TVT SECUR? System: Final results of a prospective, observational, multicentric study

Introduction and hypothesis  

This is an observational multicentre prospective study into the complications and effectiveness of TVT SECUR™.     

Absorption of irrigation fluid during XPS™ GreenLight laser vaporization of the prostate: results from a prospective breath ethanol monitoring study

Purpose

To assess whether and to what extent irrigation fluid absorption occurs during laser vaporization (LV) of the prostate using the 180 W XPS? GreenLight laser.

Methods

This prospective investigation was performed in a tertiary care center with a consecutive series of patients undergoing 180 W LV of the prostate. Intraoperative irrigation was performed with isotonic saline containing 1 % ethanol. The volume of irrigation fluid absorption was calculated from periodically performed breath ethanol measurements during LV. Additionally, intraoperative changes in biochemical and hematological blood parameters were assessed.

Results

Positive breath ethanol tests were detectable in 22 of 54 patients. The median absorption volume in these patients was 950 ml (range 208–4579 ml). Ten patients absorbed more than 2000 ml. Absorbers had smaller prostates, more capsular perforations and injuries to venous sinuses, and more total energy was applied with higher output power. Five patients had transient symptoms potentially related to fluid absorption. A significant drop in hemoglobin, hematocrit, venous pH and bicarbonate and an increase in chloride were detectable in the absorber group. These changes were significantly different in the non-absorber group.

Conclusions

Absorption of irrigation fluid did occur in a relevant proportion of patients undergoing XPS? GreenLight LV. High-volume absorption (≥2000 ml), which might be clinically relevant, was detectable in almost 20 % of all procedures. Absorption of saline irrigation fluid does not result in a classical TUR syndrome, but fluid and chloride overload can lead to serious complications, particularly in cardiovascular high-risk patients. Thus, patients with symptoms potentially related to fluid absorption should be monitored carefully.

     

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.     

Do cigarette smokers with erectile dysfunction benefit from stopping?: a prospective study

OBJECTIVE: To assess whether stopping smoking can improve erectile dysfunction (ED) in smokers, as cigarette smoking is a known risk factor for ED. PATIENTS AND METHODS: Smokers who requested nicotine replacement therapy (NRT) and complained of ED were first evaluated for hypertension, dyslipidaemia, diabetes, psychiatric disorders and drug history. The grade of ED in smokers with none of these risk factors was then determined using the five-item version of the International Index of Erectile Function (IIEF-5) before NRT, and the grading repeated after 1 year of follow-up. The correlation between the exposure to smoking (pack-years) and severity of ED was assessed before the follow-up. The ED status between patients who stopped smoking after NRT and those who continued during the follow-up was then compared before and after the follow-up. RESULTS: The severity of ED correlated significantly with the level of exposure to smoking. Age and ED status before the follow-up were not significantly different between 118 patients who stopped (ex-smokers) and 163 who continued smoking (current smokers). After 1 year the ED status improved in > or = 25% of ex-smokers but in none of the current smokers; 2.5% of ex-smokers and 6.8% of current smokers had a deterioration in ED. Ex-smokers had a significantly better ED status after the follow-up (P = 0.009). Among ex-smokers, patients with advanced ED and those who were older had less improvement. CONCLUSION: There is a strong association between the intensity of cigarette smoking and degree of ED. Stopping cigarette smoking can improve ED in a considerable proportion of smokers. Age and the severity of ED before stopping are inversely related to the chance of improvement.     

Early results of a prospective study on the pyrolytic carbon (pyrocarbon) Amandys? for osteoarthritis of the wrist

INTRODUCTION

The preliminary results of a pyrocarbon interpositional radiocarpal implant in a small cohort of patients were reviewed. As it is currently only a limited release product, we describe to potential users early complications and negative outcomes.

METHODS

Patients were assessed using pain levels, ranges of motion, grip strength, type of and time to return to work as well as pre-operative and post-operative DASH (Disabilities of the Arm, Shoulder and Hand) scores. Radiographs were taken and patient satisfaction was recorded.

RESULTS

All six patients were contacted. One was not satisfied. Three had reduced motion. None experienced squeaking. There were no immediate or late post-operative complications. There was one early volar displacement of an implant.

CONCLUSIONS

Although our early results are somewhat encouraging, further and longer studies are warranted before supporting the use of this particular pyrocarbon implant as a primary procedure.     

Colorectal anastomosis facilitated by the use of the LigaSure® sealing device: comparative study in an animal model

Background

Recently, there has been speculation about the possibility of fusing intestinal tissue using bipolar sealing devices. In this study we compare in a porcine model the anastomoses created using the LigaSure^® device with those created with a stapler after section and closure of a rectal stump.

Methods

Thirty pigs underwent laparoscopic colorectal anastomosis. In group A (n = 15), the division of the intestine and distal stump closure were done with a 10-mm LigaSure Atlas^® device. In group B, these steps were carried out using an endoscopic stapler. Subsequently, the colorectal anastomosis was performed using circular stapling in both groups. The 4-week follow-up included health status, weight gain, blood tests, X-rays, and colonoscopy. Anastomotic tissue was processed to study the mechanical tensile strength and histopathology.

Results

There was no difference in the rate of conversion to open surgery or in average operating time between the groups. In the sealing device group, there was a significantly higher rate of failure in rectal stump closure (p = 0.042). There was one death in group B due to anastomotic leak. There was no difference in adhesion formation or stenosis. Mid-section anastomosis area was 89.7 mm² in group A compared with 100 mm² in group B (p = 0.52). In tensile strength studies, the maximum load resisted by the sample was 13.8 ± 4.9 N (group A) versus 15.7 ± 4.4 N (group B) (p = 0.17). There was no difference between the groups in degree of reepithelialization, number of inflammatory cells, or the presence of microabscesses.

Conclusions

Division and sealing of the rectal stump with the LigaSure^® device is feasible in the proposed experimental model, but it is less reliable than conventional closure with a stapler, since it has a significantly greater failure rate. Therefore, The LigaSure^® device should not be used for this purpose in the clinical setting as this could lead to serious and dramatic complications.     

Pain from donor site after anterior cervical fusion with bone graft: a prospective randomized study with 12 months of follow-up

Introduction

Harvesting bone graft from the iliac crest in spinal fusion surgery is a widely used technique. However, complications can occur and there are also reports of patients with persistent graft site pain after surgery. The aim of this study was to evaluate pain from the donor site (DS) over time, and register associated complications and if it affected health-related quality of life (HRQoL).

Material and methods

One hundred and seven patients participating in an RCT between two different methods of reconstruction after cervical decompression were included in this study. One group underwent surgery with bone graft (BG) from the iliac crest and the other with no bone graft (NBG). All patients were evaluated concerning pain at DS and HRQoL preoperatively, at 4  weeks, 3 months and 1 year. Pain was evaluated with visual analog scale (VAS) and HRQoL with EQ-5D.

Results

A statistically significant difference was found at all times of follow-up in the BG group compared to preoperative levels and the NBG group. The VAS levels at follow-ups at 3 months and 1 year were however of questionable clinical importance. Two patients in the BG group had superficial wound infections postoperatively and five patients still had sensory disturbance in the area of graft site at 12 months. No major complications were registered. No difference could be seen in EQ-5D at any time of follow-up between the groups.

Conclusion

Harvesting of iliac crest bone graft is associated with significant pain. However, at 3 months postoperatively, the negative effect of clinical importance seemed to have disappeared compared to when no bone graft was harvested. The pain from bone graft harvesting does not seem to affect the quality of life at 4 weeks postoperatively and onward.     

Use of double-layer autologous dermal flap in the treatment of recurrent and/or infected incisional hernias: presentation of the surgical technique and the results of 1-year follow-up—a prospective,consecutive cohort study

Introduction

The difficulties of treating recurrent and/or infected incisional hernias are well known in surgical practice. Several surgical techniques and various types of grafts are available for surgeons. This study presents a new surgical technique option together with the results of the 1-year follow-up.

Purpose

The primary aim of the study is to present the surgical technique of the procedure suitable for the treatment of recurrent and/or infected incisional hernias. The secondary aim is to determine the recurrence rate and analyse the surgical complications. The tertiary aim is to present the quality of life test results performed 3, 6 and 12 months after the surgery.

Patients and method

The authors evaluated the results of 36 recurrent and/or infected incisional hernia surgeries (11 men, average age 60.6 years; 25 women, average age 58.9 years) performed with their own surgical method in the framework of a tightly controlled, prospective, interventional and observational consecutive cohort study conducted between 1 January 2011 and 31 December 2013 at a university surgical department. The study evaluates the results of the 1-year follow-up period. All 36 patients had at least one recurrence of abdominal wall hernia; 12 of them also had concurrent infection of the synthetic graft and a complicating fistula. The mean BMI was 31.82 kg/m² (25.2–43.5 kg/m²). The average size of the abdominal wall defect was 145.9 cm² (59–275 cm²). The abdominal wall reconstruction was performed using an autologous, double-layer dermal flap. The grafts, which had been inserted during previous surgeries, were removed completely. The autologous dermal tissue was prepared using the flap harvested during dermolipectomy. The reconstruction was achieved using a tension-free technique. The essence of the abdominal wall reconstruction is the completion of the abdominal wall defect by a double-layer autologous dermal flap. The original abdominal wall defect was not closed by direct sutures. The quality of the prepared dermal flap was histologically evaluated. IAPMS (intra-abdominal pressure monitoring set) was applied to verify intra-abdominal pressure in the post-operative period. The result of the surgeries was assessed using a quality of life questionnaire.

Results

No recurrence of the abdominal wall hernia was registered during the 1-year follow-up period. Abdominal bulking was observed in case of three patients (8.3 %). Wound infection occurred in one patient (2.77 %) and skin dehiscence in two patients (5.55 %). Haematoma was registered in case of one patient (2.77 %) on the fifth post-operative day. Seroma formation occurred in case of eight patients (22.22 %), which required percutaneous tapping. A fistula formation was observed in one patient (2.77 %) 45 days after the surgery. The intra-abdominal pressure remained moderately elevated during the early post-operative period (9.65–5.76 mmHg on post-operative days 1 and 5). Reoperation was performed in one case due to haematoma. No fatality occurred.

Conclusions

The 1-year recurrence rate in case of the abdominal wall reconstruction using double-layer autologous dermal flap is favourable. Being compliant with the surgical technique developed, the procedure is safe to perform. The number of surgical site infections and fistula formations is low. Based on the questionnaires evaluated, all patients would choose this method instead of the previous reconstruction(s). The method is cost-effective. Based on the results, this procedure is feasible for the treatment of recurrent and/or infected abdominal wall, incisional ventral hernias in obese “high risk” patients.

     

Anterior cervical fusion with a bio-resorbable composite cage (beta TCP–PLLA): clinical and radiological results from a prospective study on 20 patients

A resorbable composite material (40% PLLA and 60% beta TCP) with a high breaking strength and capacity to withstand plastic and elastic strain has been developed for cervical interbody fusion. This is a prospective study to evaluate clinical and radiological results of 20 patients implanted with 27 cages (mean follow-up, 27 months). Clinical (neck disability index, VAS, neurological evaluation) and radiological (anteroposterior, lateral, bending X-rays) data were assessed before and after surgery. At the end of the study, CT scan was performed to evaluate fusion, resorption of the cage and density of the new tissue substituting the cage. The mean patient age was 50.3 years (range, 18–79 years). The average improvement was 55% for neck pain, 83% for arm pain and 65% for NDI, with 85% good or excellent results at final outcomes. Radiologically, lordosis was significantly improved (mean gain of 5.4° and 3.7° for overall and segmental lordosis, respectively). This correction was conserved in 95% of cases. Fusion was obtained in 96% (CT evaluation). Resorption was started in all cases and completed in an average of 36 months after surgery. The mean density of tissue substituting the cage was 659 UH with a range, of 455–911 UH (compatible with bone nature). Over time, the amount of bony tissue increased and the graft remodelled with an increase in density value. This demonstrates a biological activity and changing bone mineral content of this tissue. The new composite cage under investigation provides long-term fusion without loss of correction or inflammatory reaction. The ceramic block guarantees the maintenance of the disc height and its slow resorption allows long-term fusion and stability with good and reliable clinical and radiological outcomes.     

Internal fixation of acetabular fractures in an older population using the TIMI approach – Midterm results of a prospective study

IntroductionThe incidence of geriatric acetabular fractures continues to increase due to demographic changes. In the elderly, anterior column fractures are common, and standard approaches are associated with a considerable risk for surgery-associated complications. Therefore, a minimally invasive approach was developed in our department. The aim of this study was to examine early and mid-term results regarding the use of this novel two-incision minimally invasive (TIMI) approach in patients aged over 55 years with acetabular fractures.MethodsFrom July 2007 to April 2014, 47 patients aged over 55 years were treated via the TIMI approach; these patients were included in the present prospective study. The patients' characteristics, data, and early phase of care were assessed during acute care. A radiological evaluation comprised pre- and postoperative CT scans and x-rays, including Judet views at follow-up. Follow-up examinations were performed after 6 and 24 months and comprised a clinical and radiological examination and an evaluation of hip function (Harris Hip Score) and health-related quality of life (EQ-5D).ResultsThe mean age of the patients was 74 ± 11 years, with a gender ratio of 35/12 (m/f). The average operation time was 93 ± 30 min, and perioperative blood loss amounted to 858 ± 463 ml. In total, five (11%) complications associated with the operative procedure occurred, and revision surgery was necessary in three patients. We observed no wound infections, abdominal wall hernias or cases of heterotopic ossification in our sample. The Harris Hip Score at six months after surgery was 81, and it slightly improved to 84 after 24 months. The mean EQ5D index was 0.91 at six months after surgery and 0.92 at 24 months after surgery.ConclusionThe TIMI approach represents a valuable alternative to the ilioinguinal and modified Stoppa approach for the treatment of acetabular fractures located in the anterior column, which are often observed in geriatric patients.Level of evidenceTherapeutic Level II (Prospective cohort study).     

Clinical and radiological outcome of the Total Evolutive Shoulder System (TESS®) reverse shoulder arthroplasty: a prospective comparative non-randomised study

Purpose

The aims of this study were to assess the function and quality of life after the Total Evolutive Shoulder System (TESS) reverse shoulder arthroplasty (RSA), to evaluate the radiological stability of the stemless version and to address the effect of arm lengthening and scapular notching (SN) on the outcome.

Methods

This was a prospective comparative non-randomised study. A total of 37 consecutive patients (40 shoulders) underwent TESS RSA between October 2007 and January 2012; 16 were stemless and 26 were stemmed. At a mean follow-up of 39 months (15–66), we evaluated range of motion (ROM), pain and functional outcome with QuickDASH and quality of life with EQ-5D score. Radiologically, component positioning, signs of loosening, SN and arm length difference were documented.

Results

We found a significant improvement in functional outcome and reduction of pain in both stemmed and stemless groups. No humeral loosening was evident, but there were four glenoid loosenings. In 12 shoulders that developed SN, seven already had scapular bone impression (SBI) evident on initial post-operative radiographs. Glenoid overhang seemed to decrease the risk of SN. Arm lengthening was associated with better EQ-5D but did not influence ROM or functional outcome.

Conclusions

Reverse shoulder arthroplasty markedly improved shoulder function. SN is of concern in RSA, but proper positioning of the glenoid component may prevent its development.