Pre- or postoperative radiotherapy in rectal and rectosigmoid carcinoma. Report from a randomized multicenter trial.

Between October 1980 and December 1985, 471 patients with a resectable rectal carcinoma entered a randomized multicenter trial for comparison of pre- and postoperative irradiation. Two hundred thirty-six patients were allocated to receive high-dose fractionated preoperative irradiation (total dosage, 25.5 Gy in five to seven days) and 235 patients to receive postoperative irradiation to a very high dosage level with conventional fractionation (60 Gy in a total 8 weeks). The postoperative treatment was delivered only to a high-risk group of patients (Astler-Coller stages B2, C1, and C2). The preoperative irradiation was well tolerated, with no immediate irradiation-related complications and no increased postoperative mortality (3%, 7 of 217 patients, compared to 5%, 10 of 215 patients in the postoperatively irradiated group). More patients in the preoperative irradiation group had perineal wound sepsis after abdominoperineal resection and this prolonged the stay in hospital after surgery. In 50% of the patients the postoperative treatment could not be commenced until more than 6 weeks after surgery. The postoperative treatment was not as well tolerated as the preoperative one. The local recurrence rate was statistically significantly lower after preoperative than after postoperative radiotherapy (12% versus 21%; p = 0.02). In both groups more patients developed a local recurrence if the bowel was perforated at surgery or if the resection line was microscopically close to the tumor. To date, with a minimum follow-up of 3 years and a mean follow-up of 6 years, there is no difference in survival rates between the two groups.     

A comparative randomized trial of heparin versus streptokinase in the treatment of acute proximal venous thrombosis: an interim report of a prospective trial.

A controlled, prospective study comparing streptokinase and heparin treatment has been completed in 51 patients presenting with acute proximal venous thrombosis of less than 8 days' clinical duration. Patients were studied by means of pre-treatment, post-treatment, 3- and 12-monthly phlebography and pulmonary perfusion scanning and were followed up at 3-monthly intervals. Of the 26 patients randomized to receive streptokinase, therapy was stopped in 3 because of complications. Phlebography 5 days after starting treatment showed 80--100 per cent lysis in 17 of the 23 patients who completed the course of streptokinase. Two patients later developed partial rethrombosis. One patient developed an asymptomatic pulmonary embolus during treatment. During follow-up (mean 19 months) only 1 of the 17 patients with 80--100 per cent lysis developed postphlebitic symptoms, 3 patients died of unrelated causes and 1 patient was lost to follow-up. In patients randomized to heparin therapy no significant lysis was achieved in any of the 25 patients and only 2 of these patients were found to have asymptomatic legs on follow-up. Two patients in this group died and autopsy confirmed massive pulmonary embolus during treatment. These data suggest that streptokinase is superior to heparin in the treatment of acute proximal venous thrombosis of less than 1 week's clinical duration especially if the thrombus is largely non-occlusive. It must be stressed that in order to avoid the bleeding complications of thrombolytic therapy, streptokinase must not be used within 10 days of major surgery, or even longer after vascular, neurosurgical or eye operations.     

Mono- versus polyaxial locking plates in distal femur fractures: a prospective randomized multicentre clinical trial

Purpose

Treatment of complex fractures of the distal femur utilizing monoaxial locking plates (e.g. Less Invasive Stabilisation System, LISS®, Synthes) is considered to be superior to conventional plating systems. Due to the limitation that the thread forces the screw into pre-determined positions, modifications have been made to allow screw positioning within a range of 30° (Non Contact Bridging, NCB®-DF, Zimmer). For the first time, this multicenter prospective randomized clinical trial (RCT) investigates the outcome of LISS® vs. NCB®-DF treatment following complex fractures of the distal femur.

Methods

Since June 2008, 27 patients with a fracture of the distal femur (AO ASIF 33-A-C and periprosthetic fractures) were enrolled in this study by four university trauma centres in southern Germany. Clinical (e.g. range of motion, Oxford knee score, Tegner score) and radiological (e.g. axis deviation, secondary loss of realignment) follow-ups were conducted one and six weeks, as well as three, six, and 12 months after the operation.

Results

This study comprises data of 27 patients (8 male, 19 female; 15 NCB®-DF, 12 LISS®). Polyaxial osteosynthesis using the NCB® system tended to result in better functional knee scores and a higher range of motion. Interestingly, fracture union tended to be more rapid using the polyaxial plating system.

Conclusions

We present the analysis of a multicenter prospective RCT to compare the monoaxial LISS® vs. the polyaxial NCB®-DF treatment following complex fractures of the distal femur. NCB®-DF treatment tended to result in better functional and radiological outcomes than LISS® treatment.

Level of Evidence

Level I     

直肠癌根治术前辅助放射治疗随机研究的meta分析

目的探讨直肠癌根治术前辅助放射治疗的临床价值。方法通过Pubmed、CNKI和VIP联机检索，对1994—2006年有关直肠癌术前放疗的随机对照研究文献资料进行meta分析。结果现有的证据（3篇前瞻性随机试验）可以说明对于直肠癌根治术前进行辅助放射治疗可提高12年存活率（OR=1．2612，95％CI=1．0539—1．5091），“抽屉文件”数为4。并且对于不同Dukes分期的直肠癌术前进行辅助放疗均可以降低局部复发率（ORA=2．5564．95％CI=1．3448—4．8595．ORB=3．6807,95％CI=2．2859—5．9266．ORC=2．3667，95％CI=1．6030—3．4944）。“抽屉文件”数分别为4、20、12。结论直肠癌根治性术前辅助放射治疗可提高12年存活率，并可以降低局部复发率。     

Sevoflurane versus halothane: postoperative maladaptive behavioral changes: a randomized, controlled trial

BACKGROUND: The authors conducted a double-blind, randomized, controlled trial to determine whether the use of sevoflurane in children undergoing anesthesia and surgery results in a higher incidence of postoperative maladaptive behavioral changes as compared with halothane. METHODS: Children and their parents (n = 102) were randomly assigned to either a halothane group (n = 50) or a sevoflurane group (n = 52). The intraoperative anesthetic protocol was strictly controlled, and the postoperative analgesic consumption and pain levels were recorded. The effect of the group assignment on emergence status and maladaptive postoperative behavioral changes was assessed both by validated psychological measures and physiologic instruments (actigraphy) on postoperative days 1-7. Anxiety of the parent and child was also assessed, as was the child's postoperative recovery (Recovery Inventory). RESULTS: There were no group differences in preoperative state anxiety, postoperative analgesic requirements, postoperative pain, or the incidence of emergence delirium (P = not significant). Two-way repeated-measures analysis of variance showed no group differences in the incidence of postoperative maladaptive behaviors (F4,72 = 0.60, P = 0.701) or actigraphic variables such as percent sleep, number of night awakenings, and night awakenings that lasted for more than 5 min (P = not significant). CONCLUSION: The authors found no increased incidence of emergence delirium, maladaptive postoperative behavior changes, or sleep disturbances in children undergoing anesthesia with sevoflurane as compared with halothane.     

Malar metastasis from rectal carcinoma: a case report

Facial metastasis from colorectal carcinoma is extremely rare. Only two cases have been reported in the literature. This is the first reported case of malar metastasis from colon carcinoma. The patient was a 64-year-old, white woman who underwent a low anterior resection for a nearly obstructive carcinoma at 20 cm. Her chest X-ray revealed lung metastases. Postoperatively she was treated with fluorouracil and leucovorin. Twenty months later, she presented with left facial edema, which progressively increased in size. CT scan and magnetic resonance imaging with gadolinium showed a large soft tissue mass centered about the left anterior zygomatic arch. The platysma muscle was displaced laterally, and the masseter muscle was involved. There was extension into the masticator space and bony involvement of the zygomatic arch. True-cut biopsy of the left cheek revealed metastatic adenocarcinoma. Histology was similar to that of the primary rectal adenocarcinoma. Metastasis to the malar region is extremely rare. It is a grave prognostic sign, as it is associated with advanced terminal disease. Because of the widespread metastases, only palliative treatment can be provided.     

Piggy-back versus conventional technique in liver transplantation: report of a randomized trial

Liver transplantation with preservation of the recipient vena cava (the “piggy-back” technique) has been proposed as an alternative to the traditional method. We performed a randomized study on 39 cirrhotic patients, 20 who underwent the piggy-back technique (group 1) and 19 the traditional method using venovenous bypass (group 2) to evaluate the feasibility and true advantages of the piggy-back technique compared to the traditional method. Two patients were switched to the conventional technique due to the presence of a caudate lobe embracing the vena cava in one patient and a caval lesion in the other. Statistically significant differences between the two groups were only found for the warm ischemia time (48.5 ± 13 min for piggy-back vs 60 ± 12 min for the conventional method) and for renal failure (zero cases in group 1 vs four cases in group 2). We therefore believe that liver transplantation with the piggy-back technique can easily be performed in almost all cases, and that only a few, specific situations, such as a very enlarged caudate lobe, do not justify its routine use. Received: 30 May 1996 Received after revision: 7 October 1996 Accepted: 28 October 1996     

Diethylstilboestrol versus bicalutamide in hormone refractory prostate carcinoma: a prospective randomized trial

OBJECTIVE: To compare the efficacy of diethylstilboestrol (DES) with bicalutamide in the treatment of hormone refractory prostate cancer in relation to its effect on prostate-specific antigen (PSA) and survival. METHODS: Patients on LHRH analogues for prostate carcinoma with evidence of biochemical or clinical progression were randomized into one of the treatment arms (n=58). The first group (group A, n=26) received 1 mg of DES with 75 mg of aspirin per day in addition to the primary hormonal treatment. The second group (group B, n=32) received bicalutamide at a dose of 50 mg/day in addition to the primary treatment. Patients were followed up every 3 months with their PSA being checked and were also monitored for any clinical progression and adverse effects as a result of treatment. Any adverse event occurring after patients were started on treatment was attributed to the drug and patients were clinically assessed at each visit. Failure of treatment was defined as a 50% or greater increase in PSA after commencing treatment. Once randomized, all patients were followed up for survival regardless of failure of second-line hormonal manipulation. RESULTS: The mean age of the patients was 76.7 years (60-88, SD 7.4) in group A and 76 years (67-86, SD 6.9) in group B. Twelve patients in each group had metastatic disease. The median follow-up periods for both groups were 24 months (range 6-48 in group A, range 3-54 in group B). 65% of the patients in group A (17/26) and 43.5% (14/32) in group B had a fall in their PSA levels (p=0.08, Fisher's exact test) with 23% (6/26) and 31% (10/32) having a >50% response respectively (p=0.34, Fisher's exact test). Mean PSA nadir in those who responded were 20.6 ng/ml (range 1.6-59.4) and 7.41 ng/ml (range 0.1-42.6) in groups A and B respectively. The median duration of response was 9 months (3-18 months) for group A and 12 months (3-18 months) for group B. Seven patients in group A and 6 in group B experienced adverse events. Three of the 7 in the group A experienced cardiovascular related adverse effects (1 congestive cardiac failure, 1 pulmonary embolism and 1 stroke). At the end of the study period, 14 (54%) of group A patients were alive and 12 (46%) were dead. In group B, 15 (47%) were alive, 16 (50%) were dead and 1 (3%) lost to follow-up. At the completion of the study, 3 patients in each group were still on treatment. CONCLUSION: Low-dose DES and 50 mg of bicalutamide per day are equally effective in hormone refractory prostate carcinoma with respect to biochemical response, although DES has more severe adverse effects. This is a small sample and larger multicentre trials are needed to give us a definite conclusion.     

Management of postoperative urinary retention: a randomized trial of in-out versus overnight catheterization

BACKGROUND: There has been no consensus on the best catheterization strategy for the management of postoperative urinary retention. A prospective randomized trial was undertaken to establish the best practice guidelines for the management of postoperative urinary retention. The authors also evaluated the contemporary incidence of urinary retention following different categories of general surgery and examined risk factors associated with its occurrence. METHODS: All patients who underwent elective inpatient surgery between January 2002 and June 2003 were recruited into the study. Patients who developed postoperative urinary retention were randomized to either having in-out catheterization or placement of an indwelling catheter for 24 h after surgery. RESULTS: A total of 1448 patients was recruited. The overall incidence of urinary retention was 4.1% (n = 60). Significant risk factors associated with postoperative urinary retention included old age, anorectal procedures and use of spinal anaesthesia. Comparison of re-catheterization and urinary tract infection rates between patients who were treated with in-out versus overnight catheterization found no significant differences. CONCLUSIONS: Postoperative urinary retention should be managed by in-out catheterization. Indwelling catheterization for 24 h appeared to bestow no additional benefits. The incidence of urinary retention increases with age, anorectal procedures and the use of spinal anaesthesia.     

Long-term outcome of a multicentre randomized clinical trial of stapled haemorrhoidopexy versus Milligan-Morgan haemorrhoidectomy

INTRODUCTION: Stapled haemorrhoidopexy is less painful than Milligan-Morgan haemorrhoidectomy, allowing an earlier return to working activities, but its long-term efficacy is not fully established. This study reports the long-term follow-up of a randomized clinical trial comparing the two techniques in 100 patients affected by third- and fourth-degree haemorrhoids. METHODS: All patients were contacted and invited to attend the clinic to assess long-term functional outcome. The degree of continence and satisfaction were assessed by questionnaire. Anal manometry and anoscopy were performed. RESULTS: Eighty patients were available after a median follow-up of 87 months. No statistically significant differences were found between the two groups in terms of incontinence, stenosis, pain, bleeding, residual skin tags or recurrent prolapse. A tendency towards a higher recurrence rate was reported in patients with fourth-degree haemorrhoids, irrespective of the technique used. No significant changes in anal manometric values were found after surgery in either group. CONCLUSION: Both techniques are effective in the long term.     

直肠腺癌合并转移性巨大卵巢癌一例报告

病例：女,30岁。因下腹胀痛伴腹泻、便血1月余入院。入院查体：腹隆,腹正中可及巨大包块,质硬无压痛。肛指检查：截石位于直肠前壁9—12点距肛门约8cm处可触及一菜花状肿块,质硬,触之出血。实验室检查：血红蛋白83g／L,大便隐血（＋＋＋＋）;     

Laparoscopic-assisted versus open surgery for colorectal cancer: postoperative morbidity in a single center randomized trial

AIM: The primary objective of the study was to compare the effect of laparoscopic-assisted (LPS) versus open surgery (LPT) for colorectal cancer on postoperative morbidity. The secondary objectives were to evaluate immune response and intestinal wall oxygen perfusion. METHODS: A total of 610 patients with colorectal cancer were randomly assigned to receive colon resection by either LPS (n=306) or LPT (n=304). Four surgical staff members not involved in the study recorded postoperative complications up to 30 days after the operation. Immune response was evaluated by measuring lymphocytic proliferation after challenge with Candida albicans and phytohemoagglutinin before, at 3 and 15 days after the operation. Intestinal wall oxygen perfusion was continuously monitored using a probe. RESULTS: The conversion rate was 4.6% in the LPS group. Morbidity was 18.6% in the LPS group and 34.5% in the LPT group (P<0.0005). Infections developed in 9.1% of LPS-treated patients and in 20.2% of LPT-treated patients (P<0.0005). The mean length of stay was 9.7+/-2.6 days in the LPS group and 12.2+/-4.2 days in the LPT group (P<0.0001). In both groups lymphocytic proliferation was low at 3 days postoperative but returned to normal range at 15 days only in the LPS group. Interoperative intestinal oxygen perfusion values were higher in the LPS group. CONCLUSIONS: Laparoscopic colorectal surgery reduced both postoperative morbidity and length of stay. Lymphocytic proliferation and intestinal wall oxygen perfusion were higher in patients who underwent laparoscopic-assisted surgery.     

Safety of pre- or postoperative accelerated radiotherapy in 5 fractions: A randomized pilot trial

ObjectiveNeo-adjuvant radiotherapy (NART) for breast cancer has shown promising survival results in retrospective trials. However, there are some obstacles such as a chemotherapy delay, an increased overall treatment time (OTT) and the risk of increasing surgical morbidity. Accelerated radiotherapy (RT) in 5 fractions allows to deliver NART in a very short time span and minimizes the delay of surgery and chemotherapy. This trial investigates this NART schedule for safety, feasibility and OTT.Material and methodsTwenty patients eligible for neo-adjuvant chemotherapy (NACT) and breast conserving surgery, were randomized between NART before NACT or NACT and postoperative RT. In both arms, RT treatment was given in 5 fractions to the whole breast with a simultaneously integrated boost (SIB) on the tumor(bed). Lymph node irradiation was given concomitantly in case of lymph node involvement. OTT was defined as the time from diagnosis to last surgery in the intervention group, while in the control group the time between diagnosis and last RT-fraction was used. In the intervention group NACT-delay was defined as time between diagnosis and start of chemotherapy.Results20 patients were included, and 19 patients completed treatment. OTT was significantly shorter in the intervention group (mean 218 days, range 196–253) compared to the control group (mean 237, range 211–268, p = 0.001). The difference in mean duration from diagnosis to the first treatment was a non-significant 4 days longer (31 vs 27 days, p = 0.28), but the start of NACT after diagnosis was delayed by 21 days (48 vs 27 days, p < 0.001). NART did not result in additional surgery complications.ConclusionThis pilot trial is the first to report on accelerated NART in 5 fractions with SIB. NART before NACT resulted in a shorter OTT with good safety results.