Evolution in Laparoscopic Gastrectomy From a Randomized Controlled Trial Through National Clinical Practice.

OBJECTIVE: To examine the influence of the LOGICA RCT (randomized controlled trial) upon the practice and outcomes of laparoscopic gastrectomy within the Netherlands. BACKGROUND: Following RCTs the dissemination of complex interventions has been poorly studied. The LOGICA RCT included 10 Dutch centers and compared laparoscopic to open gastrectomy. METHODS: Data were obtained from the Dutch Upper Gastrointestinal Cancer Audit (DUCA) on all gastrectomies performed in the Netherlands (2012-2021), and the LOGICA RCT from 2015 to 2018. Multilevel multivariable logistic regression analyses were performed to assess the effect of laparoscopic versus open gastrectomy upon clinical outcomes before, during, and after the LOGICA RCT. RESULTS: Two hundred eleven patients from the LOGICA RCT (105 open vs 106 laparoscopic) and 4131 patients from the DUCA data set (1884 open vs 2247 laparoscopic) were included. In 2012, laparoscopic gastrectomy was performed in 6% of patients, increasing to 82% in 2021. No significant effect of laparoscopic gastrectomy on postoperative clinical outcomes was observed within the LOGICA RCT. Nationally within DUCA, a shift toward a beneficial effect of laparoscopic gastrectomy upon complications was observed, reaching a significant reduction in overall [adjusted odds ratio (aOR):0.62; 95% CI: 0.46-0.82], severe (aOR: 0.64; 95% CI: 0.46-0.90) and cardiac complications (aOR: 0.51; 95% CI: 0.30-0.89) after the LOGICA trial. CONCLUSIONS: The wider benefits of the LOGICA trial included the safe dissemination of laparoscopic gastrectomy across the Netherlands. The robust surgical quality assurance program in the design of the LOGICA RCT was crucial to facilitate the national dissemination of the technique following the trial and reducing potential patient harm during surgeons learning curve.

Pain and Opioid Consumption After Laparoscopic Versus Open Gastrectomy for Gastric Cancer: A Secondary Analysis of a Multicenter Randomized Clinical Trial (LOGICA-Trial).

BACKGROUND: Laparoscopic gastrectomy could reduce pain and opioid consumption, compared to open gastrectomy. However, it is difficult to judge the clinical relevance of this reduction, since these outcomes are reported in few randomized trials and in limited detail. METHODS: This secondary analysis of a multicenter randomized trial compared laparoscopic versus open gastrectomy for resectable gastric adenocarcinoma (cT1-4aN0-3bM0). Postoperative pain was analyzed by opioid consumption in oral morphine equivalents (OME, mg/day) at postoperative day (POD) 1-5, WHO analgesic steps, and Numeric Rating Scales (NRS, 0-10) at POD 1-10 and discharge. Regression and mixed model analyses were performed, with and without correction for epidural analgesia. RESULTS: Between 2015 and 2018, 115 patients in the laparoscopic group and 110 in the open group underwent surgery. Some 16 patients (14%) in the laparoscopic group and 73 patients (66%) in the open group received epidural analgesia. At POD 1-3, mean opioid consumption was 131, 118, and 53 mg OME lower in the laparoscopic group, compared to the open group, respectively (all p < 0.001). After correcting for epidural analgesia, these differences remained significant at POD 1-2 (47 mg OME, p = 0.002 and 69 mg OME, p < 0.001, respectively). At discharge, 27% of patients in the laparoscopic group and 43% patients in the open group used oral opioids (p = 0.006). Mean highest daily pain scores were between 2 and 4 at all PODs, < 2 at discharge, and did not relevantly differ between treatment arms. CONCLUSION: In this multicenter randomized trial, postoperative pain was comparable between laparoscopic and open gastrectomy. After laparoscopic gastrectomy, this was generally achieved without epidural analgesia and with fewer opioids. TRIAL REGISTRATION: NCT02248519.

Cost-effectiveness of Laparoscopic vs Open Gastrectomy for Gastric Cancer: An Economic Evaluation Alongside a Randomized Clinical Trial.

Importance: Laparoscopic gastrectomy is rapidly being adopted worldwide as an alternative to open gastrectomy to treat gastric cancer. However, laparoscopic gastrectomy might be more expensive as a result of longer operating times and more expensive surgical materials. To date, the cost-effectiveness of both procedures has not been prospectively evaluated in a randomized clinical trial. Objective: To evaluate the cost-effectiveness of laparoscopic compared with open gastrectomy. Design, Setting, and Participants: In this multicenter randomized clinical trial of patients undergoing total or distal gastrectomy in 10 Dutch tertiary referral centers, cost-effectiveness data were collected alongside a multicenter randomized clinical trial on laparoscopic vs open gastrectomy for resectable gastric adenocarcinoma (cT1-4aN0-3bM0). A modified societal perspective and 1-year time horizon were used. Costs were calculated on the individual patient level by using hospital registry data and medical consumption and productivity loss questionnaires. The unit costs of laparoscopic and open gastrectomy were calculated bottom-up. Quality-adjusted life-years (QALYs) were calculated with the EuroQol 5-dimension questionnaire, in which a value of 0 indicates death and 1 indicates perfect health. Missing questionnaire data were imputed with multiple imputation. Bootstrapping was performed to estimate the uncertainty surrounding the cost-effectiveness. The study was conducted from March 17, 2015, to August 20, 2018. Data analyses were performed between September 1, 2020, and November 17, 2021. Interventions: Laparoscopic vs open gastrectomy. Main Outcomes and Measures: Evaluations in this cost-effectiveness analysis included total costs and QALYs. Results: Between 2015 and 2018, 227 patients were included. Mean (SD) age was 67.5 (11.7) years, and 140 were male (61.7%). Unit costs for initial surgery were calculated to be €8124 (US $8087) for laparoscopic total gastrectomy, €7353 (US $7320) for laparoscopic distal gastrectomy, €6584 (US $6554) for open total gastrectomy, and €5893 (US $5866) for open distal gastrectomy. Mean total costs after 1-year follow-up were €26 084 (US $25 965) in the laparoscopic group and €25 332 (US $25 216) in the open group (difference, €752 [US $749; 3.0%]). Mean (SD) QALY contributions during 1 year were 0.665 (0.298) in the laparoscopic group and 0.686 (0.288) in the open group (difference, -0.021). Bootstrapping showed that these differences between treatment groups were relatively small compared with the uncertainty of the analysis. Conclusions and Relevance: Although the laparoscopic gastrectomy itself was more expensive, after 1-year follow-up, results suggest that differences in both total costs and effectiveness were limited between laparoscopic and open gastrectomy. These results support centers' choosing, based on their own preference, whether to (de)implement laparoscopic gastrectomy as an alternative to open gastrectomy.

Body Composition Is a Predictor for Postoperative Complications After Gastrectomy for Gastric Cancer: a Prospective Side Study of the LOGICA Trial.

PURPOSE: There is a lack of prospective studies evaluating the effects of body composition on postoperative complications after gastrectomy in a Western population with predominantly advanced gastric cancer. METHODS: This is a prospective side study of the LOGICA trial, a multicenter randomized trial on laparoscopic versus open gastrectomy for gastric cancer. Trial patients who received preoperative chemotherapy followed by gastrectomy with an available preoperative restaging abdominal computed tomography (CT) scan were included. The CT scan was used to calculate the mass (M) and radiation attenuation (RA) of skeletal muscle (SM), visceral adipose tissue (VAT), and subcutaneous adipose tissue (SAT). These variables were expressed as Z-scores, depicting how many standard deviations each patient's CT value differs from the sex-specific study sample mean. Primary outcome was the association of each Z-score with the occurrence of a major postoperative complication (Clavien-Dindo grade ≥ 3b). RESULTS: From 2015 to 2018, a total of 112 patients were included. A major postoperative complication occurred in 9 patients (8%). A high SM-M Z-score was associated with a lower risk of major postoperative complications (RR 0.47, 95% CI 0.28-0.78, p = 0.004). Furthermore, high VAT-RA Z-scores and SAT-RA Z-scores were associated with a higher risk of major postoperative complications (RR 2.82, 95% CI 1.52-5.23, p = 0.001 and RR 1.95, 95% CI 1.14-3.34, p = 0.015, respectively). VAT-M, SAT-M, and SM-RA Z-scores showed no significant associations. CONCLUSION: Preoperative low skeletal muscle mass and high visceral and subcutaneous adipose tissue radiation attenuation (indicating fat depleted of triglycerides) were associated with a higher risk of developing a major postoperative complication in patients treated with preoperative chemotherapy followed by gastrectomy.

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.

Laparoscopic Versus Open Gastrectomy for Gastric Cancer (LOGICA): A Multicenter Randomized Clinical Trial.

BACKGROUND: The oncological efficacy and safety of laparoscopic gastrectomy are under debate for the Western population with predominantly advanced gastric cancer undergoing multimodality treatment. METHODS: In 10 experienced upper GI centers in the Netherlands, patients with resectable (cT1-4aN0-3bM0) gastric adenocarcinoma were randomly assigned to either laparoscopic or open gastrectomy. No masking was performed. The primary outcome was hospital stay. Analyses were performed by intention to treat. It was hypothesized that laparoscopic gastrectomy leads to shorter hospital stay, less postoperative complications, and equal oncological outcomes. RESULTS: Between 2015 and 2018, a total of 227 patients were randomly assigned to laparoscopic (n = 115) or open gastrectomy (n = 112). Preoperative chemotherapy was administered to 77 patients (67%) in the laparoscopic group and 87 patients (78%) in the open group. Median hospital stay was 7 days (interquartile range, 5-9) in both groups (P = .34). Median blood loss was less in the laparoscopic group (150 v 300 mL, P < .001), whereas mean operating time was longer (216 v 182 minutes, P < .001). Both groups did not differ regarding postoperative complications (44% v 42%, P = .91), in-hospital mortality (4% v 7%, P = .40), 30-day readmission rate (9.6% v 9.1%, P = 1.00), R0 resection rate (95% v 95%, P = 1.00), median lymph node yield (29 v 29 nodes, P = .49), 1-year overall survival (76% v 78%, P = .74), and global health-related quality of life up to 1 year postoperatively (mean differences between + 1.5 and + 3.6 on a 1-100 scale; 95% CIs include zero). CONCLUSION: Laparoscopic gastrectomy did not lead to a shorter hospital stay in this Western multicenter randomized trial of patients with predominantly advanced gastric cancer. Postoperative complications and oncological efficacy did not differ between laparoscopic gastrectomy and open gastrectomy.

Fit4SurgeryTV At-home Prehabilitation for Frail Older Patients Planned for Colorectal Cancer Surgery: A Pilot Study.

OBJECTIVE: The preoperative phase is a potential window of opportunity. Although frail elderly patients are known to be more prone to postoperative complications, they are often not considered capable of accomplishing a full prehabilitation program. The aim of this study was to assess the feasibility of Fit4SurgeryTV, an at-home prehabilitation program specifically designed for frail older patients with colorectal cancer. DESIGN: The Fit4SurgeryTV program consisted of a daily elderly adapted computer-supported strength training workout and two protein-rich meals. Frail patients 70 yrs or older with colorectal cancer were included. The program was considered feasible if 80% of the patients would be able to complete 70% of the program. RESULTS: Fourteen patients (median age, 79 yrs; 5 males) participated. At baseline, 86% patients were physically impaired and 64% were at risk for malnourishment. The median duration of the program was 26 days. The program was feasible as patients followed the exercises for 6 (86%) of 7 days and prepared the recipes 5 (71%) of 7 d/wk. Patients specifically appreciated at-home exercises. CONCLUSIONS: This study showed that at-home prehabilitation in frail older patients with colorectal cancer is feasible. As a result, patients might be fitter for surgery and might recover faster. The perioperative period could serve as a pivotal time point in reverting complications of immobility.

Oral Nutrition as a Form of Pre-Operative Enhancement in Patients Undergoing Surgery for Colorectal Cancer: A Systematic Review.

BACKGROUND: Nutritional status has major impacts on the outcome of surgery, in particular in patients with cancer. The aim of this review was to assess the merit of oral pre-operative nutritional support as a part of prehabilitation in patients undergoing surgery for colorectal cancer. METHODS: A systematic literature search and meta-analysis was performed according to the Preferred Reporting of Systematic Reviews and Meta-Analyses (PRISMA) recommendations in order to review all trials investigating the effect of oral pre-operative nutritional support in patients undergoing colorectal surgery. The primary outcome was overall complication rate. Secondary outcomes were incision infection rate, anastomotic leakage rate, and length of hospital stay. RESULTS: Five randomized controlled trials and one controlled trial were included. The studies contained a total of 583 patients with an average age of 63 y (range 23-88 y), of whom 87% had colorectal cancer. Malnourishment rates ranged from 8%-68%. All investigators provided an oral protein supplement. Overall patient compliance rates ranged from 72%-100%. There was no significant reduction in the overall complication rate in the interventional groups (odds ratio 0.82; 95% confidence interval 0.52 - 1.25). CONCLUSION: Current studies are too heterogeneous to conclude that pre-operative oral nutritional support could enhance the condition of patients undergoing colorectal surgery. Patients at risk have a relatively lean body mass deficit (sarcopenia) rather than an absolute malnourished status. Compliance is an important element of prehabilitation. Targeting patients at risk, combining protein supplements with strength training, and defining standardized patient-related outcomes will be essential to obtain satisfactory results.

Comprehensive evaluation of endoscopic fundoplication using the EsophyX™ device.

BACKGROUND: There are limited studies that evaluate the efficacy of endoscopic fundoplication (EF) for gastroesophageal reflux disease (GERD) with the EsophyX™ device, especially with the most recent procedural iteration (TIF-2). This study was a prospective evaluation of our early experience with this device and procedure. METHODS: Data were collected prospectively on 23 consecutive patients undergoing EF (March 2009 to August 2010). All patients completed a symptom questionnaire assessing frequency and severity of gastrointestinal and respiratory symptoms, 24-h pH, and manometry studies preoperatively and were encouraged to repeat these at 6 months. RESULTS: All patients had abnormal pH studies and were on proton-pump inhibitor (PPI) therapy prior to EF. Median age was 47 years (19-62 years), and six (23%) were male. Nine (41%) patients had Body Mass Index (BMI) ≥ 30 kg/m(2), and three (14%) had a small hiatal hernia (≤ 2 cm). The procedure was aborted in two patients for retained food. Three patients underwent subsequent laparoscopic Nissen fundoplication for persistent or recurrent symptoms. Median hospitalization was 1 day, and there were no major perioperative complications. At 6 month follow-up, 19 (86%) patients completed a symptom questionnaire, and 14 (64%) and 11 (50%) patients underwent pH and manometry studies, respectively. There was a significant reduction in heartburn (P = 0.02), total percentage acid contact time (P = 0.002), DeMeester score (P = 0.002), and PPI use (P = 0.003). Overall, 8 out of 14 (57%) patients had abnormal pH studies and 11 out of 19 (58%) remained on PPI therapy at 6 months. CONCLUSION: EF with EsophyX™ is associated with significant reduction in heartburn and abnormal acid exposure at 6 months, although the majority of patients did not experience normalization of their pH studies and remained on PPI therapy. The procedure has an acceptable safety profile, but the question remains as to whether it is effective enough to warrant a place in the armamentarium for the treatment of GERD.

The safety of biologic mesh for laparoscopic repair of large, complicated hiatal hernia.

BACKGROUND: Biologic mesh is widely used for repair of large, complicated hiatal hernias. Recently, there have been reports of complications after its implantation. We studied the course of a large group of patients who had undergone hiatal hernia repair with use of biologic mesh to determine the rate of immediate and late complications related to its use. METHODS: All patients who had biologic mesh placed at the hiatus and who had been followed for at least 1 year were included. Perioperative data were reviewed, and a questionnaire was administered, designed to identify symptoms of gastroesophageal reflux, other symptoms such as dysphagia, and all other operative or endoscopic interventions that occurred after mesh implantation. In addition, postoperative radiologic and endoscopic studies were reviewed to assess signs of complications related to use of mesh. RESULTS: There were 126 patients eligible for the study. We were able to contact 73 of these patients, at median follow-up of 45 months. No mesh-related complications were found. The frequency and severity of heartburn, regurgitation, and dysphagia improved significantly compared with preoperative values, and 89% of the patients reported good to excellent results in terms of overall satisfaction. Six patients recorded worsening of dysphagia postoperatively, but after careful work-up and review of each individual case, no case seemed to be directly related to the mesh. No erosions, strictures, or other complications directly related to use of mesh were found. One patient required reoperation due to hiatal hernia recurrence with gastroesophageal reflux disease (GERD) symptoms. CONCLUSIONS: Use of biologic mesh for laparoscopic repair of large, complicated hiatal hernias appears safe. There were no major complications related to the mesh, and overall satisfaction with the operation was very good.

Barrett's esophagus: surgical treatments.

The following on surgical treatments for Barrett's esophagus includes commentaries on the indications for antireflux surgery after medical treatment; the effects of the various procedures on the lower esophageal sphincter; the role of impaired esophageal motility and delayed gastric emptying in the choice of the surgical procedure; indications for associated highly selective vagotomy, duodenal switch, and gastric electrical stimulation; therapeutic strategies for detection and treatment of shortened esophagus; the role of antireflux surgery on the regression of metaplastic mucosa and the risk of malignant progression; the detection of asymptomatic reflux brfore bariatric surgery; the role of non-GERD symptoms on the results of surgery; and the indications of Collis gastroplasty and choice of the type of fundoplication.

Effect of medical and surgical treatment of Barrett's metaplasia.

Barrett's esophagus (BE) is a change in the esophageal mucosa as a result of long-standing gastroesophageal reflux disease. The importance of BE is that it is the main risk factor for the development of esophageal adenocarcinoma, whose incidence is currently growing faster than any other cancer in the Western world. The aim of this review was to compare the common treatment modalities of BE, with the focus on proton pump inhibitors and operative fundoplication. We performed a literature search on medical and surgical treatment of BE to determine eligible studies for this review. Studies on medical and surgical treatment of BE are discussed with regard to treatment effect on progression and regression of disease. Although there is some evidence for control of reflux with either medical or surgical therapy, there is no definitive evidence that either treatment modality decreases the risk of progression to dysplasia or cancer. Even though there is a trend toward antireflux surgery being superior, there are no definitive studies to prove this.

Bulging of the mesh after laparoscopic repair of ventral and incisional hernias.

BACKGROUND AND OBJECTIVES: To investigate the prevalence, diagnosis, clinical significance, and treatment strategies for bulging in the area of laparoscopic repair of ventral hernia that is caused by mesh protrusion through the hernia opening, but with intact peripheral fixation of the mesh and actually a still sufficient repair. METHODS: Medical records of all 765 patients who underwent laparoscopic ventral hernia repair were reviewed, and all patients with a swelling in the repaired area were identified and analyzed. RESULTS: Twenty-nine patients were identified. They all underwent a computed tomography assessment. Seventeen patients (2.2% of the total group) had a hernia recurrence; in an additional 12 patients (1.6%), radiologic examinations indicated only bulging of the mesh but no recurrence. Bulging was associated with pain in 4 patients who underwent relaparoscopy and got a new, larger mesh tightly stretched over the entire previous repair. Eight asymptomatic patients decided on "watchful waiting." All patients remained symptom free during a median follow-up of 22 months. CONCLUSION: Symptomatic bulging, though not a recurrence, requires a new repair and must be considered as an important negative outcome of laparoscopic ventral hernia repair. In asymptomatic patients, "watchful waiting" seems justified.

Recurrences after laparoscopic repair of ventral and incisional hernia: lessons learned from 505 repairs.

BACKGROUND: All hernia recurrences in a series of 505 patients who underwent laparoscopic repair of a ventral hernia (n=291) or incisional hernia (n=214) were analyzed to identify factors responsible for the recurrence. METHODS: In all laparoscopic repairs, an expanded polytetrafluoroethylene prosthesis overlapping the hernia margins by >or=3 cm was fixed with a double ring of tacks alone (n=206) or with tacks as well as sutures (n=299). During the mean follow-up time of 31.3 +/- 18.4 months, nine patients (1.8%) had a recurrence, eight of which were repaired laparoscopically. Operative reports and videotapes of all initial repairs and repairs of recurrences were analyzed. RESULTS: All recurrences followed an incisional hernia repair (p<0.001). Five recurrences developed after mesh fixation with both tacks and sutures and four after mesh fixation with tacks alone (p=1.0). All recurrences were at the site of the apparently sufficient original incision scar: in eight patients, the recurrent hernia was attached to the mesh; in one, it developed in another part of the scar. All initial repairs had been performed without technical errors. Upon repair of the recurrences, a new, larger mesh was placed over the entire incision, not just the hernia. There were no re-recurrences during follow-up (mean 19.8+/-10.3 months). CONCLUSIONS: Recurrence after incisional hernia repair appears to be due primarily to disregard for the principle that the whole incision--not just the hernia--must be repaired. Our experience supports the idea that the entire incision has a potential for hernia development. Insufficient coverage of the incision scar is a risk factor for recurrence after laparoscopic repair of ventral and incisional hernia.

Removal of transabdominal sutures for chronic pain after laparoscopic ventral and incisional hernia repair.

Some patients who have undergone laparoscopic repair of ventral and incisional hernia have persistent postoperative pain, assumed to be caused by the presence of transabdominal sutures (TAS). We investigated whether removal of these sutures relieves discomfort. Of 375 patients who underwent laparoscopic repair of ventral and incisional hernia, 6 patients (1.6%) had persistent pain resistant to conservative therapy. These patients underwent relaparoscopy and removal of TAS at all apparent pain sites. Postoperatively, 3 patients had complete pain relief. Two patients had some improvement but moderate, less localized, pain remained. The sixth patient experienced no change at all. Removal of TAS deemed responsible for pain may occasionally provide relief, but the results of removal seem unpredictable and less effective than previously assumed.

Compartment syndrome of the lower leg after surgery in the modified lithotomy position: report of seven cases.

PURPOSE: Acute compartment syndrome is known to develop after trauma or after postischemic revascularization. It also can occur when a patient has been lying in the lithotomy position during prolonged surgery. Methods were searched for the prevention of this iatrogenic complication after a series of seven patients who developed compartment syndrome after surgery at our hospital. METHODS: A series of seven consecutive patients who developed compartment syndrome of the lower leg(s) after abdominoperineal surgical procedures from 1997 to 2002 is presented and so are the lessons learned to prevent this problem. RESULTS: When comparing our experiences with data from literature, the seven patients had the usual risk factors for development of a compartment syndrome: lengthy procedure (>5 hours); decreased perfusion of the lower leg because of Trendelenburg positioning combined with the lithotomy position; and external compression of the lower legs (because of positioning, stirrups, or antiembolism stockings). Measures have been taken to prevent compartment syndrome from developing after prolonged surgery in the lithotomy position. This complication has not occurred again after the introduction of these measures two years ago. CONCLUSIONS: Acute compartment syndrome can be prevented if adequate measures are taken, but after lengthy surgery, maximum alertness for emerging acute compartment syndrome remains indicated. Early diagnosis and treatment by four-compartment fasciotomy is still the only way to prevent irreversible damage.