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.

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.

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.

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.

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.

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.

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.

Laparoendoscopic single-site partial nephrectomy without ischemia.

BACKGROUND AND PURPOSE: Nephron-sparing surgery (NSS) ensures excellent oncologic and functional outcomes in small renal masses. Laparoendoscopic single-site surgery (LESS) is one of the major advances in the evolution of minimally invasive surgery. We describe our initial surgical experience and assess the feasibility of LESS unclamp-NSS. PATIENTS AND METHODS: From April to September 2009, all consecutive patients with solitary, exophytic, enhancing, small (≤4.0 cm) renal masses and normal contralateral kidney were selected to receive LESS unclamp-NSS. A multichannel port provided intra-abdominal transperitoneal access. Rigid and articulable instruments were used for dissection, tumor exposure, and excision under normal renal perfusion. Perioperative, pathologic, hematologic data together with a subjective evaluation of pain and scar were collected and evaluated. RESULTS: Six patients underwent LESS unclamp-NSS (mean operative time, 148 min; mean blood loss, 201 mL; mean renal masses size, 2.1cm). One patient needed conversion to standard laparoscopy because of excessive bleeding. Postoperatively, a cerebrovascular accident developed in one patient. No transfusion was necessary. Pathologic examination revealed two clear-cell carcinoma, three benign cysts, and one angiomyolipoma (surgical margin positive). A 2.7 g/dL hemoglobin level decrease was recorded with minimal pain and great patient satisfaction. Mean length of stay was 6 days. CONCLUSION: LESS unclamp-NSS in selected renal masses is feasible, provides postoperative outcomes overlapping the standard counterpart, and ensures subjective satisfaction. Additional trocars should be considered for the hemostatic stitches and for liver retraction. A wider experience and longer follow-up are necessary to establish the role of this technique.

Assessing feasibility and safety of laparoendoscopic single-site surgery adrenalectomy: initial experience.

BACKGROUND AND PURPOSE: Laparoendoscopic single-site surgery (LESS) is one of the most interesting surgical advances. We performed LESS adrenalectomy in three patients to assess feasibility, safety, and perioperative outcomes. PATIENTS AND METHODS: Three patients with nonfunctional adrenal masses underwent TriPort adrenalectomy. Demographics, perioperative, and pathological records were collected together with postoperative data. TriPort was used through a 3 cm subcostal incision with 10 mm 30 degrees optic and two 5 mm instruments. The specimens were extracted via a 10 mm bag instead of the optic. RESULTS: TriPort adrenalectomy was completed in all cases. The mean operative time was 200 minutes (mean blood loss, 40 mL). No perioperative complications were recorded. Pathology examination confirmed one adenoma, one lung cancer metastasis, and one myelolipoma. CONCLUSIONS: LESS adrenalectomy is feasible and safe, with favorable perioperative and short-term outcomes. It is technically more challenging than standard laparoscopy and requires advanced surgical skills. Prospective studies are needed for further conclusions.

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.

Laparo-endoscopic single-site left transperitoneal adrenalectomy.

A 53-yr-old woman presented with abdominal pain. Ultrasonography, computed tomography, and an endocrinologic work-up revealed a 4-cm nonfunctional left adrenal mass. A TriPort laparoscopic adrenalectomy was performed. The TriPort was inserted through a 3-cm subcostal incision. Using 5-mm instruments, a left adrenalectomy was performed. The specimen was dissected (harmonic scalpel) and extracted through a 10-mm bag. A TriPort adrenalectomy was successfully completed in 240 min (blood loss: 20 ml). The postoperative period was uneventful (discharge within 3 d). In our opinion, the TriPort adrenalectomy is feasible and safe, with favourable perioperative and short-term outcomes and a delighted patient at the 8-mo follow-up.