Bupivacaine use in the Insuflow® device during laparoscopic cholecystectomy: results of a prospective randomized double-blind controlled trial

Background

Recent evidence [Surg Endosc (2007) 21: 602–606] demonstrates that intraperitoneal bupivacaine administered as an aerosol via a special catheter is safe and significantly decreases postoperative pain in laparoscopic surgery. We currently use the Insuflow^® device (Lexion Medical) routinely to warm and humidify gas in laparoscopic surgery. The purpose of this study is to determine whether using bupivacaine instead of water in existing technology already in use (Insuflow) will result in decreased postoperative pain, without increasing operative time or cost.

Methods

Using a double-blind methodology, 50 patients undergoing elective outpatient laparoscopic cholecystectomy were randomized to a study drug: either 10 ml of 0.5% bupivacaine (50 mg) or 10 ml of sterile water. The study drug was injected into the Insuflow in the standard fashion and the operation commenced routinely. No perioperative nonsteroidal anti-inflammatory drugs were used. Using a standard 0–10 pain-scoring scale, patients were assessed by perioperative nurses at 1 and 2 h postoperatively. Pain was again assessed at 24 h by telephone interview, along with the number of narcotic oral analgesics used in the first 24 h.

Results

Fifty patients were randomized, 25 in each group; the groups were comparable. All patients completed the study and 100% follow-up was obtained. All patients were discharged the same day and there were no significant complications in either group, and specifically no complications attributed to bupivacaine or use of the Insuflow device. There were no differences in pain at 1 and 2 h. There was less pain in the bupivacaine group at 24 h, but this was not statistically significant (P = 0.055).

Conclusions

Bupivacaine use in the Insuflow device is safe. No significant differences in postoperative pain were noted in this study compared to using water.     

The use of Suprathel(®) in deep dermal burns: first results of a prospective study

Introduction

While autologous skin grafting has been the standard for coverage of full-thickness areas, several options for deep-partial-thickness defects exist. With regard to economising donor sites, we compared a copolymer based on dl-lactid acid (Suprathel^®) as temporary wound dressing with autologous skin, and analysed time to healing and scar quality in matched areas of deep-partial-thickness burn.

Methods

We recruited 18 patients with a median age of 45 years (range: 25–83 years), for this prospective, non-blinded controlled non-inferiority study, suffering from deep-partial-thickness burns from November 2009 to July 2010. After early tangential excision, matched deep-partial-thickness areas were covered with 1:1.5 meshed autologous skin grafts and the copolymer for direct intra-individual comparison. Scars were evaluated by means of the Vancouver Scar Scale (VSS), the Patient and Observer Scar Assessment Scale (POSAS) and suction cutometry (MPA 580, Courage and Khazaka Electronic GmbH, Cologne, Germany) on days 30 and 90, postoperatively.

Results

Fifteen days after surgery, complete wound closure was present in 44.4% (8/18) of all areas covered with copolymer and 88.9% (16/18) in the split-thickness skin graft (STSG) area (p = 0.008). Evaluation of the total VSS, POSAS and cutometry satisfied the criterion of non-inferiority for Suprathel^® on day 30. Ninety days after surgery, only the Observer Scar Scale showed that Suprathel is non-inferior to STSG, albeit the mean total VSS and Patient Scar Scale were better in Suprathel^® areas.

Conclusion

Suprathel^® represents a solid, reliable epidermal skin substitute with longer healing times in comparison to skin grafts but comparable results concerning early scar formation. Suprathel^® can serve as a tool in treatment portfolio for adult patients suffering from deep dermal burns. Especially in patients with extensive burns, Suprathel^® can be used to cover the deep dermal burn wounds to save STSGs and its donor sites for the coverage of full-thickness burned areas.     

Management of intraoperative hemorrhage during NOTES®: a prospective, randomized comparison

Background

The optimal strategy to manage intraoperative hemorrhage during NOTES^® is unknown. A randomized comparison of three instruments for hemorrhage control was performed [prototype endoscopic bipolar hemostasis forceps (BELA) vs. prototype endoscopic clip (E-CLIP) applier versus laparoscopic clip (L-CLIP) applier].

Methods

A hybrid transvaginal NOTES model in swine was used, with hemorrhage induced in either the gastroepiploic (GE) arteriovenous bundle (vessel diameter ~3 mm) or in distal mesenteric vessels (vessel diameter ~1–2 mm). Hemostasis was attempted three times per vessel using each instrument in a randomized order. Full laparoscopic salvage was performed if hemorrhage persisted beyond 10 min. Outcomes included primary success rate (PS), primary hemostasis time (PHT), number of device applications (DA), and overall hemostasis time (OHT, including salvage).

Results

Seventy hemostasis attempts were made in 12 swine. PS was 42–67 % for the GE vessels, with no difference between instruments. PHT and OHT also were similar between instruments, with the BELA and L-CLIP having a higher number of DA. PS was (80–100 %) in mesenteric vessels, with the BELA and L-CLIP resulting in a shorter mean PHT compared with the E-CLIP.

Conclusions

All three instruments had similar effectiveness in achieving primary hemostasis during hybrid NOTES. Management of small vessel bleeding (1–2 mm) in a porcine model is effective using all three instruments but may be most efficient with the BELA or L-CLIP. Large vessel bleeding (≥3 mm) may be best managed by adding laparoscopic ports for assistance while maintaining a low threshold for conversion to full laparoscopy.     

Electrophysiological evaluation of phrenic nerve injury during cardiac surgery – a prospective,controlled, clinical study

Background

According to some reports, left hemidiaphragmatic paralysis due to phrenic nerve injury may occur following cardiac surgery. The purpose of this study was to document the effects on phrenic nerve injury of whole body hypothermia, use of ice-slush around the heart and mammary artery harvesting.

Methods

Electrophysiology of phrenic nerves was studied bilaterally in 78 subjects before and three weeks after cardiac or peripheral vascular surgery. In 49 patients, coronary artery bypass grafting (CABG) and heart valve replacement with moderate hypothermic (mean 28°C) cardiopulmonary bypass (CPB) were performed. In the other 29, CABG with beating heart was performed, or, in several cases, peripheral vascular surgery with normothermia.

Results

In all patients, measurements of bilateral phrenic nerve function were within normal limits before surgery. Three weeks after surgery, left phrenic nerve function was absent in five patients in the CPB and hypothermia group (3 in CABG and 2 in valve replacement). No phrenic nerve dysfunction was observed after surgery in the CABG with beating heart (no CPB) or the peripheral vascular groups. Except in the five patients with left phrenic nerve paralysis, mean phrenic nerve conduction latency time (ms) and amplitude (mV) did not differ statistically before and after surgery in either group (p > 0.05).

Conclusions

Our results indicate that CPB with hypothermia and local ice-slush application around the heart play a role in phrenic nerve injury following cardiac surgery. Furthermore, phrenic nerve injury during cardiac surgery occurred in 10.2 % of our patients (CABG with CPB plus valve surgery).

     

Short term results of dynamic splinting for hallux valgus — A prospective randomized study

Background Hallux valgus is a common diagnosis in orthopedics. Only a few studies have analyzed the effects of conservative therapy. Therefore, the current study analyzed the effect of a dynamic hallux valgus splint.Methods Seventy patients were included in this prospective randomized trial. Patients with a hallux valgus were treated using a dynamic splint or underwent no treatment. Clinical and radiological parameters were evaluated.Results We found no significant changes in hallux valgus angle, intermetatarsal I–II angle, AOFAS score, FAOS or SF-36 score between the groups. However, a significant between-group difference was found for pain during walking and running and in the FAOS subscale for pain and pain at rest at follow-up.Conclusions Wearing a dynamic hallux valgus splint does provide some pain relief in patients with a symptomatic hallux valgus, but showed no effect on hallux valgus position.Level of evidence: 1.     

Efficacy of oral ofloxacin for single-dose perioperative prophylaxis in general surgery – a controlled randomized clinical study

BACKGROUND: Perioperative antibiotic prophylaxis surely reduces surgical infection rate. Pharmacokinetic data of oral ofloxacin in combination with its antibacterial spectrum suggest effective protection against perioperative infection. In addition, costs, adverse effects, and induction of microbial resistance are low. Therefore we performed a controlled randomized study comparing oral and intravenous single dose prophylaxis. METHODS: A total of 61 patients undergoing colonic or pancreatic resection randomly received either a single dose standard intravenous prophylaxis or ofloxacin 400 mg and metronidazole 500 mg orally 2 h before surgery. Postoperative infections were recorded for 3 weeks. RESULTS: Groups were very well comparable regarding age, overweight, concomitant disease, type and duration of surgery, blood loss, and volume support. Infectious complications occurred in 14.8% after parenteral and 3.3% after enteral antibiotic prophylaxis. There was no difference in post-operative hospital stay. CONCLUSION: The data demonstrate that single-dose oral ofloxacin is at least as effective as a standard intravenous prophylaxis in patients with colonic or pancreatic resection. It offers significant advantages regarding costs and ease of administration.     

Does transcervical intra-fallopian insemination improve pregnancy rates in cases of oligoteratoasthenozoospermia? A prospective,randomized study

The relatively low pregnancy rates (PR) after treatment of patients with oligoteratoasthenozoospermia (OTA) result in a search for different treatment modalities. The objective of this study was to assess the efficacy of transcervical intrafallopian insemination (IFI) with husband's semen in comparison to intrauterine insemination (IUI) in couples with OTA. A prospective, randomized study included 30 couples with OTA-related infertility (according to WHO criteria). The female patients underwent individually adjusted controlled ovarian stimulation by gonadotropins. Spermatozoa was prepared using the Percoll 70% technique and insemination was performed 36-40 h after human chorionic gonadotropin (HCG) administration. The Tomcat Catheter was used for IUI and the Jansen-Anderson Catheter for IFI to the fallopian tube leading to the ovary that contained more dominant follicles. The couples were divided according to sperm count, into group A (9 couples): < 10 mill ml-1 and group B (21 couples): > 10 mill ml-1. Within the groups the patients were randomly assigned for IUI or IFI treatment. Among group B couples, two pregnancies out of 15 IUI cycles (13.3% PR) and two pregnancies out of 18 IFI cycles (11.1% PR) were achieved. Group A patients completed 7 IUI and 9 IFI treatment cycles with no pregnancies observed. These data did not demonstrate a statistically significant advantage for either technique.     

Nortriptyline for treating enuresis in ADHD—a randomized double-blind controlled clinical trial

Background

Treating enuresis in children with attention deficit hyperactivity disorder (ADHD) has not been previously reported. This study aims to investigate the efficacy, tolerability, and adverse effects of nortriptyline for treating enuresis in children with ADHD.

Methods

Forty-three children aged from 5 to 14?years old were randomized into two groups. The treatment group received methylphenidate plus nortriptyline, while the placebo group received methylphenidate plus placebo. Nortriptyline and placebo were administered for 30?days and methylphenidate was administered for 45?days. The major outcome measure was parent-reported frequency of enuresis for 2?weeks prior to the intervention, during the intervention, and for 2?weeks after stopping the adjuvant therapy. Adverse effects were also checked.

Results

While nortriptyline statistically decreased the incidence of nocturnal enuresis during the intervention, the number of enuresis events did not significantly change in the placebo group. In addition, enuresis was not different from the baseline frequency of enuresis after stopping nortriptyline or placebo administration. Both nortriptyline and placebo were tolerated well.

Conclusions

Administration of nortriptyline for treating enuresis in ADHD has not been investigated before. Nortriptyline is statistically superior to placebo. However, enuresis will relapse after stopping nortriptyline in children with ADHD who continue taking methylphenidate.     

How should transection of the liver be performed?: a prospective randomized study in 100 consecutive patients: comparing four different transection strategies

OBJECTIVE: To identify the most efficient parenchyma transection technique for liver resection using a prospective randomized protocol. SUMMARY BACKGROUND DATA: Liver resection can be performed by different transection devices with or without inflow occlusion (Pringle maneuver). Only limited data are currently available on the best transection technique. METHODS: A randomized controlled trial was performed in noncirrhotic and noncholestatic patients undergoing liver resection comparing the clamp crushing technique with Pringle maneuver versus CUSA versus Hydrojet versus dissecting sealer without Pringle maneuver (25 patients each group). Primary endpoints were intraoperative blood loss, resection time, and postoperative liver injury. Secondary end points included the use of inflow occlusion, postoperative complications, and costs. RESULTS: The clamp crushing technique had the highest transection velocity (3.9 +/- 0.3 cm/min) and lowest blood loss (1.5 +/- 0.3 mL/cm) compared with CUSA (2.3 +/- 0.2 cm/min and 4 +/- 0.7 mL/cm), Hydrojet (2.4 +/- 0.3 cm/min and 3.5 +/- 0.5 mL/cm), and dissecting sealer (2.5 +/- 0.3 cm/min and 3.4 +/- 0.4 mL/cm) (velocity: P = 0.001; blood loss: P = 0.003). Clamp crushing technique was associated with the lowest need for postoperative blood transfusions. The degree of postoperative reperfusion injury and complications were not significantly different among the groups. The clamp crushing technique proved to be most cost-efficient device and had a cost-saving potential of 600 to 2400 per case. CONCLUSIONS: The clamp crushing technique was the most efficient device in terms of resection time, blood loss, and blood transfusion frequency compared with CUSA, Hydrojet, and dissecting sealer, and proved to be also the most cost-efficient device.     

Evaluation of the effectiveness of a semi-finished occlusal appliance – a randomized, controlled clinical trial

Introduction

Painful temporomandibular disorders (TMDs) are usually treated with physiotherapy, self-exercises, medication-based therapy and splint therapy. For splint therapy different types of splints are available. Therefore this randomized controlled study compared the effectiveness of a semi-finished occlusal appliance (SB) with a laboratory-made occlusal appliance (SS) in myofascial pain patients.

Method

The trial subjects allocated to the experimental groups with the (SB) occlusal appliance and those provided with a laboratory-made occlusal appliance (SS) did, in addition, receive conservative treatment (self-exercises, drug-based and manual therapy). The control group was given conservative therapy (CO) only. Overall, a total of 63 patients participated in the study with each group consisting of 21 subjects.

Results

When the first follow-up examination took place (14 days after splint insertion) mouth opening within the SB group was significantly enlarged. When the second examination was conducted (2.5 months after splint insertion) mouth opening was significantly enlarged in both splint groups when compared with the initial value. In the control group, no significant enlargement of mouth opening was detected. At no point there was a significant reduction in the number of pressure-sensitive areas of the TMJ. On palpation of the masticatory muscles however, a significant reduction in the number of pressure-sensitive areas could be observed within the CO group and the SS group after 2.5 months. When comparing pain reduction (muscle/joint pain) and mouth opening, no significant differences could be detected between the treatments.

Conclusion

The results suggest that TMD should be treated conservatively. In cases of restricted mouth opening, the additional use of occlusal appliances can eliminate the patient’s discomfort more quickly. In this context, the tested, semi-finished occlusal appliance appears to offer an immediately available, temporary alternative to laboratory-made splints.     

Augmentation of a retrognathic chin. I. use of HTR-polymer ® implants in a long-term prospective clinical and radiographic study

A total of 37 patients have had chin augmentation procedures with HTR-polymer ® implants. Indications were mandibular retrognathia in connection with dentofacial deformities in 13 and the remaining 24 had a normal occlusion. Three patients with micrognathia also had juvenile rheumatoid arthritis. The patients have been followed for at least one year and in 17 cases up to five years both clinically and radiographically. Cephalometric measurements of the effects and stability of augmentation showed that chin augmentation has highly predictable results, and few side-effects.     

The effects of xanthine oxidase inhibitor in patients with chronic heart failure complicated with hyperuricemia: a prospective randomized controlled clinical trial of topiroxostat vs allopurinol—study protocol

Background

Hyperuricemia has a close relationship with cardiovascular diseases including heart failure. However, it is controversial whether xanthine oxidase inhibition has benefits for patients with chronic heart failure. We designed the Effect of Xanthine Oxidase Inhibitor in Chronic Heart Failure Patients Complicated with Hyperuricemia study (Excited-UA study) to compare the beneficial effects between a novel xanthine oxidoreductase inhibitor, topiroxostat, and a conventional agent, allopurinol, in patients with chronic heart failure and hyperuricemia. We focus on serum N-terminal pro-brain natriuretic peptide (NT-proBNP) level, echocardiography-based cardiac function, vascular endothelial function, renal function, inflammation, and oxidative stress.

Methods

The excited-UA is a prospective, randomized, open-label, blinded-endpoint clinical trial designed to prove our hypothesis that topiroxostat is more effective than allopurinol in patients with chronic heart failure and hyperuricemia. A total of 140 patients with chronic heart failure and hyperuricemia (plasma brain natriuretic peptide level?≥?40 pg/mL and serum uric acid level?≥?7.0 mg/dL) are randomly assigned (ratio 1:1) into either the topiroxostat group (40–160 mg/day) or allopurinol group (100–300 mg/day), to achieve the target uric acid level of 6.0 mg/dL. According to the protocol, all patients are followed up annually for 24 weeks. The primary endpoint is percent change in serum NT-proBNP level at 24 weeks from baseline.

Conclusions

The Excited-UA study would provide novel evidence for the clinical relevancy of xanthine oxidoreductase inhibitor treatment in patients with chronic heart failure and hyperuricemia.

     

The value of intraoperative MRI for resection of functional pituitary adenomas—a critical assessment of a consecutive single-center series of 114 cases

Neurosurgical Review - This series sought to evaluate the role of intraoperative MRI (iMRI) for resection of functional pituitary adenomas (FPAs). We retrospectively reviewed clinical data of 114...     

Is there a role for drain use in elective laparoscopic cholecystectomy? A controlled randomized trial

Background

Although the issue of drain use in open cholecystectomy has been adequately addressed by prospective randomized trials, there is lack of evidence on the usefulness of drains in elective laparoscopic cholecystectomy, and the surgeons follow their beliefs and bias on this debate. Therefore, a controlled randomized trial was designed to assess the value of drains in elective laparoscopic cholecystectomy.

Methods

During a 5-year period (January 2002 to December 2006), 284 patients were randomized to have a drain placed (group A), whereas 281 patients were randomized not to have a drain (group B) placed in the subhepatic space. End points of this trial were to detect any differences in morbidity, postoperative pain, and hospital stay between the 2 groups.

Results

There was no mortality in either group and no statistically significant difference in morbidity or hospital stay between the 2 groups. However, postoperative pain was significantly increased in patients who had a drain placed; median visual analog scale (VAS) score was 5 (range 1 to 8) versus 3 (range 1 to 8), in the non-drained group (P < .0001). Interestingly, in 2 of 3 patients in whom a drain was placed against randomization because of bile leak suspicion, a bile leak occurred.

Conclusions

The routine use of a drain in elective laparoscopic cholecystectomy has nothing to offer; in contrast, it is associated with increased pain. It would be reasonable, however, to leave a drain if there is a worry about an unsolved or potential bile leak, bearing in mind that drain placement, although sometimes providing a false sense of security, does not guarantee either prevention or treatment of postoperative bile collections, bleeding, or bile peritonitis.     

A prospective, randomized, controlled study comparing Gynemesh®, a synthetic mesh, and Pelvicol®, a biologic graft, in the surgical treatment of recurrent cystocele

We compared safety and efficacy of Gynemesh PS® and Pelvicol® for recurrent cystocele repair. One hundred ninety patients were randomly divided into Gynemesh PS® and Pelvicol® groups and underwent tension-free cystocele repair. The Chi-square test was used to compare categorical variables, the paired t test for continuous parametric variables, and the Mann–Whitney test for continuous nonparametric variables. Ninety-six Gynemesh PS® patients and 94 Pelvicol® patients were studied. Mesh erosions occurred in 6.3% of Gynemesh PS® patients. No erosions were observed in Pelvicol® patients (p?=?0.02). Objective cure was 71.9% for Gynemesh PS® and 56.4% for Pelvicol® (p?=?0.06). Subjective cure was the same in both groups except for better sexuality in the Pelvicol® group. At 24 months follow-up, only Gynemesh PS® patients had mesh erosions. Anatomical outcome was similar in the two groups. Pelvicol® gave a better impact on voiding and sexuality.     

Is albumin administration beneficial in early stage of postoperative hypoalbuminemia following gastrointestinal surgery?: a prospective randomized controlled trial

Background

Surgeons commonly see postoperative hypoalbuminemia, but whether exogenous albumin administration is beneficial for these patients is unclear.

Methods

A prospective, randomized study design was used, allocating 127 hypoalbuminemic patients into the albumin or saline group after gastrointestinal surgery. We investigated the development of postoperative hypoalbuminemia, nutritional status, postoperative fluid balance, postoperative complications, and postoperative hospital stay.

Results

Plasma albumin concentrations of both groups decreased after operations (P <.01). No significant differences were found between groups (P >.05) in changes in postoperative plasma albumin concentration from baseline levels. Postoperative plasma albumin, total protein, and prealbumin levels were similar in the 2 groups. While 3-day and 5-day recovery ratios were similar, 7-day recovery ratios were lower in the albumin group (P <.05). No significant difference was found in overall fluid administration, urine output, or the incidence of postoperative complications between groups (23.4% for albumin group and 12.7% for control group, P = .116).

Conclusions

Albumin administration in the early stage of postoperative hypoalbuminemia following gastrointestinal surgery is not beneficial in correcting hypoalbuminemia or in clinical outcomes.