Exploring robotic total hysterectomies: a multi-site experience with the Senhance Surgical System.

Robotic-assisted surgery emerged as a technological advancement in the twentieth century, with gynaecology being a key adopter of this approach. The Senhance Surgical System has gained prominence for total hysterectomies from single-site experiences, but multi-site reporting are still lacking in present literature. This multi-site study, conducted at Klaipeda University Hospital and Academic Teaching Hospital Feldkirch, aimed to explore the safety and feasibility of total hysterectomies with the Senhance Surgical System. The study involved 295 cases, showcasing a well-established routine with minimal procedure times. The average age of the patients was 53.5 years (SD: 10.3 years), ranging from 18 to 80 years. The patients' BMI averaged 25.6 kg/m2 (SD: 6.2 kg/m2), ranging from a minimum of 17.7 kg/m2 to a maximum of 69.5 kg/m2. The duration of surgery varied between 30 and 215 min, with a median of 95 min (IQR: 81-116). The docking time was a median of 3 (IQR: 2-5) min and varied between 1.0 and 30.0 min, with a minimum to a maximum range of 1.0 to 122 min. Conversion (3 cases, 1%) and adverse events (6 cases, 2%) were infrequent. Additionally, robotic malfunctions were recorded minimally in 4,1% (12 cases) of the procedures, and pain on a 0-10 visual pain scale was reduced from mild [2.7 (± 1.2)] one day postoperative to minimal [0.9 (± 0.5)] at discharge. Overall, a great routine with the Senhance Surgical System proves good control and, thus, feasibility and safety. Therefore, the Senhance Surgical System is a viable option for total hysterectomy.

Robotic-assisted radical prostatectomy: a multicenter experience with the Senhance Surgical System.

PURPOSE: Robotic-assisted surgery for radical prostatectomy is becoming a standard treatment, and respective implementations are expanding. The Senhance Surgical System is a robotic system with existing but limited data on radical prostatectomy, including a lack of multicenter study experiences. The TRUST study aims to fill this gap and explores observations for radical prostatectomy with the Senhance Surgical System. METHODS: Between August 2019 and November 2022, 375 patients met inclusion criteria from two European sites. Patients' surgical procedure times, data on conversion, malfunction, adverse events, and pain scores were registered and evaluated. Outcomes were calculated for both sides, combined as a total and compared between the initial (1st-150th case) and later (> 150th case) period. RESULTS: The median operating time was 190 min (IQR: 167.5-215.0) and the median docking time was 3 min (IQR: 2.0-5.0). Eighteen cases (4.8%) were converted to standard laparoscopy and two (0.5%) to open. Two perioperative (0.5%) and eleven postoperative adverse events (2.9%) occurred, mostly (83.3%) categorized as mild. Pain scores were reduced from an average of 3.4 (± 1.4) on the postoperative day to 0.9 (± 0.7) at discharge. Compared to our previous data and based on a comparison between our initial and later period, operating time seems to plateau. However, docking time, complication, and conversion rates were successfully reduced. CONCLUSION: We demonstrate progressing safety and efficiency for robotic-assisted radical prostatectomy with the Senhance Surgical System.

Learning curves and procedural times in Senhance®-robotic assisted fundoplication: results from 237 consecutive patients undergoing robotic fundoplication in a single center as part of the European TRUST Robotic Surgery Registry Study.

BACKGROUND: Gastroesophageal reflux disease requiring an operative solution is common. Minimally invasive surgery to generate an anti-reflux barrier at the distal esophagus following the principle of the "floppy Nissen" technique has become the gold standard. Advanced robotic-assisted systems may deliver more consisted outcomes. METHODS: This registry study analyzed safety and efficacy of the Senhance® surgical system in the surgical treatment of reflux disease and procedural proficiency. Data from 237 consecutive patients operated in a single center were evaluated. Historic standard laparoscopies from the same center were analyzed to compare robotic surgery learning curve effects. RESULTS: Using the Senhance® Surgical System, during the first 50 patients there was a significant decrease in surgery time which was maintained over the duration of study, pointing to the surgical staff's system-specific learning. After this phase, procedural times were comparable between the robotic-assisted and traditional laparoscopic surgery. The effect of learning was greater than for standard laparoscopy. For 237 patients, there were four conversions to laparoscopic surgery. Two serious adverse events were recorded, both cardiac in nature and not related to the use of the robot. CONCLUSIONS: Robotic fundoplication was swiftly implemented in a non-university hospital with 65 surgical beds. The operating time was no longer than in standard laparoscopy, the procedure was more standardized than open or laparoscopic surgery and hospitalization times may have been sustainably shortened. The autonomy at the system's digital platform (cockpit) to conduct robotic fundoplications is a big step forward in surgery.

Safety in Senhance™ Robotic Gastrointestinal Surgery in 530 Patients.

The Senhance Robotic System™ (Asensus Surgical, Durham, NC, USA) has been used in abdominal surgery since 2016, and provides an eye-tracker for camera movement and haptic tactile feedback. Safety aspects are very important in robotic surgery, such as regarding the presence of system malfunctions and surgical outcomes. The data for robotic function in gastrointestinal surgical procedures in 530 patients (colorectal surgery, fundoplication, others) were prospectively listed in the TRUST registry after informed patient consent in three German gastrointestinal surgery centers (center A, N = 46 patients; center B, N = 457; center C, N =27). Adverse events were noted in 14.3% (76/530 patients) of the overall surgeries, with an equal distribution among the procedures. Robotic malfunctions, such as console/camera/arm malfunctions, collisions, or limited motion, were experienced in 5.5 % (29/530 patients), with some differences among the centers (A, 0.0%; B, 4.2%; C, 37%). These differences were explained in terms of team experience and case load. In conclusion, the Senhance™ Robotic System can be safely applied to routine abdominal surgery procedures.

Single-Center Results of Colorectal Procedures Performed with Fully Articulated Laparoscopic Artisential® Devices.

INTRODUCTION: The ArtiSential® line of products from LivsMed (Seongnam, Republic of Korea) are fully articulated hand-held laparoscopic instruments, possessing end-effectors that closely imitate those of surgical robots with regard to shape and dexterity. Feasibility and safety studies describing the initial experiences with these devices in upper and lower gastrointestinal as well as thoracic surgery have been published. This report presents the outcomes of the largest cohort to date of colorectal procedures performed with Artisential® instruments in a single center. MATERIALS AND METHODS: Between September 2020 and May 2022, prospective data were collected from patients undergoing ArtiSential®-assisted laparoscopic surgery. A retrospective data analysis was performed for all patients who underwent ArtiSential®-assisted surgery for colorectal indication. Indications for colorectal surgery included rectal and colon cancer, complicated diverticular disease, inflammatory bowel disease, obstructed defecation syndrome, endoscopically nonresectable adenomas and chronic anastomotic fistula following a low anterior resection (LAR). RESULTS: A total of 73 patients (49 males, 24 females) underwent Artisential®-assisted colorectal surgery. The median age of the patients was 62 years (range 34-88) and the median body mass index (BMI) was 27 kg/m2 (range 19-51). Indications for surgery were colorectal malignancy (n=55, 75%), complicated diverticular disease (n=11, 15%), obstructed defecation syndrome (n=3, 4.1%), inflammatory bowel disease (n=2, 2.7%), endoscopically nonresectable adenomas (n=1, 1.4%) and chronic anastomotic fistula following LAR (n=1, 1.4%). The median operative time was 240 minutes (range 95-458). There were no conversions to standard straight-stick laparoscopy or to laparotomy, and no intraoperative complications. All patients who were operated upon for colorectal malignancy had an adequate oncological resection (R0=100%). The median length of stay was 7 days (range 3-36). The overall complication rate was 10.9 % (Clavien-Dindo II: 1 patient, Clavien-Dindo IIIb: 7 patients). There were two readmissions, one unrelated, and no mortalities. CONCLUSIONS: This larger series confirms the results of previous reports on the safety and feasibility of Artisential® use in complex laparoscopic colorectal surgery. To examine potential benefits in outcome, comparative studies involving Artisential®, robotic-assisted and standard laparoscopic surgery are needed.

Pneumoretroperitoneum after a STARR Procedure Performed One Year after a Posterior Colporrhaphy: A Case Report and Review of the Literature.

Transanal rectal resection with a stapling instrument (STARR) has been shown to be effective and safe for the treatment of obstructed defecation syndrome (ODS). Nevertheless, the wide range of complications described in the literature necessitates a rigorous patient selection and a tailored approach for the management of complications. We present here a case of pneumoretroperitoneum which occurred after a STARR procedure for ODS was performed nearly a year after previous anterior and posterior colporrhaphy. The diagnostic workup did not reveal a staple-line defect. Laparoscopy did not show any intra-abdominal pathology. The symptoms resolved under oral antibiotics. The patient was discharged on day 10 after admission. Scarring in the rectovaginal septum from a colporrhaphy 1 year earlier might have contributed to a suboptimal staple-line closure during the STARR procedure, leading to a pneumoretroperitoneum. We discuss this complication and provide a brief review of the literature.

The Artisential® Articulated Laparoscopic Forceps: A Dry Lab Study to Examine Dexterity and Learning Effects in Operators with Different Levels of Laparoscopic Experience.

PURPOSE: The advent of robotic surgery has highlighted the advantages of articulation. This dry-lab study examined the dexterity and learning effect of a new articulated laparoscopic instrument: the ArtiSential® forceps (LIVSMED, Seongnam, Republic of Korea). METHODS: A peg board task was designed. Three groups of volunteers with varying levels of laparoscopic expertise were organized to perform the task: expert, intermediate and novice. The participants performed the task using articulated and straight instruments, once before a 30-min training session and once afterwards. The times required to perform the task were recorded. The performances were analyzed and compared between the groups as well as between the straight and articulated instruments. RESULTS: The experts were significantly faster than the novices with both instruments before the 30-min training session (p = 0.0317 for each instrument). No significant time difference was found among the three groups after the 30-min training session. The decrease in the time required to perform the peg-transfer task with the articulated instrument was significantly greater in the novice and intermediate groups (p = 0.0159 for each group). No significant difference in time reduction was observed between the groups with the straight instrument. Regardless of the user, the articulated device was associated with faster task performance than the straight device after 8 hours of training (p = 0.0039). CONCLUSION: The ArtiSential® articulated device can improve dexterity. A significantly greater learning effect was observed in the novice and intermediate groups in comparison with experts. A plateau in the learning curve was observed after a few hours of training.

The TransEnterix European Patient Registry for Robotic-Assisted Laparoscopic Procedures in Urology, Abdominal, Thoracic, and Gynecologic Surgery ("TRUST").

INTRODUCTION: Robotic surgery was first introduced in the mid-1980s, and at the end of the '90s, the da Vinci® System (Intuitive Surgical Inc., Sunnyvale, California) was introduced in Europe and held a monopoly for years afterward. In 2016, Senhance™ digital laparoscopic platform (TransEnterix Inc., Morrisville, North Carolina) came to the market. This new platform is based on laparoscopic movements and is designed for laparoscopic surgeons. This study shows the surgical outcomes of patients after different visceral, colorectal, gynecological, and urological surgical procedures done with the Senhance™ digital laparoscopic platform with a focus on safety. MATERIALS AND METHODS: The study population consists of 871 patients who underwent robotic surgery with the Senhance™ platform. The most common procedures were hernia repairs (unilateral and bilateral), cholecystectomies, and prostatectomies. The procedures were performed in five centers in Europe between February 2017 and July 2020 by experienced laparoscopic surgeons. RESULTS: 220 (25.3 %) out of 871 patients had a unilateral hernia repair, 70 (8.0%) a bilateral hernia repair, 159 (18.3%) underwent a cholecystectomy, and 168 (19.3%) a prostatectomy. The other procedures included visceral, colorectal, and gynecological surgery procedures. The median docking time was 7.46 minutes for the four most common procedures. The duration of surgery varied from 32 to 313 minutes, the average time was 114.31 minutes. Adverse events were rare overall. There were 48 (5.5 %) adverse events out of 871 patients, 24 of them (2.8 % of all cases) were severe. Out of all 24 severe adverse events, five events (20.8%) were likely related to the robot, 17 events (70.8%) were unlikely related to the robot, and two events (8.3%) could not be categorized. Regarding complications following unilateral hernia repairs, data from 212 patients was available. Thirteen (6.1%) complications occurred, and six of those (2.8%) were serious. Out of 68 patients with a bilateral hernia repair, six patients (8.8%) developed complications, three of which were severe (4.4%). The complication rate was 2.8% in the patients following a cholecystectomy (4/144); two of them serious. After prostatectomy, six out of 141 patients (4.3 %) had complications; one serious (0.7%) No mortality was observed. Data about unplanned conversions to laparoscopic surgery could be collected from 761 patients which is a rate of 3.7%. There were 12 conversions out of 760 procedures to open surgery (1.6%). CONCLUSIONS: Our series shows these procedures are safe and reproducible. The findings suggest that the surgical results after robotic surgery with the Senhance™ system are promising. Long-term data regarding complication rates should be the subject of future studies.

Prevention of Fascial Retraction in the Open Abdomen with a Novel Device.

The open abdomen requires intensive and specific treatment efforts. Long hospital admissions, treatment duration, high mortality rates, deferred and delayed wound closures with alloplastic materials or elaborate closure techniques, and the need for subsequent surgical procedures justify and call for implementation of new therapy options. The case presented here demonstrates the use of a new product (Fasciotens Abdomen) to prevent fascial retraction in the open abdomen of an extubated, conscious patient with four-quadrant peritonitis after perforated appendicitis. Controlled, anteriorly directed fascial traction of 50-60 Newtons prevented fascial retraction during open treatment of the abdomen. Once edema was reduced, abdominal closure was completed without difficulty. This new form of therapy was well tolerated by the patient and led to a markedly more rapid abdominal closure without mesh or abdominal wall reconstruction.

First Clinical Use of 5 mm Articulating Instruments with the Senhance® Robotic System.

INTRODUCTION: While the well-known DaVinci ® robotic system (Intuitive Surgical, Inc., Sunnyvale, CA) uses 8 mm articulated instruments, the Senhance ® robotic system (TransEnterix, Morrisville, NC), available since 2016, uses 5 mm instruments, which is the standard size in laparoscopy. We report here the first 43 procedures using 5 mm articulating instruments with the Senhance ® system (TransEnterix). METHODS: From September 9, 2019, to January 15, 2020, we performed 43 various robotic-assisted abdominal procedures. Before the first clinical intervention, the surgeons and surgical nurses were trained in the handling and operation of the articulating instruments. The main procedure was Inguinal Hernia Repair with the TAPP technique. We performed the operations with a 5 mm articulating bipolar forceps and a 5 mm articulating needle holder. In all cases, the Senhance ® (TransEnterix) articulating instruments were inserted through a 5 or 10 mm trocar, connected to the robotic arm and used for tissue dissection (inguinal hernia repair, cholecystectomy, and sigmoid resection) on the left hand of the robot arm and for suturing (inguinal hernia repair) on the right hand of the robot arm. RESULTS AND DISCUSSION: We observed technical issues in three patients: two resulted from user error and one occurred due to a software update. No technical issues were observed in the remaining 40 cases. There were two unscheduled conversions to laparoscopic surgery and no conversions to open surgery. No case of damage to surrounding tissue was observed. In one case, the branches of the grasper were jammed due to severe clot buildup after extensive coagulation following a strong bleed. After unproblematic laparoscopic bleeding control, robotic surgery was continued. There were no further intraoperative or early postoperative complications. The first impression of the participating surgeons and surgical nurses was that the smaller instruments were easy to handle after special training and offered a wider range of movement within the surgical field. All of the surgeons involved saw advantages with the use of 5 mm articulating instruments. CONCLUSION: Senhance ® (TransEnterix) 5 mm articulating instruments are technically stable and can be safely used in various abdominal procedures. The initial results suggest that these 5 mm articulating instruments can be a supportive tool in further robotic surgery, providing advantages in suturing and dissection with less risk of injury to surrounding tissue.

Robotic-Assisted Nissen Fundoplication with the Senhance® Surgical System: Technical Aspects and Early Results.

INTRODUCTION: Robotic-assisted surgery continues to evolve. Technical advantages are reported for intracorporal suturing, a technique with a long learning curve in conventional laparoscopy. The success of laparoscopic fundoplication relies on precise suturing at the hiatus and of the fundal wrap. Therefore, robotic assistance can be a useful tool for this particular procedure. In March 2017, the Senhance® Surgical System (Transenterix, Inc., Morrisville, North Carolina) was introduced into robotic-assisted procedures at the St. Marien-Krankenhaus, Siegen, Germany. MATERIALS AND METHODS: Between March 2017 and July 2019, we performed 36 surgeries of the upper GI tract with the Senhance® Surgical System. Eighteen patients underwent the classic Nissen fundoplication and are the subject of this study. All patients gave informed consent for robotic assistance with prospective data acquisition and analysis. RESULTS: Seven male and 11 female patients were included in the study. The median age of the cohort was 58.5 years (range 30-81 years) and the median body mass index (BMI) was 30.4 kg/m2 (range 22.7-40.1 kg/m2). The median total operative time was 95.5 minutes (range 68-194 minutes) and, despite the small sample size, we observed a significant learning curve throughout the study period (p<0.05). Before the introduction of the Senhance® Ultrasonic energy device, conversion to laparoscopic fundoplication was necessary in two patients. We performed one re-do laparoscopy on the day of surgery due to pain without any significant intraoperative findings and one laparoscopic revision to Toupet fundoplication after seven months due to dysphagia. CONCLUSION: This first report of robotic-assisted Nissen fundoplication with the Senhance® Surgical System demonstrates technical feasibility. After successful introduction of the Senhance® Ultrasonic, our conversion rate to standard laparoscopic surgery was significantly reduced.

Spectrophotometric assessment of bowel perfusion during low anterior resection: a prospective study.

Good perfusion of the bowel and a tension-free anastomosis are the two main prerequisites for an uneventful anastomotic healing in rectal surgery. This prospective cohort study investigates the noninvasive intraoperative spectrophotometric assessment of the bowel perfusion using a device called "Oxygen to See" (O2C®). Forty patients, planned for low anterior resection, were prospectively enrolled in this study to undergo an intraoperative spectrophotometric assessment of the bowel. Three different O2C® parameters were collected from the colonic and the rectal stumps before fashioning the anastomosis: SO2 (capillary venous oxygen saturation), rHb (relative hemoglobin amount), and flow (blood flow velocity). Bowel perfusion was also assessed with the cold-steel-test (CST), which involves severing the colic marginal artery of Drummond at the tip of the colon stump. The data collected from the spectrophotometric measurement and the CST were analyzed for correlation of both methods with respect to each other and to the outcome of the anastomosis. Nine patients were excluded due to different reasons, thus leaving 31 patients for statistical analysis. Three flow parameters collected at the colonic stump significantly predicted an anastomotic leak (p: 0.0057; p: 0.0250; p: 0.0404). One rHb parameter collected at the rectal stump correlated weakly with the anastomotic outcome (p: 0.0768). The CST did not correlate significantly with anastomotic leak (p: 0.1195), but showed significant correlations to some rHb values. Intraoperative noninvasive spectrophotometric measurement is feasible and could be a useful method in assessing bowel perfusion before fashioning a colorectal anastomosis.

Robotic Inguinal Hernia Repair (TAPP) First Experience with the New Senhance Robotic System.

INTRODUCTION: This retrospective study was performed to evaluate the safety and feasibility of the new Senhance Robotic System (TransEnterix Inc., Morrisville, North Carolina) for inguinal hernia repairs using the transabdominal preperitoneal approach. MATERIALS AND METHODS: From March to September 2017, 76 inguinal hernia repairs in 64 patients were performed using the Senhance Robotic System. Patients were between 18 and 90 years of age, eligible for a laparoscopic procedure with general anesthesia, had no life-threatening disease with a life expectancy of less than 12 months, and a body mass index (BMI) < 35. A retrospective chart review was performed for a variety of pre-, peri-, and postoperative data including, but not limited to, patient demographics, hernia characteristics, and intraoperative and postoperative complications. RESULTS: Fifty-four male and 10 female patients were included in the study. Median age was 56.5 years (range 22-86 years), and median BMI was 25.9 kg/m2 (range 19.5-31.8 kg/m2). Median docking time was seven minutes (range 2-21 minutes), and median operative time was 48 minutes (range 18-142 minutes). Two cases were converted to standard laparoscopic surgery due to robot malfunction and abdominal wall bleeding, respectively. Median length of stay was one day. CONCLUSION: We report the first series of laparoscopic inguinal hernia repairs using the new Senhance Robotic System. Compared to conventional laparoscopic transabdominal preperitoneal (TAPP) hernia repairs, there was no significant difference in operative time or perioperative complications. Additionally, there was no significant learning curve detected due to its intuitive applicability. Therefore, the Senhance Robotic System promises broad applicability across a range of laparoscopic general surgical operations.

Baroreceptor Activation Therapy 2 Decades after Vascular Surgery on Both Carotid Arteries in a Patient with Resistant Hypertension: First Case Report in the Literature.

Patients with previous surgery of the carotids or significant stenosis are not included in the study populations of baroreceptor activation therapy (BAT). In this case report about a 78-year-old woman with implantation of a BAT system 2 decades after bilateral thromboendarterectomy, control of hypertensive dysregulation could be observed even 20 months after implantation. Successful modulation of the baroreceptors requires intact adventitial tissue near the carotid sinus. In our case with previous longitudinal incision and patch angioplasty, the nerval innervation had been preserved. After careful evaluation, patients with a history of carotid thromboendarterectomy might be considered for BAT.

First Experiences with the New Senhance® Telerobotic System in Visceral Surgery.

Until recently, robotic-assisted surgery has exclusively been connected to the name DaVinci®. In 2016, a second robotic system, the Senhance®, became available. To introduce the new robotic system into clinical routine, detailed team training and an integration program were useful. Within the first 6 months, 116 cases were performed with this system. The integration program intended to start with simple and well-standardized clinical cases. We chose inguinal hernia repair using the TAPP (transabdominal preperitoneal) technique as the starting procedure. Subsequently, we added upper gastrointestinal surgery and cholecystectomies, and colorectal procedures have since also been included. Initial experience with the Senhance system as the first installation in Germany shows that it is suitable for surgery in general and for visceral surgery in particular. The application is safe due to the unproblematically quick changeover to normal laparoscopy and easy to integrate due to the very short system integration times (docking times). Since it is a laparoscopic-based system, following an integration program will enable experienced laparoscopic surgeons to very quickly manage more complex procedures. Due to lower costs, introducing robotic surgery starting with simple and standardized procedures is more feasible. After the establishment of this second robotic system, future studies will have to specifically look at differences in surgical results and basic conditions of different robotic-assisted systems. This paper documents the decision-making process of a hospital towards the integration of a robotic system and the selection criteria used while also demonstrating the planning and execution process during the introduction of the system into clinical routine.

[Insufficient symptom control under long-term treatment with PPI in GERD - fact or fiction?]. / Unzureichende Symptomkontrolle unter Langzeittherapie mit PPI bei GERD - Fakt oder Fiktion?

BACKGROUND: Randomized controlled trials show that patients with gastroesophageal reflux disease (GERD) and treatment with proton pump inhibitors (PPI) in about 30% of the cases complain about persisting reflux symptoms (heartburn, regurgitation). The aim of the study was to evaluate the efficacy of PPI long-term treatment in patients with GERD in the family doctor's office. METHOD: Patients with GERD and a PPI therapy of at least one year participated in a prospective, multicenter observational study. The patients obtained a questionnaire together with a further prescription of PPI. They were asked about the intensity and frequency of heartburn, regurgitation and sleep disorders due to reflux symptoms, satisfaction with PPI therapy, diagnostics performed up to now (endoscopy, pH monitoring, manometry) and surgical consultation. The questionnaire included a validated instrument for the diagnosis of GERD (GerdQ). Patients with the diagnosis "GERD " according to the questionnaire who were very dissatisfied with their current PPI therapy (score 1 or 2 on a 5-point Likert scale) were defined as "lost patients " (LOPA). RESULTS: 39% of the patients still suffered from heartburn at least two days a week, 30% of regurgitation. In 22% of the patients, reflux symptoms led to sleep disorder at least two days a week. 20% of the patients were very dissatisfied with the current PPI therapy. 70% of them (= 14% of the total patient population) were "lost patients " according to the definition. An endoscopy was performed in 86% of the patients and function diagnosis (pH monitoring ± manometry) in 8%. A surgeon was consulted in 8% of the patients, a third of which had received function diagnosis before. CONCLUSIONS: A poor symptom control can often be found in GERD patients with PPI long-term therapy, but does not stand out in the daily routine. So diagnosis will not continue and treatment alternatives will not be searched for. In the future quality of treatment should be verified e. g. by questionnaires.

Multicenter double-blinded randomized controlled trial of standard abdominal wound edge protection with surgical dressings versus coverage with a sterile circular polyethylene drape for prevention of surgical site infections: a CHIR-Net trial (BaFO; NCT01181206).

OBJECTIVE: To determine whether circular plastic wound edge protectors (CWEPs) significantly reduce the rate of surgical site infections (SSIs) in comparison to standard surgical towels in patients undergoing laparotomy. BACKGROUND: SSIs cause substantial morbidity, prolonged hospitalization, and costs and remain one of the most frequent surgical complications. CWEPs have been proposed as a measure to reduce the incidence of SSIs. METHODS: In this randomized controlled, multicenter, 2-arm, parallel-group design, patient- and observer-blinded trial patients undergoing open elective abdominal surgery were assigned to either intraoperative wound coverage with a CWEP or standard coverage with surgical towels. Primary endpoint was superiority of intervention over control in terms of the incidence of SSIs within a 30-day postoperative period. RESULTS: Between September 2010 and November 2012, 608 patients undergoing laparotomy were randomized at 16 centers across Germany. Three patients in the device group and 11 patients in the control group did not undergo laparotomy. Patients' and procedural characteristics were well balanced between the 2 groups. Forty-eight patients discontinued the study prematurely, mainly because of relaparotomy (control, n=9; intervention, n=9) and death (control, n=4; intervention, n=7). A total of 79 patients experienced SSIs within 30 days of surgery, 27 of 274 (9.9%) in the device group and 52 of 272 (19.1%) in the control group (odds ratio=0.462, 95% confidence interval: 0.281-0.762; P=0.002). Subgroup analyses indicate that the effect could be more pronounced in colorectal surgery, and in clean-contaminated/contaminated surgeries. CONCLUSIONS: Our trial shows that CWEPs are effective at reducing the incidence of SSIs in elective and clean or clean-contaminated open abdominal surgery.

Annexin and survivin in locally advanced rectal cancer: indicators of resistance to preoperative chemoradiotherapy?

BACKGROUND: The aim of preoperative chemoradiotherapy is improvement of local control in patients with locally advanced rectal cancer (LARC). Recent studies have shown that annexin and survivin are involved in the resistance capability of tumours. We sought to determine whether survivin, annexin A4 or annexin A5 expression predict resistance to preoperative chemoradiotherapy. MATERIAL AND METHODS: Biopsies of tumour and normal rectal tissue were taken from 38 patients with LARC (cT3/4Nx or Tx/N+) before the start of chemoradiotherapy and during surgery. mRNA expression of annexin A4/A5 and survivin was measured by real-time polymerase chain reaction (RT-PCR) and correlated with down-staging and progression-free survival (PFS). RESULTS: Significantly higher mRNA levels of survivin, and annexin A4/A5 were detected in untreated tumour compared with normal mucosa. After chemoradiotherapy, this difference disappeared for survivin and annexin A4. Annexin A5 expression in the tumour increased during chemoradiotherapy. No correlation between the mRNA levels of survivin, annexin A4/A5 and tumour down-staging or PFS was noticed. CONCLUSIONS: In the present analysis of 38 patients with LARC undergoing neoadjuvant chemoradiotherapy, the expression levels of survivin and annexin A4 and A5 did not correlate with down-staging. Moreover, with regard to PFS, none of these markers was found to be prognostically relevant.