Topical Lidocaine or Lidocaine/Diltiazem Ointment Following Rubber Band Ligation of Hemorrhoids: A Prospective 3-Armed Randomized Controlled Trial.

BACKGROUND: Rubber band ligation of hemorrhoids causes less pain than excisional hemorrhoidectomy, but many patients still experience significant postprocedure discomfort. OBJECTIVE: This study aimed to determine whether topical lidocaine, with or without diltiazem, is more effective than placebo for analgesia after hemorrhoid banding. DESIGN: This is a prospective, randomized, double-blinded, placebo-controlled trial. Patients were randomly assigned to 2% lidocaine, 2% lidocaine with 2% diltiazem, or a placebo ointment. SETTINGS: This study was performed at 2 university public teaching hospitals and 2 private hospitals in Australia. PATIENTS: Consecutive patients aged ≥18 years undergoing hemorrhoid banding were selected. INTERVENTIONS: Topical ointments were applied postprocedure 3× daily for 5 days. MAIN OUTCOME MEASURES: Visual analog pain score, opiate analgesia usage, and patient satisfaction were the main outcome measures. RESULTS: Of 159 eligible patients, 99 were randomly assigned (33 in each group). Pain scores were reduced at 1 hour for the lidocaine (OR 4.15 [1.12-15.41]; p = 0.03) and lidocaine/diltiazem groups (OR 3.85 [1.05-14.11]; p = 0.04) compared with placebo. Patients in the lidocaine/diltiazem group had improved satisfaction (OR 3.82 [1.28-11.44]; p = 0.02) and were more likely to recommend the procedure to others (OR 9.33 [1.07-81.72]; p = 0.04). Patients in the lidocaine/diltiazem group required approximately 45% less total and in-hospital analgesia compared with the placebo. There was no difference in complications between any of the groups. LIMITATIONS: A cost/benefit analysis was not performed. Analgesic efficacy appeared to be short term and the procedures were performed only in the hospital/nonambulatory setting. CONCLUSIONS: Topical lidocaine reduced short-term analgesia use, whereas combination lidocaine/diltiazem was associated with both improved analgesia and patient satisfaction after hemorrhoid banding. LIDOCANA TPICA O UNGENTO DE LIDOCANA/DILTIAZEM DESPUS DE LA LIGADURA HEMORROIDAL CON BANDA ELSTICA UN ENSAYO PROSPECTIVO CONTROLADO Y ALEATORIZADO DE TRES BRAZOS: ANTECEDENTES:La ligadura de hemorroides con banda elástica causa menos dolor que la hemorroidectomía escisional, pero muchos pacientes siguen experimentando molestias significativas tras el procedimiento.OBJETIVO:Este estudio tiene como objetivo determinar si la lidocaína tópica, con o sin diltiazem, es más eficaz que el placebo para la analgesia tras la ligadura hemorroidal.DISEÑO:Este es un ensayo prospectivo, aleatorizado, doble ciego, controlado con placebo. Los pacientes fueron aleatorizados para recibir lidocaína al 2 %, lidocaína al 2 % con diltiazem al 2 % o ungüento de placebo.AJUSTES:Este estudio se realizó en dos hospitales públicos con docencia universitaria y dos hospitales privados en Australia.PACIENTES:Se seleccionaron pacientes consecutivos de ≥18 años sometidos a ligadura para hemorroides.INTERVENCIONES:Se aplicaron ungüentos tópicos tras el procedimiento tres veces al día durante 5 días.PRINCIPALES MEDIDAS DE RESULTADO:La puntuación analógica visual del dolor, el uso de analgésicos opiáceos y la satisfacción del paciente fueron las principales medidas de resultado.RESULTADOS:De 159 pacientes elegibles, 99 fueron aleatorizados (33 en cada grupo). Las puntuaciones de dolor se redujeron a la hora para los grupos de lidocaína (OR 4,15 (1,12-15,41); p = 0,03) y lidocaína/diltiazem (OR 3,85 (1,05-14,11), p = 0,04) en comparación con el placebo.Los pacientes del grupo de lidocaína/diltiazem mejoraron su satisfacción (OR 3,82 (1,28-11,44), p = 0,02) y eran más propensos de recomendar el procedimiento a otros (OR 9,33 (1,07-81,72), p = 0,04). Los pacientes del grupo de lidocaína/diltiazem requirieron aproximadamente un 45 % menos de analgesia total e intrahospitalaria en comparación con el grupo de placebo. No hubo diferencia en las complicaciones entre ninguno de los grupos.LIMITACIONES:No se realizó un análisis de costo/beneficio. La eficacia analgésica pareció ser a corto plazo y los procedimientos solo se realizaron en el hospital/entorno no ambulatorio.CONCLUSIÓN:La lidocaína tópica mejora la analgesia a corto plazo, mientras que la combinación de lidocaína/diltiazem se asocia tanto con una mejor analgesia como con la satisfacción del paciente tras la colocación de bandas para hemorroides. (Traducción-Dr Osvaldo Gauto ).

Life-threatening gastrointestinal haemorrhage requiring surgical resection caused by SARS-CoV-2 induced ANCA associated vasculitis: A case report.

Introduction and importance: SARS-CoV-2 infection has been linked to the de novo diagnosis of various autoimmune conditions as well as flares in pre-existing disease. With such high prevalence of SARS-CoV-2 in the community, it is important to consider rare manifestations of autoimmune conditions when patients present with severe symptoms. Multi-specialty care is required to ensure optimal outcomes and prompt diagnosis. Case presentation: A 28-year-old male presented to our tertiary referral centre with progressive debilitating polyarthritis, a purpuric rash on both flanks and aphthous ulcers 6 weeks after infection with SARS-CoV-2. On the second day of admission, he developed severe gastrointestinal haemorrhage requiring multiple blood transfusions. Attempted angioembolisation failed to identify a site of active haemorrhage. On failing trial of conservative management, the decision was made to perform an exploratory laparotomy. The small bowel was found to have an extensive vasculitis requiring resection to control haemorrhage. Autoimmune serology revealed c-ANCA positivity with anti-PR3 antibodies. Clinical discussion: Patients presenting with acute vasculitic pathologies related to SARS-CoV-2 have the potential to rapidly progress to severe life-threatening gastrointestinal haemorrhage. Prompt surgical management is appropriate in selected cases. Conclusion: In the current era of COVID-19, the differential diagnosis of SARS-CoV-2 induced ANCA vasculitis must be considered for such cases with gastrointestinal haemorrhage. Compilation of similar cases and further studies are required to determine an optimal management pathway for these patients.

Biomarkers and anastomotic leakage in colorectal surgery: C-reactive protein trajectory is the gold standard.

BACKGROUND: Anastomotic leakage is a feared complication following colorectal surgery. Early prediction results in improved clinical outcome, but accurate predictive factors remain elusive. Many biomarkers have been studied with respect to diagnosis of anastomotic leakage but the concept of trajectory testing, using biomarkers, has not been assessed with regards to early diagnosis of anastomotic leak. METHODS: C-reactive protein (CRP), procalcitonin (PCT), white cell count (WCC) and gamma-glutamyl transferase were assessed for predictive utility in diagnosing anastomotic leakage with emphasis on identifying an association with change in their levels or trajectory. Levels were collected preoperatively and daily for the first 5 post-operative days on patients undergoing elective colorectal surgery, involving an anastomosis. Anastomotic leakage was defined clinically by operative or radiological intervention. Comparison was made between biomarkers and clinical anastomotic leakage, using receiver operator characteristic curves for logistic models, based on trajectory of the four biomarkers. RESULTS: A total of 197 consecutive patients were analysed. Eleven patients developed clinical anastomotic leakage. An association of biomarker trajectory with anastomotic leakage was observed for WCC, PCT and CRP, but not for gamma-glutamyl transferase. CRP was the superior biomarker based on trajectory, with area under the receiver operator curve of 0.961. CONCLUSION: This study identifies change in CRP, WCC and PCT as potential markers of anastomotic leakage following colorectal surgery and in particular highlights CRP trajectory as extremely accurate in diagnosing anastomotic leakage requiring intervention. External validation should be sought before incorporating this into routine clinical practice, given the numbers in this study.

Tranexamic Acid for Lower GI Hemorrhage: A Randomized Placebo-Controlled Clinical Trial.

BACKGROUND: Lower GI hemorrhage is a common source of morbidity and mortality. Tranexamic acid is an antifibrinolytic that has been shown to reduce blood loss in a variety of clinical conditions. Information regarding the use of tranexamic acid in treating lower GI hemorrhage is lacking. OBJECTIVE: The aim of this trial was to determine the clinical efficacy of tranexamic acid when used for lower GI hemorrhage. DESIGN: This was a prospective, double-blind, placebo-controlled, randomized clinical trial. SETTINGS: The study was conducted at a tertiary referral university hospital in Australia. PATIENTS: Consecutive patients aged >18 years with lower GI hemorrhage requiring hospital admission from November 2011 to January 2014 were screened for trial eligibility (N = 265). INTERVENTIONS: A total of 100 patients were recruited after exclusions and were randomly assigned 1:1 to either tranexamic acid or placebo. MAIN OUTCOME MEASURES: The primary outcome was blood loss as determined by reduction in hemoglobin levels. The secondary outcomes were transfusion rates, transfusion volume, intervention rates for bleeding, length of hospital stay, readmission, and complication rates. RESULTS: There was no difference between groups with respect to hemoglobin drop (11 g/L of tranexamic acid vs 13 g/L of placebo; p = 0.9445). There was no difference with respect to transfusion rates (14/49 tranexamic acid vs 16/47 placebo; p = 0.661), mean transfusion volume (1.27 vs 1.93 units; p = 0.355), intervention rates (7/49 vs 13/47; p = 0.134), length of hospital stay (4.67 vs 4.74 d; p = 0.934), readmission, or complication rates. No complications occurred as a direct result of tranexamic acid use. LIMITATIONS: A larger multicenter trial may be required to determine whether there are more subtle advantages with tranexamic acid use in some of the secondary outcomes. CONCLUSIONS: Tranexamic acid does not appear to decrease blood loss or improve clinical outcomes in patients presenting with lower GI hemorrhage in the context of this trial. see Video Abstract at http://links.lww.com/DCR/A453.

Blood-based detection of RAS mutations to guide anti-EGFR therapy in colorectal cancer patients: concordance of results from circulating tumor DNA and tissue-based RAS testing.

An accurate blood-based RAS mutation assay to determine eligibility of metastatic colorectal cancer (mCRC) patients for anti-EGFR therapy would benefit clinical practice by better informing decisions to administer treatment independent of tissue availability. The objective of this study was to determine the level of concordance between plasma and tissue RAS mutation status in patients with mCRC to gauge whether blood-based RAS mutation testing is a viable alternative to standard-of-care RAS tumor testing. RAS testing was performed on plasma samples from newly diagnosed metastatic patients, or from recurrent mCRC patients using the highly sensitive digital PCR technology, BEAMing (beads, emulsions, amplification, and magnetics), and compared with DNA sequencing data of respective FFPE (formalin-fixed paraffin-embedded) tumor samples. Discordant tissue RAS results were re-examined by BEAMing, if possible. The prevalence of RAS mutations detected in plasma (51%) vs. tumor (53%) was similar, in accord with the known prevalence of RAS mutations observed in mCRC patient populations. The positive agreement between plasma and tumor RAS results was 90.4% (47/52), the negative agreement was 93.5% (43/46), and the overall agreement (concordance) was 91.8% (90/98). The high concordance of plasma and tissue results demonstrates that blood-based RAS mutation testing is a viable alternative to tissue-based RAS testing.

Transversus abdominis plane blockade in laparoscopic colorectal surgery: a double-blind randomized clinical trial.

INTRODUCTION: Adequate postoperative analgesia is essential for recovery following colorectal surgery. Transversus abdominis plane (TAP) blocks have been found to be beneficial in improving pain following a variety of abdominal operations. The objective of this study was to determine if TAP blocks are useful in improving postoperative recovery following laparoscopic colorectal surgery. MATERIALS AND METHODS: A prospective double-blind randomized clinical trial, involving 226 consecutive patients having laparoscopic colorectal surgery, was performed by a university colorectal surgical department. Patients were randomized to either TAP blockade using ultrasound guidance, or control, with the primary outcome being postoperative pain, as measured by analgesic consumption. Secondary outcomes assessed were pain visual analogue score (VAS), respiratory function, time to return of gut function, length of hospital stay, postoperative complications, and patient satisfaction. RESULTS: A total of 142 patients were followed up to trial completion (74 controls, 68 interventions). Patients were well matched with regard to demographics. No complications occurred as a result of the intervention of TAP blockade. There was no difference between groups with regards to analgesic consumption (161 mEq morphine control vs 175 mEq morphine TAP; p = 0.596). There was no difference between the two groups with regards to the secondary outcomes of daily VAS, respiratory outcome, time to return of gut function, length of hospital stay, postoperative complications, and patient satisfaction. CONCLUSION: We conclude that TAP blockade appears to be a safe intervention but confers no specific advantage following laparoscopic colorectal surgery.

Sham feeding with chewing gum after elective colorectal resectional surgery: a randomized clinical trial.

OBJECTIVE: To determine whether sham feeding with chewing gum improved gastrointestinal recovery after colorectal resection surgery, in the presence of routine postoperative feeding. BACKGROUND: Sham feeding with chewing gum has been shown to accelerate the return of gut function after colorectal surgery. This study sought to determine whether sham feeding with gum, after colorectal resection, accelerates return of gastrointestinal function in patients on a rapid feeding enhanced recovery program. METHODS: A randomized "two armed" controlled clinical trial was performed. Equal groups of open and laparoscopic colorectal resection surgical patients were recruited. Patients in the intervention arm received chewing gum 4 times a day postoperatively. All patients in the trial were placed on an established, standardized Enhanced Recovery After Surgery program. The primary outcome was time to return of gut function, assessed by time to flatus and first bowel motion. Secondary outcomes were time to tolerate diet, symptoms of ileus in the form of nausea, vomiting and distension, pain as assessed by analgesic consumption and visual analogue scales, complications, and length of hospital stay. RESULTS: A total of 161 patients were recruited. Postoperative morbidity was equivalent between groups, with no complications related to gum chewing. There was no difference between groups with respect to the primary outcomes of time to flatus and bowel motion. There was less perception of pain in the intervention group on days 2 to 5, and no difference with respect to all other secondary outcomes. CONCLUSIONS: Sham feeding with gum, after open and laparoscopic colorectal resectional surgery is safe, but does not hasten the return of gastrointestinal function in patients who receive accelerated postoperative feeding. (ACTRN12607000538448).

Barrier wound protection decreases surgical site infection in open elective colorectal surgery: a randomized clinical trial.

PURPOSE: Surgical site infection following colorectal surgery is a frequent and costly problem. Barrier protection at the time of this form of surgery has been used with varying results. The aim of this randomized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open, elective colorectal surgery. METHODS: One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were randomly assigned to have either barrier retractional wound protection or standard wound retraction. Patients were then followed up for a minimum of 30 days postoperatively. The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention. The secondary end point was performance of the wound protector as assessed by operating surgeons. RESULTS: There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used: 3 of 64 (4.7%) vs 15 of 66 (22.7%); P = .004. Most surgical site infections were diagnosed after discharge from the hospital (78%), and there was no difference in the rates of reoperation, readmission, or formal wound drainage between the 2 groups. Surgeons found the wound protector to be helpful with retraction during surgery, with 88% (7/8) adopting it as part of their standard setup. CONCLUSIONS: In this study the use of barrier wound protection in elective open colorectal resectional surgery resulted in a clinically significant reduction in incisional surgical site infections. Barrier wound protection of this nature should be considered routine in this type of surgery.

Integrin expression in colon cancer cells is regulated by the cytoplasmic domain of the beta6 integrin subunit.

We have previously reported that the alphavbeta6 integrin upregulates its own expression in a protein kinase C-dependent manner with increasing cell density. The wild-type beta6 integrin subunit has also been shown to promote tumour growth in vivo and its growth-enhancing effect is regulated by both a MAP kinase binding motif on beta6 and the 11 amino acid C-terminal cytoplasmic extension unique to the beta6 subunit. Herein, we show that the 11 amino acid cytoplasmic extension is essential for the cell density-dependent increase in beta6 expression and that the 11 amino acid tail exerts a dominant negative effect on cell density- and PKC-mediated beta5 expression in alphavbeta6-expressing colon cancer cells. Cells that express beta6 lacking the 11 amino acid tail respond to PKC simulation with increased expression of only the beta5 subunit as seen for cells that lack constitutive alphavbeta6 expression. In contrast, loss of the ERK binding site on beta6 markedly impairs cell density- and PKC-dependent expression of either beta6 or beta5 in the presence or absence of the 11 amino acid tail, respectively. Our findings suggest that in alphavbeta6-expressing cells, a hierarchy of kinase signalling cascades exists and that the beta6-ERK2 interaction dominates over PKC-mediated signalling pathways responsible for integrin upregulation with cell confluence. Given the dominance of the beta6-ERK2 interaction over PKC-mediated expression of both beta5 and beta6 integrin subunits, targeting the beta6-ERK2 interaction may prove useful as an anticancer strategy in colon cancer.