Does Tri-Staple™ technology reduce the risk of anastomotic leakage in colorectal surgery? A propensity score matching analysis.

BACKGROUND AND OBJECTIVES: This study evaluates the Tri-Staple™ technology in colorectal anastomosis. METHODS: Patients who underwent rectosigmoidectomy between 2016 and 2022 were retrospectively evaluated and divided into two groups: EEA™ (EEA) or Tri-Staple™ (Tri-EEA). The groups were matched for age, sex, American Society of Anesthesiologists (ASA), and neoadjuvant radiotherapy using propensity score matching (PSM). RESULT: Three hundred and thirty-six patients were included (228 EEA; 108 Tri-EEA). The groups were similar in sex, age, and neoadjuvant therapy. The Tri-EEA group had fewer patients with ASA III/IV scores (7% vs. 33%; p < 0.001). The Tri-EEA group had a lower incidence of leakage (4% vs. 11%; p = 0.023), reoperations (4% vs. 12%; p = 0.016), and severe complications (6% vs. 14%; p = 0.026). There was no difference in complications, mortality, readmission, and length of stay. After PSM, 108 patients in the EEA group were compared with 108 in the Tri-EEA group. The covariates sex, age, neoadjuvant radiotherapy, and ASA were balanced, and the risk of leakage (4% vs. 12%; p = 0.04), reoperation (4% vs. 14%; p = 0.014), and severe complications (6% vs. 15%; p = 0.041) remained lower in the Tri-EEA group. CONCLUSION: Tri-Staple™ reduces the risk of leakage in colorectal anastomosis. However, this study provides only insights, and further research is warranted to confirm these findings.

Robot-assisted transanal minimally invasive surgery for the treatment of rectal adenocarcinoma.

This is a video vignette of a 57-year-old asymptomatic female patient. The patient underwent a screening colonoscopy which revealed a 10 mm scar in the rectum. Biopsy resulted in a well-differentiated tubular adenocarcinoma. Computed tomography and pelvic magnetic resonance imaging confirmed tumor characteristics without distant or lymph nodal metastasis. A minimally invasive robotic transanal resection using the Da Vinci Xi platform was performed, achieving full-thickness lesion excision with uneventful recovery. Histopathology revealed intramucosal adenocarcinoma with free margins. Local resection is advocated for selected T1 lesions and demands a thorough preoperative assessment. Robotic-assisted surgery presents a valuable alternative for early rectal adenocarcinoma management.

Bowel preparation for elective colectomy in Crohn's disease: results from a global cohort study using the NSQIP database.

AIM: The role of bowel preparation before colectomy in Crohn's disease patients remains controversial. This retrospective analysis of a prospective cohort study aimed to investigate the clinical outcomes associated with mechanical and antibiotic colon preparation in patients diagnosed with Crohn's disease undergoing elective colectomy. METHOD: Data were collected from the American College of Surgeons National Surgical Quality Improvement Program participant user files from 2016 to 2021. A total of 6244 patients with Crohn's disease who underwent elective colectomy were included. The patients were categorized into two groups: those who received combined colon preparation (mechanical and antibiotic) and those who did not receive any form of bowel preparation. The primary outcomes assessed were the rate of anastomotic leak and the occurrence of deep organ infection. Secondary outcomes included all-cause short-term mortality, clinical-related morbidity, ostomy creation, unplanned reoperation, operative time, hospital length of stay and ileus. RESULTS: Combined colon preparation was associated with significantly reduced risks of anastomotic leak (relative risk 0.73, 95% CI 0.56-0.95, P = 0.021) and deep organ infection (relative risk 0.68, 95% CI 0.56-0.83, P < 0.001). Additionally, patients who underwent colon preparation had lower rates of ostomy creation, shorter hospital stays and a decreased incidence of ileus. However, there was no significant difference in all-cause short-term mortality or the need for unplanned reoperation between the two groups. CONCLUSION: This study shows that mechanical and antibiotic colon preparation may have clinical benefits for patients with Crohn's disease undergoing elective colectomy.

Intracorporeal anastomosis could be associated with a higher lymph node yield in right colon cancer surgery: Results of the ICA-LATAM study, a retrospective, multicentre, comparative analysis in Latin America.

AIM: The aim of this work was to compare lymph node (LN) yield in patients operated on for right colon cancer (RCC) using a laparoscopic approach between those receiving an intracorporeal (ICA) or extracorporeal anastomosis (ECA). METHOD: This is a retrospective multicentre study involving patients operated on for RCC in nine tertiary referral centres in Latin America during a 2-year period. The main comparative outcome between groups was the number of LNs harvested between groups. RESULTS: The study included 416 patients, 261 (62.7%) in the ECA group and 155 (37.3%) in the ICA group. Patients in the ECA group were elderly (66 vs. 61 years, p < 0.001). Patients receiving an ICA achieved a significantly higher LN yield than those receiving an ECA (24 vs. 18, p < 0.001). This group also had a lower percentage of patients achieving a substandard LN yield (<12 LNs) (10% vs. 24.8%, p = 0.001) and more patients achieving a high number of harvested LNs (>32 LNs) (15.5% vs. 8.3%, p = 0.039). In the multivariate analysis, ICA was independently related to the primary outcome (LN yield) (OR 3.28, p = 0.027, 95% CI 1.14-9.38). CONCLUSION: In this retrospective study, patients operated on for RCC who received an ICA achieved a higher LN yield. Further studies are needed to reconfirm these findings, and also to find an explanation for these results.

Surgical and medical outcomes in robotic compared to laparoscopic colectomy global prospective cohort from the American college of surgeons national surgical quality improvement program.

BACKGROUND: Evidence regarding the outcomes benefits of robotic approach, when compared to a laparoscopic approach, in colectomy remain limited. OBJECTIVE: This study aimed to analyze the value of robotic approach compared to laparoscopic approach in minimally invasive colectomy. DESIGN: Cohort study of the National Surgical Quality Improvement Program (NSQIP). SETTING: This study included data from the NSQIP from 1/2016 to 12/2021. PATIENT: Adult patients undergoing minimally invasive (laparoscopic or robotic) colorectal surgery. INTERVENTION: Robotic versus laparoscopic colectomy. OUTCOME MEASURES: Risk ratios for the incidence of medical and surgical morbidity and overall mortality. RESULTS: Compared to laparoscopic, robotic colectomy was associated with a significant decrease in postoperative morbidity [RR 0.84 (95%CI 0.72-0.96), P < 0.001], a significant reduction in postoperative mortality [RR 0.83 (95%CI 0.79-0.90), P 0.010)], and in post operative ileus [RR: 0.80 (95%CI 0.75-0.84), P < 0.001]. Yet, robotic approach was associated with a significant increase in total operative time despite a significant decrease in total length of stay. No benefit was observed regarding anastomotic leak. LIMITATIONS: Observational nature of the study cannot exclude residual bias. CONCLUSIONS: In this prospective cohort from the NSQIP, robotic colectomy was associated with a significant reduction in postoperative ileus, unplanned conversion to open surgery, morbidity, and overall mortality when compared to laparoscopic colectomy.

Risk Factors for Early Lower Limb Re-Amputation in Vascular Diseases.

BACKGROUND: Numerous risk factors for lower limb amputations are known; however, this study aimed to identify risk factors for re-amputation in patients within 6 months from an initial lower limb amputation procedure. METHODS: This single-center retrospective cohort study was performed at the Hospital Regional Hans Dieter Schmidt in Brazil. The study included patients who were aged at least 18 years and had undergone lower limb amputation between 2013 and 2022. Patients who died while hospitalized and patients who were lost to follow-up after hospital discharge were excluded from the study. Patient age, sex, number of amputations, revision time, comorbidities, and potential risk factors were extracted from the physical therapy service database and electronic medical records of the hospital. Chi-squared test and student's t-test were used to identify statistical significance. RESULTS: A total of 652 patients were included, of which 35.2% (230) patients underwent re-amputation within 6 months of the first operation. We found that dialysis (P = 0.004; odds ratio [OR] 8.36, 95% confidence interval [CI] 3.09-20.5), smoking (P = 0.004; OR 1.67, 95% CI 1.18-2.35), and hypertension (P = 0.02; OR 1.55, 95% CI 1.09-2.19) were predictive factors for re-amputation within 6 months of lower limb amputation. CONCLUSIONS: Therefore, it is important to intervene early and provide additional support to patients undergoing lower limb amputation with these risk factors to reduce the potential for re-amputation in the future.

A multi-centre randomized controlled trial investigating Consolidation Chemotherapy with and without oxaliplatin in distal rectal cancer and Watch & Wait.

BACKGROUND: Neoadjuvant chemoradiation(nCRT) has been considered the preferred initial treatment strategy for distal rectal cancer. Advantages of this approach include improved local control after radical surgery but also the opportunity for organ preserving strategies (Watch and Wait-WW). Consolidation chemotherapy(cCT) regimens using fluoropyrimidine-based with or without oxalipatin following nCRT have demonstrated to increase complete response and organ preservation rates among these patients. However, the benefit of adding oxaliplatin to cCT compared to fluoropirimidine alone regimens in terms of primary tumor response remains unclear. Since oxalipatin-treatment may be associated with considerable toxicity, it becomes imperative to understand the benefit of its incorporation into standard cCT regimens in terms of primary tumor response. The aim of the present trial is to compare the outcomes of 2 different cCT regimens following nCRT (fluoropyrimidine-alone versus fluoropyrimidine + oxaliplatin) for patients with distal rectal cancer. METHODS: In this multi-centre study, patients with magnetic resonance-defined distal rectal tumors will be randomized on a 1:1 ratio to receive long-course chemoradiation (54 Gy) followed by cCT with fluoropyrimidine alone versus fluoropyrimidine + oxaliplatin. Magnetic resonance(MR) will be analyzed centrally prior to patient inclusion and randomization. mrT2-3N0-1 tumor located no more than 1 cm above the anorectal ring determined by sagittal views on MR will be eligible for the study. Tumor response will be assessed after 12 weeks from radiotherapy(RT) completion. Patients with clinical complete response (clinical, endoscopic and radiological) may be enrolled in an organ-preservation program(WW). The primary endpoint of this trial is decision to organ-preservation surveillance (WW) at 18 weeks from RT completion. Secondary endpoints are 3-year surgery-free survival, TME-free survival, distant metastases-free survival, local regrowth-free survival and colostomy-free survival. DISCUSSION: Long-course nCRT with cCT is associated with improved complete response rates and may be a very attractive alternative to increase the chances for organ-preservation strategies. Fluoropyrimidine-based cCT with or without oxaliplatin has never been investigated in the setting of a randomized trial to compare clinical response rates and the possibility of organ-preservation. The outcomes of this study may significantly impact clinical practice of patients with distal rectal cancer interested in organ-preservation. TRIAL REGISTRATION: www. CLINICALTRIALS: gov NCT05000697; registered on August 11th, 2021.

Embolization of the Superior Rectal Arteries versus Closed Hemorrhoidectomy (Ferguson Technique) in the Treatment of Hemorrhoidal Disease: A Randomized Clinical Trial.

PURPOSE: To compare short-term and medium-term results of superior rectal artery embolization versus surgical hemorrhoidectomy in the treatment of patients with hemorrhoidal disease. MATERIAL AND METHODS: This study was a prospective randomized clinical trial following 33 patients with symptomatic hemorrhoidal disease Grades 2 and 3 who were randomly assigned to 2 different groups: the superior rectal artery embolization group (n = 15) and Ferguson closed hemorrhoidectomy surgical group (n = 14). Four patients were excluded from the analysis. Pain using the visual analog scale and the use of analgesics were evaluated 3 times daily during the first 7 days of the postoperative period. Recurrent symptoms and satisfaction with treatment were also evaluated in the subsequent first, third, sixth, and twelfth months. RESULTS: The mean pain during the first bowel movement after the procedure was 6.08 ± 4.41 in the surgery group and 0 in the embolization group (P = .001). The mean use of pain medication was higher in the surgery group (28.92 doses ± 15.78 vs 2.4 doses ± 5.21; P < .001). In the embolization group, the most prevalent preprocedural symptom was bleeding in 14 patients, with complete improvement in 12 (83.3%) patients. Mucus, skin tag, and pruritus were symptoms that showed little improvement in both groups. The frequency of symptoms (bleeding, pain, prolapse, and pruritus) was similar between the groups at 12 months (P = .691). No severe adverse events were observed in both groups. CONCLUSIONS: Despite no difference in outcomes, embolization of the superior rectal arteries for the treatment of hemorrhoidal disease showed pain levels lower than those observed after surgical treatment.

The impact of the institutional abdominoperineal resections volume on short-term outcomes and expenses: a nationwide study.

BACKGROUND: The aim of this study was to evaluate the influence of the institutional volume of abdominoperineal resections (APR) on the short-term outcomes and costs in the Brazilian Public Health system. METHODS: This population-based study evaluated the number of APRs by institutions performed in the Brazilian Public Health system from January/2010 to July/2022. Data were extracted from a public domain from the Brazilian Public Health system. RESULTS: Four hundred and twelve hospitals performed APRs and were included. Only 23 performed at least 5 APRs per year on average and were considered high-volume institutions. The linear regression model showed that the number of hospital admissions for APRs was negatively associated with in-hospital mortality (Coef. = - 0.001; p = 0.013) and length of stay in the intensive care unit (Coef. = - 0.006; p = 0.01). The number of hospital admissions was not significantly associated with personnel, hospital, and total costs. The in-hospital mortality in high-volume institutions was significantly lower than in low-volume institutions (2.5 vs. 5.9%; p: < 0.001). The mean length of stay in the intensive care unit was shorter in high-volume institutions (1.23 vs. 1.79 days; p = 0.021). In high-volume institutions, the personnel (R$ 952.23 [US$ 186.64] vs. R$ 11,129.04 [US$ 221.29]; p = 0.305), hospital (R$ 4078.39 [US$ 799.36] vs. R$ 4987.39 [US$ 977.53]; p = 0.111), and total costs (R$ 5030.63 [US$ 986.00] vs. R$ 6116.71 [US$ 1198.88]; p = 0.226) were lower. CONCLUSIONS: Higher institutional APR volume is associated with lower in-hospital mortality and less demand for intensive care. The findings of this nationwide study may affect how Public Health manages APR care.

Response to Abemaciclib and Immunotherapy Rechallenge with Nivolumab and Ipilimumab in a Heavily Pretreated TMB-H Metastatic Squamous Cell Lung Cancer with CDKN2A Mutation, PIK3CA Amplification and TPS 80%: A Case Report.

Inactivation of the cyclin-dependent kinase inhibitor 2A (CDKN2A) gene is considerably more frequent in squamous cell lung cancer (SqCLC) than in other subtypes of lung cancer and may be a promising target for this histology. Here, we present the course of diagnosis and treatment of a patient with advanced SqCLC, harboring not only CDKN2A mutation but also PIK3CA amplification, Tumor Mutational Burden-High (>10 mutations/megabase), and a Tumor Proportion Score of 80%. After disease progression on multiple lines of chemotherapy and immunotherapy, he responded favorably to treatment with the CDK4/6i Abemaciclib and later achieved a durable partial response to immunotherapy rechallenge with a combination of anti-PD-1 and anti-CTLA-4, nivolumab, and ipilimumab.

Production of Recombinant Zika Virus Envelope Protein by Airlift Bioreactor as a New Subunit Vaccine Platform.

The Zika Virus (ZIKV) is an emerging arbovirus of great public health concern, particularly in the Americas after its last outbreak in 2015. There are still major challenges regarding disease control, and there is no ZIKV vaccine currently approved for human use. Among many different vaccine platforms currently under study, the recombinant envelope protein from Zika Virus (rEZIKV) constitutes an alternative option for vaccine development and has great potential for monitoring ZIKV infection and antibody response. This study describes a method to obtain a bioactive and functional rEZIKV using an E. coli expression system, with the aid of a 5-L airlift bioreactor and following an automated fast protein liquid chromatography (FPLC) protocol, capable of obtaining high yields of approximately 20 mg of recombinant protein per liter of bacterium cultures. The purified rEZIKV presented preserved antigenicity and immunogenicity. Our results show that the use of an airlift bioreactor for the production of rEZIKV is ideal for establishing protocols and further research on ZIKV vaccines bioprocess, representing a promising system for the production of a ZIKV envelope recombinant protein-based vaccine candidate.

An Overview of Robotic Colorectal Surgery Adoption and Training in Brazil.

Background and Objectives: Robotic surgical systems have rapidly become integrated into colorectal surgery practice in recent years, particularly for rectal resections, where the advantages of robotic platforms over conventional laparoscopy are more pronounced. However, as with any technological advancement, the initial high costs can be a limiting factor, leading to unequal health service access, especially in middle- and lower-income countries. Materials and Method: A narrative review was conducted with the objective of providing an overview of the escalating adoption, current training programmes, and certification process of robotic colorectal surgery in Brazil. Results: Brazil has witnessed a rapid increase in robotic platforms in recent years. Currently, there are 106 robotic systems installed nationwide. However, approximately 60% of the medical facilities which adopted robotic platforms are in the Southeast region, which is both the most populous and economically prosperous in the country. The Brazilian Society of Coloproctology recently established clear rules for the training programme and certification of colorectal surgeons in robotic surgery. The key components of the training encompass theoretical content, virtual robotic simulation, observation, assistance, and supervised procedures in colorectal surgery. Although the training parameters are well established, no colorectal surgery residency programme in Brazil has yet integrated the teaching and training of robotic surgery into its curriculum. Thus far, the training process has been led by private institutions and the industry. Conclusion: Despite the fast spread of robotic platforms across Brazil, several challenges still need to be addressed to democratise training and promote the widespread use of these platforms. It is crucial to tackle these obstacles to achieve greater integration of robotic technology in colorectal surgery throughout the country.

Timing of resection of synchronous colorectal liver metastasis: A systematic review and meta-analysis.

INTRODUCTION: The resection of the primary colorectal tumor and liver metastases is the only potentially curative strategy. In such cases, there is no consensus on whether the resection of the primary tumor and metastases should be performed simultaneously or whether a staged approach should be performed (resection of the primary tumor and after, hepatectomy, or the "liver first" approach). The aim of this study is to evaluate the results of hepatectomy associated with colectomy in colorectal neoplasms, comparing simultaneous and staged resection. METHODS: A systematic literature review was performed in PubMed, Embase, Cochrane, Lilacs, and manual reference search. The last search was in July/2021. Inclusion criteria were: studies that compared simultaneous and staged hepatectomy for colorectal liver metastasis; studies that analyze short and/or long-term outcomes. Exclusion criteria were reviews, letters, editorials, congress abstract, and full-text unavailability. Perioperative outcomes and overall survival were evaluated and, for staged resections, the outcomes associated with each procedure were added. The ROBINS-I and GRADE tools were used to assess the risk of bias and quality of evidence. Synthesis was performed using Forest plots. The PRISMA criteria (PROSPERO: CRD42021243762) were followed. RESULTS: The initial search collected 5655 articles and, after selection, 33 were included, covering 6417 patients. Simultaneous resection was associated with shorter length of stay (DR: -3.48 days [95% confidence interval {CI}: -5.64, -1.32]), but with a higher risk of postoperative mortality (DR: 0.02 [95% CI: 0.01, 0.02]). There was no difference between groups for blood loss (risk difference [RD]: -141.38 ml [95% CI: -348.84, 66.09]), blood transfusion (RD: -0.06 [95% CI: -0.14, 0.03]) and general complications (RD: 0.01 [95% CI: -0.06, 0.04]). The longest operating time in staged surgery was not statistically significant (RD: -50.44 min [95% CI: -102.38, 1.49]). Regarding overall survival, there is no difference between groups (hazard ratio: 0.88; 95% CI: 0.71-1.04). CONCLUSION: Patients must be well selected for each strategy. Simultaneous approach to patients at high surgical risk should be avoided due to increased perioperative mortality. However, when the patient presents a low surgical risk, the simultaneous approach reduces the hospital stay and guarantees long-term results equivalent to staged surgery.

Robotic and standard surgical intervention as adjunct therapies for retroperitoneal ganglioneuroma resection: a case report.

BACKGROUND: Ganglioneuroma (GN) is ranked by the International Neuroblastoma Pathology Classification as a benign tumor. It can occur anywhere along the sympathetic nerve chain and surgical excision is the treatment of choice. CASE PRESENTATION: An 18-year-old female patient sought medical assistance after 6 months of constant dorsal and back pain radiating from the thoracic region to the right abdominal flank. Magnetic resonance imaging revealed a solid nodular lesion with heterogeneous post-contrast enhancement and lobulated contours, centered on the right foramina of D12-L1, with a projection to the intracanal space, which compressed and laterally displaced the dural sac and had a right paravertebral extension between the vertebral bodies of D11 and superior aspect of L2. Ganglioneuroma was diagnosed using immunohistochemical analysis. It was decided to use a surgical approach in two stages: robot assisted for the anterior/retroperitoneal mass and a posterior hemilaminectomy/microsurgical approach to attempt total resection, avoiding the traditional anterior thoracoabdominal surgical incision and optimizing the patient's postoperative outcomes. No postoperative adverse events were noted, and the patient was discharged on postoperative day 5. CONCLUSION: This retroperitoneal GN presentation was peculiar because it originated at the D12 nerve root, which extended to the retroperitoneal space and inside the spinal canal. We hope that our case report can assist future decisions in similar circumstances.

Value of Nontechnical Skills in Minimally Invasive Surgery.

Nontechnical skills are of increasing importance in surgery and surgical training. The main studies on its impact on the safety and effectiveness of surgical interventions were mainly published in the first decade of the 2000s. Due to the significant technical complexity and great diversity of instruments for nontechnical skills evaluation, the interest in training and in measuring the impact on surgical safety has relatively decreased. However, the advent of minimally invasive surgery and its peculiar technical characteristics of sophisticated technique and constant innovation through the adoption of new materials and drugs has rekindled interest in this expertise area. In the present review, we have revisited the main instruments available to measure nontechnical skill of surgical teams and analyzed the role of the main competencies on which they are based, such as situational awareness, leadership and communication skills, and the consistency of the intraoperative decision-making process. We conclude that despite the great consensus that exists among all members of the health team on the importance of nontechnical skills for the surgical team in minimally invasive surgery, the reproducible evidence on the subject is scarce and laborious to obtain. To the extent that protecting and expanding nontechnical skills is fundamental to the path toward the high reliability of health institutions, it is possible to anticipate here the role of these institutions as promoters of continuity and new research models in this area of knowledge, especially in minimally invasive surgery, an access route to which more and more patients undergoing surgical treatment in these same institutions are submitted.

Role of Simulation-Based Training in Minimally Invasive and Robotic Colorectal Surgery.

Properly performing minimally invasive colorectal procedures requires specific skills. With a focus on patient safety, the training of surgeons on patients is only accepted under exceptionally controlled, expensive, and challenging conditions. Moreover, many new techniques in colorectal surgery have been developed. Therefore, undertaking minimally invasive colorectal surgery in modern times requires specific psychomotor skills that trainee surgeons must gather in less time. In addition, there are not enough proctors with sufficient expertise for such an expressive number of new different techniques likes transanal and robotic procedures. Studies that have demonstrated an improvement in minimally invasive surgery skills to the actual operating room in general surgery and a stepwise approach to surgical simulation with a combination of various training methods appears to be useful in colorectal surgery training programs. However, the scientific evidence on the transfer of skills specifically for colorectal surgery is extremely scarce and very variable. Thus, the evaluation of the results remains quite difficult. In this review, we present the best available evidence on the types of training based on simulation, their characteristics, advantages and disadvantages, and finally the results available on their adoption. Nevertheless, scientific evidence about the benefit of simulation training in minimally invasive colorectal surgery is limited and there is a need to build more robust evidence.

Organ Preservation in cT2N0 Rectal Cancer After Neoadjuvant Chemoradiation Therapy: The Impact of Radiation Therapy Dose-escalation and Consolidation Chemotherapy.

OBJECTIVE: To demonstrate the difference in organ-preservation rates and avoidance of definitive surgery among cT2N0 rectal cancer patients undergoing 2 different chemoradiation (CRT) regimens. BACKGROUND: Patients with cT2N0 rectal cancer are more likely to develop complete response to neoadjuvant CRT. Organ preservation has been considered an alternative treatment strategy for selected patients. Radiation dose-escalation and consolidation chemotherapy have been associated with increased rates of response and may improve chances of organ preservation among these patients. METHODS: Patients with distal and nonmetastatic cT2N0 rectal cancer managed by neoadjuvant CRT were retrospectively reviewed. Patients undergoing standard CRT (50.4 Gy and 2 cycles of 5-FU-based chemotherapy) were compared with those undergoing extended CRT (54 Gy and 6 cycles of 5-FU-based chemotherapy). Patients were assessed for tumor response at 8 to 10 weeks. Patients with complete clinical response (cCR) underwent organ-preservation strategy ("Watch and Wait"). Patients were referred to salvage surgery in the event of local recurrence during follow-up. RESULTS: Thirty-five patients underwent standard and 46 patients extended CRT. Patients undergoing extended CRT were more likely to undergo organ preservation and avoid definitive surgical resection at 5years (67% vs 30%; P = 0.001). After development of a cCR, surgery-free survival is similar between extended and standard CRT groups at 5 years (78% vs 56%; P = 0.12). CONCLUSIONS: Dose-escalation and consolidation chemotherapy leads to increased long-term organ-preservation rates among cT2N0 rectal cancer. After achievement of a cCR, the risk for local recurrence and need for salvage surgery is similar, irrespective of the CRT regimen.

Achieving a Complete Clinical Response After Neoadjuvant Chemoradiation That Does Not Require Surgical Resection: It May Take Longer Than You Think!

BACKGROUND: Patients with rectal cancer who achieve complete clinical response after neoadjuvant chemoradiation have been managed by organ-preserving strategies and acceptable long-term outcomes. Controversy still exists regarding optimal timing for the assessment of tumor response after neoadjuvant chemoradiation. OBJECTIVE: The purpose of this study was to estimate the time interval for achieving complete clinical response using strict endoscopic and clinical criteria after a single neoadjuvant chemoradiation regimen. DESIGN: This was a retrospective review of consecutive patients managed by 54-Gy and consolidation 5-fluorouracil-based chemotherapy. Assessment of response was performed at 10 weeks after radiation. Patients with suspected complete clinical response were offered watch-and-wait strategy and reassessment every 6 to 8 weeks until achievement of strict criteria of complete clinical response or overt residual cancer. SETTINGS: This study was conducted at a single tertiary care center. PATIENTS: Patients with complete clinical response who underwent a successful watch-and-wait strategy until last follow-up were eligible. Dates of radiation completion and achievement of strict endoscopic and clinical criteria (mucosal whitening, teleangiectasia, and no ulceration or irregularity) were recorded. Patients with incomplete response or with initial complete clinical response followed by local recurrence or regrowth were excluded. MAIN OUTCOMES MEASURES: The distribution of time intervals between completion of radiation and achievement of strict complete clinical response was measured. Patients who achieved early complete clinical response (≤16 wk) were compared with late complete clinical response (>16 wk). RESULTS: A total of 49 patients achieved complete clinical response and were successfully managed nonoperatively. A median interval of 18.7 weeks was observed for achieving strict complete clinical response. Only 38% of patients achieved complete clinical response between 10 and 16 weeks from radiation completion. Patients with earlier cT status (cT2/T3a) achieved a complete clinical response significantly earlier when compared with those patients with more advanced disease (T3b-d/4; 19 vs 26 wk; p = 0.03). LIMITATIONS: This was a retrospective study with a small sample size. CONCLUSIONS: Assessment at 10 to 16 weeks may detect a minority of patients who achieve complete clinical response without additional recurrence after neoadjuvant chemoradiation. Patients suspected for a complete clinical response should be considered for reassessment beyond 16 weeks before definitive management when considered for a watch and wait strategy. See Video Abstract at http://links.lww.com/DCR/A901.