10 Years of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC): A Systematic Review and Meta-Analysis.

BACKGROUND: Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is a novel intraperitoneal drug delivery method of low-dose chemotherapy as a pressurized aerosol in patients affected by peritoneal cancer of primary or secondary origin. We performed a systematic review and meta-analysis with the aim of assessing the feasibility, safety, and efficacy of PIPAC. METHODS: A systematic literature search was performed using Medline and Web of Science databases from 1 January 2011, to inception, to 31 December 2021. Data were independently extracted by two authors. The Newcastle-Ottawa Scale was used to assess the quality and risk of bias of studies. Meta-analysis was performed for pathological response, radiological response, PCI variation along treatment, and for patients undergoing three or more PIPAC. Pooled analyses were performed using the Freeman-Tukey double arcsine transformation, and 95% CIs were calculated using Clopper-Pearson exact CIs in all instances. RESULTS: A total of 414 papers on PIPAC were identified, and 53 studies considering 4719 PIPAC procedure in 1990 patients were included for analysis. The non-access rate or inability to perform PIPAC pooled rate was 4% of the procedures performed. The overall proportion of patients who completed 3 or more cycles of PIPAC was 39%. Severe toxicities considering CTCAE 3-4 were 4% (0% to 38.5%). In total, 50 studies evaluated deaths within the first 30 postoperative days. In the included 1936 patients were registered 26 deaths (1.3%). The pooled analysis of all the studies reporting a pathological response was 68% (95% CI 0.61-0.73), with an acceptable heterogeneity (I2 28.41%, p = 0.09). In total, 10 papers reported data regarding the radiological response, with high heterogeneity and a weighted means of 15% (0% to 77.8%). PCI variation along PIPAC cycles were reported in 14 studies. PCI diminished, increased, or remained stable in eight, one and five studies, respectively, with high heterogeneity at pooled analysis. Regarding survival, there was high heterogeneity. The 12-month estimated survival from first PIPAC for colorectal cancer, gastric cancer, gynecological cancer and hepatobiliary/pancreatic cancer were, respectively, 53%, 25%, 59% and 37%. CONCLUSIONS: PIPAC may be a useful treatment option for selected patients with PM, with acceptable grade 3 and 4 toxicity and promising survival benefit. Meta-analysis showed high heterogeneity of data among up-to-date available studies. In a subset analysis per primary tumor origin, pathological tumor regression was documented in 68% of the studies with acceptable heterogeneity. Pathological regression seems, therefore, a reliable outcome for PIPAC activity and a potential surrogate endpoint of treatment response. We recommend uniform selection criteria for patients entering a PIPAC program and highlight the urgent need to standardize items for PIPAC reports and datasets.

Prophylactic surgery plus hyperthermic intraperitoneal chemotherapy (HIPEC CO2) versus standard surgery in colorectal carcinoma at high risk of peritoneal carcinomatosis: short-term and long-term outcomes from the CHECK study - protocol for a randomised, multicentre, phase 3 trial.

INTRODUCTION: Up to one-fifth of patients with colorectal cancer will develop peritoneal metastases, frequently without other districts' involvement. Despite the recent unsuccesses of hyperthermic intraperitoneal chemotherapy (HIPEC) for colorectal cancer peritoneal metastases treatment, the rationale in the prophylactic setting remains strong. Several clinical and pharmacokinetic data suggest that the efficacy of intraperitoneal chemotherapy is highest when the disease is microscopic. However, robust evidence demonstrating whether the addition of HIPEC for high-risk colorectal cancers offers better control of local recurrence is lacking. METHODS AND ANALYSIS: This is a multicentre randomised phase 3 trial comparing prophylactic surgery plus HIPEC CO2 with mitomycin, over standard surgical excision in patients with colorectal cancer at high risk of peritoneal carcinomatosis; 388 patients will be included in this study. The primary objective is to compare the efficacy of prophylactic surgery (radical colorectal resection, omentectomy, appendectomy, round ligament of the liver resection and bilateral adnexectomy) plus HIPEC CO2 with mitomycin and standard surgery in terms of local recurrence-free survival. The main secondary endpoints are disease-free survival (DFS), overall survival (OS) and safety. The primary endpoint will be described with a cumulative incidence function and will be analysed with Grey test to take account of the competing risks. DFS and OS will be described with the Kaplan-Meier method. ETHICS AND DISSEMINATION: This trial has been evaluated by the Italian Medicines Agency, local ethics committees and will be submitted to the Ministry of Health to notify the start of the trial according to the regulation of trials on devices with CE mark/certification.The results will be submitted for presentation at academic meetings and for publication in a peer-reviewed journal, whatever the findings. TRIAL REGISTRATION NUMBER: NCT03914820.

Body composition and immunonutritional status in patients treated with pressurized intraperitoneal aerosol chemotherapy (PIPAC) for gastrointestinal peritoneal metastases: a prospective single-center analysis.

Objectives: Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is a novel drug administration method with promising efficacy for the treatment of peritoneal metastases (PM). This study aimed to evaluate the prognostic value of an immunonutritional assessment on the feasibility, safety, and survival in this setting. Methods: Data of PM patients undergoing PIPAC between September 2018 and May 2020 were prospectively recorded. A CT scan-derived body composition assessment was performed for each patient. Results: Fifty-one patients were enrolled, of which 30 (58%) underwent multiple PIPAC cycles, with a pathological response rate of 55%. Prognostic nutritional index (PNI) and neutrophil-to-lymphocytes predicted completion of more than one PIPAC cycle, with a cut off of 36.5 and 4.8 respectively. Muscle attenuation and body fat tissues were associated with pathological response. At multivariate Cox regression analysis, only the presence of a low PNI (HR 2.41, 95% CI 1.08-5.46) was significantly associated with a worse OS. Conclusions: A pretreatment immunonutritional assessment may provide valuable information for PIPAC patients' selection and survival, while body composition parameters are able to predict pathological response. Further larger studies are needed to validate the role of these biomarkers in tailoring the treatment and monitoring PM patients undergoing PIPAC.

The prognostic value of skeletal muscle index on clinical and survival outcomes after cytoreduction and HIPEC for peritoneal metastases from colorectal cancer: A systematic review and meta-analysis.

BACKGROUND: Cytoreductive surgery (CRS) and hypertermic intraperitoneal chemotherapy (HIPEC) represent the most effective strategy to manage peritoneal metastases (PM). This systematic review and meta-analysis aimed to assess the impact of body composition on clinical outcomes in patients with PM. METHODS: A systematic literature search was performed using Medline, Web of Science and EMBASE databases from inception to the 20st August 2020. Data were independently extracted by 3 authors. Newcastle-Ottawa Scale was used to assess quality and risk of bias of studies. Pooled analyses were performed using Mantel-Haenszel method to estimate overall effect size with mean differences or odd ratios (ORs) and 95% confidence interval (CI). The primary outcome was postoperative complication (POC) rate, while secondary outcomes were severe POC and postoperative mortality. RESULTS: A total of 4 studies were included in the systematic review and meta-analysis, including 582 patients. A significant association between low skeletal muscle mass and POC was found (OR 1.45, 95% CI 1.04 to 2.03; p = 0.03), while no differences were found in terms operative time, estimated blood loss, length of hospital stay, and postoperative mortality (p > 0.05). CONCLUSIONS: Low skeletal muscle mass at diagnosis is a valid prognostic factor for POC development in colorectal and PM patients undergoing CRS. Prospective and larger studies are needed to better investigate the role of CT scan derived body composition and to understand how to implement this tool in clinical practice.

Prognostic Factors for Surgical Failure in Malignant Bowel Obstruction and Peritoneal Carcinomatosis.

Introduction: Patients with peritoneal metastasis frequently develop malignant bowel obstruction (MBO). Medical palliative management is preferred but often fails. Conversely, the role of palliative surgery remains unclear and debated. This study aims to identify patients who could benefit from invasive surgical interventions and factors associated with successful surgical palliation. Materials and Methods: In this retrospective study, 98 consecutive patients who underwent palliative surgery for MBO over 5 years were reviewed. We evaluate as the primary outcome surgical failure to select patients who could benefit from palliative surgery, avoiding unnecessary surgery. A prognostic score was developed based on a logistic regression model to identify patients at risk of surgical failure. The score was evaluated for overall accuracy by receiver operating characteristic curve analysis. Results: Palliative surgery was achieved in 76 (77.5%) patients. The variables that were found to be significant factors for surgical failure are recurrent disease (P = 0.015), absence of bowel obstruction (P < 0.001), absence of bowel distension (P < 0.001), and mesenteric involvement (P = 0.001) and retraction (P < 0.001). The absence of bowel distension (P = 0.046) and bowel obstruction (P = 0.012) emerged as independent predictors of surgical failure. Carcinomatosis level assessment for peritoneum score, based on these factors, was built to evaluate the risk of surgical failure. Conclusion: Our proposed scoring system might help select patients most likely to benefit from palliative surgery.

Cytoreduction and Hyperthermic Intraperitoneal Chemotherapy for Pseudomyxoma Peritonei of Appendiceal Origin: A Single Center Experience.

Background: Pseudomyxoma peritonei (PMP) originating from appendiceal mucinous neoplasm is a rare peritoneal malignancy characterized by the progressive intraperitoneal accumulation of mucus leading to death if left untreated. In recent years, cytoreductive surgery (CRS) combined with hyperthermic intraperitoneal chemotherapy (HIPEC) offered increased survival rates. This study aims to identify the clinical, pathological, and surgical features influencing safety and survival outcomes of patients undergoing CRS and HIPEC for PMP of appendiceal origin. Methods: A retrospective analysis of all patients undergoing CRS and HIPEC for PMP of appendiceal origin from January 2015 to May 2019 was conducted at our institution. Results: Study population included 50 patients (74% female, 26% male). The median age at CRS was 60 (38-84). The median peritoneal cancer index (PCI) was 17. Complete cytoreductive surgery (CC 0-1) was achieved in 47 patients (94%). HIPEC chemotherapeutic regimen was based on oxaliplatin for 13 (28%) patients and mitomycin for 34 (72%) patients. We experienced a total of 19 (38%) postoperative complications, of which 14 (74%) of grade I-II and 5 (26%) of grade III-IV, according to the Clavien-Dindo classification. The median follow-up period was 27 months (12-107) from the date of cytoreductive surgery. The mean survival rate was 100 months, with a 5-year OS of 91%. The mean progression-free survival rate was 77 months (0-107), with a 5-year PFS of 63%. Multivariate analysis identified adenocarcinoma histotype and incomplete cytoreduction to significantly worsen progression-free survival, while incomplete cytoreduction was the only independent predictor of poorer overall survival. Conclusion: Complete cytoreduction and appendiceal neoplasm histotype play a crucial role in the survival of patients affected by PMP of appendiceal origin. The rates of morbidity associated with CRS and HIPEC for PMP are acceptable.

Clinical and Molecular Features in Patients Undergoing Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy for Peritoneal Carcinosis from Colorectal Cancer.

PURPOSE: Careful patient selection plays a crucial role in avoiding overtreatment and further increases survival rates in patients undergoing cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) for colorectal cancer (CRC) with peritoneal metastases (PM). METHODS: The clinical and molecular factors influencing survival in patients who had undergone CRS with HIPEC between January 2015 and December 2018 were analyzed. RESULTS: Sixty-six patients underwent CRS with HIPEC during the study period. The median overall survival (OS) was 36 months, with a 3-year OS of 43%. Multivariate analysis revealed increased PCI (HR: 1.21; 95% CI: 1.02-1.41; p = 0.020), right-sided primary tumor (HR: 3.01; 95% CI: 1.27-7.13; p = 0.017), and BRAF V600E mutation (HR: 4.55; 95% CI: 1.21-17.21; p = 0.025) as independent predictors for worse OS. CONCLUSION: In addition to confirming the prognostic role of PCI, our study extends the role of BRAF mutation and right primary tumor location as markers for worse prognosis.

Cytoreductive surgery and mitomycin C hyperthermic intraperitoneal chemotherapy with CO2 recirculation (HIPEC-CO2) for colorectal cancer peritoneal metastases: analysis of short-term outcomes.

Peritoneal dissemination from colorectal cancer (CRC) has long been associated with unfavorable prognosis. However, in the last decades, the combination of cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) was able to obtain up to 30% 5-year survival rate in selected centers. Despite the wide diffusion of CRS and HIPEC, until now, there are no clear recommendations on the drug of choice for HIPEC nor its technique, and safety and efficacy data of HIPEC regimens and techniques are lacking. We performed a retrospective analysis of a prospectively maintained database of 26 CRS and mitomycin C HIPEC with CO2 recirculation (HIPEC-CO2) for CRC peritoneal metastasis (PM) performed at our center. The main endpoints were morbidity, mortality, the temperature of perfusate during HIPEC and metabolic changes throughout the procedure. Morbidity was assessed by analysis of postoperative adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE version 4.0). Continuous variables of Arterial Blood Gas (ABG) analysis at three time-points were compared by the Student t test. There were no postoperative deaths. The overall grade 3-4 CTCAE complications rate at 30 days was 38.4%, with ten severe adverse events occurring to six (23.0%) patients. The temperature within HIPEC perfusion maintained between 41 and 42 °C in all cases and we experienced no HIPEC-related intraoperative complications. We observed a significant difference between all baseline and pre-HIPEC ABG parameters evaluated but no statistically significant differences between pre- and post-HIPEC ABG outcomes. This study shows that mitomycin C HIPEC-CO2 is feasible and has a safety profile comparable to that of other HIPEC techniques reported in the literature. Further research is needed to validate prospectively the safety and efficacy of this technique.

Systemic chemotherapy and pressurized intraperitoneal aerosol chemotherapy (PIPAC): A case report of a multimodal treatment for peritoneal metastases of pancreatic origin.

INTRODUCTION: Pancreatic ductal adenocarcinoma (PDAC) with peritoneal metastases (PM) has a dismal prognosis and palliative systemic chemotherapy, which represents the standard treatment option, has significant pharmacokinetics limitations and low efficacy. Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is a new method of drug delivery that is expected to maximize exposure of peritoneal nodules to antiblastic agents. A combination of systemic chemotherapy and PIPAC may be valuable. PRESENTATION OF CASE: A 55 years old male affected by PDAC with synchronous PM underwent a multimodal treatment comprising systemic chemotherapy and PIPAC without any procedural-related adverse events. Tumor genomic profiling evaluation from peritoneal biopsies addressed further tailored systemic chemotherapy. DISCUSSION: The presented case illustrates the possibility of adding PIPAC to systemic chemotherapy with a fair tolerance profile and good quality of life while allowing monitoring of therapy-response and tailoring of the antiblastic treatment.

Unexpected finding of urachal remnant cyst. Tips for laparoscopic approach.

INTRODUCTION: Incomplete obliteration of the urachal lumen could cause different types of anomalies and urachal cyst is the most common among these in the adult population. It is usually asymptomatic and may be an incidental finding during a surgical exploration for other reasons. However, it can be subject to complications. PRESENTATION OF CASE: A 38-year-old female patient with history of worsening lower-quadrants abdominal pain, associated with fever and chills, presented to emergency room; clinical examination revealed a painful, tender, and fixed lump to the left inferior abdominal quadrant. Ultrasound reveled a left adnexal mass and, along the midline, between the adnexal mass, the bladder and the uterus, was evident a 3-cm unilocular cyst with regular walls and hypoechoic content. MRI confirmed the suspicion of a left tubo-ovarian abscess and suggested a diagnosis of urachal remnant for the smaller midline cyst. In this report, we describe the step-by-step laparoscopic management of the case, paying attention to "the tips and tricks" for urachal cyst excision. DISCUSSION: The urachal cyst, which results from the accumulations of secretions in urachal remnant, presents as a single or multiple parietal abdominal mass, per se asymptomatic. However, this condition is not without risk and infection represents the most common complication. Ultrasound is very useful in the diagnostic phase. Today, the main approach has become laparoscopic excision, with particular attention to a radical removing of the mass, due to high recurrence rate and the risk of malignancy. CONCLUSION: In our experience, laparoscopy represents an excellent diagnostic and therapeutic tool for urachal cyst, especially for patients with acute urgent conditions, doubtful clinical history, and no clear signs or symptoms.

Uterine preservation in pelvic organ prolapse and urinary stress incontinence using robot-assisted laparoscopic surgery. Case report.

INTRODUCTION: To report a case of uterine preservation in pelvic organ prolapse robot-assisted laparoscopic surgery. PRESENTATION OF CASE: The patient is a 42-year old Caucasian woman with pelvic organ prolapse. She previously had undergone a pelvic floor reconstruction with vaginal surgical approach, she had suffered from anorexia nervosa and she had two childbirths with vaginal deliveries. The woman was treated with robotic-assisted laparoscopic sacrohysteropexy and retropubic colposuspension. DISCUSSION: Data suggest that abdominal surgery, typically with an abdominal sacralcolpopexy, provides better objective anatomic outcomes, than vaginal procedures, despite the longer operating times and grater delay in the resumption of activities which can be mitigated by the use of laparoscopic or robotic surgery. Several studies about vaginal approaches suggest that uterus-preserving surgery with vaginal procedures have similar success rates, less blood loss and shorter surgical time compared with hysterectomy. A multicenter study compared laparoscopic sacrohysteropexy with vaginal mesh hysteropexy reported similar one-year cure rates, improvement in pelvic floor symptoms, improvement in sexual function, and satisfaction rates. CONCLUSION: We found robotic-assisted laparoscopic sacrohysteropexy to be a feasible and successful procedure. Combining robotic retropubic colposuspension to sacrohysteropexy is a safe and efficient approach for the treatment of stress urinary incontinence. Further studies are needed to define the standard surgical steps and confirm the efficacy and the advantages of this procedure.

Systemic chemotherapy and pressurized intraperitoneal aerosol chemotherapy (PIPAC): A bidirectional approach for gastric cancer peritoneal metastasis.

BACKGROUND: Few patients affected by gastric cancer peritoneal metastasis (GCPM) are offered locoregional treatment, despite several proof-of-efficacy trials. Pressurized intraperitoneal aerosol chemotherapy (PIPAC) has emerged in recent years as a promising tool to control peritoneal carcinomatosis. The combination of PIPAC with systemic chemotherapy may offer a greater clinical benefit than standard treatment alone. METHODS: A single-center cohort of 28 consecutive patients affected by GCPM was scheduled for bidirectional treatment, comprising PIPAC and systemic chemotherapy, from September 2017 to September 2019. Data recorded included safety, efficacy and survival outcomes. Ascite volumes, the Peritoneal Cancer Index (PCI) and pathological response through the Peritoneal Regression Grading Score (PRGS) were compared in those patients who underwent more than one PIPAC procedure. RESULTS: Forty-six PIPAC procedures were administered, with a mean of 1.7 PIPAC procedures per patient. The median time to resume systemic chemotherapy after PIPAC was 6 days (range 4-7). Concerning safety, two grade 3-4 CTCAE (Common Terminology Criteria for Adverse Events v4.0) toxicity events and one intraoperative complication were recorded. Thirteen patients repeated PIPAC. A pathological response was recorded in 61.5% of patients (one with complete and seven with partial regression). The median overall survival was 12.3 months in the overall population and 15.0 months in patients undergoing more than one PIPAC procedure. CONCLUSIONS: A bidirectional approach for GCPM was feasible and safe, as the PIPAC procedure integrates well with several systemic chemotherapy regimens. The pathological response demonstrated the antitumoral efficacy of PIPAC. The proposed bidirectional approach may be further investigated in the first-line treatment of metastatic gastric cancer.

Pressurized intraperitoneal aerosol chemotherapy with cisplatin and doxorubicin or oxaliplatin for peritoneal metastasis from pancreatic adenocarcinoma and cholangiocarcinoma.

BACKGROUND: Systemic chemotherapy for pancreatic adenocarcinoma (PDAC) and cholangiocarcinoma (CC) with peritoneal metastases (PM) is affected by several pharmacological shortcomings and low clinical efficacy. Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is expected to maximize exposure of peritoneal nodules to antiblastic agents. This study aims to evaluate safety and efficacy of PIPAC for PM of PDAC and CC origin. METHODS: This is a retrospective analysis of consecutive PDAC and CC cases with PM treated with PIPAC at two European referral centers for peritoneal disease. We prospectively recorded from August 2016 to May 2019 demographic, clinical, surgical, and oncological data. We performed a feasibility and safety assessment and an efficacy analysis based on clinical and pathological regression. RESULTS: Twenty patients with PM from PDAC (14) and CC (six) underwent 45 PIPAC administrations. Cisplatin-doxorubicin or oxaliplatin were administered to eight and 12 patients, respectively. We experienced one intraoperative complication (small bowel perforation) and 18 grade 1-2 postoperative adverse events according to Common Terminology Criteria for Adverse Events version 4.0. A pathological regression was recorded in 50% of patients (62% in the cisplatin-doxorubicin cohort and 42% in the oxaliplatin one). Median survival from the first PIPAC was 9.7 and 10.9 months for PDAC and CC, respectively. CONCLUSION: PIPAC resulted feasible and safe without relevant toxicity issues, with both cisplatin-doxorubicin and oxaliplatin. The pathological response observed supports the evidence of antitumoral activity. Despite the study limitations, these outcomes are encouraging, recommending PIPAC in prospective, controlled trials in the palliative setting or the first line chemotherapy for PM from PDAC and CC.

From palliation to cure: PIPAC for peritoneal malignancies.

INTRODUCTION: Systemic chemotherapy offers poor control over peritoneal disease, maybe as a consequence of restricted drug availability within the abdominal cavity. Locoregional chemotherapy may overcome these shortcomings but its administration is limited to a few patients with confined peritoneal spread. Pressurized intraperitoneal aerosol chemotherapy (PIPAC) emerged in the last years as a novel method of intraperitoneal drug administration. EVIDENCE ACQUISITION: We report a meta-analysis of published studies on PIPAC safety and pathological anti-tumoral efficacy on PC from various tumor entities, with the aim of providing more evidence to support further research. This systematic review and meta-analysis were designed, conducted and reported according to the PRISMA statement. EVIDENCE SYNTHESIS: An overall pathological response rate of 43.7% was calculated on a total of 668 patients who underwent 1480 PIPAC cycles across the 20 studies. Pooled severe adverse events rate (CTCAE grade 3-4) was 10% and seven deaths across all studies were reported, of which only four were related to PIPAC. CONCLUSIONS: PIPAC is a safe procedure which has a relevant anti-tumoral activity on peritoneal carcinomatosis. Further studies, even in the early stage of disease, are awaited to assess the clinical benefit of PIPAC. This review may serve as a reliable basis for future research.

The role of robotic aortic lymphadenectomy in gynecological cancer: surgical and oncological outcome in a single institution experience.

BACKGROUND AND OBJECTIVE: This study aims to investigate the surgical outcomes observed in robotic transperitoneal aortic lymphadenectomy (AL) in gynecological cancer patients. METHODS: Retrospective data were collected and analyzed on 71 patients undergoing robotic surgical procedures for gynecological cancers, including transperitoneal AL, between December 2014 and February 2018 at the Catholic University of the Sacred Heart, Rome, Italy. RESULTS: Median age of the sample population was 50 years (range, 26-76 years). The median operative time was 210 minutes (range, 75-480 minutes), the median estimated blood loss was 50 ml (range, 20-300 ml). The number of para-aortic nodes removed was 12 (range, 7-43). In the whole series, 13 patients (18.3%) had at least one metastatic node. Overall, 10 patients (14.1%) experienced any grade early postoperative complications. Three patients experienced more than one complication. Three intraoperative complications occurred with two cases of vascular injury. Conversion to laparotomy was necessary for one patient (1.4%). CONCLUSIONS: The present study shows the safety and adequacy of robotic transperitoneal AL as surgical staging step for gynecological cancers in terms of perioperative and postoperative outcomes.

Total laparoscopic hysterectomy using a percutaneous surgical system: a pilot study towards scarless surgery.

OBJECTIVE: The evolution of minimally invasive surgery has moved beyond reduction of surgical trauma while maintaining adequate efficacy and safety standards. Percuvance™ Percutaneous Surgical System (PSS) instruments represents the last novelty in this panorama. Consisting of less than 3mm laparoscopic shaft introduced percutaneously with an interchangeable 5mm tool installed in place of the needle tip, they combine micro-invasiveness and operative performance. STUDY DESIGN: We prospectively collected and retrospectively analyzed data of 10 cases of laparoscopic total hysterectomy with Percuvance™ PSS for benign or early malignant gynecological diseases in order to assess the capability and safety of this new device. Data were recorded in a prospectively designed clinical database including patient demographics characteristics, operative data, intra- and postoperative complications, conversion rate, length of hospital stay and cosmetic outcome. RESULTS: The reported series consisted of 10 patients undergoing total laparoscopic hysterectomy with a median age of 51.5 years (range 44-72 years) and a median BMI (body mass index) of 25.3 (range 19.7-30.4). All patients had bilateral salpingo-oophorectomy or bilateral salpingectomy and two of them underwent pelvic lymphadenectomy. A median operative time of 67min (range 45-180min) and a median estimated blood loss (EBL) of 50ml (range 10-100ml) were registered. Median PSS introduction time was 5min (range 3-10min). No conversions to standard laparoscopy or laparotomy were required and no intraoperative complications occurred. Discharge was on day 1 in 4 cases, on day 2 in the other 6 cases. All patients conveyed complete satisfaction with the cosmetic result and postoperative pain control. No complications were registered within 30 days after surgery. CONCLUSIONS: PSS total laparoscopic hysterectomy is safe and feasible with good results in terms of operative time, cosmesis, postoperative pain, recovery and short hospitalization. Further studies are needed to compare PSS total hysterectomy to conventional multi-access laparoscopic and other mini-invasive approaches.

Interstitial pregnancy: a 'road map' of surgical treatment based on a systematic review of the literature.

An electronic search concerning the surgical approach in cases of interstitial pregnancy from January 2000 to May 2013 has been carried out. Fifty three studies have been retrieved and included for statistical analysis. Conservative and radical surgical treatments in 354 cases of interstitial pregnancy are extensively described. Hemostatic techniques have been reported as well as clinical criteria for the medical approach. Surgical outcome in conservative versus radical treatment were similar. When hemostatic techniques were used, lower blood losses and lower operative times were recorded. Conversion to laparotomy involved difficulties in hemostasis and the presence of persistent or multiple adhesions. Laparoscopic injection of vasopressin into the myometrium below the cornual mass was the preferred approach.

Laparoscopic management of interstitial pregnancy: the "purse-string" technique.

We report five cases of interstitial pregnancy, treated between 2004 and 2010, to evaluate surgical and obstetric outcome of laparoscopic cornual resection with a "purse-string" technique. A hemostatic suture was passed at the base of the mass in a purse-string fashion prior to resection, to minimize intraoperative blood loss. Subsequent pregnancies were analysed, with a mean follow-up time of 48 months. The mean operating time was 39 min and mean blood loss 47 mL. Three of four patients who desired children delivered at term uneventfully. Laparoscopic cornual resection with a "purse-string" technique appears to be useful for treatment of early interstitial pregnancy. The technique ensures effective and safe treatment, with satisfactory obstetric outcome.