Arthroscopic versus open acromioplasty: a prospective, randomized, blinded study

The purpose of this study is to determine whether arthroscopic acromioplasty is equivalent or superior to open acromioplasty, in a prospective, randomized, controlled, blinded clinical trial. Seventy-one patients with a clinical diagnosis of impingement syndrome were randomized to arthroscopic or open acromioplasty. Nine were excluded because of full-thickness rotator cuff tears diagnosed after randomization. Sixty-two patients (49 men and 13 women) with a minimum follow-up of 12 months (mean, 25 months) were included. The patient groups were virtually identical with regard to duration of symptoms, shoulder functional demands, age, sex, hand dominance, mechanism of onset, range of motion, strength, joint laxity, and the presence of a compensation claim. Patients were prospectively randomized to arthroscopic or open acromioplasty after stratification for age (>50 years),associated ligamentous laxity, and the presence of an ongoing compensation claim. The main outcome measure was visual analog scales for pain and function. Also recorded were UCLA shoulder scores and visual analog scales for postoperative improvement, patient satisfaction, and a variety of clinical measures. An independent blinded examiner assessed all patients. There was no significant difference between open and arthroscopic acromioplasty in visual analog scales for postoperative improvement (P =.30), patient satisfaction (P =.94), UCLA shoulder score (P =.69), or strength (P =.62); however, open was superior to arthroscopic acromioplasty for pain and function (P =.01). Overall, 67% of patients had a good or excellent result. This increased to 87% when unsettled compensation claims were excluded. Repeat (open) acromioplasty was performed in 5 patients in the unsuccessful arthroscopic group without improvement. Open acromioplasty was equivalent to arthroscopic acromioplasty for UCLA scores and patient satisfaction. For pain and function, both gave significant improvement but the open technique may be superior. Unsettled compensation is a predictor of poor outcome.     

Comparison of water seal and suction after pulmonary lobectomy: a prospective, randomized trial

BACKGROUND: The objective of the present study was to assess whether placing chest tubes on water seal after pulmonary lobectomy reduced the duration of air leak compared with suction. METHODS: One hundred forty-five patients who underwent pulmonary lobectomy for lung cancer and with an air leak on the first postoperative day were prospectively randomly assigned to two groups: in group 1 (72 patients), chest tubes were placed on water seal on the morning of the first postoperative day; in group 2 (73 patients), chest tubes were on continuous suction (-20 cm H(2)O). Eighty percent of the patients who underwent upper lobectomy had also a pleural tent procedure. Preoperative, operative, and postoperative variables were compared between the groups. RESULTS: The two groups were evenly matched for preoperative and operative characteristics. No statistically significant differences were found between group 1 and group 2 in terms of air leak duration (6.5 versus 6.3, respectively; p = 0.9) and the incidence of prolonged air leak cases (27.8% versus 30.1%, respectively; p = 0.8). Similar results were obtained when the analysis was corrected for the length of the stapled parenchyma and the site of resection (upper and lower resections) or restricted to patients with a forced expiratory volume in 1 second less than 80% of predicted. Water seal patients had increased postoperative complications compared with suction patients (31.9% versus 17.8%, respectively; p = 0.056). CONCLUSIONS: Chest tubes placed on water seal after pulmonary lobectomy were generally well tolerated and safe; however, they did not reduce the duration of air leak or the incidence of prolonged air leak compared with suction.     

Lung sealant and morbidity after pleural decortication: a prospective randomized,blinded study

Objectives  

Prolonged postoperative air leaks (AL) are a major cause of morbidity. Aim of this work was evaluating use of a Lung Sealant System (Pleuraseal™, Covidien, Mansfield, MA, U.S.A.) in pleural decortications for empyema thoracis.     

Prospective randomized study evaluating a biodegradable polymeric sealant for sealing intraoperative air leaks that occur during pulmonary resection

BACKGROUND: To evaluate the safety and effectiveness of a new biodegradable polymeric sealant to close intraoperative air leaks after pulmonary resection. METHODS: In a multicenter prospective randomized trial, 161 patients with a median age of 67 years old (range 18-85 years old), were randomized in a 2:1 ratio to receive sealant or control for at least one significant air leak (> or = 2.0 mm in size) after pulmonary resection. In the sealant group, all significant air leaks underwent attempted repair by standard methods (sutures, staples, or cautery) prior to the application of sealant. The control group underwent only standard methods. Blood was analyzed for immunologic response. Patients were followed up 1 month after surgery. RESULTS: Intraoperative air leaks were sealed in 77% of the sealant group compared with 16% in the control group (p < 0.001). The sealant group had significantly fewer patients with postoperative air leaks compared with the control group (65% vs 86%, p = 0.005). Median length of hospitalization was 6 days (range, 3-23 days) for the sealant group compared with 7 days (range 4-38 days) for controls (p = 0.028). There was no difference in mortality, morbidity, duration of chest tubes, or immune responses between the two groups. CONCLUSIONS: This study demonstrates the effectiveness of a biodegradable polymer when used as an adjunct to standard closure methods for sealing significant intraoperative air leaks that develop from pulmonary surgery. Use of the sealant led to a reduction in postoperative air leaks, which may have decreased the length of hospitalization.     

Early postoperative pain after subxiphoid uniportal thoracoscopic major lung resection: a prospective,single- blinded,randomized controlled trial

Open in a separate window OBJECTIVESPreoperative selection bias led to the inability to generalize the proposed benefit of subxiphoid uniportal video-assisted thoracoscopic surgery (SVATS) as having less postoperative pain than uniportal intercostal VATS. So, we conducted this prospective, single-blinded, randomized controlled trial to investigate the hypothesis that SVATS may have less early postoperative pain than UVATS in patients who undergo major lung resection for early-stage lung cancer.METHODSA total of262 patients were randomly allocated between 2 groups (each with 131 patients), the first being the UVATS group and the second being the SVATS group. The values indicated on the numerical rating scale (NRS) of pain were collected at 24 h and 48 h during rest and during coughing. In addition, different perioperative variables were analysed and compared between the 2 groups.RESULTSMultiple linear regression analysis showed that the type of surgical approach was a significant predictor of the postoperative NRS values. The postoperative NRS pain values were significantly lower in the SVATS group after 24 h during rest and coughing and after 48 h during coughing. Postoperatively, patients in the SVATS group got out of bed significantly earlier [16.37 (2.54) vs 18.05 (3.29) h, p < 0.001]. The SVATS group showed a significantly higher rate of intraoperative arrhythmia [20 (15.3%) vs 3 (2.3%) patients, p = 0.03].CONCLUSIONSSVATS major pulmonary resection in early-stage lung cancer is associated with less early postoperative pain than the UVATS approach. Operating on patients with cardiac problems using the SVATS approach is still a limiting factor for randomization due to the potential compression on the heart with resulting arrhythmia.Clinical trial registrationThe trial was registered under clinical trials.gov Identifier: {"type":"clinical-trial","attrs":{"text":"NCT03331588","term_id":"NCT03331588"}}NCT03331588. https://clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT03331588","term_id":"NCT03331588"}}NCT03331588.     

Teaching cognitive skills improves learning in surgical skills courses: a blinded, prospective, randomized study.

OBJECTIVE: To investigate the teaching of cognitive skills within a technical skills course, we carried out a blinded, randomized prospective study. METHODS: Twenty-one junior residents (postgraduate years 1-3) from a single program at a surgical-skills training centre were randomized to 2 surgical skills courses teaching total knee arthroplasty. One course taught only technical skill and had more repetitions of the task (5 or 6). The other focused more on developing cognitive skills and had fewer task repetitions (3 or 4). All were tested with the Objective Structured Assessment of Technical Skill (OSATS) both before and after the course, as well as a pre- and postcourse error-detection exam and a postcourse exam with multiple-choice questions (MCQs) to test their cognitive skills. RESULTS: Both groups' technical skills as assessed by OSATS were equivalent, both pre- and postcourse. Taking their courses improved the technical skills of both groups (OSATS, p < 0.01) over their pre-course scores. Both groups demonstrated equivalent levels of knowledge on the MCQ exam, but the cognitive group scored better on the error-detection test (p = 0.02). CONCLUSIONS: Cognitive skills training enhances the ability to correctly execute a surgical skill. Furthermore, specific training and practice are required to develop procedural knowledge into appropriate cognitive skills. Surgeons need to be trained to judge the correctness of their actions.     

Infection prophylaxis in pulmonary surgery: a randomized prospective study

A prospective randomized study to evaluate the efficacy of antibiotic prophylaxis against postoperative infections was carried out on 120 patients undergoing pulmonary operations. The patients were randomized into two groups of 60 patients each. One group received doxycycline (deoxytetracycline) prophylaxis for five days, and the other received cefuroxime (a second-generation cephalosporin) for one day. The groups were comparable with regard to age, sex, common risk factors, diagnosis, and operative procedures. A reduction in the infection rate was noted in the cefuroxime group (10/60) compared with the doxycycline group (19/60), but the difference was not statistically significant (p = 0.055). In major infections (empyema and pneumonia) there was no difference between the groups (4/60 in the cefuroxime group and 5/60 in the doxycycline group), but a significant (p less than 0.05) reduction was noted in minor infections (6/56 and 14/55, respectively) such as lower respiratory tract infections and prolonged fever. There were no wound infections in the two study groups. There were significantly (p less than 0.05) fewer postoperative fever reactions (axillary temperature greater than 37.5 degrees C) in the cefuroxime group (30/60) compared with the doxycycline group (44/60). Both antibiotics were effective in preventing wound infections, but cefuroxime may also be beneficial in preventing minor respiratory infections. The bactericidal effect of cefuroxime may explain this finding.     

负压吸引与常规引流对肺切除术后迁延性肺瘘的作用分析

目的研究分析持续负压吸引和常规闭式引流对肺切除术后迁延性肺瘘（PAL）中所起的作用和价值。方法将我院2004年3月至2011年5月203例肺切除术患者随机分为负压组（98例）和常规组（105例）。负压组于术后第一天胸腔引流管连接负压吸引装置,给予持续低负压吸引（压力为-10至-20cmH：O）。常规组手术后仅行常规的胸腔闭式引流。对两组并发症、PAL发生率以及漏气时间进行统计分析。结果本组共行肺切除术203例,发生迁延性肺瘘24例,发生率11．8％。负压组98例,出现并发症48例,其中迁延性肺瘘14例（14．3％）;常规组105例,出现并发症33例,其中迁延性肺瘘10例（9．5％）。负压组平均漏气时间5．3d,常规组4．9d,两组间差异无统计学意义（P〉0．05）;两组均无死亡病例。结论肺切除术后持续负压吸引并没有降低漏气持续时间以及PAL的发生率,在防治PAL的过程中持续负压吸引并不优于常规的闭式引流,不推荐肺切除术后常规使用负压吸引。     

Pelvic floor muscle training before transurethral resection of the prostate: a randomized, controlled, blinded study

OBJECTIVE To evaluate the effect of preoperative pelvic floor muscle training (PFMT) in men scheduled for transurethral resection of the prostate (TURP) in a randomized, single-blind study. MATERIAL AND METHODS: Fifty-eight men with benign prostatic obstruction were included, and 49 completed the study (training group, n=26; control group, n=23). The preoperative training included a 1-h individual lesson, three 1-h group lessons and a home training programme. Postoperatively and before discharge from hospital both groups received verbal instructions regarding PFMT. Pelvic floor muscle function was assessed by anal examination before and 4 weeks after surgery by one physiotherapist who was blinded to the randomization. The primary outcome parameter was the total score on the Danish Prostatic Symptom Score questionnaire. Secondary outcome measures were other subjective and objective voiding and incontinence parameters and four tests of the pelvic floor muscle: function; strength; static endurance; and dynamic endurance. RESULTS: Baseline characteristics were similar in the two groups. Improved static endurance occurred in the training group but not in the control group (p=0.004). Regarding dynamic endurance, a difference in favour of training developed between the groups (p=0.049). Many men produced results that were outside the test scales. At follow-up at 2 and 4 weeks and 3 months there were no differences between the groups in any of the lower urinary tract parameters. CONCLUSIONS: Preoperative PFMT produced a significant improvement in pelvic floor muscle endurance after TURP, but clinically relevant storage or voiding improvements did not occur. Pelvic floor muscle assessment tests need to be sex-specific.     

Acupuncture relieves menopausal discomfort in breast cancer patients: A prospective,double blinded,randomized study

BackgroundThis study evaluates the effect of acupuncture on hot flashes and disturbed night sleep in patients treated for breast cancer. The effect of acupuncture was tested against a sham-acupuncture group and a no-treatment control group. Plasma estradiol was measured to rule out this as cause of effect. Side effects of the treatment were registered.MethodsWe randomized 94 women into the study: 31 had acupuncture, 29 had sham acupuncture and 34 had no treatment.FindingsIn the acupuncture group, 16 patients (52%) experienced a significant effect on hot flashes compared with seven patients (24%) in the sham group (p < 0.05). The effect came after the second acupuncture session and lasted for at least 12 weeks after last treatment. A statistically significant positive effect was seen on sleep in the acupuncture group compared with the sham-acupuncture and no-treatment groups. The effect was not correlated with increased levels of plasma estradiol. No side effects of acupuncture were registered.InterpretationWe find that acupuncture significantly relieves hot flashes and sleep disturbances and is a good and safe treatment in women treated for breast cancer.The project is registered at Clinical Trials.gov (no: NCT00425776).     

Fibrin glue as a biologic vascular patch--a comparative study

Fibrin glue is a biologic two component hemostatic adhesive. Fibrin glue acts as an effective vascular plus after arterial injury without suture at pressures twice systolic. It is also effective on vein at physiologic pressures, however, venous distensibility precludes its efficacy beyond these limits. Recent studies have documented its utility as a preclot material on vascular grafts and as a seal for sutured vascular anastomoses. This study was designed to characterize the glue's sealant ability when applied to open arterial and venous injuries, and to compare its efficacy with currently available hemostatic agents. Segments of canine peripheral artery and vein were isolated and perforated with a 16-gauge needle. This injury was treated by random application of either fibrin sealant (FS), oxidized cellulose (OC), microcrystalline collagen (MC), or MC plus thrombin (MCT). Five minutes after patch application, intralumenal pressure was increased progressively with saline infusion to ascertain bursting threshold. The arterial bursting threshold was significantly higher for FA (250 +/- 59.7 mm Hg) than for OC (12.5 +/- 6.1 mm Hg), MC (17.2 +/- 21.9 mm Hg) or MCT (10.8 +/- 13.8 mm Hg) (P less than 10(6)). The bursting threshold of FS applied to vein (17.5 +/- 11.7) was not significantly different from other agents (P less than 0.05).     

Focused versus conventional parathyroidectomy for primary hyperparathyroidism: a prospective,randomized, blinded trial

BACKGROUND: For many years bilateral neck exploration (BNE) was the gold standard operation for primary hyperparathyroidism (pPHP). With advances in preoperative pathological gland localization and intraoperative parathyroid hormone (IPTH) monitoring, minimally invasive approaches have evolved. This study is aimed to compare BNE and focused parathyroidectomy (FP) in a prospective, randomized, blind trial. PATIENTS AND METHODS: Between 2005 and 2007, 48 patients with pPHP were enrolled in our study. Twenty three patients were randomized to the BNE group and 24 to the FP group. Patients in the FP group underwent preoperative localization studies. All parathyroidectomies were guided by intraoperative intact parathyroid hormone (IIPTH) monitoring. In the BNE group, neither IIPTH nor preoperative localization studies were performed. RESULTS: All patients were cured by the primary operation. Overall, the operative time was similar in both groups. In the focused exploration (FE) group, compared to the BNE group, there was lower pain intensity at 4, 8, 16, 24, 36 and 48 h after surgery (p < 0.001), lower consumption of analgesics (p < 0.001), lower analgesia request rate (p < 0.001), shorter scar length (p < 0.001), higher cosmetic satisfaction rate 2 days, 1 month (p < 0.001) and 6 months after surgery (p < 0.05), but after 1 year cosmetic satisfaction rate became not significant (p = 0.38). Focused exploration (FE) was more expensive (p < 0.05). We did not find any difference in quality of life after 1 month and 6 months after surgery in both groups. CONCLUSION: Both methods of parathyroidectomy for PHP are safe and effective. Focused exploration (FE) has several advantages: lower postoperative pain, lower analgesic request rate, lower analgesic consumption, shorter scar length, better cosmetic satisfaction rate in a short time period.     

Repeated dose administration of desmopressin acetate in uncomplicated cardiac surgery: A prospective, blinded, randomized study

The effects of single or repeated doses of desmopressin on blood loss were examined in uncomplicated cardiac surgery, while assessing the potential for thrombogenic side effects. Seventy patients undergoing elective coronary artery bypass grafting (CABG) were studied. Patients were randomized into three blinded groups: Group I received DDAVP (0.3 micrograms/kg), IV, after cardiopulmonary bypass (CPB) and 12 hours later in the Intensive Care Unit (ICU); Group II, DDAVP (0.3 micrograms/kg), IV, after termination of CPB and saline (placebo) 12 hours later in the ICU; Group III, saline (placebo) IV after CPB and 12 hours later in the ICU. Blood loss and bleeding time decreased for Group I at 24 hours (P < 0.04) when compared to Group III; however, blood product replacement, as well as intraoperative and total blood loss at 36 hours, were not different among treatment and control groups. There were four myocardial infarctions recorded in Group I, two in Group II, and one in Group III. These differences were not found to be statistically significant. It is concluded that in routine CABG the prophylactic use of single or repeat dose DDAVP does not effectively decrease blood loss or blood product replacement.     

Radiologic versus endoscopic evaluation of the conduit after esophageal resection: a prospective,blinded, intraindividually controlled diagnostic study

Background

Anastomotic leakage is a major complication in esophageal surgery. Although contrast swallow is performed by many surgical centers before reintroduction of oral intake to exclude anastomotic leakage postoperatively, endoscopy is increasingly used in this situation and may be superior. This study compares radiographic contrast study and endoscopy for the identification of local complications after subtotal esophagectomy.

Methods

Between January 2006 and September 2007, a prospective, blinded, intraindividually controlled study was conducted in patients who underwent transthoracic esophagectomy due to esophageal cancer. A radiographic contrast study was performed prior to endoscopy on postoperative day 5–7. Technical feasibility, sensitivity, and specificity of the radiologic and endoscopic evaluations of the esophageal substitute were described.

Results

Radiographic contrast study was possible in only 64 % of the patients (35 of 55). The contrast study could not be performed in 20 patients due to contraindications or mechanical ventilation. Endoscopy could be performed in all patients (p < 0.001). Pathologic findings were detected in 13 patients by endoscopy but in only 1 patient by contrast swallow. Leakage of the anastomosis or the conduit was correctly detected in 7 patients by endoscopy but in only 1 patient by contrast swallow (p = 0.01). Endoscopy detected focal conduit necrosis or ischemia in six additional patients. Contrast studies showed false-positive results in two patients. Both sensitivity and specificity of endoscopy were 100 %, while sensitivity and specificity of the contrast study were only 20 and 94 %. No complications resulted from postoperative endoscopy or radiologic imaging.

Conclusions

Endoscopic evaluation of the esophageal substitute in the early postoperative course is possible in all patients without complications. Endoscopy is superior to the contrast study in detecting pathological findings after esophageal reconstruction. Radiologic contrast swallow in the early postoperative days is often not possible, has no further relevance, and should be replaced by endoscopic evaluation.     

Hospital readmission after pulmonary resection: prevalence, patterns, and predisposing characteristics

Background. Our objective was to define the prevalence, patterns, and predisposing characteristics for hospital readmission after pulmonary resection.

Methods. Five years of pulmonary resections, excluding lung biopsies, were analyzed from a prospective, computerized database. Readmission was defined as inpatient or emergency department admission within 90 days of operation. Search of 1,173,912 admissions to the Providence Health System in Oregon identified readmissions. Readmission analysis excluded operative deaths.

Results. A total of 374 patients underwent pulmonary resections, of whom 8 died (2.1%). Of 366 patients discharged, 69 (18.9%) were readmitted a total of 113 times: 42 had only one readmission, 16 had two readmissions, 7 had three readmissions, 2 had four readmissions, and 2 had five readmissions. Slightly more than half (51%) were readmitted as inpatients. Causes of the 113 readmissions included pulmonary (27%), postoperative infection (14%), cardiac (7%), and other (16%). Mean time to readmission was 32.5 ± 24.6 days. Inpatient readmission mean length of stay was 4.9 ± 3.4 days. Readmission to hospitals other than the hospital of the operation was as follows: first readmission, 15.9%; second readmission, 14.8%; third readmission, 36.3%; fourth readmission, 25%; fifth readmission, 0%. Analysis revealed only pneumonectomy as a risk for readmission. Twelve of 33 (36%) pneumonectomies were readmitted (p = 0.005). Of the 297 patients discharged after pulmonary resection and not requiring readmission, 12 (4%) died over the study interval, whereas 8 of 69 patients (11.6%) requiring readmission died.

Conclusions. Readmission after pulmonary resection is frequent and multiple readmissions are common. Causes are predominately pulmonary diagnoses and infections related to the operation. Pneumonectomy is a risk for readmission. An important portion of readmissions occurs outside the hospital of operation. The population requiring readmission after successfully undergoing pulmonary resection is at increased risk of subsequent mortality.     

Fibrin glue in perianal fistulas--a pilot study.

BACKGROUND AND AIMS: Anal fistula surgery is associated with considerable morbidity, mainly related to anal incontinence. As promising results of the use of fibrin glue in the treatment of complex anal fistulas were recently shown, we planned to do a randomized trial comparing the use of fibrin glue and surgery in the treatment of perianal fistulas. There were no reports of the use of fibrin glue in the management of previously untreated anal fistulas. MATERIAL AND METHODS: Prior to the planned study a pretrial pilot series of 10 patients with different perianal fistulas were treated. Informed consent was obtained from every patient. Under spinal anesthesia, the fistula track was identified and brushed to remove granulous tissue, then washed with hydrogen peroxide and thereafter filled with fibrin glue. RESULTS: We performed fibrin gluing on 10 patients with perianal fistulas of different etiology and type. The gluing was done once to 7 patients, twice to 2 and three times to one patient. In all but one patient the fistula and symptoms recurred after only one month. One patient with a low trans-sphincteric fistula of which the internal opening was not found, was symptom-free for 6 months. At the one-month follow-up visit the external opening of the fistula was almost unidentifiable, suggesting that the fistula had healed. However, due to recurrence fistulotomy was performed after 6 months. CONCLUSIONS: Fistulas around the anus, with or without associated inflammatory bowel disease, do not seem to heal after fibrin gluing.