SafeHeal Colovac Colorectal Anastomosis Protection Device evaluation (SAFE-2) pivotal study: an international randomized controlled study to evaluate the safety and effectiveness of the Colovac Colorectal Anastomosis Protection Device.

AIM: Although proximal faecal diversion is standard of care to protect patients with high-risk colorectal anastomoses against septic complications of anastomotic leakage, it is associated with significant morbidity. The Colovac device (CD) is an intraluminal bypass device intended to avoid stoma creation in patients undergoing low anterior resection. A preliminary study (SAFE-1) completed in three European centres demonstrated 100% protection of colorectal anastomoses in 15 patients, as evidenced by the absence of faeces below the CD. This phase III trial (SAFE-2) aims to evaluate the safety and effectiveness of the CD in a larger cohort of patients undergoing curative rectal cancer resection. METHODS: SAFE-2 is a pivotal, multicentre, prospective, open-label, randomized, controlled trial. Patients will be randomized in a 1:1 ratio to either the CD arm or the diverting loop ileostomy arm, with a recruitment target of 342 patients. The co-primary endpoints are the occurrence of major postoperative complications within 12 months of index surgery and the effectiveness of the CD in reducing stoma creation rates. Data regarding quality of life and patient's acceptance and tolerance of the device will be collected. DISCUSSION: SAFE-2 is a multicentre randomized, control trial assessing the efficacy and the safety of the CD in protecting low colorectal anastomoses created during oncological resection relative to standard diverting loop ileostomy. TRIAL REGISTRATION: NCT05010850.

Protocol of the LATFIA trial (Laser Assisted Treatment of Fistula in Ano): a multicentre, prospective, randomized controlled trial comparing fistula-tract laser closure (FiLaC™) with rectal advancement flap for high trans-sphincteric fistulas.

AIM: Anal fistula is one of the most common anal diseases, affecting between 1 and 3 per 10 000 people per year. Symptoms have a potentially severe effect on a patient's quality of life. Surgery is the mainstay of treatment, aiming to cure the fistula and preserve anal sphincter function. Rectal advancement flap (RAF) is currently the gold standard treatment but has recurrence rates varying between 20% and 50% and might lead to disturbance of continence. The aim of the trial described in this work is to discover if the minimally invasive fistula tract laser closure (FiLaC™) technique could achieve higher healing rates and a better functional outcome than RAF. METHOD: We will perform a randomized prospective multicentre noninferiority study of the treatment of high trans-sphincteric perianal fistulas, comparing FiLaC™ with RAF in terms of fistula healing, recurrence rate, functional outcome and quality of life. Primary and secondary fistula healing will be evaluated at 26 and 52 weeks' follow-up. Quality of life will be evaluated using the SF-36 questionnaire, the Faecal Incontinence Quality of Life Scale questionnaire and the Vaizey score at 3, 6, 12 and 26 weeks postoperatively. CONCLUSION: High trans-sphincteric fistulas have a potentially severe effect on a patient's quality of life. Classical treatment with RAF is a time-consuming invasive procedure. The LATFIA trial aims to compare FiLaC™ with the gold standard treatment with RAF. In case of noninferiority, FiLaC™ treatment could be standardized as a first line treatment for high trans-sphincteric fistulas. Better conservation of the patient's anal sphincter function could possibly be obtained. Likewise, we will report on the postoperative quality of life when applying these two techniques.

A systematic review of patient-derived tumor organoids generation from malignant effusions.

This review assesses the possibility of utilizing malignant effusions (MEs) for generating patient-derived tumor organoids (PDTOs). Obtained through minimally invasive procedures MEs broaden the spectrum of organoid sources beyond resection specimens and tissue biopsies. A systematic search yielded 11 articles, detailing the successful generation of 190 ME-PDTOs (122 pleural effusions, 54 malignant ascites). Success rates ranged from 33% to 100%, with an average of 84% and median of 92%. A broad and easily applicable array of techniques can be employed, encompassing diverse collection methods, variable centrifugation speeds, and the inclusion of approaches like RBC lysis buffer or centrifuged ME supernatants supplementation, enhancing the versatility and accessibility of the methodology. ME-PDTOs were found to recapitulate primary tumor characteristics and were primarily used for drug screening applications. Thus, MEs are a reliable source for developing PDTOs, emphasizing the need for further research to maximize their potential, validate usage, and refine culturing processes.

Ventral mesh rectopexy. Does a descending perineum impact functional results and quality of life?

PURPOSE: The impact of perineal descent (PD) on functional outcome and quality of life after ventral mesh rectopexy (VMR) is unknown. The purpose of this study was to analyze the effect of PD on the functional outcome and quality of life (QOL) after VMR. METHODS: A retrospective analysis was performed on fifty-five patients who underwent robotic VMR between 2018 and 2021. Pre and postoperative data along with radiological studies were gathered from a prospectively maintained database. The Cleveland Clinic Constipation score (CCCS), the Rome IV criteria and the 36-Item Short-Form Health Survey (SF-36), were used to measure functional results and QOL. RESULTS: All 55 patients (mean age 57.8 years) were female. Most patients had radiological findings of severe PD (n = 31) as opposed to mild/moderate PD (n = 24). CCCS significantly improved at 3 months and 1 year post-VMR (mean difference = -4.4 and -5.4 respectively, p < 0.001) with no significant difference between the two groups. The percentage of functional constipation Rome IV criteria only showed an improved outcome at 3 months for severe PD and at 1 year for mild/moderate PD (difference = -58.1% and -54.2% respectively, p < 0.05). Only the SF-36 subscale bodily pain significantly improved in the mild/moderate PD group (mean difference = 16.7, p = 0.002) 3 months post-VMR which subsided after one year (mean difference = 5.5, p = 0.068). CONCLUSION: Severe PD may impact the functional outcome of constipation without an evident effect on QOL after VMR. The results, however, remain inconclusive and further research is warranted.

Cost associated with diverting ostomy after rectal cancer surgery: a transnational analysis.

BACKGROUND: Diverting ileostomy and colostomy after total mesorectal excision reduces the risk of complications related to anastomotic leakages but is associated with a reduction in health-related quality of life and long-term economic consequences that are unknown. Our objective was to estimate the lifetime costs of stoma placement after rectal cancer resection in the U.S., England, and Germany. METHODS: Input parameters were derived from quasi-systematic literature searches. Decision-analytic models with survival from colorectal cancer-adjusted life tables and country-specific stoma reversal proportions were created for the three countries to calculate lifetime costs. Main cost items were stoma maintenance costs and reimbursement for reversal procedures. Discounting was applied according to respective national guidelines. Sensitivity analysis was conducted to explore the impact of parameter uncertainty onto the results. RESULTS: The cohort starting ages and median survival were 63 and 11.5 years for the U.S., 69 years and 8.5 years for England, and 71 and 6.5 years for Germany. Lifetime discounted stoma-related costs were $26,311, £9512, and €10,021, respectively. All three models were most sensitive to the proportion of ostomy reversal, age at baseline, and discount rate applied. CONCLUSION: Conservative model-based projections suggest that stoma care leads to significant long-term costs. Efforts to reduce the number of patients who need to undergo a diverting ostomy could result in meaningful cost savings.

Evaluation of the SafeHeal Colovac+ anastomosis protection device after low anterior resection for rectal cancer: the safe anastomosis feasibility evaluation (SAFE) 2019 trial.

BACKGROUND: Protective ileostomy (PI) is the current standard of care to protect the anastomosis after low anterior resection (LAR) for rectal cancer, but is associated with significant morbidity. Colovac is an anastomosis protection device designed to shield the anastomosis from fecal content. A second version (Colovac+) was developed to limit the migration risk during the implantation period. The objective of this clinical trial was to evaluate the preliminary efficacy and safety of the Colovac+. METHODS: This was a prospective, multicenter, pilot study aiming to enroll 15 patients undergoing LAR with Colovac+ placement. After 10 days, a CT scan was performed to evaluate the anastomosis and the Colovac+ was retrieved endoscopically. During the 10-day implantation and 3-month follow-up period, we collected data regarding predefined efficacy and safety endpoints. The primary endpoint was the rate of major (Clavien-Dindo III-V) postoperative complications related to the Colovac+ or LAR procedure. RESULTS: A total of 25 patients were included (68% male), of whom 15 were consecutively treated with the Colovac+ and Vacuum Loss Alert System. The Colovac+ was successfully implanted in all 15 patients. No major discomfort was reported during the implantation period. The endoscopic retrieval was performed in 14/15 (93%) patients. The overall major postoperative morbidity rate was 40%, but none of the reported complications were related to the Colovac+. A device migration occurred in 2 (13%) patients, but these were not associated with AL or stoma conversion. Overall, Colovac+ provided effective fecal diversion in all 15 patients and was able to avoid the PI in 11/15 (73%) patients. CONCLUSIONS: Colovac+ provides a safe and effective protection of the anastomosis after LAR, and avoids the PI in the majority (73%) of patients. The improved design reduces the overall migration rate and limits the clinical impact of a migration.

Low anterior resection syndrome (LARS) and quality of life after colectomy.

PURPOSE: Clinical experience shows complaints similar to LARS not only after rectal surgery, but even after other types of colorectal surgery. Our aim was to investigate the occurrence of LARS after several types of colorectal surgery and its impact on quality of life. METHODS: We included adult patients who underwent colorectal surgery at our centre from January 2016 until March 2019, regardless of indication. A questionnaire was sent evaluating LARS and quality of life. RESULTS: The questionnaire was answered by 119 patients. We noticed highest LARS-score after rectum surgery (26.1), but also surprisingly higher LARS-score after right-sided colectomy (21.0) compared to left-sided colectomy (16.4). We report lowest quality of life after rectal surgery, but higher quality of life in left colectomy compared to right colectomy. CONCLUSION: LARS-score did not significantly correlate with type of procedure; however, higher LARS-scores were noted after right-sided colectomy compared to left-sided colectomy with similar impact on quality of life. We suggest CORS (colorectal resection syndrome) as a more suiting conceptual name instead of LARS to describe functional bowel complaints after colorectal surgery.

Posterior compartment prolapse and perineal descent: systematic review of available support devices.

OBJECTIVE: The aim of our study is to systematically review the literature about available devices facilitating perineal support during defecation in patients with obstructive defecation syndrome (ODS) and posterior pelvic organ prolapse (POP). METHODS: We searched for the terms "defecat/ion or ODS" and" pessar/ies or device/aid/tool/perineal/perianal/prolapse and support" in MEDLINE, PubMed and Web of Science. Data abstraction was performed according to PRISMA (Preferred Reporting Items for Systematic reviews and Meta-analysis) guidelines. A two-stage inclusion was performed, selecting first on title and abstract and secondly the full text. For variables with sufficient data, a meta-analysis was performed using a random-effects model. Other variables were descriptively reported. RESULTS: Ten studies out of 1332 were included for systematic review. The devices could be categorized into three groups: pessaries (n = 8), vaginal stent (n = 1) and external support device (n = 1). Methodology and data reporting is heterogeneous. Meta-analysis could be performed for the Colorectal-Anal Distress Inventory (CRADI-8) and Impact Questionnaire (CRAI-Q-7) in three pessary studies which showed a significant mean change. Significant improvement of stool evacuation was seen in two other pessary studies. The vaginal stent significantly decreases ODS. Subjective perception of constipation improved significantly using the posterior perineal support device. CONCLUSION: All reviewed devices seem to improve ODS in patients with POP. There are no data on their efficacy with regard to perineal descent-associated ODS. There is a lack of comparative studies between devices. Studies are difficult to compare due to different inclusion criteria and evaluation tools.

Does minimally invasive laser-assisted treatment of pilonidal sinus disease live up to its expectations: a multi-center study with 226 patients.

PURPOSE: The minimally invasive character, the possibility to perform under local anesthesia, and the ease to repeat have led to increasing popularity of laser-assisted treatment of pilonidal sinus disease. Hereby, potentially avoiding prolonged need for medical care at home, incapacity to work, and high expenses for patients and society. This retrospective, multi-center study is aimed at evaluating the feasibility of laser-assisted treatment for pilonidal sinus disease. METHODS: The patient population is comprised of all patients undergoing laser-assisted treatment of pilonidal sinus disease at three Belgian hospitals between January 2017 and December 2021. Data were retrospectively collected. The primary endpoint was overall wound healing after one or more laser assisted procedures. RESULTS: A total of 226 patients were included with a mean follow-up time of 129 days [7-1120]. The healing rate after one laser procedure was 78.8%. Some of these patients were healed by a second or third procedure adding up to an overall healing rate of 85.4% after one or more laser procedures. Wound infections were the main postoperative complication (8.0%) of which 5 patients required drainage (2.2%). For 29 patients (12.8%), laser-assisted treatment was insufficient, leading to a secondary operation (drainage, excision, or flap). CONCLUSION: This study shows that laser-assisted treatment is feasible for pilonidal sinus disease. The minimally invasive character of this technique might make up for a higher non-healing rate compared to other techniques like flap repair. However, care must be taken that healing rate might be related to the presentation of the sinus and expectations should be lowered as presumed high healing rates are not always achieved.

An accidental finding of a giant intra-abdominal mass.

INTRODUCTION: Mesenteric cysts are rare intra-abdominal tumours often found incidentally on imaging studies or during surgery. The clinical presentation is various with most subjects being asymptomatic, but complications can occur such as torsion, rupture, hemorrhage or obstruction of nearby structures. The etiology of mesenteric cysts remains uncertain. Complete surgical resection is preferred, although there are no specific guidelines concerning optimal treatment strategy. CASE REPORT: We present a 61-year-old male with type 2 diabetes mellitus who underwent a routine abdominal ultrasound examination which accidentally uncovered a large mass. The patient had no complaints nor any physical discomfort. Magnetic resonance imaging and computed tomography revealed a giant thin-walled cyst with multiple septa spanning 24 × 24 cm2 originating from the mesentery. The primary differential diagnosis included a mesenteric cyst, a hydatid cyst due to echinococcus or malignancy. After multidisciplinary team approach, open surgical exploration was preferred. Surgical drainage and cyst sac resection were performed without any peri- or postoperative complications. Histopathology confirmed the presence of a large mesenteric cyst, probably caused post-traumatically. The patient has made a full recovery. CONCLUSION: Mesenteric cysts can develop asymptomatically and reach enormous proportions. They are often found accidentally. Imaging studies aid in the differential diagnosis, but histopathology remains the diagnostic gold standard. Surgical resection prevails compared to a conservative approach due to the risk of complications. The choice between open or laparoscopic surgery should be determined based on the perioperative risk.

BSW light, the first completely virtual surgical congress in Belgium: out of the box.

BACKGROUND: Due to the SARS-COV2 pandemic-related restrictions the 2020 Belgian Surgical Week (BSW) was organized as a virtual congress, being the first surgical, virtual congress in Belgium. Since this was a new experience and probably not the last, we aim to share our experience to assist other professionals in organizing their virtual events. METHODS: The 'BSW-light' was organized by the RBSS in collaboration with a Professional Congress Organizer (PCO), which is described in detail. Analytical data of the event were provided by the PCO and a UEMS 'live educational events participant evaluation form' based survey was sent out to all registered participants, using google forms, to evaluate the event. RESULTS: During 2 days, 78 prerecorded presentations were broadcasted in 2 virtual conference rooms, each followed by a live Q & A session. The plenary session on the third day contained 8 live presentations, both from Belgium and from abroad. A total of 503 people registered for the congress, of whom 224 trainees. Each session attracted 158 visitors on average, each spending an average of 73 min. Attendees were satisfied with the technical aspect of the virtual congress, but they preferred an event that is at least partially live. CONCLUSION: Although the 'BSW-light' proved to be successful, a preference to meet in real life remained. However, given its potential, we should keep an open mind towards integrating the advantages of a virtual meeting into a live event.

Functional outcome after Hartmann's reversal surgery using LARS, COREFO & QoL scores.

BACKGROUND: Functional complaints after colorectal surgery have a profound effect on quality of life (QoL). Our goal was to investigate the prevalence of functional complaints and quality of life after Hartmann's reversal surgery. METHOD: A cross-sectional study was performed where one hundred nineteen patients were included. All patients underwent Hartmann's reversal procedure between 2007 and 2019. All patients were asked to complete 3 validated questionnaires related to bowel function in benign and colorectal cancer surgery as well as general QoL. RESULTS: The response rate was 67%. Among responders, 32.8% reported LARS-like symptoms whereas 25% had significant COREFO Scores (>15). Higher LARS and COREFO scores were significantly associated with worse global QoL and several QoL domain scores (p < 0.05). CONCLUSION: This study highlights the prevalence of bowel dysfunction after Hartmann's reversal surgery. Patients undergoing this procedure show similar functional complaints compared to those in literature who had a resection without colostomy.

Rectocele: victim of availability bias? Results of a Belgian survey of colorectal and gynecological surgeons.

INTRODUCTION AND HYPOTHESIS: Women with a symptomatic rectocele may undergo different trajectories depending on the specialty consulted. This survey aims to evaluate potential differences between colorectal surgeons and gynecologists concerning the management of a rectocele. METHODS: A web-based survey was sent to abdominal surgeons (CS group) and gynecologists (G group) asking about their perceived definition, diagnostic workup, multidisciplinary discussion (MDT) and surgical treatment of rectoceles. The answers of both groups were analyzed with the chi-square test or Fisher's exact test at p < 0.050. RESULTS: A rectocele was defined as a prolapse of the posterior vaginal wall by 78% of the G and 41% of the CS group. All gynecologists and 49% of the CS group evaluated a rectocele clinically in dorsal decubitus, with 91% of gynecologists using a speculum and 65% using the Pelvic Organ Prolapse-Quantification (POP-Q) scoring system, compared to < 1/3 of colorectal surgeons. A digital rectal examination was performed by 90% of the CS group and 57% of the G group. A transvaginal ultrasound was only used by the G group, while anal manometry was opted for by the CS group (65%) and minimally by the G group (14%). In the G group, a posterior repair was the preferred surgical technique (78%), whereas 63% of the CS group preferred a rectopexy. Multidisciplinary discussions (MDT) were mostly organized ad hoc. CONCLUSIONS: An availability bias is seen in different aspects of rectocele evaluation and treatment. Colorectal surgeons and gynecologists are acting based on their training and experience. Motivation for pelvic floor MDT starts with creating awareness of the availability bias.

Evaluation of the SafeHeal Colovac+ Anastomosis Protection Device: A Preclinical Study.

BackgroundThe protective ostomy is the current standard of care to protect a low colorectal anastomosis from leakage, but exposes patients to complications requiring an alternative strategy. The Colovac+ is a vacuum-based intraluminal bypass device designed to shield the anastomosis from fecal content, preventing the clinical outcomes of anastomotic leakage. The objective of this study was to evaluate the preliminary efficacy, safety, and technical feasibility of the Colovac+ in a porcine model. Methods: Twelve pigs received a colorectal anastomosis with Colovac+ implantation. The device was left in situ for 10 days and then retrieved endoscopically. Six pigs were to be sacrificed immediately after device retrieval and the other 6 were to be sacrificed on day 38. Clinical, endoscopic, and histopathological examinations were performed to evaluate the following endpoints: prevention of contact between the anastomosis and fecal content, device migration, feasibility of the implantation and retrieval procedure, collateral damage to the colonic wall, colon healing after device retrieval, and systemic toxicity related to the device. Results: Eleven pigs completed the study. One pig died prematurely due to a surgical complication unrelated to the device (bladder damage with uroperitoneum). There was no evidence of contact between the anastomosis and fecal content, none of the pigs developed symptomatic anastomotic leakage, there were no significant device migrations, and there was no evidence of systemic toxicity. Colovac+ implantation was easily performed in all cases except 1 (due to an inappropriate lubricant). Colovac+ retrieval was achieved successfully in all cases. Postretrieval examinations on day 10 revealed ulcerations at the anchoring site in 4 cases indicating mechanical damage caused by the stent. However, in the recovery group, no ulcerations were observed on day 38, and the colonic wall had properly healed in all animals. Conclusions: The Colovac+ is a technically feasible, safe, and efficient device for the protection of a colorectal anastomosis in a porcine model. The device holds promise for clinical use and warrants further research.

Is length of the rectal stump predictive for postoperative outcome in Hartmann's reversal surgery? A multicenter experience of 105 consecutive cases.

PURPOSE: Although Hartmann's procedure is commonly performed, subsequent reversal is less frequent. The most common reasons for reversal surgery are advanced age, comorbidities, and perceived surgical difficulties. The main objective of this study was to investigate if the length of the rectal stump influences the outcome of Hartmann's reversal surgery. METHOD: We conducted a retrospective case study analyzing data from 105 patients who underwent Hartmann's reversal procedure between 2007 and 2019 in two centers. We evaluated patient demographics, length of rectal stump, intraoperative surgical details, short-term and long-term outcomes. RESULTS: From 2007 to 2019, 105 patients underwent Hartmann's reversal surgery. Short-term morbidity rate was 58% (61 patients), including 16% (17 patients) with severe postoperative complication (Clavien-Dindo ≥ 3). Anastomotic leakage rate was 2.9% (3 patients). Long-term complications were present in 41% (43 patients) of which abdominal wall defect was the most frequent complication. The mean length of the rectal stump was 15 cm. In almost 1 out of 5 patients (17%) the rectal stump was shorter than 10 cm. The three anastomotic leakages appeared in the long rectal stump group (3.6% vs. 0%, p = 0.273). The complication rate for patients with a short rectal stump was similar to those with a longer rectal stump (50% vs. 63%, p = 0.275). Smoking, high ASA score, obesity, and advanced age did not influence the outcomes of the reversal procedure either. CONCLUSION: Length of the rectal stump is not a predictive factor for postoperative complications after Hartmann's reversal surgery.

LekCheck: A Prospective Study to Identify Perioperative Modifiable Risk Factors for Anastomotic Leakage in Colorectal Surgery.

OBJECTIVE: To assess potentially modifiable perioperative risk factors for anastomotic leakage in adult patients undergoing colorectal surgery. SUMMARY BACKGROUND DATA: Colorectal anastomotic leakage (CAL) is the single most important denominator of postoperative outcome after colorectal surgery. To lower the risk of CAL, the current research focused on the association of potentially modifiable risk factors, both surgical and anesthesiological. METHODS: A consecutive series of adult patients undergoing colorectal surgery with primary anastomosis was enrolled from January 2016 to December 2018. Fourteen hospitals in Europe and Australia prospectively collected perioperative data by carrying out the LekCheck, a short checklist carried out in the operating theater as a time-out procedure just prior to the creation of the anastomosis to check perioperative values on 1) general condition 2) local perfusion and oxygenation, 3) contamination, and 4) surgery related factors. Univariate and multivariate logistic regression analysis were performed to identify perioperative potentially modifiable risk factors for CAL. RESULTS: There were 1562 patients included in this study. CAL was reported in 132 (8.5%) patients. Low preoperative hemoglobin (OR 5.40, P < 0.001), contamination of the operative field (OR 2.98, P < 0.001), hyperglycemia (OR 2.80, P = 0.003), duration of surgery of more than 3 hours (OR 1.86, P = 0.010), administration of vasopressors (OR 1.80, P = 0.010), inadequate timing of preoperative antibiotic prophylaxis (OR 1.62, P = 0.047), and application of epidural analgesia (OR, 1.81, P = 0. 014) were all associated with CAL. CONCLUSIONS: This study identified 7 perioperative potentially modifiable risk factors for CAL. The results enable the development of a multimodal and multidisciplinary strategy to create an optimal perioperative condition to finally lower CAL rates.

C-reactive protein (CRP) trajectory as a predictor of anastomotic leakage after rectal cancer resection: A multicentre cohort study.

AIM: This study aimed to identify whether CRP-trajectory measurement, including increase in CRP-level of 50 mg/l per day, is an accurate predictor of anastomotic leakage (AL) in patients undergoing resection for rectal cancer. METHODS: A prospective multicentre database was used. CRP was recorded on the first three postoperative days. Sensitivity, specificity, positive and negative predictive values, and area under the receiver operator characteristic (ROC) curve were used to analyse performances of CRP-trajectory measurements between postoperative day (POD) 1-2, 2-3, 1-3 and between any two days. RESULTS: A total of 271 patients were included in the study. AL was observed in 12.5% (34/271). Increase in CRP-level of 50 mg/l between POD 1-2 had a negative predictive value of 0.92, specificity of 0.71 and sensitivity of 0.57. Changes in CRP-levels between POD 2-3 were associated with a negative predictive value, specificity and sensitivity of 0.89, 0.93 and 0.26, respectively. Changes in CRP-levels between POD 1-3 showed a negative predictive value of 0.94, specificity of 0.76 and sensitivity of 0.65. In addition, 50 mg/l changes between any two days showed a negative predictive value of 0.92, specificity of 0.66 and sensitivity of 0.62. The area under the ROC curve for all CRP-trajectory measurements ranged from 0.593-0.700. CONCLUSION: The present study showed that CRP-trajectory between postoperative days lacks predictive value to singularly rule out AL. Early and safe discharge in patients undergoing rectal surgery for adenocarcinoma cannot be guaranteed based on this parameter. High negative predictive values are mainly caused by the relatively low prevalence of AL.

Impact of the first wave of the SARS-CoV-2/Covid-19 pandemic on digestive surgical activities: a Belgian National Survey.

BACKGROUND: Belgium was one of the first European countries affected by the first wave of the Covid-19 epidemic after Italy and France and has the highest rate of Covid-19-related deaths. Very few studies have evaluated the impact of the pandemic on surgical activity on a large scale. The primary objective of this national survey was to evaluate the impact of the first wave of the Covid-19 pandemic on surgical activities (elective non-oncological and oncological) in Belgian hospitals. METHODS: A nationwide, multicenter survey was conducted in Belgium by the Royal Belgian Surgical Society (RBSS) board. The questionnaire focused on digestive surgical activity at different time points: period 1 (P1), before the epidemic; period 2 (P2), lockdown; and period 3 (P3), after stabilization of the epidemic. RESULTS: The participation rate in the survey was 28.2% (24 out of 85 solicited hospitals), including 15 (62.5%) from the French speaking part of Belgium and 9 (37.5%) from the Flemish speaking part. Eighteen (75%) were non-academic and 6 (25%) were academic hospitals. All surgical activities were impacted by the Covid-19 pandemic except for the number of cholecystectomies. No statistical differences were observed between regions or according to the type of hospital. CONCLUSIONS: Our national survey confirms that the COVID-19 outbreak has severely impacted in-person consultations and surgical activity for benign and malignant disease and for acute appendicitis. However, procedures for benign disease were much more affected than those for malignancies.

Patient-derived organoids as individual patient models for chemoradiation response prediction in gastrointestinal malignancies.

Chemoradiotherapy (CRT) is an important treatment modality for specific gastrointestinal (GI) cancers, as it has been shown to improve clinical outcomes. Recent developments in the neoadjuvant setting such as wait-and-see strategies for rectal as well as for esophageal cancers have even proven that CRT might be an effective organ-sparing treatment. However, due to molecular heterogeneity, only a subset of patients will show a complete response to CRT, which addresses the need for an individualized treatment approach. In recent years, the demand for more physiologically relevant predictive in vitro models has fostered the development of patient-derived tumor organoids. In this review, we describe the current treatment options for patients with GI cancers who are treated with (neo)adjuvant CRT. Furthermore, we provide an in-depth discussion of the organoid technology in the context of predicting CRT response for GI cancers as well as possible challenges for clinical implementation.

Treatment of Fecal Incontinence With a Rechargeable Sacral Neuromodulation System: Efficacy, Clinical Outcome, and Ease of Use-Six-Month Follow-Up.

OBJECTIVE: Sacral neuromodulation is an effective treatment for fecal incontinence (FI) after conservative treatments have failed. A new rechargeable sacral neuromodulation system (r-SNM) includes a rechargeable implantable neurostimulator (INS). No data is available of the use of this technology in patients with fecal incontinence. MATERIALS AND METHODS: Fifteen patients with FI were implanted with the Axonics rechargeable SNM system in a single-stage implant procedure and prospectively followed. Primary outcome was fecal incontinence episodes at four weeks and six months measured with stools diary. Success was defined as at least 50% improvement of fecal incontinence episodes. Additionally, quality of life and ease of use were evaluated. RESULTS: At four weeks, 13 participants (87%) were test responders based on ≥50% reduction in FI episodes as documented on their bowel diary. Weekly FI episodes decreased from a median (25%-75% range) of 8 (5.8-20.3) at baseline to a median of 1.5 (0.4-4.5) at four weeks (p = 0.001), and 1.5 (0-2.6) at six months (p = 0.001), corresponding to 75% and 79% reduction in weekly FI episodes. Of the 13 subjects having ≥50% reduction in FI episodes at four weeks, 12 (PP = 92%) were therapy responders at six months. There were no unanticipated device or procedure-related adverse events. Mean time to recharge the system was 37 ± 3 min once or twice per week. All patients were moderately or very satisfied with the system and its effect. CONCLUSIONS: The r-SNM system provides safe and effective therapy in patients with FI at six months.