First experience in colorectal surgery with a new robotic platform with haptic feedback.

The use of robotic techniques is increasing in colorectal surgery. Recently, the Senhance™ surgical robotic system was introduced as a novel robotic platform designed to overcome some of the limits of standard laparoscopy. This study describes the initial, single center experience, evaluating feasibility and safety of the new robotic system in performing colorectal surgical procedures. METHODS: From June 2015 to November 2016, perioperative data of the first 45 patients who underwent robotic colorectal surgery with the SenhanceTM surgical robotic system were collected and analyzed. Indications for surgery included inflammatory bowel disease, colorectal cancer, endoscopically unresectable adenomas and complicated diverticular disease. RESULTS: The median age was 57 years (18-92) and the median BMI was 24 Kg/m2 (16-30). Surgical indications were colorectal cancer (66%), complicated inflammatory bowel disease (18%), diverticular disease (11%) and endoscopically unresectable adenoma (4.4%). The median operative time was 256 minutes; the median docking time 10.7 min (range 2-25). There were 3 conversions to standard laparoscopy, and none to laparotomy. All patients operated on for malignancy (28 adenocarcinoma, 2 neuroendocrine tumors) underwent an appropriate oncological procedure. The median time to discharge was 5 days (range 3-19). The incidence of post-operative complications was 35.5% (Clavien-Dindo I/II-14 patients, III-2 patients). One patient was readmitted in the postoperative period. No patient required reoperation. CONCLUSION: The results of this audit suggest that adoption of The Senhance™ surgical robotic system in colorectal surgery is feasible and safe. More clinical data are needed to determine whether this approach can offer any other benefits over other minimally invasive surgical techniques. This article is protected by copyright. All rights reserved.

Telelap Alf-X-Assisted Laparoscopy for Ovarian Cyst Enucleation: Report of the First 10 Cases.

This prospective single-institutional clinical trial sought to assess the safety and feasibility of laparoscopic benign ovarian cyst enucleation with a novel robotic-assisted laparoscopic system. Here we report a series of 10 patients treated using the Telelap ALF-X system in the first clinical application on patients at the Division of Gynecologic Oncology, Catholic University of the Sacred Heart of Rome. The primary inclusion criterion was the presence of monolateral ovarian cyst without a preoperative assessment suspicious for malignancy. Intraoperative data, including docking time, operative time, estimated blood loss, intraoperative and perioperative complications, and conversion to either standard laparoscopy or laparotomy, were collected. The cysts were removed with an ovary-sparing technique with respect to conservative surgical principles. The median operative time was 46.3 minutes, and patients without postoperative complications were discharged at 1 or 2 days after the procedure. Telelap ALF-X laparoscopic enucleation of benign ovarian cysts with an ovary-sparing technique is feasible, safe, and effective; however, more clinical data are needed to determine whether this approach can offer any other benefits over other minimally invasive surgical techniques.

A new telesurgical platform--preliminary clinical results.

A new European telesurgical system, the Telelap Alf-x, is introduced. Its main features are individual arms, which enable free access to the patient throughout surgery, a large range of reusable surgical instruments, an open console with eye-tracking system, where the camera follows the eye and head movements of the surgeon, and the existing force feedback enables for the first time to feel the consistency of the tissues and avoid tearing of the stitches while suturing. The system combines the benefits of open surgery and endoscopy. The first clinical application, which involved 146 operations at the gynecological department of the Gemelli University Hospital in Rome, proved the safety and the surgical team's quick adaptation to the system.

Experimental Nephrectomies Using a Novel Telesurgical System: (The Telelap ALF-X)-A Pilot Study.

PURPOSE: The SOFAR® Telelap Alf-X (Milan, Italy) is a novel telesurgical system which combines the advantages of both laparoscopy and open surgery. It offers some new features like tactile perception, open site view, eye-tracking control of the camera, and optimal ergonomics. OBJECTIVE: The aim of this study is to examine the feasibility and the safety of nephrectomy using a novel telesurgical system with haptic sensation: the Telelap Alf-X. MATERIALS AND METHODS: Twelve female swine underwent nephrectomies using the Telelap Alf-X system. Data regarding operative times, estimated blood loss (EBL), surgical methodology, and intraoperative complications are presented. RESULTS: The Telelap Alf-X's docking took less than one minute, the system was versatile during each step of the nephrectomy and the operative times have reduced dramatically along the learning curve. One intraoperative complication was recorded (Vena Cava injury-repaired using the robotic system) and the estimated blood loss was minimal. CONCLUSIONS: The Telelap Alf-X proved to be safe and reliable and can be easily used by the surgeon. The porcine model nephrectomies proved to be an excellent way to gain experience and avoid future complications.

Vesicourethral anastomosis using a novel telesurgical system with haptic sensation, the Telelap Alf-X: a pilot study.

Vesicourethral anastomosis is a necessary part of radical prostatectomy and presents technical challenges when performed endoscopically. This study demonstrates the feasibility of the van Velthoven anastomosis method in swine model using a novel telesurgical system with haptic sensation: the Telelap Alf-X. Twenty vesicourethral anastomoses were performed using the system in female swine with two working ports and a camera. With two 2.0 Vicryl, a single knot vesicourethral anastomosis was performed as described by van Velthoven with Telelap Alf-X. The time of each operation was recorded, water tightness and tension were examined at the end of the procedure by irrigation through a 12 Fr catheter. The 1:1 haptic sensation, improved ergonomy, the open architecture of the robotic system, and articulated handles contributed to the easiness of performance and short learning curve, as the time of the procedure decreased by 50% after the first 5 cases. All the anastomoses were functional and proved to be successful and watertight. No leakage occurred. The novel features of the Telelap Alf-X contribute to its ease of use and make the telesurgical performance of vesicourethral anastomosis similar to open surgery, without the disadvantages of the latter.

Telelap Alf-X: a novel telesurgical system for the 21st century.

OBJECTIVE: To introduce a new telesurgical concept and system, we describe the TELELAP Alf-X system and report the results of the preliminary laboratory experiments on dry lab skill exercises. METHODS: The TELELAP Alf-X system offers a novel approach to remotely operated 3-dimension endoscopy by adding haptic sensation, an eye-tracking system, and a high degree of configuration versatility. The Alf-X system consists of a remote control unit, manipulator arms, connection node, and reusable endoscopic instruments. To test the hand-eye coordination, manual dexterity, depth offield, and ability to make optimal sutures and knots, the Alf-X system was used in a laparoscopic trainer utilizing specific tools by a single surgeon (SG) who repeated three different exercises ten times. The time and accuracy of the exercises were recorded. RESULTS: By using the TELELAP Alf-X system, the surgeon was able to work repeatedly and to perform all the exercises scheduled. In all exercises, the best results were achieved after the first five cases. CONCLUSION: The TELELAP Alf-X system shows excellent stability, easy-to-use interface, and ability to perform essential endoscopic skills. Further experimentation, especially in live tissue, could identify the role of this new technology for the surgical repertoire.

Development and Validation of a Novel Skills Training Model for PCNL, an ESUT project.

BACKGROUND AND AIM: The aim of this study is to validate a totally non biologic training model that combines the use of ultrasound and X ray to train Urologists and Residents in Urology in PerCutaneous NephroLithotripsy (PCNL). METHODS: The training pathway was divided into three modules: Module 1, related to the acquisition of basic UltraSound (US) skill on the kidney; Module 2, consisting of correct Nephrostomy placement; and Module 3, in which a complete PCNL was performed on the model. Trainees practiced on the model first on Module 1, than in 2 and in 3. The pathway was repeated at least three times. Afterward, they rated the performance of the model and the improvement gained using a global rating score questionnaire. RESULTS: A total of 150 Urologists took part in this study. Questionnaire outcomes on this training model showed a mean 4.21 (range 1-5) of positive outcome overall. Individual constructive validity showed statistical significance between the first and the last time that trainees practiced on the PCNL model among the three different modules. Statistical significance was also found between residents, fellows and experts scores. Trainees increased their skills during the training modules. CONCLUSION: This PCNL training model allows for the acquisition of technical knowledge and skills as US basic skill, Nephrostomy placement and entire PCNL procedure. Its structured use could allow a better and safer training pathway to increase the skill in performing a PCNL.

First Italian experience in single-incision laparoscopic nephrectomy.

We describe our laparoscopic nephrectomy technique of placing trocars directly on the fascia once the skin and the subcutaneous layers are prepared. A series of 10 consecutive patients were operated on by single-incision laparoscopic nephrectomy (SILN). With a 5-cm mean skin incision, the fascia was prepared and 3/4 trocars inserted separately directly on the fascia. Surgical strategy followed the standard technique, except for the use of articulating instruments and 5-mm optic. Demographics, body mass index (BMI), operative time, blood loss, perioperative complications, transfusions, hemoglobin decrease, analgesic requirement, length of stay, and final pathology were recorded. Postoperative and prior-to-discharge visual analogue scale (VAS) pain evaluations were also collected, together with the limitations inherent in the instruments' placement and parallel driving during the procedure. The procedures were successfully completed in all but one case. The mean operative time was 169 min. (mean blood loss 113 ml). Without major perioperative complications, the patients were discharged early (mean 5.3 days). Four patients had a BMI>30. For specimen retrieval (neoplasms) two trocar holes were joined. One patient required analgesics; the mean post-operative and prior-to-discharge VAS scores were 5.7 and 1.4, respectively. Pathology examination confirmed 4 pyelonephritic kidneys, 4 renal carcinomas, and 2 upper-urinary tract carcinomas. The laparoscopic nephrectomy via a single incision is feasible and safe, with favorable perioperative and short-term outcomes. It's technically more challenging than standard laparoscopy requiring advanced surgical skills.

First Italian experience in single incision laparoscopic nephrectomy. Assessing and overcoming new challenges.

BACKGROUND: The need to enlarge one of laparoscopic holes for specimen retrieval at the end of a laparoscopic nephrectomy, suggested us to use this final access for the entire procedure. We describe our technique placing trocars directly on the fascia once the skin and the subcutaneous layers were prepared. MATERIAL AND METHODS: A 10 consecutive patients series operated by Single Incision Laparoscopic Nephrectomy (SILN) is presented. With a 5 cm mean skin incision, the fascia was prepared and 3/4 trocars inserted separately directly on the fascia. Surgical strategy followed the standard technique, except for the use of articulating instruments and 5 mm optic. Demographics, Body Mass Index (BMI), operative time, blood loss, perioperative complications, transfusions, hemoglobin decrease, analgesic requirement, length of stay, final pathology were recorded. Postoperative and prior-to-discharge Video Analogue Scale Pain (VAS) evaluation were also collected, together with the limitations inherent to the instruments placing and parallel driving during the procedure. RESULTS: SILN was successfully completed in all but one cases. The mean operative time was 169 min (mean blood loss 113 ml). Without major perioperative complications, the patients were discharged early (mean 5.3 days). Four patients had a BMI > 30. For specimen retrieval (neoplasms) two trocars holes were joined. One patient required analgesics; the mean post-operative and prior-to-discharge VAS scores were 5.7 and 1.4, respectively. Pathology examination confirmed 4 pyelonephritic kidneys, 4 renal carcinoma and 2 upper-urinary tract carcinoma. CONCLUSION: SILN is feasible, safe, with favourable perioperative and short-term outcomes. It's technically more challenging than standard laparoscopy requiring advanced surgical skills.

Evaluation of a new robotic-assisted laparoscopic surgical system for procedures in small cavities.

No data exists concerning the application of a new robotic system with 3-mm instruments (Senhance™, Transenterix, Milano, Italy) in small cavities. Therefore, the aim of this study was to test the system for its performance of intracorporal suturing in small boxes simulating small body cavities. Translucent plastic boxes of decreasing volumes (2519-90 ml) were used. The procedures (two single stitches, each with two consecutive surgical square knots) were performed by a system-experienced and three system-inexperienced surgeons in each box, starting within the largest box, consecutively exchanging the boxes into smaller ones. With this approach, the total amount of procedures performed by each surgeon increased with decreasing volume of boxes being operated in. Outcomes included port placement, time, task completion, internal and external instrument/instrument collisions and instrument/box collisions. The procedures could be performed in all boxes. The operating time decreased gradually in the first three boxes (2519-853 ml), demonstrating a learning curve. The increase of operating time from boxes of 599 ml and lower may be attributed to the increased complexity of the procedure in small cavities as in the smallest box with the dimensions of 2.9 × 6.3 × 4.9 cm. This is also reflected by the parallel increase of internal instrument-instrument collisions. With the introduction of 3-mm instruments in a new robotic surgical system, we were able to perform intracorporal suturing and knot tying in cavities as small as 90 ml. Whether this system is comparable to conventional three-port 3-mm laparoscopic surgery in small cavities-such as in pediatric surgery-has to be evaluated in further studies.

Efficacy and safety of the haemostasis achieved by Vivostat system during laparoscopic partial nephrectomy.

INTRODUCTION: Haemostasis remains the greatest challenge during laparoscopic partial nephrectomy. We describe the use of the Vivostat system helping effective haemostasis during laparoscopic partial nephrectomy (LPN). PATIENTS AND METHOD: Twenty-eight patients underwent LPN. Autologous fibrin sealant was prepared with the Vivostat system and applied to the resection bed. This system is an automated medical device for the preparation of an autologous fibrin sealant from the patient's blood. Pre and postoperative clinical parameters and laboratory values were evaluated, for acute and delayed bleeding. RESULTS: Median patient's age was 58 years (range, 25-75). All patients underwent LPN for renal tumors (mean size 2.5 cm; range 0.9-4.5 cm). Six resection were performed without vessels clamping, and 22 were realized with selective arterial Bulldog clamping. Haemostasis was achieved by a cellulose bolster (80%), by stitches (67%) and by sealant application after declamping (100%) (mean amount applied: 5.1 ml). The mean warm ischemia time was 26 minutes (range, 16-45) for 22 interventions. Mean blood loss was 128 cc (range, 20-500). Pre-operative and post-operative creatinine values (mean, 0.91 vs. 1 ng/mi) did not differ significantly; whereas mean Hb levels slightly decreases after surgery (mean, 14.7 vs. 12.5 g/dl). Mean operative time was 131 minutes (range, 60-190). All but one had negative surgical margins. One intraoperative bleeding occurred needing blood transfusion (1 unit). Postoperatively, we observed only 1 perirenal hematoma treated conservatively requiring blood transfusion. CONCLUSIONS: In this study, an effective haemostasis was achieved and maintained after kidney reperfusion. These data support the previous finding with the same system and encourage its use in LPN.

Expanding indication for elective nephron-sparing surgery in renal cell carcinoma.

Nephron-sparing surgery is the reference standard for the management of a small renal masses, especially in patients with a solitary kidney or bilateral renal tumors. The rationale for elective partial nephrectomy is based on the risk of developing kidney failure and the significant percentage of benign lesions on final histopathologic examination. Recent studies have demonstrated comparable survival and recurrence rates with partial and radical nephrectomy for renal tumors of 4 cm or less, and it is well demonstrated that radical nephrectomy is a significant risk factor for the development of chronic kidney disease. The latest evidences indicate that the outcomes are similar after partial nephrectomy for selected tumors 4 to 7 cm in size. The laparoscopic partial nephrectomy showed functional and oncologic outcomes comparable to those after open partial nephrectomy. Nevertheless, laparoscopic partial nephrectomy is a technically demanding procedure. With increasing experience and technical refinements, the complications rates have decreased substantially. Simultaneously, the indications of laparoscopic partial nephrectomy are being carefully extended to include more complex tumors. The purpose of this paper was to underline the evolution of, and expanding indications for, a nephron-sparing approach also for renal masses between 4 and 7 centimeters and a normal contralateral kidney, presuming a careful and sensible patient selection. This option should be reserved only to experienced centers.

Laparoscopic nephrectomy for complete renal infarction due to post traumatic renal artery thrombosis.

We report a case of post traumatic thrombosis of the renal artery with renal infarction and associated liver injury. Conservative treatment was initially planned in consideration of the delayed diagnosis (> 3 hours), but the patient subsequently developed hypertension not controllable with anti-hypertensive drugs. He underwent laparoscopy with nephrectomy and liver injury repair. Hypertension resolved after nephrectomy without further medical treatment. Laparoscopic nephrectomy is not a standard procedure for renal trauma but it could be an option in selected patients.

Case report: Laparoscopic removal of 10-cm retroperitoneal liposarcoma.

BACKGROUND: Liposarcomas are the second most frequent tumors in the retroperitoneal space and classically present as a large mass with minimal symptoms and a high local recurrence rate. The gold standard of treatment remains surgical excision. CASE REPORT: We describe the first successful removal of a well-differentiated retroperitoneal liposarcoma using a laparoscopic approach. An asymptomatic patient presented a large fatty mass in the retroperitoneal space on CT imaging. A transperitoneal laparoscopic approach was planned. A well-capsulated mass was exposed under Gerota's fascia that was dissected easily and removed completely without complications. Histologic examination revealed a well-differentiated liposarcoma. No recurrence was found at 12 months' followup. CONCLUSION: Resecting the mass completely remains the most important predictor of local recurrence and overall survival in liposarcoma. Thus, the success of radical surgical treatment is very important. The laparoscopic approach is technically safe and successful in maintaining oncologic principles and avoiding recurrences in retroperitoneal liposarcomas, representing a feasible alternative to open surgery.

Learning a new robotic surgical device: Telelap Alf X in gynaecological surgery.

BACKGROUND: To assess the learning curve associated with tele-assisted surgery. METHODS: We performed a training box-based study, describing speed and accuracy in volunteers performing basic and complex laparoscopic tasks, to assess performance and in the skill acquisition of inexperienced users, using the Telelap Alf X system. Ten surgeons in gynaecology who had never received formal instruction on this new surgical device, completed four modules during a consecutive 3 day training programme. RESULTS: All the participants completed the training programme with a good learning curve. CONCLUSIONS: Use of the TELELAP Alf X advanced surgical robotic system is associated with a rapid learning curve among experienced surgeons. Copyright © 2015 John Wiley & Sons, Ltd.

Alpha- and beta-tubulin expression in rectal cancer development.

BACKGROUND: Microtubules are involved in cell growth and division, motility, signalling and in the development and maintenance of cell shape. Consequently, the non-equilibrium dynamics of these microtubules can be crucial to cellular function, including cancer development. Although the involvement of tubulins in human development has been well investigated, the role of alpha- and beta-tubulins in human tumorigenesis still remains controversial. The aim of this study was to investigate alpha- and beta-tubulin protein expression in rectal cancer development. PATIENTS AND METHODS: By immuno-histochemistry, using alpha- and beta-tubulin monoclonal antibodies, 66 patients were examined, 32 of whom (22 male, 10 female; range 31-60 years, mean age 49.5 years) had preneoplastic lesions discovered during endoscopic surveillance, which were classified as mild, moderate and severe dysplastic polyps of the rectum, and 34 had invasive adenocarcinomas (24 male, 10 female; range 39-60 years, mean 52 years) of the rectum, with no local or distant metastases at the time of surgical resection. RESULTS: In preneoplastic lesions, no statistically significant relationship was found among alpha- and beta-tubulin protein expression, grade of dysplasia, or other clinical data. Statistical association among alpha- and beta-tubulin immunoreactivity and Dukes' stages B and C was found with p = 0.017 and p = 0.009, respectively. No statistical relationship was found between alpha- and beta-tubulin protein expression among different grades of dysplasia. On the contrary, a significant relationship was detected among tubulins in different stages of cancer. CONCLUSION: In this preliminary study a significant difference of alpha- and beta-tubulin protein expressions was found in polyps and invasive cancer of the rectum, indicating a possible role of tubulins in invasive, but not in preinvasive cancer development. This preliminary data suggest the possibility of performing alpha- and beta-tubulin protein expression in order to identify B stage versus C stage rectal cancer, before surgical treatment.

The differentiation of humane adult mesenchimal stem cells of bone marrow (hMSC) into urothelial cells on bio-engineering support (scaffold): preliminary experience of tissue engineering.

OBJECTIVES: Tissue Engineering can develop scaffolds of Poly-L-Lactic Acid (PLLA) for tissue regeneration. The purpose of the present job is to test the possibility to seed human adult mesenchymal stem cells on a scaffold supplemented with specific grow factors to differentiate them into urothelium. METHODS: The Electrospinning technique was used to realize three scaffolds. The first one was seeded with urothelial cells, of a primary culture, and Keratinocyte serum free medium (KSFM); the second one was seeded with human mesenchymal stem cells (hMSC) and a minimum essential medium (aMEM); the third one was seeded with hMSC and conditioned medium. RESULTS: Electron microscopy showed scaffolds with cellular vitality (>90%) and their cellular proliferation. Moreover, the differentiation of hMSC, seeded in conditioned medium, into urothelial cells was demonstrated through immunofluorescence assays. CONCLUSIONS: Tissue Engineering can develop PLLA scaffolds thanks to the Electrospinning technique. The scaffold is a perfect environment for cellular culture and proliferation; a protocol for the differentiation of hMSC into urothelial cells is now available. Immunofluorescence assays can demonstrate the hMSC differentiation into urothelial cells.