Randomized controlled trial of intravenous sedation vs general anesthesia for esophageal dilation with percutaneous endoscopic gastrostomy in esophageal cancer patients.

BACKGROUND: Esophageal squamous cell cancer (ESCC) is mostly diagnosed in its later stages, when patients present with dysphagia and weight loss. Esophageal dilation with percutaneous endoscopic gastrostomy (PEG) is a common surgical procedure in patients with locally advanced ESCC because of tumor obstruction and enteral nutrition support during neoadjuvant or definitive concurrent chemoradiotherapy (CCRT). Esophageal dilation with PEG is widely performed under general anesthesia (GA) with endotracheal intubation. AIM OF THE STUDY: To determine the overall success rate of completing this procedure using intravenous (IV) sedation with dexmedetomidine (DEX) relative to GA and to compare its perioperative conditions, including procedure times, pain scores (visual analog scale), adverse events, and costs. SETTINGS: Songklanagarind Hospital, Faculty of Medicine, Prince of Songkla University, Thailand. PATIENTS AND METHODS: Prospective randomized controlled trial (RCT) of locally advanced ESCC patients who had dysphagia and needed esophageal dilation with PEG between January 2020 and December 2021. Esophageal dilation (using a Savary-Gilliard dilator) and PEG were performed using the pull technique. RESULTS: Seventy patients were randomly assigned to either the DEX group (n = 34) or the GA group (n = 36). All patients in both groups underwent successful surgery. The DEX group had a significantly shorter procedure time, lower procedure cost, and lower total hospital cost than the GA group. However, there were no significant between-group differences in pain scores or length of hospital stay. There were no serious adverse events in either group; however, the GA group had some incidences of sore throat, transient hoarseness, and atelectasis. CONCLUSION: This study found that IV sedation with DEX during esophageal dilation with PEG was as effective and safe as using GA.

Achievement of benchmark outcomes by a young surgical attendant performing pancreatoduodenectomies.

PURPOSE: Pancreatoduodenectomy is a challenging procedure for young general surgeons, and no benchmark outcomes are currently available for young surgeons who have independently performed pancreatoduodenectomies after completing resident training. This study aimed to identify the competency of a young surgeon in performing pancreatoduodenectomies, while ensuring patient safety, from the first case following certification by a General Surgical Board. METHODS: A retrospective review of data from the university hospital was performed to assess quality outcomes of a young surgical attendant who performed 150 open pancreatoduodenectomies between July 13, 2006, and July 13, 2020. Primary benchmark outcomes were hospital morbidity, mortality, postoperative pancreatic fistula, postoperative hospital stay, and disease-free survival. RESULTS: All benchmark outcomes were achieved by the young surgeon. The 90-day mortality rate was 2.7%, and one patient expired in the hospital (0.7% in-hospital mortality). The overall morbidity rate was 34.7%. Postoperative pancreatic fistula grades B and C were observed in 5.3% and 0% of patients, respectively. The median postoperative hospital stay was 14 days. The 1- and 3-year disease-free survival were 71.3% and 51.4%, respectively. CONCLUSION: Pancreatoduodenectomy requires good standards of care as it is associated with high morbidity and mortality. As only one surgeon could be included in this study, our benchmark outcomes must be compared with those of other institutions. CLINICAL TRIAL REGISTRATION: The study was registered at Thai Clinical Trials Registry and approved by the United Nations (registration identification TCTR20220714002).

The efficacy of cefazolin in reducing surgical site infection in laparoscopic cholecystectomy: a prospective randomized double-blind controlled trial.

BACKGROUND: A prophylactic antibiotic is recommended in open cholecystectomy surgeries, but in laparoscopic cholecystectomies such prophylaxis is controversial. Recent reviews have not found conclusive evidence that routine prophylaxis, especially in low risk patients, is effective. This clinical trial was undertaken to evaluate the efficacy of cefazolin in reducing surgical site infection SSI in laparoscopic cholecystectomies in a sample not screened for high or low risk patients. METHODS: A randomized double-blind controlled trial was conducted in a single university hospital. Scheduled cholecystectomy patients without selection for patient risk factors were randomized into two groups. Pre-operatively, group A patients received a placebo of 10 ml isotonic sodium chloride, and group B patients received 1 g of cefazolin as a prophylactic antibiotic. All patients underwent a standard laparoscopic cholecystectomy, and were followed up for at least 30 days. RESULTS: Two hundred ninety-nine patients were randomized (149 in group A and 150 in group B). SSI occurred in seven patients (2.34 %), five (1.67 %) in the placebo group, and two (0.67 %) in the prophylactic antibiotic group. The difference was not statistically significant (p value = 0.512), and no specific risk factors for post-operative infection were identified. CONCLUSIONS: A single dose of preoperative prophylactic cefazolin has no significant benefit in reducing the incidence of SSI in laparoscopic cholecystectomy. Whether or not to use a prophylactic depends on the individual patient, and the consideration of the attending surgeon.

Randomized study of antiinflammatory and immune-modulatory effects of enteral immunonutrition during concurrent chemoradiotherapy for esophageal cancer.

Concurrent chemoradiotherapy (CCRT) induces toxicities from inflammation and immunological suppression. Omega-3 fatty acids, glutamine, and arginine are therapeutic factors that can attenuate such inflammation and promote cellular immunity. The question is whether immunonutrition (IN) during CCRT reduces inflammation and improves the immune function in patients with esophageal squamous cell carcinoma (ESCC). Seventy-one locally advanced ESCC patients being treated with CCRT (5-FU and cisplatin) were randomized into 2 groups. The IN group received a combination of omega-3 fatty acids, glutamine, and arginine, whereas the control group received standard formula. The levels of C-reactive protein (CRP), tumor necrosis factor (TNF), interferon-gamma (IFN), interleukin (IL-6, IL-10), CD3, CD4, CD8, white blood cells, neutrophils, and total lymphocytes were measured before and during treatment. The levels of CRP (P = 0.001) and TNF (P = 0.014) increased more during treatment in the control group than the treatment group, whereas IFN, IL-6, and IL-10 were similar but not significantly. CD3, CD4, CD8, white blood cells, neutrophils, and total lymphocytes decreased more in the control group than in the treatment group, but not significantly. Enteral IN during CCRT reduced the increase of inflammatory cytokine levels.

Urogenital dysfunction after laparoscopic surgery for rectal or sigmoid colon cancer.

BACKGROUND/OBJECTIVE: Urogenital dysfunction is a common complication after surgery for sigmoid colon or rectal cancers and may result from various causes. Herein, we evaluated urogenital dysfunction and the associated factors after laparoscopic surgery at different follow-up times. METHODS: We conducted a prospective study on 91 patients who were diagnosed with sigmoid colon and rectal cancers and underwent laparoscopic surgery during 2014-2016. Voiding and male and female sexual dysfunctions following surgery were evaluated by the International Prostate Symptom Score (IPSS), International Index of Erectile Function-5 (IIEF-5), and Female Sexual Function Index-6 (FSFI-6), respectively. Urogenital function was compared at pre-surgery and 3 and 12 months postoperatively, and factors associated with urogenital dysfunction were identified. RESULTS: The overall urinary function after surgery was better when compared to that at pre-surgery; however, there was deterioration in both male and female sexual functions. The mean preoperative IPSS, IIEF-5, and FSFI-6 scores were 9.35, 12.18, and 6.09, respectively. The mean differences among IPSS, IIEF-5, and FSFI-6 at 12 months postoperatively and pre-surgery were -3.08 (95% confidence interval [CI] -4.77 to -1.40), -2.57 (95% CI -4.33 to -0.80), and -2.58 (95% CI -4.73 to 0.42), respectively. Multivariate analysis demonstrated that age ≤60 years (odds ratio 4.22) and postoperative complications (odds ratio 2.77) were correlated with erectile dysfunction. CONCLUSION: Voiding function improved after laparoscopic surgery in both sigmoid colon and rectal cancer patients. However, sexual function in both male and female patients was worse. Age ≤60 years and postoperative complications were strongly associated with male sexual dysfunction.

Variation of prophylactic antibiotic in laparoscopic cholecystectomy: Songklanagarind Hospital perspective.

OBJECTIVE: Evaluate the effectiveness of variation of prophylactic antibiotic in laparoscopic cholecystectomy. MATERIAL AND METHOD: A retrospective data review was undertaken of patients who received a laparoscopic cholecystectomy between January 1, 2005 and December 31, 2008 in Songklanagarind Hospital. The prevalence of surgical site infection (SSI), the variation of antibiotic prescription, and associated factors with SSI were reviewed and analyzed. RESULTS: Four hundred thirty nine patients received a successful laparoscopic cholecystectomy. The prophylactic antibiotic was utilized in 328 patients (74.7%). Cefazolin was the most common antibiotic used. Only 3 patients (0.9%) received the antibiotic according to the recommendation of center for disease control and prevention (CDC). The SSI was accounted in 41 patients (9.3%); 29 had the prophylactic antibiotic, while 12 did not. There was no statistically significant difference in the prevalence of SSI between the two groups (p = 0.54). Factor significantly associated with SSI was the operative time more than three hours (p = 0.03). CONCLUSION: Various patterns of prophylactic antibiotic were encountered. The practice variation seemed to be ineffective in the prevention of SSI. The selectively risk factors should be considered in the antibiotic prophylaxis.

Effectiveness of a preoperative single dose intravenous dexamethasone in reducing the prevalence of postoperative sore throat after endotracheal intubation.

OBJECTIVE: To evaluate the effectiveness of two-different doses of prophylactic dexamethasone intravenous administration in reducing the prevalence of postoperative sore throat following general endotracheal anesthesia. MATERIAL AND METHOD: All patients (105 cases) of different procedures of elective surgery scheduled to have general anesthesia performed with endotracheal intubations were included. The subjects randomized into three pre-operative intravenous substance/drug administrations, group I (35 cases) with normal saline 2 ml, group II (35 cases) with dexamethasone 4 mg, and group III (35 cases) with dexamethasone 8 mg, respectively. The prevalence of sore throat and its severity was assessed, using visual analogue scale (VAS), scores of O to 10; 0 = no pain, and 10 = most severe pain. RESULTS: Among three groups, the duration of surgery, and intubation-induced trauma had no statistical significance. The prevalence of sore throat at 1-hour/24-hour postoperative was 48.6/48.6%, 54.3/28.6%, and 54.3/42.9% in group I, II, and III respectively, and without statistical significance. CONCLUSION: The intravenous dexamethasone had no significant effectiveness against postoperatively sore throat after endotracheal intubation.

Establishment the cost-effectiveness through set criteria of laparoscopic cholecystectomy.

OBJECTIVE: To assess the set criteria of laparoscopic cholecystectomy (LC) in reducing the length of hospital stay (LOHS), and total treatment expenditure. MATERIAL AND METHOD: The measurement outcomes were prospectively analyzed through the medical record, and self questionnaire of the patients. RESULTS: During the 1-year trial, a total of 122 patients were scheduled for LC. Among these, 85 cases had met the set criteria of low risk clients of both preoperative indicator of a) American Society of Anesthesiologists (ASA) class 1 or 2, and postoperative indicators of b) no surgical drainage, and c) no immediate complication, while 37 cases were excluded due to ASA class 3 or 4, and various reasons. Distributed by the duration of hospital stay, the patients were classified in to three groups; group A was overnight hospital stay, 15 of 85 subjects (17.6%), group B was short hospital stay (within 3 days), 51 of 85 subjects (60.0%), and group C was long hospital stay (more than 3 days), 19 of 85 subjects (22.4%). The mean length of hospital stay (LOHS) was 24 +/- 1.61 hours in group A, 55 +/- 11.16 in group B, and 108 +/- 21.59 in group C, while the average total expenditure was 531.22 +/- 111.09, 665.5 +/- 133.35 and 812.33 +/- 158.62, respectively. For the overnight hospital stay group, the LOHS and the total treatment expenditure was significantly lower the other groups (p < 0.001). The majority of the overnight hospital stay group had rated the patient satisfaction as excellent. CONCLUSION: The set criteria of laparoscopic cholecystectomy (LC) are helpful and establish the cost-effectiveness in terms of reduction of LOHS and total treatment expenditure.

Pretreatment Esophageal Wall Thickness Associated with Response to Chemoradiotherapy in Locally Advanced Esophageal Cancer.

PURPOSE: A multimodality approach using concurrent chemoradiotherapy (CRT) followed by esophagectomy has been the standard treatment in patients with locally advanced esophageal squamous cell carcinoma (ESCC). Computed tomography (CT) is widely utilized to evaluate esophageal cancer before and after CRT. This study evaluated the utility of pretreatment maximal esophageal wall thickness on CT scans to predict treatment outcomes after CRT in patients with locally advanced ESCC. METHODS: Eighty-one patients with T3 locally advanced ESCC, whom were treated completely with CRT with and without surgery, and had available CT scans before and after CRT at a university hospital between 2005 and 2015, were retrospectively reviewed. RESULT: Twenty patients (24.7%) had esophagectomy after neoadjuvant CRT and sixty-one patients (75.3%) had definitive CRT. The maximal esophageal wall thicknesses were measured retrospectively and correlated with the response and survival after treatment. A total of 40% of neoadjuvant CRT patients achieved a pCR. There was a significant difference in pretreatment maximal esophageal wall thickness between the pCR and non-pCR groups (mean 11.9 ± 5.3 mm versus 16.9 ± 3 mm; p = 0.01). Pretreatment maximal esophageal wall thickness < 10 mm was significantly related to better overall survival than ≥ 10 mm (median survival 79 months versus 15 months; HR 3.21, 95%CI 1.14-9; p = 0.02). The neoadjuvant CRT group had significantly better survival than the definitive CRT group (median survival 51 months versus 14.5 months; HR 0.46; 95%CI 0.25-0.85; p = 0.01). CONCLUSION: In our study, pretreatment esophageal wall thickness of T3 locally advanced ESCC is a useful indicator for predicting survival and pCR after treatment.

Initial experience and result of thoracoscopic and laparoscopic esophagectomy.

BACKGROUND: Conventional esophagectomy requires either a laparotomy or a thoracotomy. Currently, the minimally invasive esophagectomy is an evolving alternative to the open technique. OBJECTIVE: Assess and evaluate the early outcomes of the authors' experiences with the minimally invasive esophagectomy for esophageal cancer. MATERIAL AND METHOD: Outcome data were collected prospectively from 28 consecutive patients, 22 men and six women with a mean age of 63 years and a range of 36-77 years. RESULTS: Thoracoscopic esophageal mobilizations were successful in 17 patients. Four patients were converted to open thoracotomy. Laparoscopic gastric mobilizations were successful in eight patients and only one patient was converted to laparotomy. Mortality was one (3.5%), and perioperative morbidity was nine (32%), including pneumonia, pleural effusion, wound infection, anastomosic leakage, and hoarseness. CONCLUSION: Minimally invasive esophagectomy is feasible and can be performed at the Prince of Songkla University Hospital. Optimal results require appropriate patient selection and surgeon experience.

A randomized double-blind controlled trial comparing two forms of enema for flexible sigmoidoscopy.

OBJECTIVE: To compare bowel preparation quality and patient tolerance of two common enema solutions for flexible sigmoidoscopy. MATERIAL AND METHOD: Three hundred adults were randomized to receive a hypertonic sodium chloride or hypertonic sodium phosphate enema regime, each consisting of two enemas administered 60 and 30 min before the procedure. Patients completed surveys on preparation comfort. Patients and endoscopist were blinded to the preparation used During the procedure, the endoscopist took pictures of the mucosa and intraluminal content. All pictures were later evaluated by a single doctor who graded the quality of the preparation. RESULTS: There were no serious complications during or following the procedures. The preparation quality was rated as excellent or good by 76.9% of the hypertonic sodium chloride group and 72.9% of the hypertonic sodium phosphate group (p = 0.423). The hypertonic sodium chloride enema was associated with more abdominal discomfort (p = 0.018). CONCLUSION: Both enemas were safe for all patients with no statistical difference between the qualities of the two bowel preparations. Both preparations performed their bowel-cleaning function well and were suitable for the preparation of patients before flexible sigmoidoscopy. The less expensive hypertonic sodium chloride solution may be an option for hospitals where budgetary considerations are important.

Costs and benefits of different methods of esophagectomy for esophageal cancer.

Background A minimally invasive approach to esophagectomy is being used increasingly, but concerns remain regarding the feasibility, safety, cost, and outcomes. We performed an analysis of the costs and benefits of minimally invasive, hybrid, and open esophagectomy approaches for esophageal cancer surgery. Methods The data of 83 consecutive patients who underwent a McKeown's esophagectomy at Prince of Songkla University Hospital between January 2008 and December 2014 were analyzed. Open esophagectomy was performed in 54 patients, minimally invasive esophagectomy in 13, and hybrid esophagectomy in 16. There were no differences in patient characteristics among the 3 groups Minimally invasive esophagectomy was undertaken via a thoracoscopic-laparoscopic approach, hybrid esophagectomy via a thoracoscopic-laparotomy approach, and open esophagectomy by a thoracotomy-laparotomy approach. Results Minimally invasive esophagectomy required a longer operative time than hybrid or open esophagectomy ( p = 0.02), but these patients reported less postoperative pain ( p = 0.01). There were no significant differences in blood loss, intensive care unit stay, hospital stay, or postoperative complications among the 3 groups. Minimally invasive esophagectomy incurred higher operative and surgical material costs than hybrid or open esophagectomy ( p = 0.01), but there were no significant differences in inpatient care and total hospital costs. Conclusion Minimally invasive esophagectomy resulted in the least postoperative pain but the greatest operative cost and longest operative time. Open esophagectomy was associated with the lowest operative cost and shortest operative time but the most postoperative pain. Hybrid esophagectomy had a shorter learning curve while sharing the advantages of minimally invasive esophagectomy.

Prediction of major postoperative complications and survival for locally advanced esophageal carcinoma patients.

BACKGROUND: Predicting the major complications after esophagectomy is important and may help in preselecting patients who are most likely to benefit from surgery, especially in locally advanced esophageal cancer patients who have poor prognosis. OBJECTIVE: To identify the factors associated with the development of pneumonia and anastomotic leakage complications, and the survival characteristics in locally advanced esophageal cancer patients. METHODS: A consecutive series of 232 locally advanced esophageal cancer patients (183 men and 49 women, median age 63 years) who underwent esophagectomy at Prince of Songkla University Hospital between 1998 and 2007 was analyzed. RESULTS: There were nine (3.8%) 30-day mortalities. Pneumonia occurred in 53 patients (22.8%) and anastomotic leakage in 37 patients (15.9%). Multivariate analyses showed that low body mass index was related to leakage (p = 0.015), while soft-diet dysphagia (p = 0.009), forced expiratory volume in 1 second <75% (p = 0.0005), type of surgery (McKeown technique) (p = 0.019), and long operative time (p = 0.006) were related to pneumonia. The median survival rate was 13.0 months. Stage 2b patients had longer survival than stages 3 and 4a patients (p = 0.0001). CONCLUSION: Patient body mass index, dysphagia, spirometry, type of surgical technique, and operative time can help predict the likelihood of pulmonary or leak complications after esophagectomy. TNM (Tumor, Node, Metastasis) staging can help predict the overall survival after resection in locally advanced cases.