Protocol for a Randomised Controlled Trial Investigating Decompression for Leprous Neuropathy (The DELN Protocol).

Objectives: An expert group of peripheral nerve surgeons, reconstructive surgeons, and immunologists who have extensive experience with Hansen's Disease convened to discuss the status of nerve decompression as a treatment for leprous neuropathy. The expert group recommended an international, multi-center randomised controlled trial (RCT). Subsequently, a study protocol called Decompression for Leprous Neuropathy (DELN) was designed and further refined by multiple investigators worldwide. The DELN Protocol: The DELN RCT seeks to determine the long-term effect of nerve decompression on sensibility, motor function, neuropathic pain, disability, and quality of life. The RCT would enroll patients with clinically diagnosed leprous neuropathy and positive Tinel signs in the upper and lower extremities. Patients would then be randomized to receive nerve decompression or not. Outcomes of interest include sensory function, motor function, pain, disability, and quality of life. The development of ulcers or amputations after surgery and the influence of corticosteroid therapy are also important outcomes that DELN seeks to determine. Conclusions: The study Decompression for Leprous Neuropathy (DELN) is an international, multi-center RCT with the potential to produce high quality data to address whether nerve decompression for leprous neuropathy can conclusively improve patient outcomes. We invite discussion from all those involved in the peripheral nerve and leprosy communities.

Decompressive surgery for treating nerve damage in leprosy.

BACKGROUND: Leprosy causes nerve damage which may result in nerve function impairment and disability. Decompressive surgery is used for treating nerve damage, although the effect is uncertain. This is an update of a review first published in 2009 and previously updated in 2010. OBJECTIVES: To assess the effects of decompressive surgery on nerve damage in leprosy. SEARCH METHODS: We searched the Cochrane Neuromuscular Disease Group Specialized Register (15 October 2012), CENTRAL (2012, Issue 9 in The Cochrane Library), MEDLINE (January 1966 to October 2012), EMBASE (January 1980 to October 2012), AMED (January 1985 to October 2012), CINAHL Plus (January 1937 to October 2012) and LILACS (from January 1982 to October 2012). We checked reference lists of the studies identified, the Current Controlled Trials Register (www.controlled-trials.com) (1 November 2012), conference proceedings and contacted trial authors. SELECTION CRITERIA: Randomised controlled trials (RCTs) and quasi-RCTs of decompressive surgery for nerve damage in leprosy. DATA COLLECTION AND ANALYSIS: The primary outcome was improvement in sensory and motor nerve function after one year. Secondary outcomes were improvement in nerve function after two years, change in nerve pain and tenderness, and adverse events. Two authors independently extracted data and assessed trial quality. We contacted trial authors for additional information. We collected adverse effects information from the trials and non-randomised studies. MAIN RESULTS: We included two RCTs involving 88 participants. The trials were at high risk of bias. The trials examined the added benefit of surgery over prednisolone for treatment of nerve damage of less than six months duration. After two years' follow-up there was only very low quality evidence of no significant difference in nerve function improvement between participants treated with surgery plus prednisolone or with prednisolone alone. Adverse effects of decompressive surgery were not adequately described. AUTHORS' CONCLUSIONS: Decompressive surgery is used for treating nerve damage in leprosy but the available evidence from RCTs is of very low quality and does not show a significant added benefit of surgery over steroid treatment alone. Well-designed RCTs are needed to establish the effectiveness of the combination of surgery and medical treatment compared to medical treatment alone.

Semmes-weinstein monofilaments: influence of temperature, humidity, and age.

PURPOSE: To determine whether the buckling force of Semmes-Weinstein monofilaments is influenced by changes in temperature, humidity, and aging. METHODS: We tested 16 Semmes-Weinstein monofilaments from North Coast Medical, varying in age from new to 12 years old. From each kit, we used the 2.83/0.07 g, 3.61/0.4 g, 4.31/2g, and 4.56/4 g filaments. Four observers tested the filaments under temperature/humidity conditions of 26°C/33%, 26°C/80%, 37°C/33%, and 37°C/80%. RESULTS: Air temperature and humidity both significantly influence buckling force. At 26°C/33% the buckling force varies by an average of 2% from the standard data supplied by the manufacturer, whereas in the other 3 conditions (26°C/80%, 37°C/33%, and 37°C/80%), the buckling force can decrease by as much as 39%. Effect of age was small and not clinically relevant. CONCLUSIONS: The significant changes in buckling force of the Semmes-Weinstein monofilaments in different temperature and humidity conditions might lead to a potential misinterpretation by the examiner regarding the level of peripheral nerve function loss. This could lead to incorrect diagnosis and treatment. CLINICAL RELEVANCE: Examiners should be aware when using Semmes-Weinstein monofilaments that the environmental effects of temperature and humidity can affect the accuracy of measurement.

Decompressive surgery for treating nerve damage in leprosy.

BACKGROUND: Leprosy causes nerve damage which may result in nerve function impairment and disability. Decompressive surgery is used for treating nerve damage, although the effect is uncertain. OBJECTIVES: To assess the effects of decompressive surgery on nerve damage in leprosy. SEARCH STRATEGY: We searched the Cochrane Neuromuscular Disease Group Trials Register (November 2007), the Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 4, 2007), MEDLINE (from January 1950 to November 2007), EMBASE (from January 1980 to November 2007), AMED (from January 1985 to November 2007), CINAHL (from January 1982 to November 2007) and LILACS (from January 1982 to November 2007) in November 2007. We checked reference lists of the studies identified, the Current Controlled Trials Register (www.controlled-trials.com), conference proceedings and contacted trial authors. SELECTION CRITERIA: Randomised and quasi-randomised controlled trials of decompressive surgery for nerve damage in leprosy. DATA COLLECTION AND ANALYSIS: The primary outcome was improvement in sensory and motor nerve function after one year. Secondary outcomes were improvement in nerve function after two years, change in nerve pain and tenderness, and adverse events. Two authors independently extracted data and assessed trial quality. We contacted trial authors for additional information. We collected adverse effects information from the trials and non-randomised studies. MAIN RESULTS: We included two randomised controlled trials involving 88 people. The trials examined the added benefit of surgery over prednisolone for treatment of nerve damage of less than six months duration. After two years follow-up there was no significant difference in nerve function improvement between people treated with surgery plus prednisolone or with prednisolone alone. Adverse effects of decompressive surgery were not adequately described. AUTHORS' CONCLUSIONS: Decompressive surgery is used for treating nerve damage in leprosy but evidence from randomised controlled trials does not show a significant added benefit of surgery over steroid treatment alone. Well-designed randomised controlled trials are needed to establish the effectiveness of the combination of surgery and medical treatment compared to medical treatment alone.

Decompressive surgery for treating nerve damage in leprosy. A Cochrane review.

OBJECTIVE: Decompressive surgery is used for treating nerve damage in leprosy. We assessed the effectiveness of decompressive surgery for patients with nerve damage due to leprosy. METHODS: A broad search strategy was performed to find eligible studies, selecting randomised controlled trials (RCTs) comparing decompressive surgery alone or plus corticosteroids with corticosteroids alone, placebo or no treatment. Two authors independently assessed quality and extracted data. Where it was not possible to perform a meta-analysis, the data for each trial was summarised. RESULTS: We included two randomised controlled trials involving 88 people. The trials examined the added benefit of surgery over prednisolone for treatment of nerve damage of less than 6 months duration. After 2 years follow-up there was no significant difference in nerve function improvement between people treated with surgery plus prednisolone or with prednisolone alone. Adverse effects of decompression surgery were not adequately described. CONCLUSIONS: Evidence from randomised controlled trials does not show a significant added benefit of surgery over steroid treatment alone. Well-designed randomised controlled trials are needed to establish the effectiveness of the combination of surgery and medical treatment compared to medical treatment alone.

Effectiveness of mini-open carpal tunnel release: An outcome study.

BACKGROUND: Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy with a high morbidity and healthcare-related costs. Currently there is no consensus about the best treatment option. The purpose of this prospective cohort study conducted at a single institution was to evaluate the clinical outcomes and patient satisfaction following a mini-open carpal tunnel release for idiopathic CTS. METHODS: A total of 72 patients (53 female and 19 male patients; mean age, 57.8±15.3 years; range, 24-94 years) had a mini-open carpal tunnel release performed by a single senior surgeon between June 2015 and June 2016. The patients were evaluated preoperatively, and at 3 and 12 months post-intervention. At every follow-up, the Boston Carpal Tunnel Syndrome Questionnaire (BCTSQ) and visual analogue scale (VAS) scores for pain and satisfaction were completed. Digital sensibility (using Semmes- Weinstein monofilaments) was assessed and pinch and grip strengths were measured. RESULTS: Statistically significant and clinically relevant improvement was found in terms of digital sensibility, grip and pinch strength (except for 2-point pinch), BCTSQ scores and pain scores. The complication rate was minimal, and no major complications occurred. Two patients experienced recurrence. The availability of follow-up records (including patient-reported outcomes, BCTSQ and VAS scores, and the complication rate) at 1-year post-intervention varied between 69% and 74% (50-53 patients) depending on which parameter was assessed. Patient satisfaction was high (mean, 80.9±26.0; range, 0-100). CONCLUSIONS: This study demonstrates that mini-incision carpal tunnel release is clinically effective in the short and long term.

Concordance between preoperative computed tomography angiographic mapping and intraoperative perforator selection for deep inferior epigastric artery perforator flap breast reconstructions.

BACKGROUND: Preoperative imaging for perforator identification prior to a deep inferior epigastric artery perforator (DIEP) flap elevation for breast reconstruction has many advantages. Currently, computed tomography (CT) angiography provides good visualization of the perforators and their course, and is thus the imaging technique of choice. The primary aim of this study was to determine the concordance between the perforators identified preoperatively and the perforators ultimately selected intraoperatively, with a standardized protocol, in a single institution. Secondly, we wanted to compare our results with those of other, similar studies and, thirdly, to identify those factors that may lead to a higher concordance. METHODS: A retrospective review was undertaken of a case series of 49 consecutive patients undergoing unilateral autologous breast reconstruction with a DIEP flap at the Gelre Hospital, in the Netherlands, over a 4-year period from 2013 to 2017. The preoperative identification and selection of perforator number and location with the aid of CT angiography scanning were compared to the intraoperative findings and preference. RESULTS: Our study revealed a concordance of 67.3% between one or more perforators advised preoperatively by the radiologist and chosen intraoperatively by the surgeon. We identified significant differences in our protocol compared to others. CONCLUSIONS: The study confirmed the benefit to both the patient and the surgeon when preoperative CT angiography is used. Scanning protocols may vary considerably and should thus be carefully scrutinized before future comparisons are made. Based on this study, the scanning range, method of selecting perforators and timing of image acquisition may have to be optimized for future prospective clinical trials.