Ischemic Optic Neuropathy Decompression Trial: twenty-four-month update. Surgical or medical decompression as a first-line treatment of optic neuropathy in Graves' ophthalmopathy? A randomized controlled trial. [Randomized controlled trial of medical and medico-surgical treatment of Hansen's neuritis]. A randomized controlled trial of surgery vs steroid injection for carpal tunnel syndrome. Prospective randomized controlled study comparing simple decompression versus anterior subcutaneous transposition for idiopathic neuropathy of the ulnar nerve at the elbow: Part 1. [Orbit decompression surgery in patients with exophthalmos caused by Graves-Basedow disease]. Surgical decompression versus local steroid injection in carpal tunnel syndrome: a one-year, prospective, randomized, open, controlled clinical trial. Prospective randomized surgical treatments for calcifying tendinopathy. Elective colon and rectal surgery without nasogastric decompression. A prospective, randomized trial.
To describe visual acuity outcomes of patients in the Ischemic Optic Neuropathy Decompression Trial (IONDT) after 24 months of follow-up.
                The IONDT is a single-masked, multicenter, randomized clinical trial.
                Patients were evaluated and followed up at 25 clinical centers located throughout the United States. Data were sent to and analyzed at a central coordinating center.
                Two hundred fifty-eight patients 50 years or older with nonarteritic anterior ischemic optic neuropathy and visual acuity of 20/64 or worse, but better than no light perception, were randomized to either a careful follow-up group (n=131) or an optic nerve decompression surgery (ONDS) group (n=127). Of these, 174 continued participation for at least 24 months, 89 in the careful follow-up group and 85 in the ONDS group.
                Randomized patients underwent a standard visual acuity examination at 3, 6, 12, 18, and 24 months of follow-up. The primary outcome was a change of 3 lines or more of visual acuity, defined as a difference of 0.3 in logMAR scores, between baseline and 6 months of follow-up. A secondary outcome was mean change in visual acuity (in logMAR units) at 3, 6, 12, 18, and 24 months following baseline. These changes were estimated using available data from all randomized patients for whom we had data.
                Of the 258 patients randomized, 143 (55.4%) were male, and 169 (65.5%) were 65 years or older. Mean visual acuity was statistically significantly improved from baseline value at all study visits and for both treatment groups, although visual acuity declined gradually in both groups after the 3-month visit. There were no significant differences between careful follow-up and ONDS in mean change in vision from the baseline and any follow-up time point. At 24 months of follow-up, 31.0% of patients in the careful follow-up group and 29.4% of patients in the ONDS group experienced an increase of 3 or more lines of vision compared with baseline acuity; 21.8% of patients in the careful follow-up group and 20.0% of patients in the ONDS group experienced a decrease of 3 or more lines. In patients who could read at least 1 letter on the Lighthouse chart, there was a gradual decline in mean visual acuity noted over time for both treatment groups, although acuity remained significantly better than at baseline.
                Analysis of visual acuity data from patients enrolled in the IONDT at 24 months of follow-up confirms that there is no benefit of ONDS compared with careful follow-up in patients with nonarteritic anterior ischemic optic neuropathy. Arch Ophthalmol. 2000;118:793-798 Only a small percentage of Graves' ophthalmopathy (GO) patients develop optic neuropathy with impending loss of visual acuity. Therapy with methylprednisolone pulses is the treatment of first choice in severe and active GO patients. When the effect is insufficient, patients are usually treated with surgical decompression. We investigated whether surgery could become the first-line treatment, thus preventing treatment with steroids.
                We performed a randomized trial in 15 patients with very active GO and optic neuropathy. Six patients were treated with surgical decompression, and nine with methylprednisolone i.v. pulses for 2 weeks, followed by oral prednisone for 4 months. The primary outcome was determined by changes in visual acuity. If the eye disease deteriorated despite treatment or did not improve sufficiently, patients were switched to the other treatment arm.
                The severity and activity of GO in both groups were similar at baseline. The Clinical Activity Score (CAS) was 6.3+/- 0.8 in the surgical group vs. 6.0+/- 0.5 in the steroids group and the Total Eye Score was 24+/- 6 vs. 25+/- 6. In the surgery group, 5/6 patients (82%) did not respond because of insufficient improvement in vision (n=3) or persistent chemosis (n=2), and all needed further immunosuppression. In the steroids group, 4/9 patients (45%) did not improve in visual acuity (P=0.132 vs. surgery group), and these needed decompressive surgery. All patients in whom therapy failed were switched to the other treatment arm and visual acuity improved in almost all patients. Visual acuity improved from 0.36 (0.02--0.40) to 0.90 (0.63--1.0) in the surgery group and from 0.50 (0.32--0.63) to 0.75 (0.32--1.0) in the steroids group at 52 weeks. At long-term follow-up in the surgery group 3/6 patients required squint surgery and 5/9 patients in the steroids group. Eyelid surgery was performed in 5/6 patients in the surgery group and in 4/9 patients in the steroids group.
                Immediate surgery does not result in a better outcome and therefore methylprednisolone pulse therapy appears to be the first-choice therapy. The aim of the study was to compare the results of the medical treatment alone and of the medico-surgical treatment on leprous neuritis. The patients were followed-up during 2 years, with regular neurological evaluations. The statistical study was performed using the Tukey test. Ninety-three nerves (ulnar, median, common peroneal and posterior tibial) with a deficit of less than 6 months duration have been studied in 31 leprosy patients. All the patients were treated by steroids but in some of them a nerve surgical decompression was performed. An improvement of the sensitive and motor deficit was observed in both groups. No significant statistical differences appeared between the 2 groups according to the nerve involved, the duration of the deficit, the form of leprosy and the type of antibacillary treatment. However, the medico-surgical treatment had a significant better result on pain and on major but incomplete nervous involvement. This study included a limited number of nerves, thus, it would be useful to perform others randomized assays to better define the indications of surgical decompression in the management of leprous neuritis. Decompressive surgery and steroid injection are widely used forms of treatment for carpal tunnel syndrome (CTS) but there is no consensus on their effectiveness in comparison to each other. The authors evaluated the efficacy of surgery vs steroid injection in relieving symptoms in patients with CTS.
                The authors conducted a randomized, single blind, controlled trial. Fifty patients with electrophysiologically confirmed idiopathic CTS were randomized and assigned to open carpal tunnel release (25 patients) or to a single injection of steroid (25 patients). Patients were followed up at 6 and 20 weeks. The primary outcome was symptom relief in terms of the Global Symptom Score (GSS), which rates symptoms on a scale of 0 (no symptoms) to 50 (most severe). Nerve conduction studies and grip strength measurements were used as secondary outcome assessments.
                At 20 weeks after randomization, patients who underwent surgery had greater symptomatic improvement than those who were injected. The mean improvement in GSS after 20 weeks was 24.2 (SD 11.0) in the surgery group vs 8.7 (SD 13.0) in the injection group (p < 0.001); surgical decompression also resulted in greater improvement in median nerve distal motor latencies and sensory nerve conduction velocity. Mean grip strength in the surgical group was reduced by 1.7 kg (SD 5.1) compared with a gain of 2.4 kg (SD 5.5) in the injection group.
                Compared with steroid injection, open carpal tunnel release resulted in better symptomatic and neurophysiologic outcome but not grip strength in patients with idiopathic carpal tunnel syndrome over a 20-week period. The main objective of this study was to compare the clinical outcome of participants treated by simple decompression (SD) of the ulnar nerve versus anterior subcutaneous transposition (AST).
                A prospective randomized controlled study was performed. Three hundred forty participants were referred to our institution between March 1999 and July 2002. One hundred fifty-two patients met the inclusion criteria and were randomized into two surgical groups: 75 were assigned to SD, and 77 were assigned to AST. Participants were followed for 1 year after surgery. The main outcome measure was clinical outcome 1 year after surgery.
                An excellent or good result was obtained in 49 of 75 participants who underwent SD and in 54 of 77 participants undergoing AST. The difference was not statistically significant. However, the complication rate was statistically lower in the SD group (9.6%) compared with the AST group (31.1%) (risk ratio, 0.32; 95% confidence interval, 0.14-0.69). Duration of symptoms, (sub)luxation of the ulnar nerve, and severity of the complaints did not influence outcome.
                Surgery for ulnar neuropathy at the elbow is effective. The outcomes of SD and AST are equivalent, except for the complication rate. Because the intervention is simpler and associated with fewer complications, SD is advised, even in the presence of (sub)luxation. To evaluate in a prospective trial two surgical technique routinely used for orbital decompression in Graves' disease ophthalmopathy.
                Patients with Graves' disease exophthalmus (greater than 22 mm) that was euthyroid for at least six months after treatment were admitted to the study and randomly assigned to two groups, twenty six orbits in 17 patients were surgically decompressed with the Walsh and Ogura technique (group I) and 18 orbits in 18 patients were decompressed with Kennedy's surgical approach (group II).
                Both surgical techniques were equally effective in reducing the exophthalmus (p < 0.05). Morbility was significantly greater in terms of diplopia and infraorbital nerve lesion with Walsh and Ogura surgical approach.
                Due to reduced morbility, orbital surgical decompression with Kennedy's technique is recommended in patients with Graves' disease exofthalmus. Optimal treatment of carpal tunnel syndrome (CTS) has not been established. This study compared the effects of local steroid injection versus surgical decompression in new-onset CTS of at least 3 months' duration.
                In a 1-year, prospective, randomized, open, controlled clinical trial, we studied the effects of surgical decompression versus local steroid injection in 163 wrists with a clinical and neurophysiologic diagnosis of CTS. Clinical assessments were done at baseline and at 3, 6, and 12 months after treatment. The primary end point was the percentage of wrists that reached a >or=20% improvement in the visual analog scale score for nocturnal paresthesias at 3 months of followup. Statistical analysis was done by Student's t-test for continuous variables and by chi-square test for categorical variables. Analyses were performed on an intent-to-treat basis. P values less than 0.05 were considered statistically significant.
                Both treatment groups had comparable severity of CTS at baseline. Eighty wrists were randomly assigned to the surgery group and 83 wrists to the local steroid injection group. In the intent-to-treat analysis, at 3 months of followup, 94.0% of the wrists in the steroid injection group versus 75.0% in the surgery group reached a 20% response for nocturnal paresthesias (P = 0.001). At 6 and 12 months, the percentages of responders were 85.5% versus 76.3% (P = 0.163) and 69.9% versus 75.0% (P = 0.488), for local steroid injection and surgical decompression, respectively.
                Over the short term, local steroid injection is better than surgical decompression for the symptomatic relief of CTS. At 1 year, local steroid injection is as effective as surgical decompression for the symptomatic relief of CTS. Thirty-eight patients with chronic calcifying tendinopathy of the shoulder were randomized prospectively into two groups: 19 patients had endoscopic decompression and 19 had open decompression. Thirty-three patients (19 with open and 14 with endoscopic decompression) were available for followup. Clinical and ultrasonographic investigations were done at followup. The purpose of the current study was to evaluate prospectively the clinical and sonographic results after open decompression and after endoscopic decompression. Apportionment of age and gender was similar in both groups. The followup was 15.7 months for patients after open decompression and 17.1 months for patients after endoscopic decompression. The average Patte score was 84.5 points (84.4 for patients who had endoscopic decompression and 84.6 for patients who had open decompression). Corresponding results were found with a Constant and Murley score of 96.6 points (97.6 for patients who had endoscopic decompression and 95.8 for patients who had open decompression). In the endoscopic group physiotherapy was recommended for 5 weeks more than in the open surgery group. Similar results were seen for the incapacity to work in both groups with 4.6 weeks for the patients who had endoscopic surgery and 5 weeks for the patients who had open surgery. No nerve injuries, wound infections, or other postoperative complications were found. Comparison of both surgical methods showed good clinical and score results. Endoscopic and open surgery are equally effective in the treatment of chronic calcifying tendinopathy. Nasogastric (NG) decompression after colorectal surgery is practiced commonly. Our aim was to determine whether routine NG decompression benefitted patients undergoing this type of surgery. Five hundred thirty-five patients were randomized prospectively to either NG decompression or no decompression. Stratification was by type of operation and patient age. Excluded were patients who had emergency surgery with peritonitis, extensive fibrous adhesions, enterotomies, previous pelvic irradiation, intra-abdominal infection, pancreatitis, chronic obstruction. prolonged operating times, or difficult endotracheal intubation. Two hundred seventy-four patients received NG decompression (Salem sump, Argyle Co., Division of Sherwood Medical, St. Louis, MO) and two hundred sixty-one did not. There were 33 protocol violations included in the 535 patients. Patients who were not decompressed experienced significantly more abdominal distention, nausea, and vomiting than did those patients who were. Moreover, 13% required subsequent NG decompression as opposed to a reinsertion rate of 5% for patients routinely decompressed. The mean length of hospitalization for both groups was 11 days. There were no significant differences in nasopharyngeal or gastric bleeding, inability to cough effectively, respiratory infections, wound disruptions, reoperation, and wound infection rates (5%) between the two groups. We conclude that even though there is an increase in the rate of minor symptoms of nausea, vomiting, and abdominal distention, routine nasgastric decompression is not warranted after elective colon and rectal surgery.
Results from the single trial indicate no evidence of a beneficial effect of optic nerve decompression surgery for NAION. Future research should focus on increasing our understanding of the etiology and prognosis of NAION. New treatment options should be examined in the context of randomized clinical trials.