An Antireflux Anastomosis Following Esophagectomy: A Randomized Controlled Trial

Background  

Reflux of duodeno-gastric fluid is a significant problem after esophagectomy with gastric conduit reconstruction. Symptoms may be severe and impact considerably upon the quality of life. Previous studies have suggested that a fundoplication type anastomosis may limit post-esophagectomy reflux.     

Implementing Fast-Track Protocol for Colorectal Surgery: A Prospective Randomized Clinical Trial

Background  

Fast-track protocols are followed by an enhanced recovery, early return to bowel function and to complete nutrition, and a reduced hospital stay. Our study was designed to implement fast-track protocol in our university hospital.     

Autologous Versus Allogeneic Transfusion in Aortic Surgery: A Multicenter Randomized Clinical Trial

OBJECTIVE: To evaluate the efficacy of acute normovolemic hemodilution (ANH) and intraoperative cell salvage (ICS) in blood-conservation strategies for infrarenal aortic surgery. SUMMARY BACKGROUND DATA: Recent concerns over the risks of transfusion-related infection have resulted in sharp rises in the cost of blood preparations. Autologous transfusion may be a safe alternative to allogeneic transfusion, which has been associated with immune modulation and postoperative infection. METHODS: This multicenter prospective randomized trial compared standard transfusion practice with autologous transfusion combining ANH with ICS in 145 patients undergoing elective aortic surgery. The primary outcome measures were the proportion of patients requiring allogeneic blood and the volume of allogeneic transfusion. The secondary outcome measures were the frequency of complications, including postoperative infection, and postoperative hospital stay. RESULTS: The combination of ANH and ICS reduced the volume of allogeneic blood transfused from a median of two units to zero units. The proportion of patients transfused was 56% in allogeneic and 43% in autologous. There were no significant differences in complications or length of hospital stay. CONCLUSIONS: Both ANH and ICS were safe and reduced the allogeneic blood requirement in patients undergoing elective infrarenal aortic surgery.     

Esmolol in Cardiac Surgery: A Randomized Controlled Trial

1. Download : Download high-res image (197KB)
2. Download : Download full-size image

     

Clinical Trial of the Neuroprotectant Clomethiazole in Coronary Artery Bypass Graft Surgery: A Randomized Controlled Trial

Background: The neuroprotective property of clomethiazole has been demonstrated in several animal models of global and focal brain ischemia. In this study the authors investigated the effect of clomethiazole on cerebral outcome in patients undergoing coronary artery bypass surgery.

Methods: Two hundred forty-five patients scheduled for coronary artery bypass surgery were recruited at two centers and prospectively randomized to clomethiazole edisilate (0.8%), 225 ml (1.8 mg) loading dose followed by a maintenance dose of 100 ml/h (0.8 mg/h) during surgery, or 0.9% NaCl (placebo) in a double-blind trial. Coronary artery grafting was completed during moderate hypothermic (28-32[degrees]C) cardiopulmonary bypass. Plasma clomethiazole was measured at several intervals during and up to 24 h after the end of infusion. A battery of eight neuropsychological tests was administered preoperatively and repeated 4-7 weeks after surgery. Analysis of the change in neuropsychological test scores from baseline was used to determine the effect of treatment.

Results: Neuropsychological assessments were completed in 219 patients (110 clomethiazole; 109 placebo). The mean plasma concentration of clomethiazole during surgery was 66.2 [mu]m. There was no difference between the clomethiazole and placebo group in the postoperative change in neuropsychological test scores.     

Standardization of Surgical Technique in Antireflux Surgery: The LOTUS Trial Experience

BACKGROUND: To date, it has been difficult to compare medical therapy for gastroesophageal reflux disease with that of surgical management from a scientific viewpoint, mainly because of the lack of standardization of the operative technique. This study was designed to identify a methodology for standardization of surgical technique and to measure the effectiveness of this standardization. METHODS: Surgeons contributing to a major international multicenter trial comparing optimum medical therapy with surgical therapy for treatment of gastroesophageal reflux attempted to optimize their surgical techniques so that a realistic comparison could be made that may aid clinical decision-making. The surgeons met, shared their techniques using video, and produced a standardized set of criteria for the surgical centers and a common operative technique. Data collection methods ensured accuracy of the records of the procedure applied and the data were analyzed for consistency with set surgical standards. RESULTS: There was a high degree of conformity (>95%) between the recommended method of performing a Nissen fundoplication as defined in the trial protocol, and variations were restricted to isolated individuals. The operations were completed without mortality, few conversions, and with very low postoperative morbidity. CONCLUSIONS: This study has shown that, contrary to commonly held belief, surgeons are able to standardize their work for the purposes of measuring the outcome of an operative procedure within the context of a randomized, controlled trial.     

Use of Antireflux Medication After Antireflux Surgery

Introduction It is claimed that a substantial number of patients who undergo antireflux surgery use antireflux medication postoperatively. This study was aimed to determine the prevalence and underlying reasons for antireflux medication usage in patients after surgery. Materials and Methods A questionnaire on the usage of antireflux medication was sent to 1,008 patients identified from a prospective database of patients who had undergone a laparoscopic antireflux procedure. Results A total of 844 patients (84%) returned the questionnaire. Mean follow-up was 5.9 years after surgery. A single or combination of medications was being taken by 312 patients (37%): 82% proton pump inhibitors, 9% H₂-blockers and 34% antacids. Fifty-two patients (17%) had never stopped taking medication, whereas 260 patients (83%) restarted medication at a mean of 2.5 years after surgery. Return of the same (31%) or different (49%) symptoms were the commonest reasons for taking medication, whereas 20% were asymptomatic or had other reasons for medication use. Postoperative 24-hour pH studies were abnormal in 16/61 patients (26%) on medication and in 5/78 patients (6%) not taking medication. Conclusions Antireflux medication is frequently taken by many patients for various symptoms after antireflux surgery. Symptomatic patients should be properly investigated before antireflux medications are prescribed.     

Point-of-Care Testing: A Prospective, Randomized Clinical Trial of Efficacy in Coagulopathic Cardiac Surgery Patients

INTRODUCTION:: The current investigation aimed to study the efficacy of hemostatic therapy guided either by conventional coagulation analyses or point-of-care (POC) testing in coagulopathic cardiac surgery patients. METHODS:: Patients undergoing complex cardiac surgery were assessed for eligibility. Those patients in whom diffuse bleeding was diagnosed after heparin reversal or increased blood loss during the first 24 postoperative hours were enrolled and randomized to the conventional or POC group. Thromboelastometry and whole blood impedance aggregometry have been performed in the POC group. The primary outcome variable was the number of transfused units of packed erythrocytes during the first 24 h after inclusion. Secondary outcome variables included postoperative blood loss, use and costs of hemostatic therapy, and clinical outcome parameters. Sample size analysis revealed a sample size of at least 100 patients per group. RESULTS:: There were 152 patients who were screened for eligibility and 100 patients were enrolled in the study. After randomization of 50 patients to each group, a planned interim analysis revealed a significant difference in erythrocyte transfusion rate in the conventional compared with the POC group [5 (4;9) versus 3 (2;6) units [median (25 and 75 percentile)], P < 0.001]. The study was terminated early. The secondary outcome parameters of fresh frozen plasma and platelet transfusion rates, postoperative mechanical ventilation time, length of intensive care unit stay, composite adverse events rate, costs of hemostatic therapy, and 6-month mortality were lower in the POC group. CONCLUSIONS:: Hemostatic therapy based on POC testing reduced patient exposure to allogenic blood products and provided significant benefits with respect to clinical outcomes.     

Bioresorbable Hyaluronate-Carboxymethylcellulose Membrane (Seprafilm) in Surgery for Rectal Carcinoma: A Prospective Randomized Clinical Trial

Purpose To evaluate the effectiveness of Seprafilm in preventing abdominal adhesions after radical resection of rectal carcinoma, and to observe whether Seprafilm had any adverse effects in patients treated with radiotherapy and chemotherapy. Methods A total of 62 patients participated in this prospective randomized clinical study, which was conducted to compare the outcomes of patients operated on with Seprafilm (SEPRA+) with those operated on without Seprafilm (SEPRA−). All patients received preoperative radiotherapy, followed by a two-stage operation, and 5-fluorouracil (5-FU)-based systemic chemotherapy. The primary endpoint of severity and extent of adhesions were evaluated at the time of ileostomy closure. The secondary endpoint included the recurrence of tumors, late complications, and outcome. Results Seprafilm significantly reduced the adhesions in both the midline incision area and peristomal area. This in turn reduced the operation time, blood loss, and extent of the incision at ileostomy closure. Seprafilm was not associated with any postoperative complications or chemoradiation-related toxicity, nor did it affect recurrence or survival rates. Conclusion Seprafilm effectively reduced abdominal adhesions in chemoradiated patients, and had no adverse effects on the oncologic results of fully introduced adjuvant therapy. Thus, Seprafilm is a safe and effective tool for use in rectal carcinoma surgery.     

Intraperitoneal Ropivacaine Irrigation in Patients Undergoing Bariatric Surgery: a Prospective Randomized Clinical Trial

Background

Despite most bariatric procedures are actually performed by laparoscopic approach, management of postoperative pain remains a major challenge. The aim of this study was to analyze the analgesic effect of intraperitoneal ropivacaine infusion in patients undergoing bariatric surgery.

Methods

A prospective randomized clinical trial of all the patients undergoing laparoscopic sleeve gastrectomy (LSG) or laparoscopic Roux-en-Y gastric bypass (LRYGB) between January and November 2015 was performed. Patients were randomized to experimental (EG: those patients undergoing intraperitoneal ropivacain irrigation) and control groups (CG: those undergoing intraperitoneal irrigation with normal saline).

Results

One hundred ten patients were included, 83 LRYGB (75.5 %) and 27 LSG (24.5 %). Mean pain, as measured by VAS score, was 21.7?±?14.5 mm in CG and 13.3?±?10.9 mm in EG (p?=?0.002). Morphine needs during the first 24 h postoperatively were 21.8 % in CG and 3.6 % in EG (p?=?0.01). Early taking of fluids by mouth was possible 6 h after surgery in 76.4 % in EG vs 34.5 % in CG (p?=?0.001). Early mobilization ability (6 h after surgery) was feasible in 72.7 % in EG and 32.7 % in CG (p?=?0.001). Median hospital stay was 3 days (range 2–10 days) in CG and 2 days (2–7 days) in EG (p?=?0.009).

Conclusions

The intraoperative peritoneal infusion with ropivacaine in patients undergoing bariatric surgery is associated with a reduction in postoperative pain, lower morphine needs, earlier mobilization and earlier oral intake of fluids after surgery, and a shorter hospital stay.ClinicalTrials.gov Identifier: NCT02641288

     

Clinical and Angiographic Outcome of Coronary Surgery with and without Cardiopulmonary Bypass: A Prospective Randomized Trial

Abstract Background: Off-pump coronary artery bypass surgery has emerged as an alternative technique to traditional onpump surgery. The aim of this randomized study was to compare perioperative morbidity and mortality and intraoperative and short-term graft patency in off-pump and on-pump coronary artery bypass grafting. Methods: One hundred twenty patients were randomized for coronary revascularization with or without cardiopulmonary bypass. In all patients grafts and anastomoses were monitored with transit time Doppler ultrasonography and angiography. Angiography was repeated 3 months after the procedure in 115 of the patients. Results: Angiography 3 months postoperatively revealed that internal mammary artery patency was 98% in both groups. Vein graft patency was 83% in the off-pump group and 91% in the on-pump group, a difference that was not statistically significant. One perioperative death was recorded in each group. Two strokes were recorded in the on-pump group, none in the off-pump group. Conclusion: In this prospective, controlled study, perioperative and short-term outcome of off-pump coronary surgery equaled that of on-pump surgery.     

Adjustable Gastric and Esophagogastric Banding: A Randomized Clinical Trial

Background: Adjustable gastric banding and esophagogastric banding may affect the function of the lower esophageal sphincter (LES) and esophageal motility in the long-term. Both methods were evaluated in a prospective randomized trial. Materials and Methods: Group 1 comprised 28 patients who underwent laparoscopic adjustable gastric banding and Group 2 consisted of 24 patients in whom adjustable esophagogastric banding was performed. Swedish Adjustable Gastric Bands? were used in all patients. Body mass index (BMI), perioperative complications and reflux symptoms were assessed and upper gastrointestinal endoscopy, esophageal barium studies, esophageal manometry and 24-hour esophageal pH-monitoring were performed pre- and postoperatively. 18 (Group 1) and 14 (Group 2) patients completed the postoperative follow-up procedure after a median of 23 and 24 months, respectively. Results: Postoperatively the median BMI dropped equally in both groups. Perioperative complications requiring re-intervention were significantly more frequent in Group 2 than in Group 1. Heartburn improved equally in both groups following surgery; however, regurgitation and esophagitis were significantly more common in Group 2 than in Group 1.24-hour esophageal pH-monitoring and the LES resting pressure improved equally in both groups, but there was a significant impairment of the LES relaxation and the esophageal peristalsis, which was more pronounced in Group 2 than in Group 1. This caused significant esophageal stasis as shown by barium studies. Conclusions: Both techniques, gastric and esophagogastric banding, provide effective weight loss in morbidly obese patients but affect the esophagogastric junction. Although both procedures strengthen the antireflux-barrier, LES relaxation becomes impaired, thus promoting esophageal dilatation and esophageal stasis. This is more pronounced following esophagogastric banding than following the classic procedure. Since the esophagogastric banding results in more complications requiring re-intervention, we believe that this procedure should not be used any more.