Implementation of minimally invasive Ivor Lewis esophagectomy: learning curve of a single high-volume center.

Open esophagectomy is considered to be the main surgical procedure in the world for esophageal cancer treatment. Implementing a new surgical technique is associated with learning curve morbidity. The objective of this study is to determine the learning curve based on anastomotic leakage (AL) after implementing minimally invasive Ivor Lewis esophagectomy (MI-ILE) in January 2015. All 257 patients who underwent MI-ILE in a single high-volume center between January 2015 and December 2020 were retrospectively included in this study. The learning curve was evaluated using the standard CUSUM analysis with an expected AL rate of 11%. Secondary outcome parameters were postoperative complications, textbook outcome, and lymph node yield divided by the year of operation. Hierarchical binary logistic regression analysis was used to check for potential confounding variables. The CUSUM analysis showed a learning curve of 179 cases. The mean AL rate decreased from 33.3% in 2015 to 9.5% in 2020 (P = 0.007). There was an increase in the mean lymph node yield from 21 in 2018 to 28 in 2019 (P < 0.001) and textbook outcome from 37.3% in 2015 to 66.7% in 2020 (P = 0.005). A newly implemented MI-ILE has a learning curve of 179 patients based on a reference AL rate of 11% using the CUSUM method. Whether future generation surgeons will show similar learning curve numbers, implicating continuous development of different introduction programs of new techniques, will have to be the focus of future research.

C-reactive protein and drain amylase: their utility in ruling out anastomotic leakage after minimally invasive Ivor-Lewis esophagectomy.

INTRODUCTION: Anastomotic leakage (AL) is one of the most feared complications after esophagectomy for esophageal cancer. We investigated the role of serum C-reactive protein (CRP) and drain amylase levels in the early detection of AL. METHODS: This is a retrospective study of 193 patients who underwent a minimally invasive Ivor-Lewis procedure between January 2017 and October 2021. Mean CRP and median drain amylase levels between patients with and without AL were compared during the first five postoperative days (POD). ROC curves on POD 3, 4 and 5 were plotted to calculate cut-off values for CRP. RESULTS: In 30 of the 193 patients (16%), AL was diagnosed with a median time to diagnosis of 9 days. Mean CRP was significantly higher in patients with AL on POD 3, 4 and 5. Cut-off values of 59, 110 and 106 mg/L had a high sensitivity of 93%, 90% and 90% on POD 3, 4 and 5. No difference in median drain amylase levels was observed. CONCLUSIONS: CRP levels with a cut-off point of 110 mg/L on POD 4 do not improve earlier detection of AL, but have a high sensitivity for excluding AL. The value of drain amylase in the first 5 days after surgery is limited.

Patients with Isolated Brain Metastases from Esophageal Carcinoma After Minimally Invasive Esophagectomy May Not Have a Dismal Prognosis.

BACKGROUND: After esophagectomy for esophageal carcinoma, 2-13% of patients develop brain metastases (BM) which are associated with a poor prognosis. Further investigation into treatment and prognosis is beneficial given the limited available literature and varying outcomes. METHODS: Case files of all 339 patients who underwent minimally invasive esophagectomy (MIE) in a single high-volume center between January 2015 and December 2020 were retrospectively reviewed. Patients with BM and isolated brain metastases (iBM) were identified and a survival analysis was performed. RESULTS: Fifteen out of 339 patients (4,4%) undergoing MIE developed BM of which 9 (60,0%) had iBM. Most patients were diagnosed with squamous cell carcinoma (55,6%), localized in the middle third of the esophagus (66,7%), and had a pathologic complete response (66,7%) after initial treatment. Treatment of iBM consisted of gamma knife (GK) radiosurgery (44,4%), surgical resection (22,2%), GK and surgical resection (11,1%), and best supportive care (22,2%). Median time to diagnose iBM was 8,4 months (range 0,2-37,5) and survival after detection of iBM was 14,3 months (95% CI 0,0-45.9). The 2-year survival rate after detection of iBM was 44,4%. CONCLUSIONS: iBM after esophagectomy for esophageal carcinoma is rare, but when encountered can and should be treated with a curative intent in selected cases in close collaboration with large neurosurgical centers. A large-scale study should be conducted to confirm our findings.

Learning Curves of Ivor Lewis Totally Minimally Invasive Esophagectomy by Hospital and Surgeon Characteristics: A Retrospective Multinational Cohort Study.

OBJECTIVE: To describe the pooled learning curves of Ivor Lewis totally minimally invasive esophagectomy (TMIE) in hospitals stratified by predefined hospital- and surgeon-related factors. BACKGROUND: Ivor Lewis (TMIE is known to have a long learning curve which is associated with considerable learning associated morbidity. It is unknown whether hospital and surgeon characteristics are associated with more efficient learning. METHODS: A retrospective analysis of prospectively collected data of consecutive Ivor Lewis TMIE patients in 14 European hospitals was performed. Outcome parameters used as proxy for efficient learning were learning curve length, learning associated morbidity, and the plateau level regarding anastomotic leakage and textbook outcome. Pooled incidences were plotted for the factor-based subgroups using generalized additive models and 2-phase models. Casemix predicted outcomes were plotted and compared with observed outcomes. The investigated factors included annual volume, TMIE experience, clinic visits, courses and fellowships followed, and proctor supervision. RESULTS: This study included 2121 patients. The length of the learning curve was shorter for centers with an annual volume >50 compared to centers with an annual volume <50. Analysis with an annual volume cut-off of 30 cases showed similar but less pronounced results. No outcomes suggesting more efficient learning were found for longer experience as consultant, visiting an expert clinic, completing a minimally invasive esophagectomy fellowship or implementation under proctor supervision. CONCLUSIONS: More efficient learning was observed in centers with higher annual volume. Visiting an expert clinic, completing a fellowship, or implementation under a proctor's supervision were not associated with more efficient learning.

Long-term Outcomes After Surgery Involving the Pelvic Floor in Rectal Cancer: Physical Activity, Quality of Life, and Health Status.

PURPOSE: This study has aimed to evaluate the effects of surgery on physical activity (PA), quality of life (QoL), and disease-specific health status, by analyzing the differences between sphincter-preserving surgery (low anterior resection (LAR)) and abdominoperineal resection (APR) among rectal cancer survivors. METHODS: Individuals who were diagnosed with rectal cancer and who underwent an APR or a LAR between 2000 and 2009 were included. The different questionnaires on QoL, disease-specific health status, and physical activity began their surveys in 2010. Differences in QoL, health status, and physical activity were analyzed between the APR group and the LAR group. RESULTS: The study included 905 rectal cancer survivors (LAR, 632; APR, 273). Besides a higher rate of radiotherapy treatment in the APR group (94% vs. 75%, p < 0.001), there were no differences in clinical characteristics or in comorbid conditions between the LAR group and APR group. No significant differences were found in PA level between the patients who had undergone an APR vs. a LAR. Regarding QoL, APR patients did report a worse physical (p = 0.009) and role functioning (p = 0.03), as well as a worse body image (p = 0.001), compared to patients who had undergone a LAR. However, they reported fewer constipation (p = 0.02) and gastrointestinal problems (p = 0.009). Finally, compared to patients who had undergone a LAR with a permanent ostomy, APR patients reported a better body image (p = 0.048) and less stoma-related problems (p = 0.001). CONCLUSIONS: This study showed no differences in PA level among the patients who had undergone an APR versus a LAR. With respect to their QoL, their physical and role functioning seemed to be worse in the APR patients. However, these differences in outcomes resolved when comparing the APR group with patients after a LAR with a permanent ostomy.

Intrathoracic versus Cervical ANastomosis after minimally invasive esophagectomy for esophageal cancer: study protocol of the ICAN randomized controlled trial.

BACKGROUND: Currently, a cervical esophagogastric anastomosis (CEA) is often performed after minimally invasive esophagectomy (MIE). However, the CEA is associated with a considerable incidence of anastomotic leakage requiring reintervention or reoperation and moderate functional results. An intrathoracic esophagogastric anastomosis (IEA) might reduce the incidence of anastomotic leakage, improve functional results and reduce costs. The objective of the ICAN trial is to compare anastomotic leakage and postoperative morbidity, mortality, quality of life and cost-effectiveness between CEA and IEA after MIE. METHODS/DESIGN: The ICAN trial is an open randomized controlled multicentre superiority trial, comparing CEA (control group) with IEA (intervention group) after MIE. All patients with esophageal cancer planning to undergo curative MIE are considered for inclusion. A total of 200 patients will be included in the study and randomized between the groups in a 1:1 ratio. The primary outcome is anastomotic leakage requiring reintervention or reoperation, and secondary outcomes are (amongst others) other postoperative complications, new onset of organ failure, length of stay, mortality, benign strictures requiring dilatation, quality of life and cost-effectiveness. DISCUSSION: We hypothesize that an IEA after MIE is associated with a lower incidence of anastomotic leakage requiring reintervention or reoperation than a CEA. The trial is also designed to give answers to additional research questions regarding a possible difference in functional outcome, quality of life and cost-effectiveness. TRIAL REGISTRATION: Netherlands Trial Register: NTR4333 . Registered on 23 December 2013.

Early Postoperative Progression to Solid Foods Is Safe After Roux-en-Y Gastric Bypass.

BACKGROUND: Even though admission time is reduced with the implementation of various enhanced recovery protocols, many clinics still instruct patients after weight loss surgery to maintain a fluid or minced-food diet for at least 2 weeks postoperatively. We reasoned that with adequate preoperative instructions, including adequate chewing of all foods, early progression to solid foods would not increase the risk of (gastro)enterostomy leakage. METHODS: In December 2010, a new dietary protocol was implemented for all patients undergoing a Roux-en-Y gastric bypass, allowing progression to solid foods from 12 h postprocedure onwards. All patients received thorough preoperative eating instructions and eating awareness counselling from a qualified dietician and psychologist. A retrospective study was performed of 936 patients who underwent a primary or redo laparoscopic Roux-en-Y gastric bypass between January 2011 and June 2014 in our hospital. All 30-day complications, readmissions and reoperations were noted. RESULTS: No 30-day loss to follow-up occurred. Overall 30-day complication rate was 9.4%, with gastrointestinal leakage occurring in only 0.6%. A low threshold for readmission was maintained due to the short mean admission time of 1.87 days. Readmission rate was 4.8%--mainly for observation of postoperative pain--and 1.8% of our patients required reoperation within 30 days. Mortality was 0.1%. Our results are comparable to results published by other Dutch centres advocating conventional diets, showing no increase in leakage or other complications. CONCLUSIONS: We conclude that early progression to solid foods after Roux-en-Y gastric bypass surgery is a feasible alternative as no increase in complications is observed.

Relax, it's just laparoscopy! A prospective randomized trial on heart rate variability of the surgeon in robot-assisted versus conventional laparoscopic cholecystectomy.

BACKGROUND: Laparoscopic surgery might be beneficial for the patient, but it imposes increased physical and mental strain on the surgeon. Robot-assisted laparoscopic surgery addresses some of the laparoscopic drawbacks and may potentially reduce mental strain. This could reduce the risk of surgeon's fatigue, mishaps and strain-induced illnesses, which may eventually improve the safety of laparoscopic surgical procedures. METHODS: To test this hypothesis, a randomized study was performed, comparing both heart rate and heart rate variability (HRV) of the surgeon as a measure of total and mental strain, respectively, during conventional and robot-assisted laparoscopic cholecystectomy. RESULTS: Both heart rate and HRV (the low-frequency band/high-frequency band ratio) were significantly decreased when using robotic assistance. CONCLUSIONS: These data suggest the use of the daVinci® Surgical System leads to less physical and mental strain of the surgeon during surgery. However, assessing mental strain by means of HRV is cumbersome since there is no clear cutoff point or scale for maximum tolerated strain levels and its related effects on surgeon's health.

Mesh Or Patch for Hernia on Epigastric and Umbilical Sites (MORPHEUS trial): study protocol for a multi-centre patient blinded randomized controlled trial.

BACKGROUND: Evidence is accumulating that, similar to other ventral hernias, umbilical and epigastric hernias must be mesh repaired. The difficulties involved in mesh placement and in mesh-related complications could be the reason many small abdominal hernias are still primary closed. In laparoscopic repair, a mesh is placed intraperitoneally, while the most common procedure is open surgery is pre-peritoneal mesh placement. A recently developed alternative method is the so-called patch repair, in this approach a mesh can be placed intraperitoneally through open surgery. In theory, such patches are particularly suitable for small hernias due to a reduction in the required dissection. This simple procedure is described in several studies. It is still unclear whether this new approach is associated with an equal risk of recurrence and complications compared with pre-peritoneal meshes. The material of the patch is in direct contact with intra-abdominal organs, it is unknown if this leads to more complications. On the other hand, the smaller dissection in the pre-peritoneal plane may lead to a reduction in wound complications. METHODS/DESIGN: 346 patients suffering from an umbilical or epigastric hernia will be included in a multi-centre patient-blinded trial, comparing mesh repair with patch repair. Randomisation will take place for the two operation techniques. The two devices investigated are a flat pre-peritoneal mesh and a Proceed Ventral Patch®. Stratification will occur per centre. Post-operative evaluation will take place after 1, 3, 12 and 24 months. The number of complications requiring treatment is the primary endpoint. Secondary endpoints are Verbal Descriptor Scale (VDS) pain score and VDS cosmetic score, operation duration, recurrence and costs. An intention to treat analysis will be performed. DISCUSSION: This trial is one of the first in its kind, to compare different mesh devices in a randomized controlled setting. The results will help to evaluate mesh repair for epigastric an umbilical hernia, and find a surgical method that minimizes the complication rate. TRIAL REGISTRATION: Netherlands Trail Registration (NTR) www.trialregister.nl 2010 NTR2514 NL33995.060.10.

Differences in circumferential resection margin involvement after abdominoperineal excision and low anterior resection no longer significant.

OBJECTIVE: The aim of this study was to evaluate whether the abdominoperineal excision (APE) is associated with an increased risk of circumferential resection margin (CRM) involvement after rectal cancer surgery in comparison with low anterior resection (LAR). BACKGROUND: The oncologic inferiority of the APE technique in comparison with LAR has been widely reported in literature. However, because of large evolvement in rectal cancer care, outcomes after APE may have improved since then. METHODS: The population-based dataset of the Dutch Surgical Colorectal Audit was used selecting 5017 patients with primary rectal cancer undergoing surgery in 2010 to 2011. Propensity scores were calculated for the likelihood of performing an APE given relevant patient and tumor characteristics, and used in the multivariate analysis of CRM involvement. RESULTS: The APE was associated with a slight, nonsignificant, increased risk of CRM involvement [odds ratio (OR) = 1.33; confidence interval (CI) = 0.93-1.90]. Absolute percentages of CRM involvement were 8% and 12% after LAR and APE, respectively.In the subgroup analysis, advanced rectal tumors (cT3-4) were associated to a higher risk of CRM involvement after APE (OR = 1.61; CI = 1.05-1.90), whereas smaller tumors (cT1-2) were not (OR = 0.62; CI = 0.27-1.40). CONCLUSIONS: The results suggest that on a national level the APE procedure itself is not a strong predictor anymore for CRM involvement after rectal cancer surgery. However, in advanced tumors, results after APE are inferior to LAR.

Development and clinical implementation of a hemostatic balloon device for rectal cancer surgery.

BACKGROUND: Surgery for locally advanced and recurrent rectal carcinoma can be associated with major blood loss. OBJECTIVE: We developed a promising technique using a hemostatic balloon to stop uncontrollable bleeding. DESIGN: Models were developed using pelvic magnetic resonance imaging scans, and these models were tested in a cadaveric study. Eventually a model was tested in a clinical setting. The Hemostatic Balloon Device was placed in patients in whom during surgery uncontrollable bleeding from the venous presacral plexus occurred. SETTINGS: A tertiary referral hospital for locally advanced and recurrent rectal cancer. PATIENTS: Patients receiving multimodality treatment for primary or recurrent locally advanced rectal carcinomas. MAIN OUTCOME MEASURES: First the developed prototypes were tested in a cadaveric study where the developing pressure on the pelvic wall was measured. Second, the Hemostatic Balloon Device was placed in patients in whom during surgery uncontrollable bleeding from the venous presacral plexus occurred. RESULTS: The balloon was used in 9 patients. Median volume of blood loss was 7500 mL. In 8 patients treatment with the hemostatic balloon was successful. In 1 patient the balloon was dislocated cranially and the pelvis was packed with surgical gauzes. LIMITATIONS: These first results are promising but further research is needed to evaluate how effective the balloon is in controlling massive bleeding during rectal cancer surgery. Future perspectives include a possibly thinner silicon rubber that can be stretched more easily with a lower inflated volume. DISCUSSION: The hemostatic balloon is a new and promising technique for accomplishing hemostasis with controllable pressure on the pelvic cavity wall and can be removed without the need for a second laparotomy.

Dynamic article: Vaginal and perineal reconstruction using rectus abdominis myocutaneous flap in surgery for locally advanced rectum carcinoma and locally recurrent rectum carcinoma.

BACKGROUND: Surgery for locally advanced and recurrent rectal carcinoma sometimes requires partial resection of the perineum and/or vagina necessitating subsequent reconstruction. OBJECTIVE: The aim of this study was to describe the surgical and functional outcomes of reconstructing the vagina and/or the perineum by using the vertical rectus abdominis myocutaneous flap and to evaluate the health status of patients who received reconstruction. DESIGN: This is a retrospective cohort study. SETTINGS: This study was conducted at a tertiary referral hospital for locally advanced and recurrent rectal cancer. PATIENTS: Patients receiving multimodality treatment for primary or recurrent locally advanced rectal carcinomas were included. MAIN OUTCOME MEASURES: First, the surgical outcome was assessed. Second, 10 female patients who received vaginal reconstruction underwent a gynecological examination including biopsies. Finally, quality of life was assessed and compared with patients who underwent treatment for rectal carcinoma without a reconstruction. RESULTS: Fifty-one patients underwent reconstruction of the dorsal vagina and/or the perineum with the use of a vertical rectus abdominis myocutaneous flap. In 13 patients, the flap was used to close a perineal defect; in 26 patients, to close a vaginal defect; and in 12 patients, to close both. In 3 patients, partial necrosis of the flap occurred that was treated conservatively. In 4 patients, stenosis of the introitus occurred, as found in the gynecological examination. Biopsies confirmed epithelialization of the vaginal wall. All groups reported good functioning and low symptom burden. After vaginal reconstruction, women reported equal or higher scores on global health status, emotional functioning, and body image. LIMITATIONS: The lack of information on the health status of the patients before the start of treatment prohibits making causal inferences in health status over time. DISCUSSION: Reconstruction of the perineum and/or dorsal vagina was successful in all patients. Surgeons and gynecologists who use the vertical rectus abdominis myocutaneous flap should be aware of stenosis of the vaginal introitus. Gynecological consultation at an early stage should be standard.

Focus on extralevator perineal dissection in supine position for low rectal cancer has led to better quality of surgery and oncologic outcome.

BACKGROUND: After abdominoperineal excision (APE), the presence of tumor cells in the circumferential resection margin (R1) and iatrogenic tumor perforations are still frequent and result in an increased rate of local recurrences. In this study, a standardized supine APE with an increased focus on the perineal dissection (sPPD) is compared to the customary supine APE. METHODS: From 2000 to 2010, a total of 246 patients underwent APE for rectal cancer (sPPD and customary supine APE). All patients were staged with preoperative magnetic resonance imaging (MRI) and received neoadjuvant treatment (n = 203) when margins were involved or threatened (cT3 + and T4). As a result of a quality improvement program in 2006, the surgical technique was modified: it became standardized, emphasis was placed on the perineal dissection, and pelvic dissection was limited to avoid false routes when following the total mesorectal excision planes deep into the pelvis. RESULTS: Overall, the percentage of involved circumferential resection margins (CRMs) was 10%. In the period before introducing sPPD, the R1 percentages for cT0-3 and cT4 tumors were 6.8 and 30.2%, compared to 2.2 and 5.7% after introduction of sPPD (P = 0.001). Risk factors for R1 resection were preoperative T4 tumors (14.9%, P = 0.011), tumor perforation (33.3%, P = 0.002), fistulating tumors (35.7%, P = 0.002), mucus-producing tumors (23.1%, P = 0.006), or bulky tumors (66.7%, P < 0.001). CONCLUSIONS: The objective of surgical treatment of low rectal cancer is to obtain negative resection margins and subsequently reduce the risk of local recurrence. A combination of the appropriate preoperative treatment and standardized surgical technique such as sPPD can achieve this goal.

T3+ and T4 rectal cancer patients seem to benefit from the addition of oxaliplatin to the neoadjuvant chemoradiation regimen.

BACKGROUND: To achieve T-downstaging and better resectability in locally advanced rectal cancer, neoadjuvant radiochemotherapy (RCT) has become the current standard of treatment. A variety of schemes have been used. This study investigates which scheme had the best effect on these parameters. METHODS: Our institution is a referral center for locally advanced rectal cancer. Different neoadjuvant radiochemotherapy regimens were administered: long course radiotherapy (RTH), 5-FU and leucovorin (5FUBolus), a combination of capecitabine and oxaliplatin (CORE), and capecitabine only (CAP). Selection of patients for 1 of the regimens was based on hospital policy rather than patient or tumor characteristics. RESULTS: The data of 504 consecutive patients (n = 181 T3+, n = 323 T4) without metastatic disease (cM0) who underwent surgery for advanced rectal carcinoma between 1994 and 2010 were reviewed. The RTH, 5FUBolus, CORE, and CAP scheme were administered to 106, 137, 155, and 106 patients, respectively. Odds ratios for downstaging were less effective for RTH, 5FUBolus, and CAP (0.31, 0.44, and 0.31; P < .0001) when compared with the CORE scheme. Odds ratios for a R1 resection (3.74, 1.94, 1.14; P = .003) or CRM+ resection (3.78, 2.73, 1.34; P = .001) were also in favor of the CORE. Hazard ratios for CSS were significantly better for the CORE scheme. CONCLUSIONS: Downstaging with neoadjuvant treatment results in an increased number of radical resections. In our study, the combination of capecitabine and oxaliplatin appears to be the most effective regimen for locally advanced rectal cancer tumors. However, longer follow-up will be necessary to confirm this conclusion.