Pelvic Floor Rehabilitation After Rectal Cancer Surgery: A Multicenter Randomized Clinical Trial (FORCE Trial).

OBJECTIVE: To investigate the effects of PFR after LAR compared to usual care without PFR. SUMMARY OF BACKGROUND DATA: Functional complaints, including fecal incontinence, often occur after LAR for rectal cancer. Controversy exists about the effectiveness of PFR in improving such postoperative functional outcomes. METHODS: This was a multicenter, randomized controlled trial involving 17 Dutch centers. Patients after LAR for rectal cancer were randomly assigned (1:1) to usual care or PFR and stratified by sex and administration of neoadjuvant therapy. Selection was not based on severity of complaints at baseline. Baseline measurements were taken 3 months after surgery without temporary stoma construction or 6 weeks after stoma closure. The primary outcome measure was the change in Wexner incontinence scores 3 months after randomization. Secondary outcomes were fecal incontinence-related quality of life, colorectal-specific quality of life, and the LARS scores. RESULTS: Between October 2017 and March 2020, 128 patients were enrolled and 106 randomly assigned (PFR n = 51, control n = 55); 95 patients (PFR n = 44, control n = 51) were assessable for final analysis. PFR did not lead to larger changes in Wexner incontinence scores in nonselected patients after LAR compared to usual care [PFR: -2.3, 95% confidence interval (CI) -3.3 to -1.4, control: -1.3, 95% CI -2.2 to -0.4, P = 0.13]. However, PFR was associated with less urgency at follow-up (odds ratio 0.22, 95% CI 0.06-0.86). Patients without near-complete incontinence reported larger Wexner score improvements after PFR (PFR: -2.1, 95% CI -3.1 to -1.1, control: -0.7, 95% CI -1.6 to 0.2, P = 0.045). For patients with at least moderate incontinence PFR resulted in relevant improvements in all fecal incontinence-related quality of life domains, while the control group deteriorated. These improvements were even larger when patients with near-complete incontinence were excluded. No serious adverse PFR-related events occurred. CONCLUSION: No benefit was found of PFR in all patients but several subgroups were identified that did benefit from PFR, such as patients with urgency or with at least moderate incontinence and no near-complete incontinence. A selective referral policy (65%-85% of all patients) is suggested to improve postoperative functional outcomes for patients after LAR for rectal cancer. TRIAL REGISTRATION: Netherlands Trial Registration, NTR5469, registered on 3 September 2015.

Impact of Endoscopic Ultrasonography on 18F-FDG-PET/CT Upfront Towards Patient Specific Esophageal Cancer Treatment.

INTRODUCTION: In patients with potentially resectable esophageal cancer (EC), the value of endoscopic ultrasonography (EUS) after fluorine-18 labeled fluorodeoxyglucose positron emission tomography with computed tomography (18F-FDG-PET/CT) is questionable. Retrospectively, we assessed the impact of EUS after PET/CT on the given treatment in EC patients. METHODS: During the period 2009-2015, 318 EC patients were staged as T1-4aN0-3M0 with hybrid 18F-FDG-PET/CT or 18F-FDG-PET with CT and EUS if applicable in a nonspecific order. We determined the impact of EUS on the given treatment in 279 patients who also were staged with EUS. EUS had clinical consequences if it changed curability, extent of radiation fields or lymph node resection (AJCC stations 2-5), and when the performed fine-needle aspiration (FNA) provided conclusive information of suspicious lymph node. RESULTS: EUS had an impact in 80 (28.7%) patients; it changed the radiation field in 63 (22.6%), curability in 5 (1.8%), lymphadenectomy in 48 (17.2%), and FNA was additional in 21 (7.5%). In patients treated with nCRT (n = 194), EUS influenced treatment in 53 (27.3%) patients; in 38 (19.6%) the radiation field changed, in 3 (1.5%) the curability, in 35 (18.0%) the lymphadenectomy, and in 17 (8.8%) FNA was additional. EUS influenced both the extent of radiation field and nodal resection in 31 (16.0%) nCRT patients. CONCLUSIONS: EUS had an impact on the given treatment in approximately 29%. In most patients, the magnitude of EUS found expression in the extent of radiotherapy target volume delineation to upper/high mediastinal lymph nodes.

The effect of a preoperative warm-up with a custom-made Nintendo video game on the performance of laparoscopic surgeons.

BACKGROUND: It has previously been shown that short, pre-operative practice with a simulator, box trainer, or certain video games can temporarily improve one's basic laparoscopic skills; the so-called warm-up effect. In this experiment, we tested the hypothesis that Underground video game made for training basic laparoscopic skills, can also be used for a pre-operative warm-up. MATERIALS AND METHODS: 29 laparoscopic experts were randomized into two different groups, which were tested on two different days. Group 1 (n = 16) did a laparoscopic skill baseline measurement using the FLS peg transfer test and the Top Gun cobra rope drill on day 1, and did the same tests on day 2 after a 15 min session with the Underground game. Group 2 (n = 13) did the same, but started with the video game, followed by baseline measurement on day 2. This way, each participant served as its own control. Video recordings of both tasks were later analyzed by two blinded reviewers. RESULTS: On day 1, group 2 was 14.33 % (P = 0.037) faster in completing the peg transfer test. A trend toward better cobra rope scores is also seen. When comparing the average improvement between both days, group 1--which used the game as a warm-up on day 2--showed a 19.61 % improvement in cobra rope score, compared to a 0.77 % score decrease in group 2 (P = 0.002). CONCLUSIONS: This study shows that the Underground video game can be used as a pre-operative warm-up in an experimental setting.

Construct and concurrent validity of a Nintendo Wii video game made for training basic laparoscopic skills.

BACKGROUND: Virtual reality (VR) laparoscopic simulators have been around for more than 10 years and have proven to be cost- and time-effective in laparoscopic skills training. However, most simulators are, in our experience, considered less interesting by residents and are often poorly accessible. Consequently, these devices are rarely used in actual training. In an effort to make a low-cost and more attractive simulator, a custom-made Nintendo Wii game was developed. This game could ultimately be used to train the same basic skills as VR laparoscopic simulators ought to. Before such a video game can be implemented into a surgical training program, it has to be validated according to international standards. METHODS: The main goal of this study was to test construct and concurrent validity of the controls of a prototype of the game. In this study, the basic laparoscopic skills of experts (surgeons, urologists, and gynecologists, n = 15) were compared to those of complete novices (internists, n = 15) using the Wii Laparoscopy (construct validity). Scores were also compared to the Fundamentals of Laparoscopy (FLS) Peg Transfer test, an already established assessment method for measuring basic laparoscopic skills (concurrent validity). RESULTS: Results showed that experts were 111 % faster (P = 0.001) on the Wii Laparoscopy task than novices. Also, scores of the FLS Peg Transfer test and the Wii Laparoscopy showed a significant, high correlation (r = 0.812, P < 0.001). CONCLUSIONS: The prototype setup of the Wii Laparoscopy possesses solid construct and concurrent validity.

Trans rectus sheath extra-peritoneal procedure (TREPP) for inguinal hernia: the first 1,000 patients.

INTRODUCTION: After the introduction of mesh in inguinal hernia repair, the focus to improve surgical technique has changed from recurrence to chronic postoperative inguinal pain. At present, the most common surgical techniques are the Lichtenstein hernioplasty and total extraperitoneal procedure. Both techniques have their own specific disadvantages, with regard to potential nerve damage and the necessity of general anesthesia, respectively. OBJECTIVE: The goal of this study was to evaluate the results of a new technique in which the inguinal nerves are not at risk, and in which general anesthesia is not needed: trans rectus sheath extraperitoneal procedure (TREPP). MATERIAL AND METHODS: Between 2006 and 2010, a total of 1,000 patients were treated for inguinal hernia with TREPP. A questionnaire concerning pain, sensibility changes, patient satisfaction, and recurrence was sent to all patients. RESULTS: The questionnaire was completed by 932 patients. Almost 90% of patients had not experienced any pain since the surgical procedure; 8% of patients reported experiencing some pain, but less than preoperatively; and 2% of patients reported an increase in pain postoperatively. Recurrence occurred in 1 and 3% were unsure about this. Reduced sensibility of the scar, scrotum, and upper leg was reported by 12.4, 1.4, and 1.5%, respectively. Overall, 97.4% of patients were satisfied with the results of the surgical procedure. The time period in which TREPP was performed was not associated with any of the outcome measures. CONCLUSION: TREPP has proven to be a feasible new technique for inguinal hernia repair, with excellent results, justifying a randomized controlled trial in which TREPP should be compared with standard techniques.

Implementation of Pelvic Floor Rehabilitation after rectal cancer surgery: A qualitative study guided by the Consolidated Framework for Implementation Research (CFIR).

BACKGROUND: Pelvic Floor Rehabilitation (PFR) is effective in a selection of patients with low anterior resection syndrome (LARS) after rectal cancer surgery. This study aimed to identify barriers and enablers to prepare for successful implementation into clinical practice. METHODS: A qualitative study was performed, guided by the Consolidated Framework for Implementation Research (CFIR). Individual interviews (n = 27) and two focus groups were conducted to synthesize the perspectives of rectal cancer patients, pelvic floor (PF) physiotherapists, and medical experts. RESULTS: Barriers were found to be the absence of guidelines about LARS treatment, underdeveloped network care, suboptimal patient information, and expectation management upfront to PFR. Financial status is frequently a barrier because insurance companies do not always reimburse PFR. Enablers were the current level of evidence for PFR, the positive relationship between patients and PF physiotherapists, and the level of self-motivation by patients. CONCLUSION: The factors identified in our study play a crucial role in ensuring a successful implementation of PFR after rectal cancer surgery.

Long-Term Functional Outcome After Early vs. Late Stoma Closure in Rectal Cancer Surgery: Sub-analysis of the Multicenter FORCE Trial.

PURPOSE: The aim of this study was to assess the effect of early stoma closure on bowel function after low anterior resection (LAR) for rectal cancer. METHODS: Patients participating in the FORCE trial who underwent LAR with protective stoma were included in this study. Patients were subdivided into an early closure group (< 3 months) and late closure group (> 3 months). Endpoints of this study were the Wexner Incontinence, low anterior resection syndrome (LARS), EORTC QLQ-CR29, and fecal incontinence quality of life (FIQL) scores at 1 year. RESULTS: Between 2017 and 2020, 38 patients had received a diverting stoma after LAR for rectal cancer and could be included. There was no significant difference in LARS (31 vs. 30, p = 0.63) and Wexner score (6.2 vs. 5.8, p = 0.77) between the early and late closure groups. Time to stoma closure in days was not a predictor for LARS (R2 = 0.001, F (1,36) = 0.049, p = 0.83) or Wexner score (R2 = 0.008, F (1,36) = 0.287, p = 0.60) after restored continuity. There was no significant difference between any of the FIQL domains of lifestyle, coping, depression, and embarrassment. In the EORTC QLQ-29, body image scored higher in the late closure group (21.3 vs. 1.6, p = 0.004). CONCLUSION: Timing of stoma closure does not appear to affect long-term bowel function and quality of life, except for body image. To improve functional outcome, attention should be focused on other contributing factors.

Learning and implementation of TransREctus sheath PrePeritoneal procedure for inguinal hernia repair.

PURPOSE: The TransREctus sheath PrePeritoneal procedure (TREPP) was introduced as an alternative open and preperitoneal technique for inguinal hernia mesh repair, demonstrating safety and efficacy in retro- and prospective studies. However, little is known about the technique's inherent learning curve. In this study, we aimed to determine TREPP learning curve effects after its implementation in high-volume surgical practice. METHODS: All primary, unilateral TREPP procedures performed in the first three years after implementation (between January 2016 and December 2018) were included out of a large preconstructed regional inguinal hernia database. Data were analyzed on outcome (i.e., surgical complications, hernia recurrences, postoperative pain). Learning curve effects were analyzed by assessing outcome in relation to surgeon experience. RESULTS: In total, 422 primary, unilateral TREPP procedures were performed in 419 patients. In three patients a unilateral TREPP procedure was performed on both sides separated in time. A total of 99 surgical complications were registered in 83 procedures (19.6% of all procedures), most commonly inguinal postoperative pain (8%) and bleeding complications (7%). Hernia recurrences were observed in 17 patients (4%). No statistically significant differences on outcome were found between different surgeon experience (< 40 procedures, 40-80 procedures, > 80 procedures). CONCLUSION: Implementation of TREPP seems not to be associated with a notable increase of adverse events. We were not able to detect a clear learning curve limit, potentially suggesting a relatively short learning curve among already experienced hernia surgeons compared to other guideline techniques.

Omentum preservation versus complete omentectomy in gastrectomy for gastric cancer (OMEGA trial): study protocol for a randomized controlled trial.

BACKGROUND: Potentially curative therapy for locally advanced gastric cancer consists of gastrectomy, usually in combination with perioperative chemotherapy. An oncological resection includes a radical (R0) gastrectomy and modified D2 lymphadenectomy; generally, a total omentectomy is also performed, to ensure the removal of possible microscopic disease. However, the omentum functions as a regulator of regional immune responses to prevent infections and prevents adhesions which could lead to bowel obstructions. Evidence supporting a survival benefit of routine complete omentectomy during gastrectomy is lacking. METHODS: OMEGA is a randomized controlled, open, parallel, non-inferiority, multicenter trial. Eligible patients are operable (ASA < 4) and have resectable (≦ cT4aN3bM0) primary gastric cancer. Patients will be 1:1 randomized between (sub)total gastrectomy with omentum preservation distal of the gastroepiploic vessels versus complete omentectomy. For a power of 80%, the target sample size is 654 patients. The primary objective is to investigate whether omentum preservation in gastrectomy for cancer is non-inferior to complete omentectomy in terms of 3-year overall survival. Secondary endpoints include intra- and postoperative outcomes, such as blood loss, operative time, hospital stay, readmission rate, quality of life, disease-free survival, and cost-effectiveness. DISCUSSION: The OMEGA trial investigates if omentum preservation during gastrectomy for gastric cancer is non-inferior to complete omentectomy in terms of 3-year overall survival, with non-inferiority being determined based on results from both the intention-to-treat and the per-protocol analyses. The OMEGA trial will elucidate whether routine complete omentectomy could be omitted, potentially reducing overtreatment. TRIAL REGISTRATION: ClinicalTrials.gov NCT05180864. Registered on 6th January 2022.

Effective and efficient learning in the operating theater with intraoperative video-enhanced surgical procedure training.

BACKGROUND: INtraoperative Video Enhanced Surgical procedure Training (INVEST) is a new training method designed to improve the transition from basic skills training in a skills lab to procedural training in the operating theater. Traditionally, the master-apprentice model (MAM) is used for procedural training in the operating theater, but this model lacks uniformity and efficiency at the beginning of the learning curve. This study was designed to investigate the effectiveness and efficiency of INVEST compared to MAM. METHODS: Ten surgical residents with no laparoscopic experience were recruited for a laparoscopic cholecystectomy training curriculum either by the MAM or with INVEST. After a uniform course in basic laparoscopic skills, each trainee performed six cholecystectomies that were digitally recorded. For 14 steps of the procedure, an observer who was blinded for the type of training determined whether the step was performed entirely by the trainee (2 points), partially by the trainee (1 point), or by the supervisor (0 points). Time measurements revealed the total procedure time and the amount of effective procedure time during which the trainee acted as the operating surgeon. Results were compared between both groups. RESULTS: Trainees in the INVEST group were awarded statistically significant more points (115.8 vs. 70.2; p < 0.001) and performed more steps without the interference of the supervisor (46.6 vs. 18.8; p < 0.001). Total procedure time was not lengthened by INVEST, and the part performed by trainees was significantly larger (69.9 vs. 54.1 %; p = 0.004). CONCLUSIONS: INVEST enhances effectiveness and training efficiency for procedural training inside the operating theater without compromising operating theater time efficiency.

Radiofrequency ablation combined with systemic treatment versus systemic treatment alone in patients with non-resectable colorectal liver metastases: a randomized EORTC Intergroup phase II study (EORTC 40004).

BACKGROUND: This study investigates the possible benefits of radiofrequency ablation (RFA) in patients with non-resectable colorectal liver metastases. METHODS: This phase II study, originally started as a phase III design, randomly assigned 119 patients with non-resectable colorectal liver metastases between systemic treatment (n = 59) or systemic treatment plus RFA ( ± resection) (n = 60). Primary objective was a 30-month overall survival (OS) rate >38% for the combined treatment group. RESULTS: The primary end point was met, 30-month OS rate was 61.7% [95% confidence interval (CI) 48.2-73.9] for combined treatment. However, 30-month OS for systemic treatment was 57.6% (95% CI 44.1-70.4), higher than anticipated. Median OS was 45.3 for combined treatment and 40.5 months for systemic treatment (P = 0.22). PFS rate at 3 years for combined treatment was 27.6% compared with 10.6% for systemic treatment only (hazard ratio = 0.63, 95% CI 0.42-0.95, P = 0.025). Median progression-free survival (PFS) was 16.8 months (95% CI 11.7-22.1) and 9.9 months (95% CI 9.3-13.7), respectively. CONCLUSIONS: This is the first randomized study on the efficacy of RFA. The study met the primary end point on 30-month OS; however, the results in the control arm were in the same range. RFA plus systemic treatment resulted in significant longer PFS. At present, the ultimate effect of RFA on OS remains uncertain.

The learning effect of intraoperative video-enhanced surgical procedure training.

BACKGROUND: The transition from basic skills training in a skills lab to procedure training in the operating theater using the traditional master-apprentice model (MAM) lacks uniformity and efficiency. When the supervising surgeon performs parts of a procedure, training opportunities are lost. To minimize this intervention by the supervisor and maximize the actual operating time for the trainee, we created a new training method called INtraoperative Video-Enhanced Surgical Training (INVEST). METHODS: Ten surgical residents were trained in laparoscopic cholecystectomy either by the MAM or with INVEST. Each trainee performed six cholecystectomies that were objectively evaluated on an Objective Structured Assessment of Technical Skills (OSATS) global rating scale. Absolute and relative improvements during the training curriculum were compared between the groups. A questionnaire evaluated the trainee's opinion on this new training method. RESULTS: Skill improvement on the OSATS global rating scale was significantly greater for the trainees in the INVEST curriculum compared to the MAM, with mean absolute improvement 32.6 versus 14.0 points and mean relative improvement 59.1 versus 34.6% (P=0.02). CONCLUSION: INVEST significantly enhances technical and procedural skill development during the early learning curve for laparoscopic cholecystectomy. Trainees were positive about the content and the idea of the curriculum.

Results of surgery for perforated gastroduodenal ulcers in a Dutch population.

OBJECTIVE: Despite improvements in anesthesiology and intensive care medicine, mortality for perforated gastroduodenal ulcer disease remains high. This study was designed to evaluate the results of surgery for perforated ulcer disease and to identify prognostic factors for mortality in order to optimize treatment. PATIENTS AND METHODS: The medical records of 272 patients undergoing emergency surgery for perforated ulcer disease from 2000 to 2005 in two large teaching hospitals and one university hospital in the Netherlands were retrospectively analyzed. Information on 89 pre-, peri- and postoperative data were recorded. Statistical analysis was performed using multiple logistic regression analysis. The primary endpoint was 30-day mortality. RESULTS: The 30-day mortality rate was 16%. Variables associated with 30-day mortality were age, shock, tachycardia, anemia and ASA class. CONCLUSIONS: A relatively low 30-day mortality rate was achieved. Age, shock, tachycardia and anemia were significantly associated with 30-day mortality. Finding that shock, tachycardia and anemia are independently associated with 30-day mortality could indicate that patients are septic upon admission. Improvements in survival might be achieved by early sepsis treatment.

Transrectus sheath pre-peritoneal (TREPP) procedure versus totally extraperitoneal (TEP) procedure and Lichtenstein technique: a propensity-score-matched analysis in Dutch high-volume regional hospitals.

PURPOSE: Results of the most commonly used inguinal hernia repair techniques often originate from expert centers or from randomized controlled studies. In this study, we portray daily-practice results of a high-volume, regional surgical group in the Netherlands, comparing TREPP (open (posterior) transrectus sheath pre-peritoneal) with Lichtenstein (open anterior) and TEP (endoscopic (posterior) totally extraperitoneal). We hypothesize that the TREPP shows more favorable outcome compared to the current gold standard procedures: TEP and Lichtenstein. METHODS: Between January 2016 and December 2018, 3285 consecutive patients underwent surgical treatment and were included for analysis. The outcome measures were postoperative pain, recurrence rate and other surgical complications. Propensity-score matching was used to address potential selection bias. RESULTS: After propensity-score matching, there was no statistically significant difference in postoperative pain in the TREPP group compared to the Lichtenstein group (TREPP 7.3% versus Lichtenstein 6.3%; p = 0.67) nor in TREPP compared to TEP (TREPP 7.4% versus TEP 4.1%; p = 0.064). There was no statistically significant difference in recurrences in the TREPP group compared to Lichtenstein (3.8% vs 2.5%; p = 0.42), nor in the TREPP versus TEP comparison (3.9% vs 2.8%; p = 0.55) CONCLUSION: This study compares TREPP with Lichtenstein and TEP in the presence of postoperative pain, recurrences and other adverse outcomes. After propensity-score matching, no statistically significant difference in postoperative pain or recurrences remained between either TREPP compared to Lichtenstein, or TREPP compared to TEP. Based on these results, TREPP, Lichtenstein and TEP showed comparable results in postoperative pain, recurrences and other surgical site complications.

Emergency TREPP for Strangulated Inguinal Hernia Repair: A Consecutive Case Series.

Background Patients with strangulated inguinal hernia (SIH) require emergency surgical treatment. International guidelines do not specify the surgical technique of preference. Frequently, an open anterior approach such as the Lichtenstein technique is used. The TransREctus sheath Pre-Peritoneal (TREPP) technique is an alternative, open posterior approach, which has shown promising results in the elective treatment of inguinal hernias. This study aims to evaluate the feasibility and safety of the TREPP technique in the emergency setting of SIHs. Materials and Methods After medical ethical approval was warranted, all consecutive patients, who underwent emergency TREPP (e-TREPP) at a high-volume hernia institute, were retrospectively included from 2006 up to and including 2016. Data retrieved from the electronic patient files were combined with the findings during a long-term outcome physical investigation at an outpatient department visit. e-TREPP was, prior to the start of the study, defined as TREPP performed immediately at the operation room. Results Thirty-three patients underwent e-TREPP for SIH. Ten patients were clinically evaluated, ten patients were deceased, nine patients could not be contacted, and four patients did not or could not consent. Of the ten deceased patients, one patient died perioperatively due to massive aspiration followed by cardiac arrest. Nine patients died due to other causes. Two patients developed a recurrence after (after 13 days and 16 months respectively). Two patients were surgically treated for a wound infection (mesh removal in one). No patient reported chronic postoperative inguinal pain. Conclusion e-TREPP in experienced hands seems feasible and safe (Level of Evidence 4) for the treatment of patients with strangulated inguinal hernia, with percentages of postoperative complications comparable to other techniques.

Pelvic floor rehabilitation to improve functional outcome and quality of life after surgery for rectal cancer: study protocol for a randomized controlled trial (FORCE trial).

BACKGROUND: After low anterior resection (LAR), up to 90% of patients develop anorectal dysfunction. Especially fecal incontinence has a major impact on the physical, psychological, social, and emotional functioning of the patient but also on the Dutch National Healthcare budget with more than €2000 spent per patient per year. No standardized treatment is available to help these patients. Common treatment nowadays is focused on symptom relief, consisting of lifestyle advices and pharmacotherapy with bulking agents or antidiarrheal medication. Another possibility is pelvic floor rehabilitation (PFR), which is one of the most important treatments for fecal incontinence in general, with success rates of 50-80%. No strong evidence is available for the use of PFR after LAR. This study aims to prove a beneficial effect of PFR on fecal incontinence, quality of life, and costs in rectal cancer patients after sphincter-saving surgery compared to standard treatment. METHODS: The FORCE trial is a multicenter, two-armed, randomized clinical trial. All patients that underwent LAR are recruited from the participating hospitals and randomized for either standard treatment or a standardized PFR program. A total of 128 patients should be randomized. Optimal blinding is not possible. Stratification will be done in variable blocks (gender and additional radiotherapy). The primary endpoint is the Wexner incontinence score; secondary endpoints are health-related and fecal-incontinence-related QoL and cost-effectiveness. Baseline measurements take place before randomization. The primary endpoint is measured 3 months after the start of the intervention, with a 1-year follow-up for sustainability research purposes. DISCUSSION: The results of this study may substantially improve postoperative care for patients with fecal incontinence or anorectal dysfunction after LAR. This section provides insight in the decisions that were made in the organization of this trial. TRIAL REGISTRATION: Netherlands Trial Registration, NTR5469, registered on 03-09-2015. Protocol FORCE trial V18, 19-09-2019. Sponsor Radboud University Medical Center, Nijmegen.

Optimal ergonomics for laparoscopic surgery in minimally invasive surgery suites: a review and guidelines.

BACKGROUND: With minimally invasive surgery (MIS), a man-machine environment was brought into the operating room, which created mental and physical challenges for the operating team. The science of ergonomics analyzes these challenges and formulates guidelines for creating a work environment that is safe and comfortable for its operators while effectiveness and efficiency of the process are maintained. This review aimed to formulate the ergonomic challenges related to monitor positioning in MIS. Background and guidelines are formulated for optimal ergonomic monitor positioning within the possibilities of the modern MIS suite, using multiple monitors suspended from the ceiling. METHODS: All evidence-based experimental ergonomic studies conducted in the fields of laparoscopic surgery and applied ergonomics for other professions working with a display were identified by PubMed searches and selected for quality and applicability. Data from ergonomic studies were evaluated in terms of effectiveness and efficiency as well as comfort and safety aspects. Recommendations for individual monitor positioning are formulated to create a personal balance between these two ergonomic aspects. RESULTS: Misalignment in the eye-hand-target axis because of limited freedom in monitor positioning is recognized as an important ergonomic drawback during MIS. Realignment of the eye-hand-target axis improves personal values of comfort and safety as well as procedural values of effectiveness and efficiency. CONCLUSIONS: Monitor position is an important ergonomic factor during MIS. In the horizontal plain, the monitor should be straight in front of each person and aligned with the forearm-instrument motor axis to avoid axial rotation of the spine. In the sagittal plain, the monitor should be positioned lower than eye level to avoid neck extension.

Interoperative efficiency in minimally invasive surgery suites.

BACKGROUND: Performing minimally invasive surgery (MIS) in a conventional operating room (OR) requires additional specialized equipment otherwise stored outside the OR. Before the procedure, the OR team must collect, prepare, and connect the equipment, then take it away afterward. These extra tasks pose a thread to OR efficiency and may lengthen turnover times. The dedicated MIS suite has permanently installed laparoscopic equipment that is operational on demand. This study presents two experiments that quantify the superior efficiency of the MIS suite in the interoperative period. METHODS: Preoperative setup and postoperative breakdown times in the conventional OR and the MIS suite in an experimental setting and in daily practice were analyzed. In the experimental setting, randomly chosen OR teams simulated the setup and breakdown for a standard laparoscopic cholecystectomy (LC) and a complex laparoscopic sigmoid resection (LS). In the clinical setting, the interoperative period for 66 LCs randomly assigned to the conventional OR or the MIS suite were analyzed. RESULTS: In the experimental setting, the setup and breakdown times were significantly shorter in the MIS suite. The difference between the two types of OR increased for the complex procedure: 2:41 min for the LC (p < 0.001) and 10:47 min for the LS (p < 0.001). In the clinical setting, the setup and breakdown times as a whole were not reduced in the MIS suite. Laparoscopic setup and breakdown times were significantly shorter in the MIS suite (mean difference, 5:39 min; p < 0.001). CONCLUSION: Efficiency during the interoperative period is significantly improved in the MIS suite. The OR nurses' tasks are relieved, which may reduce mental and physical workload and improve job satisfaction and patient safety. Due to simultaneous tasks of other disciplines, an overall turnover time reduction could not be achieved.

Ergonomic assessment of neck posture in the minimally invasive surgery suite during laparoscopic cholecystectomy.

BACKGROUND: With the expanding implementation of minimally invasive surgery, the operating team is confronted with challenges in the field of ergonomics. Visual feedback is derived from a monitor placed outside the operating field. This crossover trial was conducted to evaluate and compare neck posture in relation to monitor position in a dedicated minimally invasive surgery (MIS) suite and a conventional operating room. METHODS: Assessment of the neck was conducted for 16 surgeons, assisting surgeons, and scrub nurses performing a laparoscopic cholecystectomy in both types of operating room. Flexion and rotation of the cervical spine were measured intraoperatively using a video analysis system. A two-question visual analog scale (VAS) questionnaire was used to evaluate posture in relation to the monitor position. RESULTS: Neck rotation was significantly reduced in the MIS suite for the surgeon (p = 0.018) and the assisting surgeon (p < 0.001). Neck flexion was significantly improved in the MIS suite for the surgeon (p < 0.001) and the scrub nurse (p = 0.018). On the questionnaire, the operating room team scored their posture significantly higher in the MIS suite and also indicated fewer musculoskeletal complaints. CONCLUSIONS: The ergonomic quality of the neck posture is significantly improved in the MIS suite for the entire operating room team.

Epidemiology and treatment of extramammary Paget disease in the Netherlands.

AIM: To determine the incidence of EMPD and to describe its epidemiology, treatment, survival and the risk of developing other malignancies. METHOD: All cases of EMPD, diagnosed between 1989 and 2001, were selected from the Netherlands Cancer Registry. RESULTS: In total, 178 cases of invasive and 48 cases of in situ EMPD had been registered. The overall relative 5-year survival for invasive tumours was 72%. Most patients with invasive as well as in situ cancer underwent surgery. Other malignancies were found in 32% of patients with invasive EMPD and 35% of patients with in situ EMPD. Patients had an increased risk of developing a second primary cancer (standardized incidence ratio: 1.7; 95% confidence interval 1.2-2.4). The most frequent localizations of the other cancers were the colorectum, the prostate, the breast and the extragenital skin. CONCLUSIONS: For EMPD, which is a rare disease in the Netherlands, there are no clear diagnostic and treatment guidelines. The prognosis is fairly good. A thorough search for other tumours is recommended for these patients.