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.

Implementation and Outcome of Robotic Liver Surgery in the Netherlands: A Nationwide Analysis.

OBJECTIVE: To determine the nationwide implementation and surgical outcome of minor and major robotic liver surgery (RLS) and assess the first phase of implementation of RLS during the learning curve. BACKGROUND: RLS may be a valuable alternative to laparoscopic liver surgery. Nationwide population-based studies with data on implementation and outcome of RLS are lacking. METHODS: Multicenter retrospective cohort study including consecutive patients who underwent RLS for all indications in 9 Dutch centers (August 2014-March 2021). Data on all liver resections were obtained from the mandatory nationwide Dutch Hepato Biliary Audit (DHBA) including data from all 27 centers for liver surgery in the Netherlands. Outcomes were stratified for minor, technically major, and anatomically major RLS. Learning curve effect was assessed using cumulative sum analysis for blood loss. RESULTS: Of 9437 liver resections, 400 were RLS (4.2%) procedures including 207 minor (52.2%), 141 technically major (35.3%), and 52 anatomically major (13%). The nationwide use of RLS increased from 0.2% in 2014 to 11.9% in 2020. The proportion of RLS among all minimally invasive liver resections increased from 2% to 28%. Median blood loss was 150 mL (interquartile range 50-350 mL] and the conversion rate 6.3% (n=25). The rate of Clavien-Dindo grade ≥III complications was 7.0% (n=27), median length of hospital stay 4 days (interquartile range 2-5) and 30-day/in-hospital mortality 0.8% (n=3). The R0 resection rate was 83.2% (n=263). Cumulative sum analysis for blood loss found a learning curve of at least 33 major RLS procedures. CONCLUSIONS: The nationwide use of RLS in the Netherlands has increased rapidly with currently one-tenth of all liver resections and one-fourth of all minimally invasive liver resections being performed robotically. Although surgical outcomes of RLS in selected patient seem favorable, future prospective studies should determine its added value.

Nationwide Outcome after Pancreatoduodenectomy in Patients at very High Risk (ISGPS-D) for Postoperative Pancreatic Fistula.

OBJECTIVE: To assess nationwide surgical outcome after pancreatoduodenectomy (PD) in patients at very high risk for postoperative pancreatic fistula (POPF), categorized as ISGPS-D. SUMMARY BACKGROUND DATA: Morbidity and mortality after ISGPS-D PD is perceived so high that a recent randomized trial advocated prophylactic total pancreatectomy (TP) as alternative aiming to lower this risk. However, current outcomes of ISGPS-D PD remain unknown as large nationwide series are lacking. METHODS: Nationwide retrospective analysis including consecutive patients undergoing ISGPS-D PD (i.e., soft texture and pancreatic duct ≤3 mm), using the mandatory Dutch Pancreatic Cancer Audit (2014-2021). Primary outcome was in-hospital mortality and secondary outcomes included major morbidity (i.e., Clavien-Dindo grade ≥IIIa) and POPF (ISGPS grade B/C). The use of prophylactic TP to avoid POPF during the study period was assessed. RESULTS: Overall, 1402 patients were included. In-hospital mortality was 4.1% (n=57), which decreased to 3.7% (n=20/536) in the last 2 years. Major morbidity occurred in 642 patients (45.9%) and POPF in 410 (30.0%), which corresponded with failure to rescue in 8.9% (n=57/642). Patients with POPF had increased rates of major morbidity (88.0% vs. 28.3%; P<0.001) and mortality (6.3% vs. 3.5%; P=0.016), compared to patients without POPF. Among 190 patients undergoing TP, prophylactic TP to prevent POPF was performed in 4 (2.1%). CONCLUSION: This nationwide series found a 4.1% in-hospital mortality after ISGPS-D PD with 45.9% major morbidity, leaving little room for improvement through prophylactic TP. Nevertheless, given the outcomes in 30% of patients who develop POPF, future randomized trials should aim to prevent and mitigate POPF in this high-risk category.

Laparoscopic peritoneal lavage versus sigmoidectomy for perforated diverticulitis with purulent peritonitis: three-year follow-up of the randomised LOLA trial.

BACKGROUND: This study aimed to compare laparoscopic lavage and sigmoidectomy as treatment for perforated diverticulitis with purulent peritonitis during a 36 month follow-up of the LOLA trial. METHODS: Within the LOLA arm of the international, multicentre LADIES trial, patients with perforated diverticulitis with purulent peritonitis were randomised between laparoscopic lavage and sigmoidectomy. Outcomes were collected up to 36 months. The primary outcome of the present study was cumulative morbidity and mortality. Secondary outcomes included reoperations (including stoma reversals), stoma rates, and sigmoidectomy rates in the lavage group. RESULTS: Long-term follow-up was recorded in 77 of the 88 originally included patients, 39 were randomised to sigmoidectomy (51%) and 38 to laparoscopic lavage (49%). After 36 months, overall cumulative morbidity (sigmoidectomy 28/39 (72%) versus lavage 32/38 (84%), p = 0·272) and mortality (sigmoidectomy 7/39 (18%) versus lavage 6/38 (16%), p = 1·000) did not differ. The number of patients who underwent a reoperation was significantly lower for lavage compared to sigmoidectomy (sigmoidectomy 27/39 (69%) versus lavage 17/38 (45%), p = 0·039). After 36 months, patients alive with stoma in situ was lower in the lavage group (proportion calculated from the Kaplan-Meier life table, sigmoidectomy 17% vs lavage 11%, log-rank p = 0·0268). Eventually, 17 of 38 (45%) patients allocated to lavage underwent sigmoidectomy. CONCLUSION: Long-term outcomes showed that laparoscopic lavage was associated with less patients who underwent reoperations and lower stoma rates in patients alive after 36 months compared to sigmoidectomy. No differences were found in terms of cumulative morbidity or mortality. Patient selection should be improved to reduce risk for short-term complications after which lavage could still be a valuable treatment option.

Potential Risk and Safety Measures in Laparoscopy in COVID-19 Positive Patients.

Background. During the COVID-19 pandemic the question arises if laparoscopy, as an aerosol forming procedure, poses a potential risk for viral transmission of SARS-CoV-2 to healthcare workers. Methods. A literature search was conducted using PubMed, Embase and MEDLINE. Articles reporting information regarding COVID-19 or other relevant viruses and laparoscopy, surgical smoke, aerosols and viral transmission were included. Results. Although aerosols produced during laparoscopy do not originate from the respiratory tract, the main transmission route of SARS-CoV-2, research did show SARS-CoV-2 to be present in other body fluids. The transmission risk via this route is however considered very low. As previous research showed potential viral transmission during laparoscopy for viruses that spread through contaminated body fluids, there might be a potential risk of SARS-CoV-2 transmission during laparoscopy, albeit considered very small. Conclusion. Due to the small risk compared to widely known benefits of laparoscopy, there is no reason to replace laparoscopy by laparotomy due to COVID-19 infection. To avoid the potential small risk of viral transmission, additional safety measures are advised.

Long-term Outcome of Surgery Versus Conservative Management for Recurrent and Ongoing Complaints After an Episode of Diverticulitis: 5-year Follow-up Results of a Multicenter Randomized Controlled Trial (DIRECT-Trial).

OBJECTIVE: The aim of this study was to establish whether surgical or conservative treatment leads to a higher quality of life (QoL) in patients with recurring diverticulitis and/or ongoing complaints. SUMMARY OF BACKGROUND DATA: The 6 months' results of the DIRECT trial, a randomized trial comparing elective sigmoidectomy with conservative management in patients with recurring diverticulitis (>2 episodes within 2 years) and/or ongoing complaints (>3 months) after an episode of diverticulitis, demonstrated a significantly higher QoL after elective sigmoidectomy. The aim of the present study was to evaluate QoL at 5-year follow-up. METHODS: From January 2010 to June 2014, 109 patients were randomized to either elective sigmoidectomy (N = 53) or conservative management (N = 56). In the present study, the primary outcome was QoL measured by the Gastrointestinal Quality of Life Index (GIQLI) at 5-year follow-up. Secondary outcome measures were SF-36 score, Visual Analogue Score (VAS) pain score, EuroQol-5D-3L (EQ-5D-3L) score, morbidity, mortality, perioperative complications, and long-term operative outcome. RESULTS: At 5-year follow-up, mean GIQLI score was significantly higher in the operative group [118.2 (SD 21.0)] than the conservative group [108.5 (SD 20.0)] with a mean difference of 9.7 (95% confidence interval 1.7-17.7). All secondary QoL outcome measures showed significantly better results in the operative group, with a higher SF-36 physical (P = 0.030) and mental score (P = 0.010), higher EQ5D score (P = 0.016), and a lower VAS pain score (P = 0.011). Twenty-six (46%) patients in the conservative group ultimately required surgery due to severe ongoing complaints. Of the operatively treated patients, 8 (11%) patients had anastomotic leakage and reinterventions were required in 11 (15%) patients. CONCLUSION: Consistent with the short-term results of the DIRECT trial, elective sigmoidectomy resulted in a significantly increased QoL at 5-year follow-up compared with conservative management in patients with recurring diverticulitis and/or ongoing complaints. Surgeons should counsel these patients for elective sigmoidectomy weighing superior QoL, less pain, and lower risk of new recurrences against the complication risk of surgery.

Morbidity and mortality in complex robot-assisted hiatal hernia surgery: 7-year experience in a high-volume center.

INTRODUCTION: Published data regarding robot-assisted hiatal hernia repair are mainly limited to small cohorts. This study aimed to provide information on the morbidity and mortality of robot-assisted complex hiatal hernia repair and redo anti-reflux surgery in a high-volume center. MATERIALS AND METHODS: All patients that underwent robot-assisted hiatal hernia repair, redo hiatal hernia repair, and anti-reflux surgery between 2011 and 2017 at the Meander Medical Centre, Amersfoort, the Netherlands were evaluated. Primary endpoints were 30-day morbidity and mortality. Major complications were defined as Clavien-Dindo ≥ IIIb. RESULTS: Primary surgery 211 primary surgeries were performed by two surgeons. The median age was 67 (IQR 58-73) years. 84.4% of patients had a type III or IV hernia (10.9% Type I; 1.4% Type II; 45.5% Type III; 38.9% Type IV, 1.4% no herniation). In 3.3% of procedures, conversion was required. 17.1% of patients experienced complications. The incidence of major complications was 5.2%. Ten patients (4.7%) were readmitted within 30 days. Symptomatic early recurrence occurred in two patients (0.9%). The 30-day mortality was 0.9%. Redo surgery 151 redo procedures were performed by two surgeons. The median age was 60 (IQR 51-68) years. In 2.0%, the procedure was converted. The overall incidence of complications was 10.6%, while the incidence of major complications was 2.6%. Three patients (2.0%) were readmitted within 30 days. One patient (0.7%) experienced symptomatic early recurrence. No patients died in the 30-day postoperative period. CONCLUSIONS: This study provides valuable information on robot-assisted laparoscopic repair of primary or recurrent hiatal hernia and anti-reflux surgery for both patient and surgeon. Serious morbidity of 5.2% in primary surgery and 2.6% in redo surgery, in this large series with a high surgeon caseload, has to be outweighed by the gain in quality of life or relief of serious medical implications of hiatal hernia when counseling for surgical intervention.

Ergonomics in handheld and robot-assisted camera control: a randomized controlled trial.

BACKGROUND: Laparoscopic surgery potentially increases the physical burden to operating theater personnel and can cause physical discomfort. This study aims to evaluate if a robotic camera holder (AutoLap™ system) can improve ergonomics for the surgeon and the camera assistant during laparoscopic procedures. METHODS: A total of thirty cases were included and randomized (15 AutoLap™, 15 control). Five types of surgery were included: right hemicolectomy, fundoplication, sigmoid resection, rectopexy, and low anterior resection. The posture of the surgeon and assistant was photographed during predefined steps of the procedure. MATLAB was used to calculate angles relevant for the RULA score. The RULA score is a validated method to evaluate body posture, force and repetition of the upper extremities. Two investigators assessed the RULA score independently. Three subjective questionnaires (SMEQ, NASA TLX, and LED) were used to assess mental and physical discomfort. RESULTS: No differences in patient characteristics were observed. Sixteen fundoplications, seven right hemicolectomies, five sigmoid resections, one rectopexy, and one low anterior resection were included. The mean RULA score of the surgeon was comparable in both groups, 2.58 (AutoLap™) versus 2.72 (control). The mean RULA score of the assistant was significantly different in both groups, with 2.55 (AutoLap™) versus 3.70 (control) (p = 0.001). The inter-observer variability (ICC) was excellent with 0.93 (surgeon) and 0.97 (assistant). The questionnaires showed a significant difference in physical discomfort for the assistant. The LED and SMEQ score were significantly lower in the robotic group. The NASA TLX demonstrated a significant reduction in scores in all domains when using robotics with the exception of the mental domain. CONCLUSION: Use of the AutoLap™ system shows improvement in ergonomics and posture of the first assistant, and ergonomics of the surgeon are not affected. Furthermore, the subjective work load is significantly reduced by using a robotic camera holder. TRIAL REGISTRATION NUMBER: NCT0339960, https://clinicaltrials.gov/ct2/show/study/NCT03339960?term=autolap&rank=5 .

Implementation and outcome of minor and major minimally invasive liver surgery in the Netherlands.

BACKGROUND: While most of the evidence on minimally invasive liver surgery (MILS) is derived from expert centers, nationwide outcomes remain underreported. This study aimed to evaluate the implementation and outcome of MILS on a nationwide scale. METHODS: Electronic patient files were reviewed in all Dutch liver surgery centers and all patients undergoing MILS between 2011 and 2016 were selected. Operative outcomes were stratified based on extent of the resection and annual MILS volume. RESULTS: Overall, 6951 liver resections were included, with a median annual volume of 50 resections per center. The overall use of MILS was 13% (n = 916), which varied from 3% to 36% (P < 0.001) between centers. The nationwide use of MILS increased from 6% in 2011 to 23% in 2016 (P < 0.001). Outcomes of minor MILS were comparable with international studies (conversion 0-13%, mortality <1%). In centers which performed ≥20 MILS annually, major MILS was associated with less conversions (14 (11%) versus 41 (30%), P < 0.001), shorter operating time (184 (117-239) versus 200 (139-308) minutes, P = 0.010), and less overall complications (37 (30%) versus 58 (42%), P = 0.040). CONCLUSION: The nationwide use of MILS is increasing, although large variation remains between centers. Outcomes of major MILS are better in centers with higher volumes.

Development and validation of a diagnostic prediction model distinguishing complicated from uncomplicated diverticulitis.

OBJECTIVES: Most diverticulitis patients (80%) who are referred to secondary care have uncomplicated diverticulitis (UD) which is a self-limiting disease and can be treated at home. The aim of this study is to develop a diagnostic model that can safely rule out complicated diverticulitis (CD) based on clinical and laboratory parameters to reduce unnecessary referrals. METHODS: A retrospective cross-sectional study was performed including all patients who presented at the emergency department with CT-proven diverticulitis. Patient characteristics, clinical signs and laboratory parameters were collected. CD was defined as > Hinchey 1A. Multivariable logistic regression analyses were used to quantify which (combination of) variables were independently related to the presence or absence of CD. A diagnostic prediction model was developed and validated to rule out CD. RESULTS: A total of 943 patients were included of whom 172 (18%) had CD. The dataset was randomly split into a derivation and validation set. The derivation dataset contained 475 patients of whom 82 (18%) patients had CD. Age, vomiting, generalized abdominal pain, change in bowel habit, abdominal guarding, C-reactive protein and leucocytosis were univariably related to CD. The final validated diagnostic model included abdominal guarding, C-reactive protein and leucocytosis (AUC 0.79 (95% CI 0.73-0.84)). At a CD risk threshold of ≤7.5% this model had a negative predictive value of 96%. CONCLUSION: This proposed prediction model can safely rule out complicated diverticulitis. Clinical practitioners could cautiously use this model to aid them in the decision whether or not to subject patients to further secondary care diagnostics or treatment.

Factors influencing health-related quality of life after gastrectomy for cancer.

AIM: Insight in health-related quality of life (HRQoL) may improve clinical decision making and inform patients about the long-term effects of gastrectomy. This study aimed to evaluate and identify factors associated with HRQoL after gastrectomy. METHODS: This cross-sectional study used prospective databases from seven Dutch centers (2001-2015) including patients who underwent gastrectomy for cancer. Between July 2015 and November 2016, European Organization for Research and Treatment of Cancer HRQoL questionnaires QLQ-C30 and QLQ-STO22 were sent to all surviving patients without recurrence. The QLQ-C30 scores were compared to a Dutch reference population using a one-sample t test. Spearman's rank test was used to correlate time after surgery to HRQoL, and multivariable linear regression was performed to identify factors associated with HRQoL. RESULTS: A total of 222 of 274 (81.0%) patients completed the questionnaires. Median follow-up was 29 months (range, 3-171) and 86.9% of patients had a follow-up >1 year. The majority of patients had undergone neoadjuvant treatment (64.4%) and total gastrectomy (52.7%). Minimally invasive gastrectomy (MIG) was performed in 50% of the patients. Compared to the general population, gastrectomy patients scored significantly worse on most functional and symptom scales (p < 0.001) and slightly worse on global HRQoL (78 vs. 74, p = 0.012). Time elapsed since surgery did not correlate with global HRQoL (Spearman's ρ = 0.06, p = 0.384). Distal gastrectomy, neoadjuvant treatment, and MIG were associated with better HRQoL (p < 0.050). CONCLUSION: After gastrectomy, patients encounter functional impairments and symptoms, but experience only a slightly impaired global HRQoL. Distal gastrectomy, the ability to receive neoadjuvant treatment, and MIG may be associated with HRQoL benefits.

First experience with THE AUTOLAP™ SYSTEM: an image-based robotic camera steering device.

BACKGROUND: Robotic camera holders for endoscopic surgery have been available for 20 years but market penetration is low. The current camera holders are controlled by voice, joystick, eyeball tracking, or head movements, and this type of steering has proven to be successful but excessive disturbance of surgical workflow has blocked widespread introduction. The Autolap™ system (MST, Israel) uses a radically different steering concept based on image analysis. This may improve acceptance by smooth, interactive, and fast steering. These two studies were conducted to prove safe and efficient performance of the core technology. METHODS: A total of 66 various laparoscopic procedures were performed with the AutoLap™ by nine experienced surgeons, in two multi-center studies; 41 cholecystectomies, 13 fundoplications including hiatal hernia repair, 4 endometriosis surgeries, 2 inguinal hernia repairs, and 6 (bilateral) salpingo-oophorectomies. The use of the AutoLap™ system was evaluated in terms of safety, image stability, setup and procedural time, accuracy of imaged-based movements, and user satisfaction. RESULTS: Surgical procedures were completed with the AutoLap™ system in 64 cases (97%). The mean overall setup time of the AutoLap™ system was 4 min (04:08 ± 0.10). Procedure times were not prolonged due to the use of the system when compared to literature average. The reported user satisfaction was 3.85 and 3.96 on a scale of 1 to 5 in two studies. More than 90% of the image-based movements were accurate. No system-related adverse events were recorded while using the system. CONCLUSION: Safe and efficient use of the core technology of the AutoLap™ system was demonstrated with high image stability and good surgeon satisfaction. The results support further clinical studies that will focus on usability, improved ergonomics and additional image-based features.

Robot-Assisted Ventral Mesh Rectopexy for Rectal Prolapse: A 5-Year Experience at a Tertiary Referral Center.

BACKGROUND: Laparoscopic ventral mesh rectopexy is being increasingly performed internationally to treat rectal prolapse syndromes. Robotic assistance appears advantageous for this procedure, but literature regarding robot-assisted ventral mesh rectopexy is limited. OBJECTIVE: The primary objective of this study was to assess the safety and effectiveness of robot-assisted ventral mesh rectopexy in the largest consecutive series of patients to date. DESIGN: This study is a retrospective cross-sectional analysis of prospectively collected data. SETTINGS: The study was conducted in a tertiary referral center. PATIENTS: All of the patients undergoing robot-assisted ventral mesh rectopexy for rectal prolapse syndromes between 2010 and 2015 were evaluated. MAIN OUTCOME MEASURES: Preoperative and postoperative (mesh and nonmesh) morbidity and functional outcome were analyzed. The actuarial recurrence rates were calculated using the Kaplan-Meier method. RESULTS: A total of 258 patients underwent robot-assisted ventral mesh rectopexy (mean ± SD follow-up = 23.5 ± 21.8 mo; range, 0.2 - 65.1 mo). There were no conversions and only 5 intraoperative complications (1.9%). Mortality (0.4%) and major (1.9%) and minor (<30 d) early morbidity (7.0%) were acceptably low. Only 1 (1.3%) mesh-related complication (asymptomatic vaginal mesh erosion) was observed. A significant improvement in obstructed defecation (78.6%) and fecal incontinence (63.7%) were achieved for patients (both p < 0.0005). At final follow-up, a new onset of fecal incontinence and obstructed defecation was induced or worsened in 3.9% and 0.4%. The actuarial 5-year external rectal prolapse and internal rectal prolapse recurrence rates were 12.9% and 10.4%. LIMITATIONS: This was a retrospective study including patients with minimal follow-up. No validated scores were used to assess function. The study was monocentric, and there was no control group. CONCLUSIONS: Robot-assisted ventral mesh rectopexy is a safe and effective technique to treat rectal prolapse syndromes, providing an acceptable recurrence rate and good symptomatic relief with minimal morbidity. See Video Abstract at http://links.lww.com/DCR/A427.

Efficacy of loop colostomy construction for acute left-sided colonic obstructions: a cohort analysis.

PURPOSE: Acute primary resection as treatment for left-sided colonic obstruction (LSCO) is notorious for its high morbidity and mortality rates. Both stenting and loop colostomy construction can serve as a bridge to surgery, hereby avoiding the high morbidity and mortality rates associated with emergency resections. This study aims to investigate the safety of a loop colostomy in patients presenting with acute LSCO. METHODS: Retrospective analysis of all patients that received a loop colostomy for LSCO between 2003 and 2015 was performed. Primary outcomes were mortality, major morbidity (Clavien-Dindo grades III-IV) and minor morbidity (Clavien-Dindo grades I-II). RESULTS: One hundred forty-six patients presenting with acute LSCO received a diverting colostomy. After colostomy construction, mortality occurred in four patients (2.7%) and major complications were reported in 20 patients (13.7%). In 61 patients, the diverting colostomy served as a palliative measure, because of metastatic disease or unfitness for major surgery. The remaining 85 patients all underwent delayed resection, resulting in an overall mortality, major morbidity and minor morbidity of 6.9% (n = 6), 14.0% (n = 12) and 26.7% (n = 23), respectively. CONCLUSIONS: Diverting colostomy construction is a minimally invasive and safe treatment option for LSCO. It can serve as a definite palliative measure, as well as a bridge to elective surgery. A diverting colostomy as a bridge to surgery might even be a valid alternative for emergency resections, since mortality and morbidity rates following colostomy construction and delayed resection appear lower than reported outcomes following primary resection.

Deviating colostomy construction versus stent placement as bridge to surgery for malignant left-sided colonic obstruction.

BACKGROUND: Acute colonic decompression using a deviating colostomy (DC) or a self-expandable metal stent (SEMS) has been shown to lead to fewer complications and permanent stomas compared to acute resection in elderly patients with malignant left-sided colonic obstruction (LSCO). However, no consensus exists on which decompression method is superior, especially in patients treated with curative intend. This retrospective study therefore aimed to compare both decompression methods in potentially curable LSCO patients. METHODS: All LSCO patients treated with curative intent between 2004 and 2013 in two teaching hospitals were retrospectively identified. In one institution, a DC was the standard of care, whereas in the other all patients were treated with SEMS. RESULTS: In total, 88 eligible LSCO patients with limited disease and curative treatment options were included; 51 patients had a SEMS placed and 37 patients a DC constructed. All patients eventually underwent a subsequent elective resection. In sum, 235 patients were excluded due to benign or inoperable disease. No significant differences were found for hospital stay, morbidity, disease-free and overall survival and mortality. Major complications were seen in 13/51 (25.5 %) patients in the SEMS group and were mostly due to stent dysfunction (n = 7). Also, one stent-related perforation occurred. Major complications occurred in 4/37 (10.8 %) patients in the DC group, including abdominal sepsis (n = 3) and wound dehiscence (n = 1). Long-term complication rate was significantly higher in the DC group (29.7 vs. 9.8 %, p = 0.01), mainly due to a high incisional hernia rate. Fewer patients had a temporary colostomy following elective resection after SEMS placement (62.2 vs. 17.6 %, p < 0.01). Permanent colostomy rate was not significantly different. CONCLUSION: SEMS and DC are both effective decompression methods for curable LSCO patients with comparable short- and long-term oncological outcomes; however, more surgical procedures are performed after DC due to an increased number of temporary colostomies and incisional hernia repairs.

Laparoscopic versus open gastrectomy for gastric cancer, a multicenter prospectively randomized controlled trial (LOGICA-trial).

BACKGROUND: For gastric cancer patients, surgical resection with en-bloc lymphadenectomy is the cornerstone of curative treatment. Open gastrectomy has long been the preferred surgical approach worldwide. However, this procedure is associated with considerable morbidity. Several meta-analyses have shown an advantage in short-term outcomes of laparoscopic gastrectomy compared to open procedures, with similar oncologic outcomes. However, it remains unclear whether the results of these Asian studies can be extrapolated to the Western population. In this trial from the Netherlands, patients with resectable gastric cancer will be randomized to laparoscopic or open gastrectomy. METHODS: The study is a non-blinded, multicenter, prospectively randomized controlled superiority trial. Patients (≥18 years) with histologically proven, surgically resectable (cT1-4a, N0-3b, M0) gastric adenocarcinoma and European Clinical Oncology Group performance status 0, 1 or 2 are eligible to participate in the study after obtaining informed consent. Patients (n = 210) will be included in one of the ten participating Dutch centers and are randomized to either laparoscopic or open gastrectomy. The primary outcome is postoperative hospital stay (days). Secondary outcome parameters include postoperative morbidity and mortality, oncologic outcomes, readmissions, quality of life and cost-effectiveness. DISCUSSION: In this randomized controlled trial laparoscopic and open gastrectomy are compared in patients with resectable gastric cancer. It is expected that laparoscopic gastrectomy will result in a faster recovery of the patient and a shorter hospital stay. Secondly, it is expected that laparoscopic gastrectomy will be associated with a lower postoperative morbidity, less readmissions, higher cost-effectiveness, better postoperative quality of life, but with similar mortality and oncologic outcomes, compared to open gastrectomy. The study started on 1 December 2014. Inclusion and follow-up will take 3 and 5 years respectively. Short-term results will be analyzed and published after discharge of the last randomized patient. TRIAL REGISTRATION: NCT02248519.

Diverticulitis in young versus elderly patients: a meta-analysis.

OBJECTIVE: To compare patients younger and older than 50 years with diverticulitis with regard to complications, disease recurrence and to the need for surgery. MATERIAL AND METHODS: A literature review and meta-analysis was conducted according to the PRISMA guidelines. MEDLINE, Embase and the Cochrane databases were searched for longitudinal cohort studies comparing patients younger and older than 50 years with diverticulitis. RESULTS: Eight studies were included with a total of 4.751 (male:female 1:0.66) patients younger and 18.328 (male:female 1:1.67) older than 50 years of age. The risk of developing at least one recurrent episode was significantly higher among patients younger than 50 years (pooled RR 1.73; 95% CI 1.40-2.13) with an estimated cumulative risk of 30% compared with 17.3% in older patients. The risk of requiring surgery during hospitalization for a primary episode of diverticulitis was equal in both age groups (pooled RR 0.99; 95% CI 0.74-1.32) and estimated at approximately 20%. Patients younger than 50 years more frequently required urgent surgery during hospitalization for a subsequent recurrent episode (pooled RR 1.46; 95% CI 1.29-1.66); the cumulative risk was 7.3% in younger and 4.9% in patients older than 50 years. CONCLUSION: Patients younger than 50 years only differ substantially in risk for recurrent disease from patients older than 50 years of age. Although the relative risk for requiring urgent surgery for recurrent disease was higher in younger patient, one should consider that the absolute risk difference is relatively small (7.3% vs. 4.9%).

Dietary restrictions for acute diverticulitis: evidence-based or expert opinion?

PURPOSE: Diet restrictions are usually advised as part of the conservative treatment for the acute phase of a diverticulitis episode. To date, the rationale behind diet restrictions has never been thoroughly studied. This study aims to investigate which factors influence the choice of dietary restriction at presentation. Additionally, the effect of dietary restrictions on hospitalization duration is investigated. METHODS: All patients hospitalized for Hinchey 0, Ia, or Ib diverticulitis between January 2010 and June 2011 were included. Patients were categorized according to the diet imposed by the treating physician at presentation and included nil per os, clear liquid, liquid diet, and solid foods. The relation between Hinchey classification, C-reactive protein, leucocyte count and temperature at presentation and diet choice was examined. Subsequently, the relation between diet restriction and number of days hospitalized was studied. RESULTS: Of the 256 patients included in the study 65 received nil per os, 89 clear liquid, 75 liquid diet, and 27 solid foods at presentation. Solely high temperature appeared to be related to a more restrictive diet choice at presentation. Patients who received liquid diet (HR 1.66 CI 1.19-2.33) or solid foods (HR 2.39 CI 1.52-3.78) were more likely to be discharged compared to patient who received clear liquid diet (HR 1.26 CI 1.52-3.78) or nils per os (reference group). This relation remained statistically significant after correction for disease severity, treatment and complications. CONCLUSION: Physicians appeared to prefer a more restrictive diet with increasing temperature at presentation. Notably, dietary restrictions prolong hospital stay.

Elective resection for ongoing diverticular disease significantly improves quality of life.

BACKGROUND: Although the risks of elective resection for diverticular disease are well studied, studies on subjective improvement are scarce. This study aims to investigate subjective improvement. METHODS: All patients who underwent elective resection for recurring or persisting complaints after an episode of diverticulitis were identified from an in-hospital database. Patients with at least 1 year of follow-up were sent visual analogue scales (VAS) to grade their quality of life (QoL) and the degree of discomfort caused by abdominal pain, abnormal defecation and fatigue before and after resection. RESULTS: One hundred and five patients responded to the questionnaire (response rate 76.6%). The median follow-up was 33 (15-53) months. Elective resection improved general QoL (median VAS improvement 40) and reduced discomfort caused by abdominal pain (median VAS improvement 60) in up to 89.3 and 87.5% of patients, respectively. The effects of elective resection are less profound for discomfort caused by abnormal defecation (77.1%, median VAS improvement 33) and fatigue (75.2%, median VAS improvement 30). CONCLUSION: Elective resection of the sigmoid for persisting or recurring symptoms after an episode of diverticulitis improves general QoL and discomfort caused by abdominal pain, abnormal defecation and fatigue in the vast majority of patients.