Short-course radiation followed by mFOLFOX-6 plus avelumab for locally-advanced rectal adenocarcinoma.

BACKGROUND: Current standard practice for locally advanced rectal cancer (LARC) entails a multidisciplinary approach that includes preoperative chemoradiotherapy, followed by total mesorectal excision, and then adjuvant chemotherapy. The latter has been accompanied by low compliance rates and no survival benefit in phase III randomized trials, so the strategy of administering neoadjuvant, rather than adjuvant, chemotherapy has been adapted by many trials, with improvement in pathologic complete response. Induction chemotherapy with oxaliplatin has been shown to have increased efficacy in rectal cancer, while short-course radiation therapy with consolidation chemotherapy increased short-term overall survival rate and decreased toxicity levels, making it cheaper and more convenient than long-course radiation therapy. This led to recognition of total neoadjuvant therapy as a valid treatment approach in many guidelines despite limited available survival data. With the upregulation (PDL-1) expression in rectal tumors after radiotherapy and the increased use of in malignant melanoma, the novel approach of combining immunotherapy with chemotherapy after radiation may have a role in further increasing pCR and improving overall outcomes in rectal cancer. METHODS: The study is an open label single arm multi- center phase II trial. Forty-four recruited LARC patients will receive 5Gy x 5fractions of SCRT, followed by 6 cycles of mFOLFOX-6 plus avelumab, before TME is performed. The hypothesis is that the addition of avelumab to mFOLFOX-6, administered following SCRT, will improve pCR and overall outcomes. The primary outcome measure is the proportion of patients who achieve a pCR, defined as no viable tumor cells on the excised specimen. Secondary objectives are to evaluate 3-year progression-free survival, tumor response to treatment (tumor regression grades 0 & 1), density of tumor-infiltrating lymphocytes, correlation of baseline Immunoscore with pCR rates and changes in PD-L1 expression. DISCUSSION: Recent studies show an increase in PD-L1 expression and density of CD8+ TILs after CRT in rectal cancer patients, implying a potential role for combinatory strategies using PD-L1- and programmed-death- 1 inhibiting drugs. We aim through this study to evaluate pCR following SCRT, followed by mFOLFOX-6 with avelumab, and then TME procedure in patients with LARC. TRIAL REGISTRATION: Trial Registration Number and Date of Registration: ClinicalTrials.gov NCT03503630, April 20, 2018.

Introduction of "Papazian Pusher: " A Modified-Design Knot Pusher for Surgical Repair of Cleft Palates.

Tying sutures is an integral aspect of any surgery and reliable instruments are essential for hassle-free procedures including craniofacial surgeries. Knot pushers have been widely known for their application in various laparoscopic, arthroscopic, and anal surgeries. The literature reveals numerous articles pertaining to knot pushers, as well as improvements on existing designs. Nevertheless, no application of knot pushers in the surgical repair of cleft palates has been described. We describe a new knot pusher "Papazian Pusher" (PP) finely designed for application in oral surgeries in general and repair of cleft palates in particular. The instrument was used satisfactorily in repair of cleft palate surgeries and no complications were encountered. The PP was found, overall, to be easy to use, and helps in performing faster, stronger, smooth, and secure knots.

The role of single-incision laparoscopic surgery in abdominal and pelvic surgery: a systematic review.

OBJECTIVE: This review aimed to determine the role of single-incision laparoscopic surgery (SILS) in abdominal and pelvic operations. DATA SOURCES: The Medline, EMBASE, and PsycINFO databases were systematically searched until October 2009 using "single-incision laparoscopic surgery" and related terms as keywords. References from retrieved articles were reviewed to broaden the search STUDY SELECTION: The study included case reports, case series, and empirical studies that reported SILS in abdominal and pelvic operations. DATA EXTRACTION: Number of patients, type of instruments, operative time, blood loss, conversion rate, length of hospital stay, length of follow-up evaluation, and complications were extracted from the reviewed items DATA SYNTHESIS: The review included 102 studies classified as level 4 evidence. Most of these studies investigated SILS in cholecystectomy (n=34), appendectomy (n=24), and nephrectomy (n=17). For these procedures, operative time, hospital stay, and complications were comparable with those of conventional laparoscopy. Conversion to conventional laparoscopy was seldom performed in cholecystectomy (range, 0-24%) and more frequent in appendectomy (range, 0-41%) and nephrectomy (range, 0-33%). CONCLUSION: The potential benefits of SILS include superior cosmesis and possibly shorter operative time, lower costs, and a shortened time to full physical recovery. Careful case selection and a low threshold of conversion to conventional laparoscopic surgery are essential. Multicenter, randomized, prospective studies are needed to compare short- and long-term outcome measures against those of conventional laparoscopic surgery.

Comparing Emergent and Elective Colectomy Outcomes in Elderly Patients: A NSQIP Study.

INTRODUCTION: With the increasing prevalence of colorectal cancer (CRC) worldwide, especially in the elderly, and the variability between physiological and chronological age and its impact on functional status, acute symptoms leading to emergent surgery due to colorectal malignancy may lead to increased morbidity and mortality. The aim of this study is to identify the outcome differences of elective vs. emergent open colectomy in patients above 80 years. METHODS: The National Surgical Quality Improvement Program (NSQIP) database was reviewed from 2010 to 2014 for open colectomy based on CPT codes. Comparison between groups was done based on the clinical context at presentation as elective or emergent surgery. Data were analyzed using SAS. RESULTS: Elective colectomies were performed in 8289 (70.8%) vs. emergent colectomies in 3409 (29.1%). Emergent colectomy patients had higher American Society of Anesthesiologists (ASA) preoperative classification III-IV, 1429 (42.0%) and 224 (6.6%), vs. 1238 (14.9%) and 21 (0.2%) in elective colectomy patients (p < 0.0001). Emergent colectomy patients had more comorbidities such as chronic obstructive pulmonary disorder (493 (14.5%) vs. 796 (9.6%)), congestive heart failure (206 (6.0%) vs. 310 (3.8%)), dialysis (106 (3.1%) vs. 56 (0.7%)), and acute renal failure (166 (4.9%) vs. 46 (0.6%)) (p < 0.0001), respectively. Postoperative morbidity and mortality were significantly higher in emergent colectomy (1651 (48.4%) and 872 (25.6%)) vs. elective colectomy (1859 (22.4%) and 567 (6.8%)) (p < 0.0001), respectively. CONCLUSION: Emergent open colectomy in elderly patients carries a higher risk of morbidity and mortality when compared to elective open colectomy with risk factors being higher ASA classification and more comorbidities.

Efficacy and safety-in analysis of short-course radiation followed by mFOLFOX-6 plus avelumab for locally advanced rectal adenocarcinoma.

BACKGROUND: Neoadjuvant chemotherapy and short-course radiotherapy followed by resection has been gaining recognition in the treatment of rectal cancer. Avelumab is a fully human immunoglobulin that binds Programmed Death-Ligand 1 (PD-L1) and prevents the suppression of the cytotoxic T cell immune response. This phase II trial evaluates the safety and pathologic response rate of short-course radiation followed by 6 cycles of mFOLFOX6 with avelumab in patients with locally advanced rectal cancer (LARC). METHODS: This study is prospective single-arm, multicenter phase II trial adopting Simon's two-stage. Short-course radiation is given over 5 fractions to a total dose of 25 Gy. mFOLFOX6 plus avelumab (10 mg/kg) are given every 2 weeks for 6 cycles. Total mesorectal excision is performed 3-4 weeks after the last cycle of avelumab. Follow up after surgery is done every 3 months to a total of 36 months. Adverse event data collection is recorded at every visit. RESULTS: 13 out of 44 patients with LARC were enrolled in the first stage of the study (30% from total sample size). All patients met the inclusion criteria and received the full short-course radiation course followed by 6 cycles of mFOLFOX6 plus avelumab. 12 out of the 13 patients completed TME while one patient had progression of disease and was dropped out of the study. The sample consisted of 9 (69%) males and 4 (31%) females with median age of 62 (33-73) years. The first interim analysis revealed that 3 (25%) patients achieved pathologic complete response (pCR) (tumor regression grade, TRG 0) out of 12. While 3 (25%) patients had near pCR with TRG 1. In total, 6 out of 12 patients (50%) had a major pathologic response. All patients were found to be MMR proficient. The protocol regimen was well tolerated with no serious adverse events of grade 4 reported. CONCLUSION: In patients with LARC, neoadjuvant radiation followed by mFOLFOX6 with avelumab is safe with a promising pathologic response rate. Trial Registration Number and Date of Registration ClinicalTrials.gov NCT03503630, April 20, 2018. https://clinicaltrials.gov/ct2/show/NCT03503630?term=NCT03503630&draw=2&rank=1 .

Does the presence of circulating tumor cells in the venous drainage of curative colorectal cancer resections determine prognosis? A meta-analysis.

BACKGROUND: Hepatic metastasis can occur following curative colorectal cancer surgery despite favorable prognostic indicators, raising the question of whether detecting circulating tumor cells in the venous drainage of colorectal cancers at resection using reverse-transcriptase polymerase chain reaction would help determine prognosis. This study compares lymph node positivity, hepatic metastasis rates, and disease-free survival in circulating tumor positive versus negative patients. METHODS: A Medline, Embase, Ovid, and Cochrane database search was conducted on all studies between 1999 and 2006 reporting the outcomes of interest. Meta-analysis was performed in line with recommendations from the Cochrane Collaboration and the Quality of Reporting of Meta-Analyses guidelines. RESULTS: Nine studies reporting on 646 subjects published between 1998 and 2006 matched the selection criteria and were suitable for inclusion in this meta-analysis. There was a significantly higher incidence of circulating tumor cells (50%) in lymph node positive compared with negative groups (21%) [odds ratio (OR) = 3.83, confidence interval (CI) = 2.46-5.94], and a significantly increased hepatic metastases rate (21%) in circulating tumor cells positive compared with in negative patients (8%, OR = 6.38; CI = 2.67-15.25. Disease-free survival was significantly higher in the circulating tumor cell negative versus positive groups at 1 year [hazard ratio (HR) = 0.04, CI = 0-0.46], 2 years (HR = 0.05, CI = 0.01-0.31), and 3 years (HR = 0.08, CI = 0.02-0.34) post resection. CONCLUSION: This study highlights the potential importance of free cancer cell detection in the venous drainage of colorectal cancers as a prognostic indicator and a mode of staging colorectal cancers.

Hemorrhoids screening and treatment prior to LVAD: is it a necessity?

Continuous-flow left ventricle assist devices (CF-LVADs) has become an essential modality in the management of stage D heart failure (HF) with significant improvement in survival and quality of life. Due to the durability of such devices and long term support complications such as bleeding and aortic insufficiency has emerged. Bleeding accounts for more than 20 % with the majority being from the gastrointestinal tract. The increase of bleeding tendency are mainly attributed to the loss of large von Willebrand's Factor (vWF) multimers due to shear stress with the chronic intake of anticoagulants. We are reporting two cases of patients with Stage D HF and history of hemorrhoids presenting for LVAD implantation. Many efforts that decrease bleeding related to CF-LVADs will be discussed with focus on hemorrhoids.

Liver resection for metastatic colorectal leiomyosarcoma: a single center experience.

BACKGROUND: Leiomyosarcoma arising in the colorectum is a rare malignancy of the smooth muscles accounting for less than 1% of gastrointestinal tumors. Surgery remains the most accepted modality for the treatment of this entity however management of liver metastases remains controversial. METHODS & RESULTS: From 1998 to 2009, five patients diagnosed with primary leiomyosarcoma of colorectal origin with metastatic liver disease, underwent liver resections at the American University of Beirut Medical Center. The median overall survival was 47 months (range, 7-135 months). CONCLUSIONS: Leiomyosarcoma of colorectal origin with liver metastasis is a very rare entity. Long-term survival can be achieved after surgical resection and should be considered for all patients.

Obturator hernias: A review of the laparoscopic approach.

BACKGROUND: Obturator hernias (OH) account for a rare presentation to the surgical unit usually associated with bowel obstruction and strangulation. The treatment of this condition is classical laparotomy with repair of the hernia and bowel resection, if deemed necessary; recently, the laparoscopic approach has been reported in literature. This review examines the existing evidence of the safety and effectiveness of the laparoscopic approach for the management of OH. MATERIALS AND METHODS: We have conducted a systematic review of the cases reported in the literature between 1991 and 2009, using Medline with PubMed as the search engine, as well as Ovid, Embase, Cochrane Collaboration and Google Scholar databases to identify articles in English language reporting on laparoscopic management for the treatment of this condition. RESULTS: A total of 17 articles reporting on 28 cases were found. We describe the pooled data for demographics, operative time, hospital stay, morbidities and method of repair. We also compare to the results of the laparoscopic repair of other types of hernias in the literature. CONCLUSION: This approach was found to be a safe and effective approach for the repair of OH as compared to the classical open approach; however, its adoption as the gold standard needs further multicenter trials.

Surgical removal of a tea spoon from the ascending colon, ten years after ingestion: a case report.

INTRODUCTION: The presentation of ingested foreign bodies in the gastrointestinal system is common in the emergency setting. The majority responds to conservative management and passes spontaneously; however, giant foreign bodies pose a management difficulty. We report a peculiar case of a giant foreign body (spoon) that presented very late after ingestion and the management of this presentation. CASE PRESENTATION: A 30-year-old British white male barrister presented with abdominal pain 10 years after he swallowed a spoon that never passed spontaneously. His workup revealed the spoon lodged in his ascending colon. Laparoscopic retrieval was not feasible so a laparotomy was done for retrieval. He did well and went home with no complications. CONCLUSION: Symptomatic giant ingested foreign bodies represent a management challenge sometimes and usually necessitate surgical intervention when all conservative means fail. We review the literature on management of giant ingested foreign bodies.

Fistula-in-ano: advances in treatment.

BACKGROUND: Several techniques have been described for the management of fistula-in-ano, but all carry their own risks of recurrence and incontinence. Technology has evolved over the past 2 decades that may enable surgeons to deal with this troublesome issue with greater success. This review summarizes the history of fistula-in-ano management, the current techniques available, and describes new technologies. METHODS: Medline searches were performed using the PubMed, Ovid, Embase, Cochrane, and Google Scholar databases to identify articles reporting on fistula-in-ano management using surgery alone, fibrin glues, and fistula plugs. Forty-one articles reporting on the history of fistula-in-ano management and the use of new technologies were included. RESULTS: Conventional fistula surgery techniques have their place, but new technologies such as fibrin glues and the anal fistula plugs offer an alternative approach, with initial studies reporting good success rates. CONCLUSIONS: New technologies provide promising alternatives to traditional methods of management. There is, however, a real need for high-quality randomized control trials.

Is minimally invasive harvesting of the great saphenous vein for coronary artery bypass surgery a cost-effective technique?

OBJECTIVE: In this study we aim to assess the cost-effectiveness analysis of minimally invasive vein harvesting. The great saphenous vein is the most commonly used conduit in coronary artery bypass surgery. In the past decade minimally invasive techniques have been developed to reduce the surgical trauma associated with the conventional open vein-harvesting technique. There is strong evidence to suggest that minimally invasive harvesting can reduce postoperative wound healing complications, pain, mobility restriction, and hospital stay. Despite the increasingly widespread use of this technique, formal cost-effectiveness analysis has never been performed. METHODS: Economic analysis was performed according to the National Institute of Healthcare and Clinical Excellence guidelines on the evaluation of technology by using published data on postoperative pain and mobility restriction, locally collected data, National Health Service reference costs, and manufacturer's data. Probabilistic sensitivity analysis was performed to investigate and quantify the uncertainty associated with the results of our analysis. RESULTS: The results of our analysis demonstrate that minimally invasive vein harvesting was more cost-effective, with an incremental cost-effectiveness ratio of $19,858.87/quality-adjusted life year (QALY), comparing favorably with other health care interventions. Probabilistic sensitivity analysis demonstrated with 95.6% certainty that endoscopic harvesting was more cost-effective at a willingness-to-pay threshold of $50,000/quality-adjusted life year. Alternative analysis suggested that even with considerable uncertainty associated with quality of life after vein harvesting, minimally invasive harvesting was more cost-effective than conventional vein harvesting. CONCLUSION: Minimally invasive harvesting is the most cost-effective method of harvesting the great saphenous vein and can significantly improve a patient's quality of life.