided based on laparoscopic findings after NACT. CONCLUSION: Laparoscopy for the assessment of surgical resectability in stage IIIC EOC has no impact on survival; but it still could be useful for the reduction of unnecessary laparotomies after NACT.