A new bioabsorbable interference screw: preliminary results of a prospective, multicenter, randomized clinical trial.

SUMMARY: A randomized clinical trial was conducted to compare a bioabsorbable polyglyconate screw (Endo-Fix; Smith & Nephew, Andover, MA) to a metal screw in anterior cruciate ligament reconstruction. A total of 124 patients were operated on and 113 assessed up to 1 year postoperatively. Assessments included a history and physical examination, the IKDC evaluation, and knee arthrometry measurements. No significant differences were found between the groups with respect to any of the IKDC problem areas at 1 year. The IKDC final evaluation was normal or nearly normal in 92% of polyglyconate patients and 90% of controls. The incidence of postoperative complications was similar in the 2 groups. One polyglyconate patient developed a subcutaneous cyst that may have been related to breakdown of the screw. This resolved without treatment and the patient had an excellent clinical outcome. This study shows that the polyglyconate screw is an effective alternative to metal in endoscopic reconstruction of the ACL.     

A new bowel preparation for elective colon and rectal surgery. A prospective, randomized clinical trial

A two-day cathartic/enema preparation with oral administration of erythromycin and neomycin was compared with an orthograde lavage preparation with oral administration of metronidazole and neomycin in a prospective randomized trial in 300 and 293 eligible patients, respectively, who were undergoing elective colon and rectal surgery. Patients were assessed for infections at six weeks after discharge from the hospital. The major infection rate was less than 1% and the minor infection rate was less than 4%. The overall infection rate was 4.2%. The type of bowel preparation used, the type of operation, and the addition of systemic antibiotic therapy did not affect infection rates significantly. We conclude that this one-day lavage technique, as described, is a safe, effective, economical, and preferred method of colonic preparation for elective colon and rectal surgery.     

A prospective,randomized, multicenter clinical trial to evaluate the safety and effectiveness of a new lesion localization device

BACKGROUND: The objective was to compare the safety and effectiveness of a new localization device to traditional flexible wires. Safety variables included blood loss, procedure time, pain and complications. Effectiveness variables included placement accuracy, lesion retrieval, histological diagnosis, procedural enhancements, and margin status. METHODS: Twelve sites enrolled 120 patients between June 2000 and June 2001, with 58 randomized to treatment and 62 to control. RESULTS: The two groups were equivalent in device placement accuracy, lesion retrieval, histological diagnosis, blood loss, pain, and complications. There was a significant difference favoring the treatment group for procedural enhancements, (ie, use as a palpable guide and retractor) and operating time. There were significantly fewer positive margins in the treatment group. CONCLUSIONS: This multicenter trial demonstrated equivalent safety and improved effectiveness for the treatment group. The new device demonstrated greater surgeon utility, reduced operative time, and fewer positive margins than the current wires.     

Transmyocardial revascularization: 5-year follow-up of a prospective, randomized multicenter trial

BACKGROUND: In prospective randomized trials at 1 year, transmyocardial revascularization (TMR) provided superior relief of angina, decreased rehospitalizations, and improved exercise times. We evaluated 5-year mortality and angina class in "no-option" patients with diffuse coronary artery disease randomized to TMR or continued medical management. METHODS: Two hundred twelve patients with refractory class IV angina who were not candidates for conventional therapy were randomized to receive holmium:yttrium-aluminum-garnet TMR (n = 100) or continued medical management (n = 112) at nine centers. Follow-up included all-cause mortality along with angina class assessment by blinded evaluators. Mean follow-up was 5.7 +/- 0.8 years. RESULTS: Mean angina scores for TMR patients were 4.0 +/- 0.0 at baseline, 1.5 +/- 1.4 at 1 year, and 1.2 +/- 1.1 at a mean of 5 years (p < 0.001). After an average of 5 years, a significantly greater proportion of TMR than medical management patients experienced two or more class improvement in angina (88% versus 44%; p < 0.001). Kaplan-Meier intention-to-treat survival at 5 years was 65% versus 52% (TMR versus medical management; p = 0.05). Cumulative hazard curves demonstrated a significantly reduced risk of late death for TMR patients; average annual mortality beyond 1 year was 8% versus 13% (TMR versus medical management; p = 0.03). CONCLUSIONS: Five-year follow-up of prospectively randomized, no-option class IV angina patients demonstrated significantly increased Kaplan-Meier survival in patients randomized to TMR. The significant angina relief observed 12 months after sole therapy TMR was sustained long term and continued to be superior to that observed for patients maintained on continued medical management alone.     

Results of a prospective randomized trial evaluating surgery versus thrombolysis for ischemia of the lower extremity. The STILE trial.

PURPOSE: This study was designed to evaluate intra-arterial thrombolytic therapy as part of a treatment strategy for patients requiring revascularization for lower limb ischemia caused by nonembolic arterial and graft occlusion. MATERIALS AND METHODS: Patients with native arterial or bypass graft occlusion were randomized prospectively to either optimal surgical procedure or intra-arterial, catheter-directed thrombolysis with recombinant tissue plasminogen activator (rt-PA) or urokinase (UK). Thrombolysis patients required successful catheter placement into the occlusion before infusion of either rt-PA at 0.05 mg/kg/hr for up to 12 hours or UK of 250,000 units bolus followed by 4000 units/min x 4 hours, then 2000 units/min for up to 36 hours. A composite clinical outcome of death, ongoing/recurrent ischemia, major amputation, and major morbidity was the primary endpoint. Additional endpoints were reduction in surgical procedure, clinical outcome classification, length of hospitalization, and outcome by duration of ischemia. RESULTS: Randomization was terminated at 393 patients because a significant primary endpoint occurred by the first interim analysis. Failure of catheter placement occurred in 28% of patients who were randomized to lysis, and thus, were considered treatment failures. Thirty-day outcomes demonstrated significant benefit to surgical therapy compared with thrombolysis (p < 0.001), primarily because of a reduction in ongoing/recurrent ischemia (p < 0.001). However, clinical outcome classification at 30 days was similar. Stratification by duration of ischemia indicated that patients with ischemic deterioration of 0 to 14 days had lower amputation rates with thrombolysis (p = 0.052) and shorter hospital stays (p < 0.04). Patients with ischemic deterioration of > 14 days who who were treated surgically had less ongoing/recurrent ischemia (p < 0.001) and trends toward lower morbidity (p = 0.1). At 6-month follow-up, there was improved amputation-free survival in acutely ischemic patients treated with thrombolysis (p = 0.01); however, chronically ischemic patients who were treated surgically had significantly lower major amputations rates (p = 0.01). More than half of thrombolysis patients (55.8%) had a reduction in magnitude of their surgical procedure (p < 0.001). There was no difference in efficacy or safety between rt-PA and UK; however, in the thrombolysis group as a whole, fibrinogen depletion predicted hemorrhagic complications (p < 0.01). CONCLUSIONS: Surgical revascularization of patients with < 6 months of ischemia is more effective and safer than catheter-directed thrombolysis. Although ongoing/recurrent ischemia is greater in the patients undergoing thrombolysis, 30-day clinical outcomes are similar, probably because of cross-over treatment to surgery. There is no difference in efficacy or safety between rt-PA and UK, although bleeding occurs in patients with greater fibrinogen depletion. A significant reduction in planned surgical procedure is observed after thrombolysis. Patients with acute ischemia (0-14 days) who were treated with thrombolysis had improved amputation-free survival and shorter hospital stays. However, for patients with chronic ischemia (> 14 days), surgical revascularization was more effective and safer than thrombolysis. Combining a treatment strategy of catheter-directed thrombolysis for acute limb ischemia with surgical revascularization for chronic limb ischemia offers the best overall results.     

A new technique for sutureless intestinal anastomosis. A prospective, randomized, clinical trial

A polyglycolic acid device has been designed for the performance of sutureless colonic anastomoses. The use of this biofragmentable anastomosis ring (BAR) was compared with conventional techniques in a prospective, randomized study of 59 patients (x age, 49 years) undergoing ileocolostomy (n = 23) or colocolostomy (n = 36). The anastomotic technique was determined at surgery by randomization (BAR, 27 patients; suture, 16 patients; staple, 16 patients). Performance of an anastomosis with the BAR required an average of 22 minutes, a stapled anastomosis required 33 minutes, and the suture technique required 37 minutes. Learning curve error contributed to the six intraoperative complications that occurred with performance of the anastomosis (BAR, three; end-to-end anastomosis [EEA] instrument, three). The two postoperative deaths were unrelated to the anastomosis. Length of hospitalization in uncomplicated patients was the same among the three groups. The 17 patients with prolonged hospitalization had complications unrelated to anastomotic technique. All patients were followed for a minimum of 6 weeks; no additional complications were identified. We concluded that 1) the BAR is a rapid, safe method for performance of sutureless anastomoses; 2) perioperative mortality and morbidity rates of the BAR are comparable to conventional techniques of suture and staple; and 3) long-term follow-up of BAR patients is warranted to determine the incidence of complications, such as structure and/or stenosis.     

Postoperative analgesia for early extubation after cardiac surgery. A prospective, randomized trial

BACKGROUND: Early extubation after cardiac surgery is a procedure recently gaining interest due to its ability to shorten intensive care unit and hospital stay and to limit the operation-related costs. Its use, however, raised new problems in terms of pain control in the early postoperative course, due to the need for limiting opioid analgesia. This study deals with non-opioid pain control after cardiac surgery and early extubation. METHODS: Prospective, randomized trial aimed to investigate the effectiveness of three intravenous analgesic drugs (ketorolac, 60 mg i.v.; propacetamol, 2 g i.v.; tramadol, 200 mg i.v.) for the management of postoperative pain in early extubated cardiac surgical patients. Each treatment group comprised 20 patients. RESULTS: The pain assessment (5-item verbal scale) demonstrated a significant (p < 0.05) lower value in patients treated with ketorolac vs propacetamol, while patients treated with tramadol did not significantly differ from the other two groups. There was a significantly (p < 0.05) higher rate of patients with severe pain in propacetamol group. Patients treated with tramadol had a significantly (p < 0.01) higher PaCO2 (48 +/- 6 mmHg) versus patients treated with ketorolac (43.4 +/- 3.7 mmHg) or propacetamol (42.9 +/- 3.4 mmHg). CONCLUSIONS: Tramadol and ketorolac seem to be the best options for treating postoperative pain in the specific setting of early extubation after cardiac surgery; high doses of tramadol may result in a significant even if clinically not relevant respiratory depression.     

Nasojejunal tube placement after total gastrectomy: a multicenter prospective randomized trial

HYPOTHESIS: Anastomotic disruption of the Roux-en-Y esophagojejunostomy after total gastrectomy is an infrequent complication that may lead to severe morbidity and mortality. Consequently, a nasojejunal tube (NJT) is frequently placed when this operation is performed. However, no studies have compared routine vs no placement of an NJT in patients undergoing total gastrectomy for gastric cancer, to our knowledge. DESIGN: Randomized controlled trial to assess the need for routine nasojejunal decompression after total gastrectomy with Roux-en-Y esophagojejunostomy in patients with gastric cancer. SETTING: Tertiary care centers. PATIENTS: Two hundred thirty-seven patients undergoing total gastrectomy for gastric cancer were randomly assigned to NJT placement (NJT group) or not (no-NJT group). The patients were monitored for postoperative complications, mortality, and postoperative course. MAIN OUTCOME MEASURES: Incidence of esophagojejunostomy leak. RESULTS: The rates of anastomotic leak were similar in both groups (6.9% and 5.8% for the NJT group and no-NJT group, respectively; P = .71), as were the rates of major postoperative complications (25.9% and 21.5%, respectively; P = .42) and overall postoperative mortality (0.9% and 0.8%, respectively; P = .50). There were no differences between the 2 groups in the mean+/-SD time to passage of flatus (4.6 +/- 1.3 and 4.5 +/- 1.7 days, respectively) or to starting a liquid diet (7.8 +/- 2.6 and 7.7 +/- 1.6 days, respectively), postoperative length of hospital stay (13.5 +/- 7.3 and 13.9 +/- 10.9 days, respectively), postoperative pain, or postoperative abdominal distention. CONCLUSION: Routine placement of an NJT after Roux-en-Y esophagojejunostomy is unnecessary in elective total gastrectomy for gastric cancer.     

Urethral catheterization in spinal surgery: a randomized prospective study

Summary In a prospective randomized study the effect of the use of an intraoperative indwelling urethral catheter (IUC) on urinary complications was investigated in patients undergoing spinal fusion. Two groups were formed; 16 patients received an intraoperative IUC and 16 patients had no intraoperative catheter (NC). All patients were, if necessary, intermittently catheterized in the postoperative period. Seven of the patients in the IUC group had positive cultures, defined as 100000 CFU/ml, compared with two patients in the NC group (n.s.). Another four patients in the NC group had cultures 10000 CFU/ml. Thirteen patients in the IUC group and 14 patients in the NC group had positive dip slides. The largest received urine volume in each patient at one intermittent catheterization did not differ significantly between the groups. However, in three patients in the NC group the volumes exceeded 1000 ml. Thus, irrespective of treatment dip slides showed bacteriuria in 84% of the patients. Perioperative indwelling catheters do not seem to cause many more infection complications than no bladder drainage during surgery, and the advantages of reduced risk of bladder distension injury and more accurate monitoring of fluid balance suggest their use.     

Conservative versus surgical treatment of venous leg ulcers: a prospective, randomized, multicenter trial

BACKGROUND: The prevalence of venous leg ulcers is as high as 1% to 1.5%, and the total costs of this disease are 1% of the total annual health care budget in Western European countries. Treatment modalities are conservative or surgical. Subfascial endoscopic perforating vein surgery (SEPS) combined with superficial vein ligation is performed in many centers to address vein incompetence in patients with chronic venous leg ulcers. Several reports describe good healing and low recurrence rates, although a randomized trial to compare surgical treatment including SEPS and treatment of the superficial venous system to conservative modalities has never been performed. Therefore, a prospective, randomized, multicenter trial was conducted to study whether ambulatory compression therapy with venous surgery is a better treatment than just ambulatory compression therapy in venous leg ulcer patients. METHODS: Patients with an active (open) venous leg ulcer (CEAP C6) qualified for the study. The study consisted of two treatment groups. All patients were treated by standardized ambulatory compression therapy, and half of the patients received SEPS. Concomitant superficial venous incompetence was also treated in the second group. For allocation to both treatment groups, each patient was assigned by a computer program at the randomization center. The primary goal of the study was to compare the ulcer-free period during follow-up in both study groups. Secondary end points were ulcer healing and recurrence rates. RESULTS: From April 1997 until January 2001, 200 ulcerated legs (170 patients) were included in the study in 12 centers in The Netherlands. A total of 97 ulcers were allocated to the surgical group and 103 to the conservative group. Patient characteristics were similar in the two treatment groups at baseline, with the exception of a higher proportion in the conservative group of diabetes mellitus. Healing rates were 83% in the surgical group and 73% in the conservative group (not significant; median time to healing, 27 months). Recurrence rates were the same in both treatment groups (22% surgical vs 23% conservative). During follow-up of a mean of 29 months (median, 27 months) in the surgical group and 26 months (median, 24 months) in the conservative group, we found that in the surgical group, the ulcer-free rate was 72%, whereas in the conservative group this rate was 53% (P = .11; Mann-Whitney test). Patients with recurrent ulceration or medially located ulcers in the surgical group had a longer ulcer-free period than those treated in the conservative group (P = .02 for both). A first-time ulcer and one of the centers also had a positive effect on the ulcer-free period during follow-up (P < .001 and P = .02), independent of the treatment group. Deep vein incompetence did not affect the ulcer-free period. CONCLUSIONS: In conclusion, we suggest that patients with medial and/or recurrent ulceration should receive surgery combined with ambulatory compression therapy. A dedicated center should provide care for those patients.     

A randomized trial evaluating a cognitive simulator for laparoscopic appendectomy

Background: The Integrated Cognitive Simulator (ICS) is a software application that integrates text, anatomy, video and simulation for training clinical procedures. The aim of this randomized controlled trial was to determine the usability of the ICS laparoscopic appendectomy module, and to determine its effectiveness in training the cognitive skills required for the procedure. Methods: Junior surgical trainees were randomized into control and intervention groups. The latter had access to the ICS. Participants had three assessments: a pre‐study questionnaire to determine demographics, 20 multiple choice questions to assess procedural knowledge (training effectiveness) after 2 weeks, and a questionnaire to assess usability after 4 months. Results: Fifty‐eight trainees were randomized. The overall response rate was 57%. The median scores for interface, functionality, usefulness and likelihood of utilization (usability) were 5/7 or higher. In the multiple choice questions (training effectiveness), first‐year trainees in the intervention group scored higher than the control group (14.9 versus 12.1, P= 0.04), but second‐year trainees did not. Use of the ICS did not alter the participants' perceived need for intra‐operative guidance. Conclusions: The ICS is considered highly usable by trainees. The ICS is effective for training cognitive skills for laparoscopic appendectomy among first‐year surgical trainees. Training cognitive skills alone does not increase confidence in the ability to perform motor tasks.