Safety and Efficacy of a Novel Miniaturized Robotic-Assisted Surgery System in Colectomy: A Prospective, Investigational Device Exemption Clinical Study Using the IDEAL Framework.

BACKGROUND: Robotics has increased rates of minimally invasive surgery, with distinct advantages over open surgery. However, current commercially available robotic platforms have device and system issues that limit robotic-assisted surgery expansion. OBJECTIVE: To demonstrate the safety and efficacy of a novel miniaturized robotic-assisted surgery device in colectomy. DESIGN: Prospective, Investigational Device Exemption clinical study following the idea, development, exploration, assessment, and long-term follow-up framework (stage 2b, exploration). SETTINGS: Three centers with high-volume robotic colorectal cases and surgeons. PATIENTS: Patients scheduled for a right or left colectomy for benign or malignant disease. INTERVENTION: Colectomy with the novel miniaturized robotic-assisted surgery device. MAIN OUTCOME MEASURES: For safety, intraoperative and device-related adverse events and 30-day morbidity. For efficacy, successful completion of predefined procedural steps without conversion. RESULTS: Thirty patients (13 women, 17 men) were analyzed. The mean age was 59.4 (SD 13.4) years. Seventy percent of patients (n = 21) were overweight/obese and 53.3% of patients (n = 16) had prior abdominal surgery. Forty percent of patients had malignant and 60% had benign disease. Cases were 15 right and 15 left colectomies. Overall operative time was a median of 146 (range, 80-309) minutes; console time was 70 (range, 34-174) minutes. There were no conversions to open surgery and no intraoperative or device-related adverse events. In 100% of patients (n = 30), the primary dissection was completed, and hemostasis was maintained with the novel miniaturized robotic-assisted surgery device. The morbidity rate was 26.7% minor and 3.3% major. The median length of stay was 2 days. There were no mortalities. LIMITATIONS: Single-arm study, short-term follow-up. CONCLUSIONS: This first clinical study of a novel miniaturized robotic-assisted surgery device along the IDEAL framework demonstrated that it was safe and effective. Given this success, further assessment and long-term follow-up of the miniaturized robotic-assisted surgery device are planned for comparative clinical and economic effectiveness in colorectal surgery. See Video Abstract . SEGURIDAD Y EFICACIA DE UN NOVEDOSO SISTEMA DE CIRUGA ASISTIDA POR ROBOT MINIATURIZADO EN COLECTOMA UN ESTUDIO CLNICO PROSPECTIVO DE INVESTIGACIN DE EXENCIN DE DISPOSITIVO QUE UTILIZA EL MARCO IDEAL: ANTECEDENTES:La robótica ha aumentado las tasas de cirugía mínimamente invasiva, con claras ventajas sobre la cirugía abierta. Sin embargo, las plataformas robóticas actualmente disponibles comercialmente tienen problemas con los dispositivos y sistemas que limitan la expansión de la cirugía asistida por robot.OBJETIVO:Demostrar la seguridad y eficacia de un novedoso dispositivo de cirugía asistida por robot miniaturizado en colectomía.DISEÑO:Estudio clínico prospectivo de investigación de exención de dispositivo siguiendo el marco IDEAL (Etapa 2b, exploración).ESCENARIO:Tres centros con cirujanos y casos colorrectales robóticos de gran volumen.PACIENTES:Pacientes programados para colectomía derecha o izquierda por enfermedad benigna o maligna.INTERVENCIÓN:Colectomía con el nuevo dispositivo de cirugía asistida por robot miniaturizado.PRINCIPALES MEDIDAS DE RESULTADO:Para la seguridad, eventos adversos intraoperatorios y relacionados con el dispositivo y morbilidad a 30 días. Para la evaluación de la eficacia, la finalización exitosa de los pasos predefinidos sin conversión.RESULTADOS:Se analizaron treinta pacientes (13 mujeres, 17 hombres). La edad media fue 59,4 (DE 13,4) años. El 70% (n=21) tenía sobrepeso/obesidad y el 53,3% (n=16) había tenido cirugía abdominal previa. El 40% tenía enfermedad maligna y el 60% benigna. Los casos fueron 15 colectomías derechas y 15 izquierdas. La mediana del tiempo operatorio general fue de 146 (rango, 80-309) minutos; 70 (rango, 34-174) minutos fue el tiempo de consola. No hubo conversiones a cirugía abierta ni eventos adversos intraoperatorios o relacionados con el dispositivo. En el 100% (n=30), se completó la disección primaria y se mantuvo la hemostasia con el novedoso dispositivo de cirugía asistida por robot miniaturizado. La tasa de morbilidad menor fue de un 26,7% y mayor un 3,3%. La mediana de estadía fue de 2 días. No hubo mortalidad.LIMITACIONES:Estudio de un solo brazo, corto plazo de seguimiento.CONCLUSIONES:Este primer estudio clínico de un novedoso dispositivo de cirugía asistida por robot miniaturizado según el marco IDEAL demostró que era seguro y eficaz. Dado este éxito, se planean evaluaciones adicionales y seguimiento a largo plazo del dispositivo de cirugía asistida por robot miniaturizado para comparar la efectividad clínica y económica en la cirugía colorrectal. (Traducción-Dr. Felipe Bellolio ).

A sutureless overlapped anastomosis technique using linear staplers with reinforced bioabsorbable material in robotic right colectomy with intracorporeal anastomosis.

AIM: Creation of an overlapped anastomosis using handsewn sutures for common enterotomy is very popular in robotic right colectomy (RRC) with intracorpareal anastomosis (IA). The aim of this study is to present a simple method for constructing a sutureless overlapped anastomosis using a 60 mm linear stapler with a reinforced bioabsorbable material in RRC with IA. METHOD: The distal ileum and proximal colon were put in overlapping positions. Enterotomies were created 2 cm proximal to the ileal stump and 8 cm distal to the colonic stump on the antimesenteric side. Subsequently, a 60 mm linear stapler with a reinforced bioabsorbable material was inserted into each lumen and fired. Finally, the bowel was elevated while holding the bioabsorbable material, and the common enterotomy was grasped with the robotic instrument in the middle and closed using a linear stapler with a reinforced bioabsorbable material. RESULTS: This technique was applied to 10 patients with tumours of the caecum, ascending colon, or transverse colon. The median operating time, anastomosis construction time, blood loss, and postoperative stay were 281 min (range 228-459 min), 12 min (range 11-17 min), 10 mL (range 0-110 mL), and 10 days (range 8-15 days), respectively. No adverse intraoperative events were observed. Postoperatively, one patient developed chylous ascites, but there were no other complications. CONCLUSION: The simple technique for constructing a sutureless overlapped anastomosis using a 60 mm linear stapler with a reinforced bioabsorbable material in robotic right colectomy with intracorporeal anastomosis appears to be safe and feasible.

Intracorporeal antimesenteric ancillary trocar: an anastomotic technique facilitating natural orifice specimen extraction in left-sided colorectal surgery.

AIM: Natural orifice specimen extraction (NOSE) in left-sided colorectal surgery requires application of the circular stapler anvil to the proximal bowel without exteriorization through an additional abdominal incision. We describe an intracorporeal method to secure the stapler anvil, termed the intracorporeal antimesenteric ancillary trocar (IAAT) technique. METHOD: The ancillary trocar is attached to the stapler anvil before introduction into the abdominal cavity through the anal or vaginal orifice. The colon is incised before the trocar spike is brought out through the antimesenteric surface 3-4 cm within the cut edge. A linear stapler is used to seal the bowel end. The ancillary trocar is detached and retrieved via the NOSE conduit. Following the NOSE procedure, a side-to-end colorectal anastomosis is performed with the transanal circular stapler. RESULTS: Ten consecutive patients underwent elective left-sided colorectal resection with IAAT for NOSE (seven transanal, three transvaginal) from January to June 2023. Median age and body mass index were 66 (range 47-74) years and 24.3 (range 17.9-30.8) kg/m2 respectively. Two (20%) patients underwent sigmoid colectomy for sigmoid volvulus while eight (80%) underwent anterior resection for colorectal cancer. Median operating time, operative blood loss and postoperative length of hospital stay were 170 (range 140-240) min, 20 (range 10-40) mL and 1 (range 1-3) day respectively. There were no postoperative complications, readmissions or reoperations. Median follow-up duration was 3 (range 1-6) months. CONCLUSION: The IAAT double-stapling side-to-end anastomotic technique is safe and feasible for patients undergoing left-sided colorectal resection with NOSE, resulting in good outcomes.

Initial Outcomes of a Novel Irrigating Wound Protector for Reducing the Risk of Surgical Site Infection in Elective Colectomies.

BACKGROUND: Surgical site infection (SSI) rates in elective colorectal surgery remain high due to intraoperative exposure of colonic bacteria at the surgical site. We aimed to evaluate 30-day SSI outcomes of a novel wound retractor that combines barrier protection with continuous wound irrigation in elective colorectal resection. MATERIALS AND METHODS: A retrospective single-center cohort-matched analysis included all patients undergoing elective colorectal resection utilizing the novel irrigating wound protector (IWP) from April 2015 to July 2019. A control cohort of patients who underwent the same procedures with a standard wound protector over the same time period were also identified. Patients from both groups were matched for procedure type, procedure approach, pathology requiring operation, age, sex, race, body mass index, diabetes, smoker status, hypertension, presence of disseminated cancer, current steroid or immunosuppressant use, wound classification, and American Society of Anesthesiologist classification. SSI frequency, SSI subtype (superficial, deep, or organ space), hospital length of stay (LOS) and associated procedure were tabulated through 30 postoperative days. Fisher's exact test and number needed to treat (NNT) were used to compare SSI rates and estimate cost between both groups. RESULTS: The IWP group had 41 patients. The control group had 82 patients. Control-matched variables were similar for both groups. 30-day SSI rates were significantly lower in the IWP group (P=0.0298). length of stay was significantly shorter in the IWP group (P=0.0150). The NNT for the IWP to prevent one episode of SSI was 8.2 patients. CONCLUSIONS: The novel IWP device shows promise to reducing the risk of SSI in elective colorectal surgery.

Single-incision plus two-port robotic surgery for sigmoid colon cancer using the Senhance robotic system.

Informed by our experiences with reduced-port surgery for colorectal cancer, we performed the first single-incision plus two-port robotic sigmoidectomy for cancer with the Senhance robotic system. A 70-year-old woman presented to our department for the treatment of sigmoid colon cancer. We performed single-incision two-port robotic sigmoidectomy. A wound protector was inserted through a 3.0-cm transumbilical incision, a multiport access device was mounted on top of it, and then a camera port and a 5-mm assistant's port were placed in the multiport access device. Two extra ports were placed on the central line of the abdomen. Lymph node dissection around the inferior mesenteric artery and mobilization of the left-sided colon were completed without any perioperative complications. The total operative time was 204 minutes, and the console time was 113 minutes. The estimated blood loss was 75 mL. The patient was discharged on postoperative day 8 without any complications.

The impact of the AirSeal® valve-less trocar system in robotic colorectal surgery: a single-surgeon retrospective review.

BACKGROUND: Traditional trocar systems suffer from several innate flaws due to their silicone seal design. The AirSeal® is a valve-less trocar system that overcomes these flaws by utilizing a system of laminar flow and CO2 recirculation. The purpose of this paper is to examine the effect of the AirSeal® versus a traditional trocar system in operative time, EBL and post-operative complications. To the best of our knowledge, this is the first analysis of this system in robotic colorectal surgery. METHODS: A single surgeon's database was reviewed and all LAR and right hemicolectomy robotic cases from 2014-2015 and 2017-2018 were included for analysis. Patient demographic information was evaluated and primary outcomes examined were operative time, EBL, post-operative complications and hospital LOS. RESULTS: Ninety four patients were identified in the LAR cohort and 56 patients were identified in the right hemicolectomy cohort. Mean operative time for LAR was 293 ± 91.6 min in 2014-2015 and 232 ± 74.6 min in 2017-2018 (p = 0.001); however, this significant difference was not seen between right hemicolectomies. Mean EBL for LAR was 209 ± 189 cc in 2014-2015 and 150 ± 173.9 cc in 2017-2018 (p = 0.05); again, this significant difference was not appreciated for right hemicolectomies. There was no statistically significant difference in rates of wound infections, pneumonia, post-operative pneumonia, DVT/PE, intra-abdominal/pelvic abscesses, or unplanned 30-day readmission rate between 2014-2015 and 2017-2018. Length of stay was reduced in both populations between 2014-2015 and 2017-2018; however, it neither reached statistical significance. CONCLUSION: In patients undergoing low anterior resections, the AirSeal® trocar system demonstrated a statistically significant reduction in mean operative time and EBL compared to the traditional trocar system. There was also a trend towards decreased length of stay and post-operative complications with AirSeal® use in low anterior resections and right hemicolectomies. In patients undergoing distal colorectal procedures, the AirSeal® trocar system should be considered.

Assessment of a circular powered stapler for creation of anastomosis in left-sided colorectal surgery: A prospective cohort study.

BACKGROUND: Circular staplers perform a critical function for creation of anastomoses in colorectal surgeries. Powered stapling systems allow for reduced force required by surgeons to fire the device and may provide advantages for creating a secure anastomosis. The objective of this study was to evaluate the clinical performance of a novel circular powered stapler in a post-market setting, during left-sided colectomy procedures. MATERIALS AND METHODS: Consecutive subjects underwent left-sided colorectal resections that included anastomosis performed with the ECHELON CIRCULAR™ Powered Stapler (ECP). The primary endpoint was the frequency in which a stapler performance issue was observed. Secondary endpoints included evaluation of ease of use of the device via a surgeon satisfaction questionnaire, and monitoring/recording of procedure-related adverse events (AEs). RESULTS: A total of 168 anastomoses were performed with the ECP. Surgical approaches included robotic-assisted (n = 74, 44.0%), laparoscopic (n = 71, 42.3%), open (n = 20, 11.9%), and hand-assisted minimally invasive (n = 3, 1.8%) procedures. There were 22 occurrences of device performance issues in 20 (11.9%) subjects during surgery. No positive intraoperative leak tests were observed, and only 1 issue was related to a procedure-related AE or surgical complication, which was an instance of incomplete surgical donut necessitating re-anastomosis. Postoperative anastomotic leaks were experienced in 4 (2.4%) subjects. Clavien-Dindo classification of all AEs indicated that 92.0% were Grades I or II. Participating surgeons rated the ECP as easier to use compared to previously used manual circular staplers in 85.7% of procedures. CONCLUSION: The circular powered stapler exhibited few clinically relevant performance issues, an overall favorable safety profile, and ease of use for creation of left-sided colon anastomoses.

[Total laparoscopic left colectomy intracorporeal anastomosis].

Laparoscopic left colectomy (LLC) has been widely performed for treating patients with left hemicolon cancer. For less invasion, totally laparoscopic left colectomy intracorporeal anastomosis (TLC/IA) has been increasingly attempted and proposed. Up to now, there is no standard for intracorporeal anastomosis. Authors list various types of intracorporeal anastomosis in terms of technical details and postoperative complications. According to the literatures, side to side anastomosis with linear laparoscopic stapler is the mainstream method. Surgeons should make flexible choices based on personal technical characteristics, colon conditions and objective economic conditions of patients. An individualized anastomosis method is acceptable.

Multiquadrant surgery in the robotic era: a technical description and outcomes for da Vinci Xi robotic subtotal colectomy and total proctocolectomy.

BACKGROUND: Common colorectal procedures that require access to all quadrants of the abdomen are subtotal colectomy (STC) and total proctocolectomy (TPC). These are frequently performed with a surgical robot, but multiquadrant operations have unique challenges during robot-assisted surgery. METHODS: Patients who underwent robotic STC or TPC with the da Vinci Xi surgical robot at our institution from July 1, 2016 through June 30, 2019 were identified by diagnosis and procedure codes. A technical description is provided for the techniques utilized at our institution. Outcomes included operative times (OT), supply cost and length of stay. Associated morbidity and mortality was also analyzed. RESULTS: From a review of our institution's robotic surgery data, 37 cases were identified that utilized the described technique. Of these cases, 21 were robotic STC and 16 were TPC. Total mean OT was 276.86 min (SD ± 119.49). Mean OT was further analyzed by year, which demonstrated an overall decrease in OT from 350.91 min (SD ± 46.38) in 2016 to 221.43 min (SD ± 16.46) in 2018 (p = 0.008). A total of 21 cases were performed prior to 2018. Overall OT for STC was 222.81 min (SD ± 14.54) compared to overall TPC OT 347.81 min (SD ± 34.35). Median length of stay was 5 days [25th and 75th percentiles 4, 6, respectively]. There was no 30-day mortality and only one return to operating room for mesenteric bleeding. There was a low risk of mortality associated with this technique. CONCLUSIONS: The current study provides the largest cohort of patients assessed who have undergone multiquadrant robotic STC or TPC. The study provides a detailed description of the technique utilized at our institution. There was no associated 30-day mortality and a low risk of morbidity. The data suggest that the learning curve for improved operative time is between 15 and 20 cases.

Evaluation of a Novel Trocar-Site Closure Device in Laparoscopic Surgery.

BACKGROUND AND OBJECTIVES: We evaluated the effectiveness and safety of EZ-CloseTM compared to those of hand suture for trocar-site closure according to obesity. METHODS: Fifty-four cases of laparoscopic colorectal surgery were enrolled. For the same patient, the right port site was closed using EZ-CloseTM and left port site was closed by hand suture among cases with port-site diameter ≥10 mm. Cases switched to use of a conventional fascial closure device or with closure time 120 s were considered failures. Closure time was analyzed according to body mass index (BMI) and abdominal wall thickness (AWT). RESULTS: The mean closure time was significantly shorter with EZ-CloseTM than with hand suture (87.9 ± 21.0 vs. 128.0 ± 59.0 s, p < 0.001). The number of failure cases was significantly lower with EZ-CloseTM than with hand suture (7 vs. 27, p < 0.001). The closure time of EZ-CloseTM was significantly shorter than that of hand suture in patients with BMI ≥ 25 and < 27 kg/m2 (n = 15, 85.9 ± 19.8 vs. 135.6 ± 67.9 s, p < 0.014) and ≥ 27 kg/m2 (n = 13, 85.1 ± 18.4 vs. 150.2 ± 70.6 s, p < 0.010). With respect to AWT, the closure time of EZ-CloseTM was significantly shorter than that of hand suture in patients with AWT ≥ 20 and < 26 mm (n = 12, 81.1 ± 11.5 vs. 142.3 ± 83.7 s, p = 0.023) and ≥ 26 mm (n = 17, 85.6 ± 22.6 vs. 160.2 ± 55.5, p < 0.001). No infection and herniation were detected in both trocar sites during the follow-up period (median 20.4 months). CONCLUSION: EZ-CloseTM could provide time efficiency in trocar-site closure, especially in obese patients.

Use of Robotic Technology in the Management of Complex Colorectal Pathology.

Use of robotic surgery is increasing in multiple surgical specialties including colorectal. We argue that the improved visualization and better instrumentation outweigh the increased cost and operating room time. However, the indications for its use are not clearly defined. This is especially true in complex pathologies such as rectal cancer and complicated diverticulitis. We explore the limited clinical data on the subject to support or dismiss the use of this currently developing technology.

The "Micro Hand S" Robot-Assisted Versus Conventional Laparoscopic Right Colectomy: Short-Term Outcomes at a Single Center.

Objective: To evaluate the safety and feasibility of using the Micro Hand S surgical robot for right colectomy by comparing the short-term efficacy of robot-assisted and laparoscopic right colectomy (LRC). Methods: Data from a total of 22 patients who underwent right colectomy from January 2018 to February 2019 in the Department of Gastrointestinal Surgery, in the Third Xiangya Hospital of Central South University, were collected retrospectively. This included 10 patients who underwent robot-assisted right colectomy with the Micro Hand S surgical robot (RRC group [Shangdong Wego Surgical Robot Co., LTD, Weihai, China]) and 12 patients who underwent LRC group. The operation time, blood loss, number of lymph nodes dissected, time to first flatus, comprehensive complication index (CCI), and postoperative hospital stay were compared. Results: Compared with the LRC group, the RRC group had a lower CCI (11.7 ± 8.3 versus 19.9 ± 6.4, P < .05), shorter hospital stay (11.4 ± 3.3 versus 15.2 ± 4.7 days, P < .05). The differences were statistically significant. Conclusion: The Micro Hand S robot-assisted right colectomy is safe and feasible.

Transanal hybrid colon resection: techniques and outcomes for benign colorectal diseases.

BACKGROUND: Transanal hybrid rectal and colon resection have been introduced in recent years at dedicated surgical centers. The anus is used as a natural orifice for large size access. The use of transanal hybrid colectomy techniques is still in its infancy with outcomes and unique complications being identified. The purpose of this work is the evaluation of outcomes for transanal hybrid colon resections (ta-CR), including intra operative and postoperative complications, results, and advantages. METHODS: A prospectively maintained database was analyzed. Inclusion criteria were any patient who underwent ta-CR for rectal prolapse, slow transit, obstructive defaecation, and chronic sigmoid diverticulitis. Patients were excluded from ta-CR if BMI > 30, major previous abdominal surgery, or presence of a large inflammatory mass in diverticulitis. Transanal access was used for all operative steps requiring access of more than 5 mm, such as staplers, large graspers, and specimen retrieval. Data acquisition and analysis was performed for operative time, complications, and postoperative quality of life. RESULTS: From 2012 to 2017, 82 patients underwent ta-CR [33 males, 49 females, median age 58 (24-80)]. Transanal-subtotal colectomy and ta-CR for constipation was performed in 12 patients; ta-CR and rectopexy in 31, and ta-CR for diverticulitis was performed in 39 patients. Conversion to traditional approach was required in 3 cases (3.6%). Intraoperative complication included 1 rectal tear requiring intervention. Post-op complications included 3 leaks requiring laparoscopic and 1 open revision, the latter developed wound infection and an incisional hernia. Gastrointestinal Quality of Life Index (GIQLI) improved significantly from preoperative 89 to postoperative 119 (p < 0.001). No patients with ta-CR without open revision developed a hernia post-op with median 18 months follow-up. CONCLUSIONS: ta-CR is a safe and effective NOTES Hybrid technique for colorectal procedures in selected patients with benign colon disorders. GIQLI shows improvement and this technique can have the potential in preventing wound and hernia complications.