Correction to: Standard (8 weeks) vs long (12 weeks) timing to minimally-invasive surgery after NeoAdjuvant Chemoradiotherapy for rectal cancer: a multicenter randomized controlled parallel group trial (TiMiSNAR).

Following publication of the original article [1], the authors reported that the family name of the author, Ludovica Baldari, was misspelled.

Standard (8 weeks) vs long (12 weeks) timing to minimally-invasive surgery after NeoAdjuvant Chemoradiotherapy for rectal cancer: a multicenter randomized controlled parallel group trial (TiMiSNAR).

BACKGROUND: The optimal timing of surgery in relation to chemoradiation is still controversial. Retrospective analysis has demonstrated in the recent decades that the regression of adenocarcinoma can be slow and not complete until after several months. More recently, increasing pathologic Complete Response rates have been demonstrated to be correlated with longer time interval. The purpose of the trial is to demonstrate if delayed timing of surgery after neoadjuvant chemoradiotherapy actually affects pathologic Complete Response and reflects on disease-free survival and overall survival rather than standard timing. METHODS: The trial is a multicenter, prospective, randomized controlled, unblinded, parallel-group trial comparing standard and delayed surgery after neoadjuvant chemoradiotherapy for the curative treatment of rectal cancer. Three-hundred and forty patients will be randomized on an equal basis to either robotic-assisted/standard laparoscopic rectal cancer surgery after 8 weeks or robotic-assisted/standard laparoscopic rectal cancer surgery after 12 weeks. DISCUSSION: To date, it is well-know that pathologic Complete Response is associated with excellent prognosis and an overall survival of 90%. In the Lyon trial the rate of pCR or near pathologic Complete Response increased from 10.3 to 26% and in retrospective studies the increase rate was about 23-30%. These results may be explained on the relationship between radiation therapy and tumor regression: DNA damage occurs during irradiation, but cellular lysis occurs within the next weeks. Study results, whether confirmed that performing surgery after 12 weeks from neoadjuvant treatment is advantageous from a technical and oncological point of view, may change the current pathway of the treatment in those patient suffering from rectal cancer. TRIAL REGISTRATION: ClinicalTrials.gov NCT3465982.

Robotic CME in 110 consecutive cases: feasibility and short-term technical and oncological outcomes.

BACKGROUND: Complete mesocolic excision (CME) has been introduced from open surgery, to compare right colon cancer surgery to total mesorectal excision for rectal cancer and it is currently being applied by robotic approach. CME concept is based on the complete removal of right mesocolon and the dissection deep at the level of the central feeding vessels. Aside the CME, intracorporeal anastomosis completes a total minimally invasive approach to the treatment of right colon cancer. This study retrospectively analyzed the feasibility and efficacy of robotic CME and intracorporeal anastomosis in a cohort of consecutive patients affected with right colon cancer. METHODS: The data of 110 patients undergone a robotic CME with IA anastomosis for right colon cancer from 2018 to 2023 were prospectively collected and retrospectively analyzed. Intraoperative, postoperative, and short-middle term outcomes were considered for analysis, as well as pathologic and oncologic outcomes. A time-to-event analysis was performed using the Kaplan-Meier method for OS and DFS. RESULTS: All patients underwent a robotic right colectomy. Median operative time was 184 min, blood loss was negligible, no intraoperative complications occurred. Three conversions (2.7%) were experienced due to bulky lymph nodes and severe local advanced tumor. Mean postoperative stay was 6 days. Six postoperative complications occurred, 4 postoperative ileus, 1 late dehiscence of the colonic stump and an iatrogenic colonic perforation. The latter needed reintervention. CONCLUSIONS: Robotic CME with central vessels ligation seems feasible and safe, with acceptable morbidity and adequate short-middle term outcomes.

Total mesorectal excision: a comparison of oncological and functional outcomes between robotic and laparoscopic surgery for rectal cancer.

BACKGROUND: Long-term data from the CLASICC study demonstrated the oncologic equivalence of laparoscopic and open rectal cancer surgery despite an increased circumferential resection margin involvement in the laparoscopic group in the initial report. Moreover, laparoscopic total mesorectal excision (TME) may be associated with increased rates of male sexual dysfunction compared to conventional open TME. Robotic surgery could potentially obtain better results than laparoscopy. The aim of this study was to compare the clinical and functional outcomes of robotic and laparoscopic surgery in a single-center experience. METHODS: This study was based on 100 patients who underwent minimally invasive anterior rectal resection with TME. Fifty consecutive robotic rectal anterior resections with TME (R-TME) were compared to the first 50 consecutive laparoscopic rectal resections with TME (L-TME). RESULTS: Median operative time was 270 min in R-TME and 275 min in L-TME. No conversions occurred in the R-TME group whereas six conversions occurred in the L-TME group. The mean number of harvested lymph nodes was 16.5 ± 7.1 for R-TME and 13.8 ± 6.7 for L-TME. The circumferential margin (CRM) was <2 mm in six L-TME patients, whereas no one in R-TME group had a CRM <2 mm. The International Prostate Symptom Score (IPSS) scores were significantly increased 1 month after surgery in both the L-TME and R-TME groups, but they normalized 1 year after surgery. Erectile function worsened significantly 1 month after surgery in both the groups but it was restored completely 1 year after surgery in the R-TME group and partially in the L-TME group. CONCLUSIONS: Robotic TME is oncologically safe and adequate for rectal cancer treatment, showing better results than laparoscopic TME in terms of CRM, conversions, and hospital length of stay. Better recovery in voiding and sexual function is achieved with the robotic technique.

Fully robotic treatment of an epiphrenic diverticulum: report of a case.

Epiphrenic diverticula are rare protrusions of the distal esophagus attributed to esophageal motility disorders or obstructive diseases. In presence of a relevant symptomatology, surgery is mandatory. Although many reports confirm the feasibility of the laparoscopic transhiatal approach, the mobilization of the esophagus and the myotomy appear challenging. The intrinsic characteristics of the da Vinci Robotic System could facilitate the approach to the esophagogastric junction and an extended mobilization of the esophagus. We describe a robotic transhiatal surgical treatment of an epiphrenic diverticulum with a Dor antireflux procedure. Robotic-assisted diverticulectomy appears feasible and safe with a low risk of esophageal perforation and pleura damage.

Full robotic gastrectomy with extended (D2) lymphadenectomy for gastric cancer: surgical technique and preliminary results.

BACKGROUND: Widespread diffusion of minimally-invasive surgery for gastric cancer treatment is limited by the complexity of performing an extended D2-lymphadenectomy. This surgical step can be facilitated by using robot-assisted surgery. The aim of this study is to describe our technique and short-term results of a consecutive series of full robotic gastrectomies with D2-lymphadenectomy for gastric cancer, using the da Vinci Surgical System. MATERIALS AND METHODS: Between May 2004 and December 2009, we performed 24 consecutive full robot-assisted total and subtotal gastrectomies with extended D2-lymphadenectomy for histologically-proven gastric adenocarcinoma. Data referring to 11 robot-assisted total gastrectomies and 13 subtotal gastrectomies were collected in a database and analyzed. RESULTS: Median operative time was 267.50 min (255-305). Median intraoperative blood loss was 30 mL. Median number of harvested lymph nodes was 28 (23-34). Resection margins were negative in all cases. No conversions occurred. Surgery-related morbidity was 8%. Thirty-day mortality was 0%. Liquid diet started on postoperative d 5 (2-5). Median length of stay was 6 d (5-8). CONCLUSIONS: Robot-assisted gastrectomy with D2-lymphadenectomy is a safe technique and allows achieving an adequate lymph node harvest and optimal R0-resection rates with low postoperative morbidity and the learning curve appears to be shorter than in laparoscopic surgery. Longer follow-up and randomized clinical trials are needed to define the role of robot-assistance in gastric cancer surgery.

Laparoscopic treatment of a carcinoma of the cecum incarcerated in a right groin hernia: report of a case.

A carcinoma in a groin hernia is uncommon. We herein report a case of an intrasaccular carcinoma of the cecum in a right inguinoscrotal hernia with a simultaneous left inguinal hernia treated by a laparoscopic approach. A 70-year-old man presented with a painful, not completely reducible bilateral hernia. Blood examinations showed severe anemia. A computed tomography scan of the abdomen confirmed the presence of the cecum in the hernia sac, showing a round wall thickening of the herniated portion of the colon. A standard laparoscopic right colectomy with radical oncological purpose was performed. An incarcerated inguinal hernia is a relatively common surgical problem. In the case of anemia or other signs suggestive of malignancy, a specific preoperative work-up should be assessed. This case demonstrates that it is possible to perform an oncologically correct laparoscopic resection when the presence of malignancy is confirmed while performing an open traditional hernioplasty to avoid any possible contamination of the mesh.

Prospective, randomised, multicentre, open-label trial, designed to evaluate the best timing of closure of the temporary ileostomy (early versus late) in patients who underwent rectal cancer resection and with indication for adjuvant chemotherapy: the STOMAD (STOMa closure before or after ADjuvant therapy) randomised controlled trial.

INTRODUCTION: Temporary ileostomy is a valuable aid in reducing the severity of complications related to rectal cancer surgery. However, it is still unclear what is the best timing of its closure in relation to the feasibility of an adjuvant treatment, especially considering patient-reported outcomes and health system costs. The aim of the study is to compare the results of an early versus late closure strategy in patients with indication to adjuvant chemotherapy after resection for rectal cancer. METHODS AND ANALYSIS: This is a prospective multicentre randomised trial, sponsored by Rete Oncologica Piemonte e Valle d'Aosta (Oncology Network of Piedmont and Aosta Valley-Italy). Patients undergone to rectal cancer surgery with temporary ileostomy, aged >18 years, without evidence of anastomotic leak and with indication to adjuvant chemotherapy will be enrolled in 28 Network centres. An early closure strategy (between 30 and 40 days from rectal surgery) will be compared with a late one (after the end of adjuvant therapy). Primary endpoint will be the compliance to adjuvant chemotherapy with and without ileostomy. Complications associated with stoma closure as well as quality of life, costs and oncological outcomes will be assessed as secondary endpoints. ETHICS AND DISSEMINATION: The trial will engage the Network professional teams in a common effort to improve the treatment of rectal cancer by ensuring the best results in relation to the most correct use of resources. It will take into consideration both the patients' point of view (patient-reported outcome) and the health system perspective (costs analysis). The study has been approved by the Ethical Review Board of Città della Salute e della Scienza Hospital in Turin (Italy). The results of the study will be disseminated by the Network website, medical conferences and peer-reviewed scientific journals. TRIAL REGISTRATION NUMBER: NCT04372992.

Robotic right colon resection: evaluation of first 50 consecutive cases for malignant disease.

BACKGROUND: Colorectal cancer is the fourth leading cause of death in the world. Minimally invasive surgery has been demonstrated to have the same oncological results as open surgery, with better clinical outcomes. Robotic assistance is an evolution of minimally invasive technique. This study aims to evaluate surgical and oncological short-term outcomes of robotic-assisted right colon resection in malignant disease. METHODS: Fifty consecutive patients affected by right-sided colon cancer were operated from May 2001 to May 2009 using the da Vinci(®) surgical system. Data regarding surgical and early oncological outcomes were systematically collected in a specific database for statistical analysis. RESULTS: Twenty-four male and 26 female patients underwent robotic right colectomy. Median age was 73.34 ± 11 years. Median operative time was 223.50 (180-270) min. No conversion occurred. Specimen length was 26.7 ± 8 cm (range 21-50 cm), number of harvested lymph nodes was 18.76 ± 7.2 (range 12-44), and mean number of positive lymph nodes was 1.65 ± 3 (range 0-17). Surgery-related morbidity was 1/50 (2%): one twisting of the mesentery in one case with extracorporeal anastomosis. All patients were included in a follow-up regimen. Disease-free survival was 90% (45/50), and overall survival was 92% (46/50). Cancer-related mortality was 8% (4/50). CONCLUSIONS: Robotic assistance allows performance of oncologically adequate dissection of the right colon with radical lymphadenectomy and to fashion a handsewn intracorporeal anastomosis as in open surgery, confirming the safety and oncological adequacy of this technique, with acceptable results and short-term outcomes.

Expression levels of circulating miRNAs as biomarkers during multimodal treatment of rectal cancer - TiMiSNAR-mirna: a substudy of the TiMiSNAR Trial (NCT03962088).

BACKGROUND: Neoadjuvant chemoradiotherapy followed by surgery is the mainstay treatment for locally advanced rectal cancer, leading to significant decrease in tumor size (downsizing) and a shift towards earlier disease stage (downstaging). Extensive histopathological work-up of the tumor specimen after surgery including tumor regression grading and lymph node status helped to visualize individual tumor sensitivity to chemoradiotherapy, retrospectively. As the response to neoadjuvant chemoradiotherapy is heterogeneous, however, valid biomarkers are needed to monitor tumor response. A relevant number of studies aimed to identify molecular markers retrieved from tumor tissue while the relevance of blood-based biomarkers is less stringent assessed. MicroRNAs are currently under investigation to serve as blood-based biomarkers. To date, no screening approach to identify relevant miRNAs as biomarkers in blood of patients with rectal cancer was undertaken. The aim of the study is to investigate the role of circulating miRNAs as biomarkers in those patients included in the TiMiSNAR Trial (NCT03465982). This is a biomolecular substudy of TiMiSNAR Trial (NCT03962088). METHODS: All included patients in the TiMiSNAR Trial are supposed to undergo blood collection at the time of diagnosis, after neoadjuvant treatment, after 1 month from surgery, and after adjuvant chemotherapy whenever indicated. DISCUSSION: TiMiSNAR-MIRNA will evaluate the association of variation between preneoadjuvant and postneoadjuvant expression levels of miRNA with pathological complete response. Moreover, the study will evaluate the role of liquid biopsies in the monitoring of treatment, correlate changes in expression levels of miRNA following complete surgical resection with disease-free survival, and evaluate the relation between changes in miRNA during surveillance and tumor relapse. TRIAL REGISTRATION: Clinicaltrials.gov NCT03962088 . Registered on 23 May 2019.

Functional evaluation at 1-year follow-up of laparoscopic Nissen-Rossetti fundoplication.

Laparoscopic Nissen fundoplication is currently the gold standard for surgical treatment of gastroesophageal reflux disease. The aim of this study was to present our experience with this procedure at 1 year of follow-up. Forty patients were operated on between January 2006 and July 2007, and 30 underwent a 24-hour postoperative pH-metry study. Ninety-two percent of the patients were asymptomatic at a follow-up of 12 months. All pH-metric parameters improved. DeMeester and Johnson's score was reduced from 44.7 to 7.75; endoscopy with histologic samples revealed the healing of esophagitis in all patients; 4 (13%) patients complained of dysphagia, which resolved within 1 month after surgery. Twenty-seven (90%) patients were completely satisfied by their surgical results. One year after surgery, 24-hour ph-metric results show that laparoscopic Nissen fundoplication can completely control acid reflux with relatively few complications and a high degree of patient satisfaction.

Robotic right colectomy in a patient with ventriculoperitoneal shunt. Report of a case.

INTRODUCTION: Ventriculoperitoneal shunt procedure has become the most common neurosurgical method for hydrocephalus because it considerably improves patients prognosis. Pneumoperitoneum has been considered a contraindication to laparoscopic surgery because of risk for increased intracranial pressure during pneumoperitoneum and/or malfunction/infection of the VP shunt itself. Laparoscopic resection of the cecum and of the rectum for cancer has been reported. PRESENTATION OF CASE: A 74-year old man with ventriculoperitoneal shunt for normal pressure hydrocephalus referred to the emergency medicine ward for COPD, lower limb oedema and severe anemia. CT Scan showed a substenotic tumor of the right colon and non-specific enlarged regional lymph nodes, with no distant metastases. Colonoscopy confirmed the presence of an ulcerated tumor of the right colon involving half of the colic lumen. A right colectomy with CME was carried out, with a stapled intracorporeal ileocolic side-to-side isoperistaltic anastomosis and without manipulating the VPS catheter. DISCUSSION: Laparoscopic surgery in patients with VPS tubes was previously contraindicated because of the possibility of shunt-associated complications, that may include shunt malfunction due to increased intra-abdominal pressure, damage or infection of the catheter. Some authors reported that intracranial pressure increased up to 25 mmHg at a pneumoperitoneum pressure of 12 mmHgHerein we report, to our knowledge, the first case report of robotic assisted right colectomy for cancer in a patient with a VP shunt. CONCLUSION: Robotic assistance may allow to perform colorectal resection safely and with low risk also in patients with ventriculoperitoneal shunt.

Robotic transanal total mesorectal excision: A new perspective for low rectal cancer treatment. A case series.

BACKGROUND: Rectal cancer treatment is still a challenging frontier in general surgery, as there is no general agreement on which surgical approach is best for its management. Total mesorectal excision (TME), influenced the practical approach to rectal cancer, and brought a significant improvement on tumor recurrence and patients survival. Robotic transanal surgery is a newer approach to rectal dissection whose purpose is to overcome the limits of the traditional transabdominal approach, improving accuracy of distal dissection and preservation of hypogastric innervation. An increasing interest on this new technique has raised, thanks to the excellent pathological and acceptable short-term clinical outcomes reported. MATERIALS AND METHODS: Three consecutive cases of robotic transanal TME were prospectically performed between May 2017 and October 2017. RESULTS: TME quality was Quirke 3 grade in all cases. Mean operative time was 530 min. None of the patients had intra-operatively or post-operatively complications. CONCLUSIONS: Robotic transanal TME is a very recent procedure. Acclaimed greatest advantage of robotic transanal TME is the facilitation of dissection with an in-line view, which translates in an improved surgical field exposure and visualization. Further investigations are needed to assure the actual value of robotic transanal approach.

Dealing with robot-assisted surgery for rectal cancer: Current status and perspectives.

The laparoscopic approach for treatment of rectal cancer has been proven feasible and oncologically safe, and is able to offer better short-term outcomes than traditional open procedures, mainly in terms of reduced length of hospital stay and time to return to working activity. In spite of this, the laparoscopic technique is usually practised only in high-volume experienced centres, mainly because it requires a prolonged and demanding learning curve. It has been estimated that over 50 operations are required for an experienced colorectal surgeon to achieve proficiency with this technique. Robotic surgery enables the surgeon to perform minimally invasive operations with better vision and more intuitive and precise control of the operating instruments, thus promising to overcome some of the technical difficulties associated with standard laparoscopy. It has high-definition three-dimensional vision, it translates the surgeon's hand movements into precise movements of the instruments inside the patient, the camera is held and moved by the first surgeon, and a fourth robotic arm is available as a fixed retractor. The aim of this review is to summarise the current data on clinical and oncologic outcomes of robot-assisted surgery in rectal cancer, focusing on short- and long-term results, and providing original data from the authors' centre.

Robotic adrenalectomy: technical aspects, early results and learning curve.

BACKGROUND: Adrenal surgery is undergoing continuous evolution, and robotic technology may extend indications for a minimally invasive approach to adrenalectomy. METHODS: Thirty robot-assisted unilateral transperitoneal adrenalectomy procedures have been performed at our Department over the last 5 years. The presence of bilateral lesions and vascular involvement were the only contra-indications for a minimally invasive approach. Several patients presented with significant co-morbidities: BMI > 35 kg/m(2) (20%); ASA score III-IV (58.7%); and moderate to severe impaired respiratory function (36.6%). In addition, 40% of patients had undergone previous abdominal surgery. RESULTS: Two patients presented with intra-operative complications (6.6%) and only one patient required conversion to an open procedure (3.3%). None of the patients required intraoperative transfusions. Hospital morbidity was 10% but no mortality was recorded. The mean hospital stay was 5.2 ± 2.2 days. The mean size of the resected adrenal mass was 5.1 ± 2.4 cm. A significant reduction in operative times was found with gaining experience. CONCLUSIONS: Thanks to robotic technology, some subpopulations of patients with clinical or oncological contra-indications to laparoscopic treatment may be addressed with minimally invasive treatment.

Robotic splenectomy for mesothelial cyst: a case report.

Cystic lesions of the spleen represent a rare entity with an overall incidence of 0.5% among splenectomies. They can remain asymptomatic in 30% to 60% of patients or may cause symptoms for secondary compression of adjacent structures. Peripheral cysts may be suitable for conservative treatment whereas splenectomy is the accepted procedure for bulky and/or central lesions. Laparoscopy is the standard approach for elective splenic surgery, but in the last decade, introduction of the da Vinci robotic system has represented a further improvement in minimally invasive surgery, thanks to 3-dimensional vision and more accurate motion control. Herein, we report a case of a mesothelial splenic cysts successfully treated by robotic splenectomy; some anatomical considerations and technical aspects of robotic procedures have been discussed: it is a feasible and safe approach, particularly indicated in the presence of anatomic features such as an enlarged pancreatic tail and a type II vascular pattern of splenic pedicle. In such patients, the choice of a robotic approach may decrease the risk of intraoperative bleeding, thereby representing a further improvement in laparoscopic techniques.