Free medial thigh perforator flap for reconstruction of the dynamic and static complex burn scar contracture

Introduction

Dynamic and static complex scar contractures after burn commonly cause tendon adhesion, deep adipose tissue stiffness and further limitation of major joints motion. Skin autografting or locoregional flaps are not adequate reconstructive options, because of the easy recurrence and limitation of donor sites. Therefore, free perforator flaps are playing increasing role in reconstruction of complex scar contractures.

Patients and methods

The free medial thigh perforator (MTP) flap is an addition to the reconstructive armamentarium and is particularly useful since the medial thigh is commonly spared in burn injury. Between December 2001 and October 2005, eight patients with severe post-burn scar contractures received free MTP flaps treatment in the Linkou Burn Center. The free MTP flap harvest was modified to enhance its reliability and versatility. Flap sizes ranged from 5 × 15 cm to 8 × 24 cm. The follow-up period was from 12 to 26 months. Flap harvest is rapid, averaging 37.8 min.

Results

The significantly improved range of motion of the contracture joints approximated to normal activity at 6–22-month follow-up (p < 0.05). No free major MTP flap complication was noted, except for mild marginal necrosis in one case.

Conclusion

The free MTP flap with new modified harvest is a good choice for dynamic an static complex scar contractures of major joints, due to short harvesting time and few variations of the pedicle. However, thick skin paddle was considered in secondary hand reconstruction.     

Non-microsurgical skin flaps for reconstruction of difficult wounds in distal legand foot

Purpose

To express the versatility of a variety of non-microsurgical skin flaps used for coverage of difficult wounds in the lower third of the leg and the foot over 4 years period. Five kinds of flaps were used. Each flap was presented with detailed information regarding indication, blood supply, skin territory and technique.

Reconstruction of a soft tissue defect in the finger using the heterodigital neurocutaneous island flap

Background

This article describes reconstruction of a soft tissue defect in the finger using the heterodigital neurocutaneous island flap and reports the results of the use of the flap.

Methods

From February of 2008 to March of 2011, the neurocutaneous island flap was used in 12 patients with soft tissue defects in the middle phalanx or the proximal interphalangeal joint, or both. The injured fingers included 4 index, 3 middle, 3 ring and 2 little fingers. The donor fingers included 7 middle fingers and 5 ring fingers. The mean size of soft tissue defects and the flaps was 2.4 cm × 1.8 cm and 2.7 cm × 2.0 cm, respectively. The mean pedicle length was 2.8 cm.

Results

Full flap survival was achieved in 11 cases. Partial distal flap necrosis was noted in one case, which healed without surgical intervention. At a mean follow-up of 22 months, the mean static 2-point discrimination and Semmes-Weinstein monofilament scores on the flap were 8.3 mm and 3.94, respectively. Based on the modified American Society for Surgery of the Hand guidelines for stratification of 2-point discrimination, 10 (83%) of 12 flaps achieved good results. According to the Michigan Hand Outcomes Questionnaire, 5 patients were strongly satisfied and 7 were satisfied with functional recovery of the reconstructed finger.

Conclusions

The neurocutaneous island flap of the dorsal branch of the digital nerve is useful, reliable, and technically easy for reconstructing a defect in the adjacent fingers, especially when sensory reconstruction is needed.     

Three-dimensional digitalized virtual planning for retrograde sural neurovascular island flaps: a comparative study

Background

The purpose of this study was to explore the effectiveness and safety of three-dimensional (3D) digitalized planning for the sural neurovascular island flap in repair of soft tissue defects in the ankle and foot.

Methods

This study included 40 patients with soft tissue defects of the ankle and foot who underwent soft tissue reconstruction between October 2008 and June 2012. The patients were randomly assigned into two groups: 3D-reconstruction group (Group A, n = 20) and control group (Group B, n = 20). Three-dimensional, digitalized virtual planning was performed in the patients in Group A, who underwent computed topographic angiography. The survival rate, operation time, and surgical accuracy were compared between the two groups.

Results

All flaps in Group A survived and the recipient site primarily healed, but 4 flaps in Group B had marginal necrosis after the operation. During the 6–12 month follow-up period, all flaps in Group A had good skin quality. In Group B, hard scarring and mild contracture occurred in 4 cases, and the patients experienced pain when walking. The survival rate of the flap in Group A (100%) was significantly higher than in Group B (70%). The operation time in Group A was significantly less than in Group B. The surgical accuracy in Group A was significantly better than in Group B.

Conclusion

The preoperative use of 3D digitalized virtual planning for the sural neurovascular island flap improves the surgical accuracy, decreases the operation time, and increases the survival rate of the flap.

Clinical question/level of evidence

Therapeutic III.     

Wound healing at adaptation zones of skin flaps harvested from acute burned skin

Background

Early reconstruction of burn defects culminates in more successful results. The wound healing process of the burned skin affects not only the curative phase of the burned area but also result of any reconstructive procedure including the regional flaps. Thus, in this study, we have evaluated the wound healing process at the distal incisions of random-pattern skin flaps prepared from burned dorsal skin of rats.

Materials and methods

Thermal burn damage was performed with dimensions of 3 cm × 3 cm on Wistar albino rats. In group 1 (n = 12), no burn was produced and 3 cm × 3 cm caudally based, random-pattern skin flaps were elevated. In group 2 (n = 12), a 5 cm × 5 cm area of partial-thickness thermal damage was produced and after three days a 3 cm × 3 cm random-pattern skin flap was elevated as in group 1 inside the burned skin site. In group 3 (n = 12), 3 cm × 3 cm area of partial-thickness thermal damage was produced and after three days 3 cm × 3 cm random-pattern skin flap was elevated. In group 4 (n = 12), 3 cm × 3 cm area of partial-thickness thermal damage was produced and after three days a 3 cm × 3 cm random-pattern skin flap was elevated at the distal margin of the burned area. The flaps were adapted to the donor sites in all groups. The histopathological evaluation was done and hydroxyproline levels were measured.

Results

There were no significant differences between groups regarding presence of epithelialization, myofibroblast numbers, and collagen texture (p > 0.05). Neovascularization level was significantly higher in group 2 than the other groups (p < 0.05). There were no statistically significant difference among the hydroxyproline levels in all four groups (p > 0.05).

Conclusion

The preference of the incision site in a burn zone while designing a flap during the acute burn period was proposed to possess no difference in terms of wound healing in an animal model.     

Comparison of the rates of elongation provided by multiple smaller rhomboid flaps and larger single rhomboid flap--an experimental study

Background

The rhomboid flap is one of the geometric relaxation techniques used for releasing burn scar contractures.

Purpose

In the present study, we evaluated the question; ‘which is better: one larger rhomboid flap or a series of multiple smaller rhomboid flaps?’

Methods

Ten male Wistar rats each weighing 250–300 g were used. In the groups, 2.5 cm of the inguinal region was used. Two 1 cm long rhomboid flaps with spaced by 0.5 cm were used in the right side and a single 2.5 cm long rhomboid flap was used in the left side.

Conclusion

An elongation by using single larger rhomboid flap (66%) is significantly bigger than an elongation by using multiple smaller rhomboid flaps (26%) (p < 0.01).     

A trial on subcutaneous pedicle island flap for eyebrow reconstruction

Introduction

Severe burn is a common problem affecting victim's eyebrows. This study aims to assess the effectiveness, complications and patients’ satisfaction in two eyebrow reconstruction surgical methods. Up to now, many reconstruction methods, their specific advantages and complications have been introduced. This study compares a new method (subcutaneous pedicle island flap), which is scarcely discussed, with a standard method (superficial temporal artery island flap).

Method

This is a clinical trial conducted during 2003–2005 at the Al’ Zahra’ Hospital. Forty patients with eyebrow defect due to burn injuries were selected by convenience sampling. They were allocated to two groups randomly. The control group underwent a surgery for ‘superficial temporal artery island flap’ and the case group for ‘subcutaneous pedicle island flap’. Data were gathered using two questionnaires. The first one included demographic data, patient history and condition of the eyebrows prior to surgery, effectiveness of surgery and complications. The second was a smiley face visual scale for patient's satisfaction. Data analysis was done using SPSS software (version 12; SPSS Inc., Chicago, IL, USA).

Result

Findings showed that in the control group, 80% were female of a mean age of 22 years (SD = 6/30) and in the case group 75% were female, of a mean age of 21/80 years (SD = 8/28). Fisher's exact test showed a significant difference between the type of surgery and hair-growth direction (p = 0.003). In addition, Mann–Whitney U test showed a significant difference between the type of surgery and patient satisfaction (p = 0.002). Analysis showed that there is no significant difference between the type of surgery and bleeding, congestion, flap necrosis, temporary hair loss in flap and donor-site alopecia (p > 0.05). Surgeon's experience shows that surgery time and learning curve in the case group is lower than that in the control group.

Discussion

Subcutaneous pedicle island flap is an appropriate and easy method with good efficacy, lower complication and more reasonable and acceptable patient's satisfaction. Therefore, this method is recommended for burn patients with eyebrow defects.     

Flow-through anterolateral thigh flap for reconstruction in electrical burns of the severely damaged upper extremity

Background

Many surgeons have to face the challenge of the sophisticated management of catastrophic high-voltage injuries to upper extremities. These patients present with both vast soft tissue defects and varied segmental main artery defects with compromised circulation of the distal limb. This study is a first attempt to analyze the outcome of the flow-through anterolateral thigh flap for reconstruction in acute electrical burns of the severely traumatized upper extremity.

Method and patient

From March 2001 to February 2012, five men were enrolled in the study. All in this series suffered from high voltage current (higher than 1000 V) electrical burn and had the presence of wide segmental soft tissue defects, exposure of underlying vital structures and segmental artery injury with compromised circulation. Flow-through anterolateral thigh flaps were used for limb salvage.

Result

Follow up for all patients was present from 6 months to 7 years. The mean age was 37.8 years old. The mean timing of free flap transfer was 5.8 days after injury. The mean flap sizes were 31.6 cm × 16.5 cm. The mean artery defect was 14.2 cm in length. Venous thrombosis occurred 1 day post-operatively in one patient. No donor site morbidity was noted. In the postoperative period, no infection, no hematoma, nor deaths were noted. Successful limb salvage rate was 80% in this series.

Conclusion

In electrical injuries of the severely damaged upper extremity, flow through anterolateral thigh flaps provide for reconstruction of both the vessels and soft tissue simultaneously. Although the risk of flap failure is higher than with other etiologies of burn, the data shows that the above reconstruction technique is useful for upper extremity salvage.     

Repair of multiple finger defects using the dorsal homodigital island flaps

Background

Providing soft-tissue coverage for multiple finger defects remains a challenge for the hand surgeons. This article reports reconstruction of multiple digital defects using the dorsal homodigital island flaps based on the dorsal branch of the digital artery.

Methods

Over 3 years, a retrospective study was conducted with 12 patients who had multiple finger defects treated with the dorsal homodigital island flaps. Our series included nine male and three female patients. There were 30 soft-tissue defects in 30 fingers. The injured fingers included seven index, nine long, nine ring and five little fingers. The average size of soft-tissue defects and flaps was 2.4 ± 0.4 cm × 1.7 ± 0.2 cm and 2.6 ± 0.4 cm × 1.9 ± 0.2 cm, and the mean pedicle length was 1.1 ± 0.2 cm.

Results

Full flap survival was achieved in 26 fingers. Partial distal flap necrosis was noted in four fingers, which healed without surgical intervention. At a median of 20 (range, 19–23) months’ follow-up, the static two-point discrimination on the flap averaged 9.1 ± 1.6 mm, and the median (range) Semmes–Weinstein monofilament score was 3.84 (3.84–4.17). The donor-site morbidity was accepted. According to the Michigan Hand Outcomes Questionnaire, seven patients were strongly satisfied and five were satisfied with functional recovery of the reconstructed fingers.

Conclusions

The dorsal homodigital island flap, based on the dorsal branch of the digital artery, is less invasive, versatile and technically easy for simultaneous coverage of small-to-moderate defects in multiple fingers.     

A systematic review of the literature to support an evidence-based Precepting Program

Aim

To provide a systematic review of the literature regarding development of an evidence-based Precepting Program for nurses transitioning to burn specialty practice.

Background

Burned patients are admitted to specialty Burn Centers where highly complex nursing care is provided. Successful orientation and integration into such a specialized work environment is a fundamental component of a nurse's ability to provide safe and holistic patient care.

Design

A systematic review of the literature was performed for the period 1995–2011 using electronic databases within PUBMED and Ovid search engines.

Data sources

Databases included Medline, CINHAL, ProQuest for Dissertations and Thesis, and Cochran Collaboration using key search terms: preceptor, preceptee, preceptorship, precept*, nurs*, critical care, personality types, competency-based education, and learning styles.

Review methods

Nurses graded the level and quality of evidence of the included articles using a modified 7-level rating system and the Johns Hopkins Nursing Quality of Evidence Appraisal during journal-club meetings.

Results

A total of 43 articles related to competency (n = 8), knowledge acquisition and personality characteristics (n = 8), learning style (n = 5), preceptor development (n = 7), and Precepting Programs (n = 14).

Conclusions

A significant clinical gap existed between the scientific evidence and actual precepting practice of experienced nurses at the Burn Center. Based on this extensive review of the literature, it was determined that a sufficient evidence base existed for development of an evidence-based Precepting Program.     

Disease Control Outcomes from Analysis of Pooled Individual Patient Data from Five Comparative Randomised Clinical Trials of Degarelix Versus Luteinising Hormone-releasing Hormone Agonists

Background

Studies comparing the gonadotropin-releasing hormone antagonist, degarelix, with luteinising hormone-releasing hormone (LHRH) agonists indicate differences in outcomes.

Objective

To assess differences in efficacy and safety outcomes in a pooled analysis of trials comparing degarelix with LHRH agonists.

Design, setting, and participants

Data were pooled from five prospective, phase 3 or 3b randomised trials (n = 1925) of degarelix and leuprolide or goserelin in men requiring androgen deprivation therapy for the treatment of prostate cancer. Patients received either 3 mo (n = 467) or 12 mo (n = 1458) of treatment.

Intervention

Men were randomised to receive degarelix (n = 1266), leuprolide (n = 201), or goserelin (n = 458).

Outcome measurements and statistical analysis

Unadjusted Kaplan-Meier analyses were supported by the Cox proportional hazards model, adjusted for disease-related baseline factors, to estimate hazard ratios (HRs) of efficacy and safety outcomes. The Fisher exact test compared crude incidences of adverse events.

Results and limitations

Prostate-specific antigen (PSA) progression-free survival (PFS) was improved in the degarelix group (HR: 0.71; p = 0.017). For patients with baseline PSA levels >20 ng/ml, the HR for PSA PFS was 0.74 (p = 0.052). Overall survival (OS) was higher in the degarelix group (HR: 0.47; p = 0.023). OS was particularly improved with degarelix in patients with baseline testosterone levels >2 ng/ml (HR: 0.36; p = 0.006). In terms of disease-related adverse events, there were, overall, fewer joint-related signs and symptoms, musculoskeletal events, and urinary tract events in the degarelix group.

Conclusions

These data indicate clinical benefits with degarelix, including a significant improvement in PSA PFS and OS, as well as reduced incidence of joint, musculoskeletal, and urinary tract adverse events, compared with LHRH agonists.     

Prognostic Significance of Bone Metastases and Bisphosphonate Therapy in Patients with Renal Cell Carcinoma

Background

Bone metastases (BMs) are frequently present in patients with metastatic renal cell carcinoma (mRCC) and cause significant morbidity.

Objective

The purpose of this analysis was to assess the impact of BMs and bisphosphonate therapy (BT) on outcomes in mRCC.

Design, setting, and participants

We conducted a pooled analysis of patients with mRCC treated from 2003 to 2011 in phase 2 and 3 trials.

Outcome measurements and statistical analysis

Statistical analyses were performed using Cox regression and the Kaplan-Meier method.

Results and limitations

We identified 2749 patients treated with sunitinib (n = 1059), sorafenib (n = 355), axitinib (n = 359), temsirolimus (n = 208), temsirolimus plus interferon-α (IFN-α) (n = 208), or IFN-α (n = 560), with 28% (n = 781) having BMs. A total of 285 patients (10.4%) received BT. The presence of BMs in patients was associated with shorter overall survival (OS) when compared with patients without BMs (13.2 vs 20.2 mo, respectively; p < 0.0001) and shorter progression-free survival (PFS) (5.1 vs 6.7 mo, respectively; p < 0.0008). When stratified by risk groups, the presence of BMs was associated with shorter OS in all risk groups. The use of BT in patients with BMs was not associated with improved OS compared with patients who did not receive BT (13.3 vs 13.1 mo, respectively; p = 0.3801) or improved PFS (5.1 vs 4.9 mo, respectively; p = 0.1785). Bisphosphonate users with BMs did not have a decreased rate of skeletal-related events (SREs) compared with nonusers (8.6% vs 5.8%, respectively; p = 0.191). In addition, BT was associated with increased rates of hypocalcemia, renal insufficiency, and osteonecrosis of the jaw (p < 0.0001). Data were analyzed retrospectively.

Conclusions

We confirm that the presence of BMs is associated with shorter survival in mRCC. BT did not affect survival or SRE prevention and was associated with increased toxicity.

Patient summary

In this analysis, we demonstrate that bone metastases are associated with shorter survival in patients with metastatic renal cell carcinoma. In addition, we call into question the utility of bisphosphonate therapy in this population.     

Definition,Incidence, Risk Factors,and Prevention of Paralytic Ileus Following Radical Cystectomy: A Systematic Review

Context

Postoperative paralytic ileus (POI) has profound clinical consequences because it represents a substantial burden on both patients and health care resources.

Objective

To determine the knowledge base regarding POI in the radical cystectomy (RC) population with an emphasis on preventive measures and risk factors.

Evidence acquisition

A systematic literature search of Medline (1966 to February 2011) and a study review were conducted. Eligible studies explicitly reported the incidence of POI and/or at least two quantitative measures of gastrointestinal recovery.

Evidence synthesis

The search identified 727 relevant articles; 77 met eligibility criteria, comprising 13 793 patients. Of these, 21 used explicit definitions of POI, and they varied widely. Across studies, the incidence of POI ranged from 1.58% to 23.5%. Possible risk factors for POI included increasing age and body mass index. Seventeen studies reported effects of an intervention on POI: 3 randomized controlled studies, 11 observational cohort studies with concurrent comparison, and 3 observational cohort studies with nonconcurrent comparison. Gum chewing was associated with shortened times to flatus (2.4 vs 2.9 d; p < 0.0001) and bowel movement (BM) (3.2 vs 3.9 d; p < 0.001) in one observational cohort study (n = 102); omission of a postoperative nasogastric tube (NGT) was associated with shorter time to flatus (4.21 vs 5.33 d; p = 0.0001) and shorter length of stay (14.4 vs 19.1 d; p = 0.001) in one observational cohort study (n = 430); and the routine use of bowel preparation was associated with an increased incidence of POI (5% vs 19%) in another series (n = 86). Additionally, readaptation of the dorsolateral peritoneal layer was shown to shorten times to flatus (p = 0.016) and times to BM (p = 0.011) in one randomized controlled study (n = 200).

Conclusions

The incidence/definition of POI after RC is highly variable. An improved reporting strategy is needed to identify true incidence and risk factors, and to guide future research for both potential preventive and therapeutic interventions.     

Resurfacing large skin defects of the face and neck with expanded subclavicular flaps pedicled by the thoracic branch of the supraclavicular artery

Background

Supraclavicular flaps had been widely used as pedicled flaps to reconstruct face and neck defects. However, the size of this traditional flap was limited even after expansion. In this study, we present a flap pedicled by the thoracic branch of supraclavicular artery (TBSA). The flap is located at the subclavicular region, and has the advantage of large dimension, matching colour and thin thickness.

Methods

In this series, 24 patients with ages ranging between 3 and 49 years (30 flaps with six patients in bilateral fashion) were treated in the authors’ institution.

Results

The maximum size of the flap was 25 cm × 25 cm, whereas the minimum size was 15 cm × 10 cm. The average size of the flaps was 241.1 ± 95.7 cm². Twenty-six flaps (86.7%) survived completely. Total flap loss was seen in one patient (3.3%) and was treated with reverse harvesting skin graft. Partial flap necrosis occurred in three flaps (10.0%). Through a mean time of 10-month follow-up, the colour and the texture of the flaps matched with the recipient area. No conspicuous flap contracture was observed.

Conclusion

This expanded subclavicular flap pedicled by the TBSA has proved to be a promising method with satisfactory outcome and high success rate.     

Pediatric thenar flaps: a modified design,case series and review of the literature

Background

Fingertip injuries are extremely common in children, and severe trauma with pulp loss requires soft-tissue reconstruction to restore length, bulk, and sensibility. The thenar flap is a well-described technique but there are few reports of its use in pediatric patients.

Methods

Pediatric thenar flap reconstructions were retrospectively identified from October 2000 to October 2010 at a single institution.

Results

Sixteen pediatric patients (eleven male, five female) underwent thenar flap procedures. The average age was 10.8 years (1.1–17.8 years). The average defect size was 1.5 cm × 1.5 cm (1 cm²–2 cm²). Division and inset occurred on average 16 days later (12–24 days). Average follow-up was 6.8 months (4.1–9.6 months). The average total active range of motion (TAM) in flexion was 248° (235°–260°) [normal maximum: 260°]. All patients had 85° metacarpophalangeal joint (MCPJ) range of motion (ROM) [normal maximum: 85°]. The average proximal interphalangeal joint (PIPJ) ROM was 103° (95°–110°) [normal maximum: 110°] in flexion, and an average 60° distal interphalangeal (DIPJ) ROM (55°–65°) [normal maximum: 65°] in flexion. Objective sensibility in the flap was ascertained as an average static two-point discrimination of 7 mm (6 mm–10 mm) in 10 compliant patients and was grossly intact in all other patients. There were no complications.

Conclusions

The thenar flap is a safe and effective option for pediatric fingertip amputation injuries requiring soft-tissue reconstruction.     

The Clinical Effectiveness of Retropubic (IVS-02) and Transobturator (IVS-04) Midurethral Slings: Randomized Trial

Background

Few series comparing the clinical efficacy of retropubic slings versus transobturator slings for the treatment of female stress urinary incontinence (SUI) are available.

Objective

To compare clinical efficacy of retropubic tape operations and transobturator suburethral tape operations for the surgical treatment of female SUI.

Design, setting, and participants

From January 2003 to December 2005, 611 patients underwent clinical and urodynamic evaluation before surgical treatment for SUI. Patients with advanced urogenital prolapse (pelvic organ prolapse-quantification scale [POP-Q] scale grade >1) were excluded, and 537 patients were included in this study. After 18 mo, 398 women were available for follow-up efficacy evaluation at a tertiary academic center.

Intervention

All patients underwent either a retropubic sling procedure or a transobturator sling procedure. Patients were randomly allocated into two study groups at a ratio of 1:1.

Measurements

After 18 mo all enrolled patients were clinically checked for clinical efficacy of both procedures.

Results and limitations

Demographic and urodynamic parameters of patients were similar in both groups. No bladder injury occurred in the transobturator sling group (IVS-04), whereas 13 intraoperational bladder perforations (6.5%) occurred in the retropubic sling group (IVS-02) (p < 0.001). The tape erosion rate was <2.5% in both groups (p = 0.7). After 18 mo, 398 patients (201 in the IVS-02 group and 197 in the IVS-04 group) were evaluated in terms of clinical efficacy of the procedures. We found out that there was no statistically significant difference in clinical efficacy between these two procedures (χ² = 1.88, p = 0.39). In the IVS-02 group, 75.1% of patients (n = 151) remained dry (cured), 16.9% of patients (n = 34) reported significant improvement, and 8.0% of patients (n = 16) were considered as failures. In the IVS-04 group, 74.1% of patients (n = 146) remained dry, 14.2% of patients (n = 28) reported significant improvement, and 11.7% (n = 23) were considered as failures.

Conclusions

Based on an 18-mo follow-up, the efficacies of both techniques are comparable; however, the retropubic route appears to be more efficient in the intrinsic sphincter deficiency (ISD) group.     

A Randomized Double-blind Placebo-controlled Phase 2 Dose-ranging Study of OnabotulinumtoxinA in Men with Benign Prostatic Hyperplasia

Background

Botulinum toxin treatment has been investigated as a minimally invasive alternative to oral medications in men with lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (LUTS/BPH).

Objective

To explore the efficacy of onabotulinumtoxinA 100 U, 200 U, and 300 U versus placebo in men with LUTS/BPH in a phase 2 dose-ranging study.

Design, setting, and participants

A multicenter double-blind randomized, placebo-controlled 72-wk study enrolled men ≥50 yr of age with LUTS/BPH, International Prostate Symptom Score (IPSS) ≥12, total prostate volume (TPV) 30–100 ml, and maximum flow rate (Q_max) 5–15 ml/s.

Intervention

Single transperineal (n = 63) or transrectal (n = 311) administration of placebo (n = 94) or onabotulinumtoxinA 100 U (n = 95), 200 U (n = 94), or 300 U (n = 97) into the prostate transition zone.

Outcome measurements and statistical analysis

The primary efficacy end point was a change from baseline in IPSS at week 12. Secondary end points were Q_max, TPV, and transition zone volume (TZV). Analysis of covariance and the Cochran-Mantel-Haenszel method assessed the efficacy and proportion of IPSS responders. Adverse events (AEs) were assessed.

Results and limitations

Significant improvements from baseline in IPSS, Q_max, TPV, and TZV were observed for all groups, including placebo, at week 12 (p < 0.001), with no significant differences between onabotulinumtoxinA and placebo. However, in an exploratory post hoc analysis, a significant reduction in IPSS versus placebo was observed with onabotulinumtoxinA 200 U in prior α-blocker users (n = 180) at week 12. AEs were comparable across all groups.

Conclusions

Reductions in LUTS/BPH symptoms were seen in all groups, including placebo, with no significant between-group differences owing to a large placebo effect from the injectable therapy. The findings from the post hoc analysis in men previously treated with α-blockers will be further explored in an appropriately designed study.

Trial registration

http://www.Clinical Trials.gov; NCT00284518.     

Predicting Recurrence and Progression of Noninvasive Papillary Bladder Cancer at Initial Presentation Based on Quantitative Gene Expression Profiles

Background

Currently, tumor grade is the best predictor of outcome at first presentation of noninvasive papillary (Ta) bladder cancer. However, reliable predictors of Ta tumor recurrence and progression for individual patients, which could optimize treatment and follow-up schedules based on specific tumor biology, are yet to be identified.

Objective

To identify genes predictive for recurrence and progression in Ta bladder cancer at first presentation using a quantitative, pathway-specific approach.

Design, setting, and participants

Retrospective study of patients with Ta G2/3 bladder tumors at initial presentation with three distinct clinical outcomes: absence of recurrence (n = 16), recurrence without progression (n = 16), and progression to carcinoma in situ or invasive disease (n = 16).

Measurements

Expressions of 24 genes that feature in relevant pathways that are deregulated in bladder cancer were quantified by real-time polymerase chain reaction on tumor biopsies from the patients at initial presentation.

Results and limitations

CCND3 (p = 0.003) and HRAS (p = 0.01) were predictive for recurrence by univariate analysis. In a multivariable model based on CCND3 expression, sensitivity and specificity for recurrence were 97% and 63%, respectively. HRAS (p < 0.001), E2F1 (p = 0.017), BIRC5/Survivin (p = 0.038), and VEGFR2 (p = 0.047) were predictive for progression by univariate analysis. Multivariable analysis based on HRAS, VEGFR2, and VEGF identified progression with 81% sensitivity and 94% specificity. Since this is a small retrospective study using medium-throughput profiling, larger confirmatory studies are needed.

Conclusions

Gene expression profiling across relevant cancer pathways appears to be a promising approach for Ta bladder tumor outcome prediction at initial diagnosis. These results could help differentiate between patients who need aggressive versus expectant management.     

Soft Tissue Reconstruction of the Foot Using the Distally Based Island Pedicle Flap after Resection of Malignant Melanoma

Background

We report on our experience with using a distally based island flap for soft tissue reconstruction of the foot in limb salvage surgery for malignant melanoma patients.

Methods

A distally based sural flap was used for 10 cases for the hindfoot reconstruction, and a lateral supramalleolar flap was used for 3 cases for the lateral arch reconstruction of the mid- and forefoot after wide excision of malignant melanomas.

Results

The length of the flap varied from 7.5 cm to 12 cm (mean, 9.6 cm) and the width varied from 6.5 cm to 12 cm (mean, 8.8 cm). Superficial necrosis developed in four flaps, but this was successfully treated by debridement and suture or a skin graft. All thirteen flaps survived completely and they provided good contour, stable and durable coverage for normal weight bearing.

Conclusions

The distally based sural flap is considered to be useful for reconstructing the hindfoot, and the lateral supramalleolar flap is good for reconstructing the lateral archs of the mid- and forefoot after resection of malignant melanoma of the foot.     

Phase 3 Study of Adjuvant Radiotherapy Versus Wait and See in pT3 Prostate Cancer: Impact of Pathology Review on Analysis

Background

In a randomised trial, radical prostatectomy (RP) followed by adjuvant radiotherapy (aRT) was compared with RP alone in patients with pT3 pN0 prostate cancer with or without positive margin at local pathology (German Cancer Society trial numbers ARO 96-02/AUO AP 09/95).

Objective

A pathology review was performed on 85% of RP specimens of patients to investigate the influence of pathology review on the analysis.

Design, setting, and participants

Patients post-RP (n = 385) were randomised before achieving an undetectable prostate-specific antigen (PSA) level to either wait and see (n = 192) or 60 Gy aRT (n = 193). Of 307 patients with undetectable PSA after RP, 262 had pathology review. These results were included prospectively into the analysis.

Outcome measurements and statistical analysis

Agreement between local and review pathology was measured by the total percentage of agreement and by simple kappa statistics. The prognostic reliability for the different parameters was analysed by Cox regression model. Event-free rates were determined by Kaplan-Meier analysis with a median follow-up of 40 mo for the wait-and-see arm and 38.5 mo for the aRT arm.

Results and limitations

There was fair concordance between pathology review and local pathologists for seminal vesicle invasion (pT3c: 91%; κ = 0.76), surgical margin status (84%; κ = 0.65), and for extraprostatic extension (pT3a/b: 75%; κ = 0.74). Agreement was much less for Gleason score (47%; κ = 0.42), whereby the review pathology resulted in a shift to Gleason score 7. In contrast to the analysis of progression-free survival with local pathology, the multivariate analysis including review pathology revealed PSMs and Gleason score >6 as significant prognostic factors.

Conclusions

Phase 3 studies of postoperative treatment of prostate cancer should be accomplished in the future with a pathology review. In daily practice, a second opinion by a pathologist experienced in urogenital pathology would be desirable, in particular, for high-risk patients after RP.