Bacterial recolonization during foot surgery: a prospective randomized study of toe preparation techniques

Fifty patients undergoing foot or ankle surgery were randomized into two groups for the purposes of toe preparation. Twenty-four patients underwent a standard preparation which included placing antiseptic between the toes while 26 were additionally cleaned by sliding a gauze swab soaked in topical antiseptic back and forth several times. Povidone iodine followed by chlorhexidine in alcohol was used in both groups. All toes were covered by a sterile glove during surgery unless the toes themselves were to be operated upon. Bacteria were cultured from the toe clefts in 4% of all patients immediately following preoperative disinfection. Significantly fewer patients whose toes had been additionally scrubbed (group 1) showed bacterial recolonization at the end of surgery compared with those undergoing a standard prep (group 2) (7.7% vs 20.8%). We conclude that additional scrubbing of toe clefts prior to surgery reduces the incidence of recolonization of bacteria during the surgical procedure.     

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.     

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.     

A comparative prospective randomized clinical study of MTA and IRM as root-end filling materials in single-rooted teeth in endodontic surgery.

OBJECTIVE: Randomized clinical prospective study to evaluate the application of MTA and IRM as retrograde sealers in surgical endodontics. STUDY DESIGN: One hundred single-rooted teeth were surgically treated. After randomization, MTA or IRM was used as a retrosealer. Radiographs were taken 1 week, 3 months, and 1 year postoperatively. Assessment was performed by 2 independent assessors 1 year after surgery. Both treatment groups were homogeneous in their composition, and clinical features and radiographic findings were classified according to Rud's classification. RESULTS: Complete healing was observed in 64% of the MTA-treated teeth vs 50% of the IRM-treated teeth. Incomplete healing was seen in 28% (MTA) vs 36% (IRM), and unsatisfactory in 6% (MTA) vs 14% (IRM). Only 1 failure was seen (MTA). No statistically significant differences were found between the 2 retrofilling materials. CONCLUSION: As root-end filling materials in this clinical prospective randomized design on single rooted teeth, MTA and IRM had the same clinical effectiveness.     

Colon and rectal surgery without mechanical bowel preparation: a randomized prospective trial

OBJECTIVE: To assess whether elective colon and rectal surgery can be safely performed without preoperative mechanical bowel preparation. SUMMARY BACKGROUND DATA: Mechanical bowel preparation is routinely done before colon and rectal surgery, aimed at reducing the risk of postoperative infectious complications. However, in cases of penetrating colon trauma, primary colonic anastomosis has proven to be safe even though the bowel is not prepared. METHODS: Patients undergoing elective colon and rectal resections with primary anastomosis were prospectively randomized into two groups. Group A had mechanical bowel preparation with polyethylene glycol before surgery, and group B had their surgery without preoperative mechanical bowel preparation. Patients were followed up for 30 days for wound, anastomotic, and intra-abdominal infectious complications. RESULTS: Three hundred eighty patients were included in the study, 187 in group A and 193 in group B. Demographic characteristics, indications for surgery, and type of surgical procedure did not significantly differ between the two groups. Colo-colonic or colorectal anastomosis was performed in 63% of the patients in group A and 66% in group B. There was no difference in the rate of surgical infectious complications between the two groups. The overall infectious complications rate was 10.2% in group A and 8.8% in group B. Wound infection, anastomotic leak, and intra-abdominal abscess occurred in 6.4%, 3.7%, and 1.1% versus 5.7%, 2.1%, and 1%, respectively. CONCLUSIONS: These results suggest that elective colon and rectal surgery may be safely performed without mechanical preparation.     

Ultrasonic versus standard electric dissection in laparoscopic colorectal surgery: a prospective randomized clinical trial

OBJECTIVE: To assess the safety and efficacy of the ultrasonic dissection (UC) compared with standard electrosurgery (ES) in laparoscopic colorectal surgery. BACKGROUND DATA: High-frequency ultrasound energy was introduced in laparoscopic surgery to improve dissection and coagulation. Very limited data have been published on its use in laparoscopic colorectal surgery. METHODS: Patients eligible for elective laparoscopic right or left hemicolectomy (RH and LH), sigmoidectomy (SG), or low anterior resection (LAR) were randomized to either UC or ES. The following data were collected and analyzed: preoperative data (individual patient data, indication for surgery), intraoperative data (conversion to open surgery, conversion ES to UC, operative time, blood loss, complication rate), and postoperative data (morbidity and mortality, volume of drainage, hospital stay). RESULTS: Between January 2002 and December 2003, 171 patients underwent elective laparoscopic colorectal resection. Twenty-5 patients did not satisfy the inclusion criteria and were excluded. The diagnosis of the remaining 146 patients was diverticulitis (44), colonic adenoma (31), adenocarcinoma (70), or epidermoid carcinoma (1). These patients underwent laparoscopic RH (28), LH (31), SG (47), or LAR (40). There were no differences in preoperative data. The overall conversion rate to open surgery was 11.6%, with no differences between the two groups; 20.8% undergoing ES were converted to UC, more frequently during right hemicolectomy or low anterior resection. Operative time, the primary endpoint of this study, did not differ between the two groups: UC 93 minutes versus ES 102.6 minutes (P = 0.46). Intraoperative blood loss was significantly less in UC 140.8 mL versus ES 182.6 mL (P = 0.032). No differences were observed in postoperative morbidity or other preoperative or postoperative parameters. CONCLUSIONS: UC is a useful device in laparoscopic colorectal surgery that facilitates completion of difficult cases and reduces intraoperative blood loss. Nevertheless, the majority of laparoscopic procedures can be completed with ES. Therefore, selective use of UC appears to be the most cost-effective policy.     

Epidural analgesia in colonic surgery: results of a randomized prospective study

Colonic surgery patients were studied to measure: the influence of continuous thoracic epidural analgesia (TEA) on a postoperative pain score, the time till onset of defaecation, blood loss, postoperative temperature elevations, rate of bacterial contamination of wounds and urine, and general surgical complications. Group I patients (n = 57) received general anaesthesia and TEA for the operation, followed by continuous TEA (0.25 per cent bupivacaine) for 72 h. Group II patients (n = 59) received general anaesthesia for the operation, followed by systemic analgesia on request. Significant beneficial effects of TEA in group I were demonstrated by lower pain scores in the first 24 h after surgery and earlier defaecation. However, there were fewer temperature elevations in group II. There was no significant difference between the groups in terms of positive bacteriological cultures, blood loss, need for postoperative mechanical ventilation and complications. However, there was a trend toward a higher rate of rectal anastomotic breakdown, increased blood replacement and intensive care therapy, and longer hospitalization in group I. These results do not suggest any significant beneficial therapeutic effect of continuous TEA in colonic surgery compared with a conventional systemic analgesic regimen. In selected patients (i.e. those with severe pain or those prone to develop postoperative ileus) continuous TEA may be beneficial.     

Ligasure versus Ultracision® in thyroid surgery: a prospective randomized study

PURPOSE: New hemostatic technologies (NT) are often employed in thyroid surgery in the effort to reduce operating time and complications. The aim of this study is to compare three different hemostatic techniques. METHODS: This is a prospective randomized study. There were 150 patients, aged 56 +/- 14 years, randomized for total thyroidectomy with conventional technique (CT), Ligasure vessel sealing system (LI) or Harmonic Scalpel (HS) at the university surgical department. One hundred thirty-five patients had benign diseases; 15 had malignancies. RESULTS: Mean postoperative hospital stay was 2.6 days. Mean operation time was 113 +/- 31 min; in HS patients, it was significantly shorter (p < 0.001). Morbidity was 43.3%; mortality was nil. Morbidity was significantly different between CT and NT groups (p = 0.0002); HS and LI groups had a higher morbidity (p = 0.0001 and p = 0.02, respectively). Mean postoperative calcemia was 1.12 +/- 0.1 mmol/l with a significant difference between groups; NT patients had a significantly lower calcemia (p < 0.05). There was no difference in recurrent laryngeal nerve palsies and in intraoperative blood losses (p = ns). CONCLUSIONS: According to our experience, the only real advantage of new hemostatic technologies was a shorter operation time with HS.     

Ultrasonic dissector for total thyroidectomy: results of prospective randomized study

In the last years, the introduction and employment in surgery of the dissectors of last generation (ultrasounds, radiofrequency, etc.) have contributed to a remarkable improvement and simplification of the performances and the surgical techniques. The present study has the aim to verify, on the basis of the experience made in the last two years and through a careful comparisons with operations performed in the usual way, the advantages of employment of ultrasonic dissector in thyroid surgery and if besides such advantages it is possible to obtain real and substantial reductions of the complications. To such aim a randomized perspective study has been lead, confronting two groups of 60 patients, submitted to total thyroidectomy in Chair of General Surgery and Surgical Physiopathology of the University of Palermo-Complex Operating Unit of General Surgery. In all patients have been considered age, sex, histological diagnosis, length of the incision, time (from the incision until suture of skin), entity of the bleeding, hospital stay, post-operative consequences and total costs of thyroidectomy. The elaboration of the obtained data shows the advantages following to the use of the dissectors of last generation: reduction of the times, reduction of the complications, better tolerance of the operation by patients, better rationalization of the resources.     

Post-herniorrhaphy urinary retention: a randomized prospective study.

Urinary retention is a known complication of inguinal herniorrhaphy. Bladder distension due to vigorous fluid administration is believed to contribute to this problem. Our hypothesis is that fluid restriction will lower the incidence of urinary retention, post-herniorrhaphy. From January 1989 through March 1991, 113 male patients entered the study. Sixty patients (Group I) received unlimited iv fluids (1294 +/- 58 ml) and 9 patients (15%) developed urinary retention. Fifty-three patients (Group II) received 500 ml or less by protocol (485 +/- 2 ml) and 5 of these patients developed retention (9%). Thus, fluid restriction lowered the incidence of urinary retention post-herniorrhaphy but the difference did not reach statistical significance. In addition age over 60 years approached significance as a risk factor for postoperative urinary retention.     

Interest of intra-operative 3D imaging in spine surgery: a prospective randomized study

Purpose

We report a single-center, prospective, randomized study for pedicle screw insertion in opened and percutaneous spine surgeries, using a computer-assisted surgery (CAS) technique with three-dimensional (3D) intra-operative images intensifier (without planification on pre-operative CT scan) vs conventional surgical procedure.

Material and method

We included 143 patients: Group C (conventional, 72 patients) and Group N (3D Fluoronavigation, 71 patients). We measured the pedicle screw running time, and surgeon’s radiation exposure. All pedicle runs were assessed according to Heary by two independent radiologists on a post-operative CT scan.

Results

3D Fluoronavigation appeared less accurate in percutaneous procedures (24 % of misplaced pedicle screws vs 5 % in Group C) (p = 0.007), but more accurate in opened surgeries (5 % of misplaced pedicle screws vs 17 % in Group C) (p = 0.025). For one vertebra, the average surgical running time reached 8 min in Group C vs 21 min in Group N for percutaneous surgeries (p = 3.42 × 10^?9), 7.33 min in Group C vs 16.33 min in Group N (p = 2.88 × 10^?7) for opened surgeries. The 3D navigation device delivered less radiation in percutaneous procedures [0.6 vs 1.62 mSv in Group C (p = 2.45 × 10^?9)]. For opened surgeries, it was twice higher in Group N with 0.21 vs 0.1 mSv in Group C (p = 0.022).

Conclusion

The rate of misplaced pedicle screws with conventional techniques was nearly the same as most papers and a little bit higher with CAS. Surgical running time and radiation exposure were consistent with many studies. Our work hypothesis is partially confirmed, depending on the type of surgery (opened or closed procedure).

     

The role of intra-aortic counterpulsation in high-risk OPCAB surgery: a prospective randomized study

BACKGROUND: High-risk patients would benefit the most of OPCAB revascularization. This prospective and randomized study evaluates the efficacy and safety of pre- and perioperative IABC in high-risk OPCAB. MATERIAL: Group A-IABC started prior to induction of anesthesia (n = 15); group B-no preoperative IABC (n = 15). Adult high-risk coronary patients to undergo OPCAB. High risk = (minimum 2) EF < 0.30, left main stenosis, unstable angina, redo. Bailout if hemodynamic instability CPB or IABC in group B. Study endpoints (a) cardiac protection (troponin 1, cardiac index (CI), ECG), (b) inflammatory response (lactate, IL-6), (c) clinical outcome (mortality, morbidity). Emergency operations 33%, re-operation 13%, unstable angina 100%, left main 60% and EF 0.29, without group differences. RESULTS: No bailout group A, 10 in group B, p < 0.0001. Postoperative IABC six (group A) and seven patients (group B), during 6.8 +/- 5.1 hours (group A) versus 41.2 +/- 25.5 hours (group B), p = 0.0110. Myocardial protection without group differences, but CI significantly better in group A. Inflammatory response significantly less in group A. CLINICAL OUTCOMES: one death, one MI and two renal failure in group B, none in group A. Intensive care unit (ICU) stay 27 +/- 3 hours (group A) versus 65 +/- 28 hours (group B), p = 0.0017. LOS 8 +/- 2 days (group A) versus 15 +/- 10 (group B), p = 0.0351. No IABC related complications. CONCLUSIONS: Pre- and perioperative IABC therapy offers efficient hemodynamic support during high-risk OPCAB surgery, lowers the risk of hemodynamic instability, is safe and shortens both ICU and hospital length of stay significantly, and is a cost-effective therapy.     

Cefamandole in gastroduodenal surgery: a controlled, prospective, randomized, double-blind study

Acceptance of the value of antibiotic prophylaxis in gastroduodenal surgery is growing, but only one controlled, double-blind study justifying this is available. In this second, controlled, randomized, double-blind study 60 patients underwent urgent and elective gastroduodenal operations. Among 32 patients receiving cefamandole perioperatively for prophylaxis, only 1 subsequently had a wound infection, but wound infections occurred in 8 of the 28 patients who received a placebo (P less than 0.01). Infection rates were higher in contaminated wounds and in urgent operations than in clean-contaminated wounds and elective surgery. The results confirm the value of antibiotic prophylaxis in this setting.     

Economic outcome of off-pump coronary artery bypass surgery: a prospective randomized study

Background. Emphasis on cost containment in coronary artery bypass surgery is becoming increasingly important in modern hospital management. The revival of interest in off-pump (beating heart) coronary artery bypass surgery may influence the economic outcome. This study examines these effects.

Methods. Two hundred patients undergoing first-time coronary artery bypass surgery were prospectively randomized to either conventional cardiopulmonary bypass and cardioplegic arrest or off-pump surgery. Variable and fixed direct costs were obtained for each group during operative and postoperative care. The data were analyzed using parametric methods.

Results. There was no difference between the groups with respect to pre- and intraoperative patient variables. Off-pump surgery was significantly less costly than conventional on-pump surgery with respect to operating materials, bed occupancy, and transfusion requirements (total mean cost per patient: on pump, $3,731.6 ± 1,169.7 vs off-pump, $2,615.13 ± 953.6; p < 0.001). Morbidity was significantly higher in the on-pump group, which was reflected in an increased cost.

Conclusions. Off-pump revascularization offers a safe, cost-effective alternative to conventional coronary revascularization with cardiopulmonary bypass and cardioplegic arrest.     

Harmonic scalpel tonsillectomy in children: a randomized prospective study.

OBJECTIVE: In this randomized prospective study, we evaluated postoperative morbidity after use of the Harmonic Scalpel (HS), an ultrasonic dissector coagulator (Ethicon Endo-Surgery Inc, Cincinnati, OH), or conventional electrocautery (EC) during tonsillectomy. STUDY DESIGN AND SETTINGS: Pediatric subjects at 2 sites were randomized and underwent tonsillectomy. Intraoperative blood loss and operation duration were recorded. Postoperative parameters and complications were recorded. RESULTS: One hundred seventeen subjects completed the study. For the HS group, mean operative time was significantly longer (P < 0.001), but intraoperative blood loss was equivalent (P = 1.000). HS subjects slept soundly on postoperative days 1, 2, 3, and 14 (P = 0.041, 0.013, 0.022, and 0.038, respectively, compared with EC group). Mean postoperative pain scores trended lower for HS subjects on postoperative days 2, 3, and 4. CONCLUSION: The use of the HS in pediatric tonsillectomy showed no increase in intraoperative or postoperative blood loss compared with the use of EC, and HS provided possible clinical advantages over EC in patient comfort. SIGNIFICANCE: Tonsillectomy subjects in the HS group showed a statistically significant ability to sleep soundly, suggesting that the subjects experienced less pain. These data correlate with the observed decrease in pain scores.     

Feasibility of colorectal surgery without colonic preparation. A prospective study

INTRODUCTION: Mechanical bowel preparation (MBP), aimed at reducing the infectious complications of colorectal surgery, was considered as indispensable. This benefit is actually disputed. The aim of this study was to report an experience of colorectal surgery without MBP. MATERIALS AND METHODS: Hundred ninety patients without MBP and without low residue diet, who underwent colorectal surgery with primary anastomosis not requiring a diverting stoma were included. The main outcome were the rate of mortality, anastomotic leak, wound infection and intra-abdominal abscess. Secondary outcomes were duration of intravenous perfusion, nasogastric aspiration, total hospitalisation stay and time to realimentation. RESULTS: The procedure was performed by laparotomy (n=142) or laparoscopy (n=48). Forty-eight patients underwent emergency surgery. Ninety-two patients were operated for malignancy. The rate of mortality was 6.3% in correlation with the scale of AFC. The rate of anastomotic leak was 3.7%. The rate of specific morbidity was independent of scale of AFC on the contrary to the frequency of non-specific complications. The mean duration of intravenous perfusion and nasogastric suction were 6 days and 0.3 day. The patient had normal diet to the 4th day (4+/-3 days). The mean hospital stay was 13.4 days. CONCLUSION: The colorectal surgery without MBP may be safely performed and could improve the quality of life of patients in the perioperatory period.     

Intracavernosal versus intraurethral alprostadil: a prospective randomized study.

OBJECTIVE: To compare the medicated urethral system for erection (MUSE) with standard intracavernosal prostaglandin E1 (PGE1) in the treatment of erectile dysfunction. PATIENTS AND METHODS: Sixty consecutive men with organic erectile dysfunction were prospectively randomized to receive either 20 microg of intracavernosal PGE1 (group 1, 30 patients) or 1 mg MUSE (group 2, 30 patients). Response to the drugs was recorded in the outpatient clinic and all patients continued a home-treatment programme for 3 months. After each home administration, patients recorded the grade of erection in diaries, whether or not sexual intercourse occurred and any adverse reactions to the drugs. Comfort and ease of administration were also recorded. RESULTS: The characteristics of the patients of both groups were similar; 10 patients in group 1 and 25 in group 2 completed the 3-month treatment programme, i.e. a withdrawal rate of 67% and 17% for groups 1 and 2, respectively (P<0.05). During outpatient dosing, 27 (90%) patients in group 1 and 18 (60%) patients in group 2 achieved a good erection (P<0.05). Intercourse during the 3 months of home treatment was reported at least once in 26 (87%) patients in group 1, compared with 16 (53%) patients in group 2 (P<0.05). After 3 months of home treatment, patients had administered a total of 242 doses of intracavernosal PGE1 and 360 doses of MUSE; intercourse was reported after 206 (85%) and 198 (55%) administrations of PGE1 and MUSE, respectively (P<0.05). The most common adverse reaction was urogenital pain, reported by 14 (47%) patients in group 1 and two (7%) patients in group 2 (P<0.05). Home treatment was assessed as easy by 12 (40%) patients in group 1 and 27 (90%) in group 2 (P<0. 05). CONCLUSION: Although MUSE is less effective than intracavernosal PGE1, it is more attractive and accepted well by most patients as an easy method of treatment with minimal or no discomfort.     

Reduction in variability of acetabular cup abduction using computer assisted surgery: a prospective and randomized study.

Optimal orientation of the acetabular component of a total hip prosthesis is an important factor in determining the early and long-term result of a total hip arthroplasty (THA). Conventional positioning of the cup component is usually done using a free-hand method, or with the help of a mechanical acetabular alignment guide. However, these methods have proven to be inaccurate, and a great variation in orientation of the cup is found postoperatively. In this study, we wished to determine if the variability of the abduction angle of acetabular cups could be reduced with the use of computer navigation. The abduction angles of the acetabular components of three groups of 50 THAs were assessed. In the first group, a free-hand method was used to position the cup component. This group was operated in the period before we started using computer navigation for hip surgery. In the second group, CT-based computer navigation was used to plan and help position the cup. The third group consisted of 50 THA cases in which a free-hand method was used to position the cup, although these procedures were performed in the period after we had begun using the Computer Assisted Surgery (CAS) system. The variability in cup abduction angle was assessed in all three groups and compared. There was a significant reduction in variability in the CAS group compared to the first group. There was also a reduction in variability in the CAS group compared to the third group, although this was not statistically significant. It is concluded that the use of computer navigation helped the surgeon to place the cup component with less variability of the abduction angle, and, more importantly, we found that no cups were placed in the more extreme positions (outliers).