Randomized clinical trial of single-port, minilaparoscopic and conventional laparoscopic cholecystectomy.

BACKGROUND: This three-armed randomized clinical trial, with blinding of patients and outcome assessors, tested the hypothesis that single-port (SP) and/or minilaparoscopic (ML) cholecystectomy are superior to conventional laparoscopic (CL) cholecystectomy. METHODS: Patients eligible for elective laparoscopic cholecystectomy were randomized to SP, ML or CL procedures. The primary outcome was pain measured on a visual analogue scale twice daily during the blinded period. Secondary outcomes included duration of operation, technical performance score, complications, quality of life, cosmesis and patient satisfaction. Postoperative follow-up lasted 1 year. RESULTS: A total of 105 patients were randomized, 35 in each group. One conversion from a SP to a CL technique was necessary in a patient with chronic cholecystitis. Pain intensity was similar in the three groups, both during the blinded period (day 0 to 3; P = 0·865) and over the whole 7-day evaluation period (P = 0·911). The presence of clinically relevant between-group differences was ruled out (95 per cent confidence interval + 1·0 to - 0·5 for difference in pain scores between SP and CL groups, and - 0·8 to + 0·6 between ML and CL groups). Operating time was significantly longer for SP and ML than for CL cholecystectomy (P = 0·001). Postoperative complications included injury to the diaphragm (1), choledocholithiasis (1), wound infection (5) and hernia (1), all after SP cholecystectomy (P = 0·001). Twelve-month follow-up was complete in 99 patients (94·3 per cent). Cosmesis as rated by patients was significantly better at 6 months after SP and ML procedures (P = 0·043), but no difference was observed at 12 months (P = 0·229). CONCLUSION: SP and ML cholecystectomy had no advantage over the CL approach in terms of postoperative outcome. REGISTRATION NUMBER: DRKS00000302 (German Registry of Clinical Trials).

Randomized sham-controlled trial of acupuncture for postoperative pain control after stapled haemorrhoidopexy.

AIM: Haemorrhoidectomy usually causes moderate to strong postoperative pain. Chinese studies have found that acupuncture may have an analgesic effect in posthaemorrhoidectomy patients. This is the first Western study aiming assess the efficacy of acupuncture as an adjunct analgesic therapy after stapled haemorrhoidopexy. METHOD: In a randomized controlled trial, 50 patients were allocated to three groups. Conventional drug therapy (oral diclofenac and metamizol, local lidocaine) served as baseline analgesia. In the control group (n = 17) only this regimen was used. In addition to baseline analgesia, 17 patients received verum acupuncture. Sham acupuncture was performed on 16 patients. Being the primary outcome measure, pain was measured twice daily using the numerical rating scale (NRS) and compared statistically by repeated-measures analysis of variance. The study was registered (DRKS00003116). Results After verum acupuncture, pain intensity was not significantly lower when compared with conventional analgesia (primary hypothesis, P = 0.057), but was when compared to sham acupuncture (P = 0.007). In the afternoon of postoperative day 1, for example, NRS was 2.7 (SD 1.5) in the verum group, but 4.0 (1.0) in the sham group and 4.1 (1.9) under conventional analgesia. Furthermore, significantly fewer rescue analgesics were necessary if verum acupuncture was applied. Cardiovascular parameters were stable in all three groups, and no complications were recorded. CONCLUSIONS: In posthaemorrhoidectomy patients, acupuncture appears to be an effective adjunct to conventional analgesia. Further studies are necessary to confirm these observations and to refine the acupuncture technique.

Joint replacement in 131 painful osteoarthritic and post-traumatic distal interphalangeal joints.

This study reports the results of Swanson replacement of 131 DIP joints for painful osteoarthritis and two for ongoing pain after injury. Thirty-seven arthroplasties (28 patients) were carried out with extensor tendon division and repair, and postoperative immobilization for 8 weeks. Ninety-four (60 patients) were then carried out without tendon division, allowing immediate mobilization. At assessment after a mean period of 57 months, the mean postoperative range of movement was 39°, and the mean extensor lag was 11°, with significant improvement of both in both operative groups. The severity of pain improved significantly following surgery. All but one patient were satisfied with the cosmetic result of replacement. The overall complication rate was 7/131(5%). Three joints developed cellulitis and one developed osteomyelitis, requiring subsequent fusion. Two joints had subsequent fusions because of persistent lateral instability and marked ulnar deviation and one had a persistent mallet-type deformity, corrected by tendon shortening.

[Memorandum registry for health services research]. / Memorandum Register für die Versorgungsforschung.

On August 30, 2010, the German Network for Health Services Research [Deutsches Netzwerk Versorgungsforschung e. V. (DNVF e. V.)] approved the Memorandum III "Methods for Health Services Research", supported by their member societies mentioned as authors and published in this Journal [Gesundheitswesen 2010; 72: 739-748]. Registries in Health Services Research vary in their aims and research questions as well as in their designs, methods of data collection, and statistical analyses. This paper aims to provide both a methodological guideline for developers to ensure a high quality of a planned registry and, to provide an instrument for users of data from registries to assess their overall quality. First, the paper provides a definition of registries and presents an overview of objectives in Health Services Research where registries can be useful. Second, several areas of methodological importance for the development of registries are presented. This includes the different phases of a registry (i. e., conceptual and preliminary design, implementation), technical organisation of a registry, statistical analysis, reporting of results, data protection, and ethical/legal aspects. From these areas, several criteria are deduced to allow the assessment of the quality of a registry. Finally, a checklist to assess a registry's quality is presented.

Stented ureterovesical anastomosis in renal transplantation: does it influence the rate of urinary tract infections?

OBJECTIVE: Our objective was to evaluate the impact of routine use of double-J stents on the incidence of urinary tract infection after renal transplantation. METHODS: We conducted a retrospective-comparative single-centre study in 310 consecutive adult deceased donor kidney recipients transplanted from 2002 to 2006. Patients were divided in two groups, with or without urinary stent implantation. To evaluate the predictive factors for UTI, donor and recipients pre- and post-transplantation data were analysed. Early urological complications and renal function within 12 months of transplantation were included as well. RESULTS: A total of 157 patients were enrolled to a stent (ST) and 153 patients to a no-stent (NST) group. The rate of urinary tract infection at three months was similar between the two groups (43.3% ST vs. 40.1% NST, p = 0.65). Of the identified pathogens Enterococcus and Escherichia coli were the most common species. In multivariate analysis neither age nor immunosuppressive agents, BMI or diabetes seemed to have influence on the rate of UTI. When compared to males, females had a significantly higher risk for UTI (54.0% vs. 33.5%). CONCLUSION: Prophylactic stenting of the ureterovesical anastomosis does not increase the risk of urinary tract infection in the early postoperative period.

Relief of the pain of neuromas-in-continuity and scarred median and ulnar nerves in the distal forearm and wrist by neurolysis, wrapping in vascularized forearm fascial flaps and adjunctive procedures.

This prospective study reports treatment by neurolysis then wrapping the nerves in vascularized forearm fascia and, when necessary, adjunctive procedures of twelve median and two ulnar nerves in continuity in the distal forearm with neurogenic pain. Preoperatively, all 14 patients had severe pain in at least one of the five modalities of pain analysed. There was complete resolution of all modalities of pain in eight of 14 patients following neurolysis and fascial nerve wrap surgery and two more patients had only mild pain in one or two modalities. After the addition of wrist pinning or arthrodesis alone or in conjunction with selective division of flexor tendons in four patients, there was complete resolution of all modalities of pain in nine of 14 patients. A further three patients had mild pain in three or less modalities and only one patient continued to have severe pain in one modality.

[Clinical research in orthopaedics--creation of a clinical trial unit in orthopaedics/trauma surgery]. / Klinische Forschung in der Orthopädie--Aufbau eines Studienzentrums in der Orthopädie/Unfallchirurgie.

AIM: The clinical trial is the link between research and medical practice and facilitates evidence-based therapies. There are specific difficulties to be faced when executing clinical trials related to surgical services (learning curve of the surgeon, blinding etc.). As a result, surgical randomised controlled clinical trials (RCT) are underrepresented in the total number of RCTs. METHOD: To make it easier to implement surgical RCT, the Clinical Trial Unit for Orthopaedics and Trauma Surgery was established. Training of the supporting physicians was reached by rotations in the structures of CHIR-Net, a BMBF-funded network created to build up a region-wide surgical research infrastructure. RESULT/CONCLUSION: Supported by the regional CHIR-Net Center and the regional Clinical Trial Center, a research institute was thus founded with the aim of contributing to a long-term improvement in clinical research in orthopaedics and trauma surgery.

Use of marginal organs in kidney transplantation for marginal recipients: too close to the margins of safety?

OBJECTIVE: Due to organ shortage, average waiting time for a kidney in Germany is about 4 years after start of dialysis. Number of kidney grafts recovered can only be maintained by accepting older and expanded criteria donors. The aim of this study was to analyse the impact of donor and recipient risk on kidney long-term function. METHODS: All deceased kidney transplantations were considered. We retrospectively studied 332 patients between 2002 and 2006; divided in 4 groups reflecting donor and recipient risk. RESULTS: Non-marginal recipients were less likely to receive a marginal organ (69 of 207, 33%) as compared to marginal recipients, of whom two-thirds received a marginal organ (p<0.0001). Graft function significantly differed between the groups, but detrimental effect of marginal recipient status on eGFR after 12 months (-6 ml/min/1.73qm, 95% CI -2 to -9) was clearly smaller than the effect of marginal donor status (-10 ml/min/1.73qm, 95% CI -7 to -14). CONCLUSIONS: As we were able to show expanded criteria donor has a far bigger effect on long-term graft function than the "extra risk" recipient. Although there have been attempts to define groups of recipients who should be offered ECD kidneys primarily the discussion is still ongoing.

Laparoscopic incisional hernia repair: evaluation of effectiveness and experiences.

INTRODUCTION: Incisional hernia is the most frequent postoperative complication following abdominal surgery and is a common and costly source of morbidity. Conventional mesh repair is the standard treatment today, but the use of laparoscopic incisional hernia repair (LIHR) seems to be a good alternative. We performed a retrospective analysis comparing open incisional hernia repair with the laparoscopic approach. METHODS: Between June 2004 and June 2006, 123 patients with incisional hernia were included. Open repair (37 men and 45 women; mean age 62.6 years) was performed in 82 cases, whereas 41 patients underwent laparoscopic repair (29 men and 12 women; mean age 64.3 years). Patient- and procedure-associated characteristics, clinical outcome, and recurrence rate were determined after a median follow-up period of 23 months for the laparoscopic group and 24 months for the open group. RESULTS: Hernia sizes were comparable between the groups. Conversion to open repair was required in two cases. Postoperative pain scores did not differ significantly. In the long-term follow-up, however, the pain score was less (P = 0.001) and the satisfaction rate was higher (P = 0.003) in the laparoscopic group. Complications occurred in 23% of patients in the open group and 20% in the LIHR group. The recurrence rate was lower in the laparoscopic group, with 9% (3/35) compared to 23% (18/77) in the open group (P = 0.089). CONCLUSIONS: Our results show the tendency that LIHR is associated with less postoperative pain and comparable postoperative complications. The low recurrence rate proves the safety and the good long-term results of this procedure. Laparoscopic hernia repair is an alternative to open procedures in cases of feasibility. Further studies, especially randomized controlled trials, are required to confirm these findings and provide the basis for future treatment guidelines.

[The curriculum for rotation physicians within the CHIR-Net]. / Kurrikulum für Rotationsärzte im CHIR-Net.

INTRODUCTION: CHIR-Net is a German national surgical network for clinical trials. It is supported by the Federal Ministry for Education and Research (BMBF 01GH0605) to establish infrastructure and expertise in the conduct of clinical trials within the surgical disciplines. An important aspect of this network is a qualified advanced training for physicians deployed at the CHIR-Net as part of a job rotation. METHODS: A catalog of activities for the time of rotation within the network has been developed in cooperation with the CHIR-Net, the deployed physicians and cooperating regional clinical trials centers (ZKS/KKS). RESULT: The focal points of the physicians' rotation in the CHIR-Net are outlined in a curriculum that has been established and evaluated in the network since January 2008. CONCLUSION: After the rotation time at the CHIR-Net the skilled physicians act as multipliers of specialized knowledge on clinical research. In this way the acquired expertise will be transferred into clinical practice and treatment of patients within research projects will benefit directly.

Evidence-based hand surgery: the role of Cochrane reviews.

A detailed literature search was performed to investigate whether the increasing importance of evidence-based hand surgery is reflected in the actual status of Cochrane reviews. Fourteen Cochrane reviews were found and evaluated. Of these, five reviews were in the field of distal radial fractures and four concerned carpal tunnel syndrome. Cochrane reviews were also found for antibiotic treatment, rehabilitation after flexor tendon injuries, mallet finger injuries, little finger metacarpal neck fractures and thumb joint arthritis. All 14 reviews were compromised by methodological flaws and significant clinical heterogeneity of the included studies. Within most reviews the underlying evidence was insufficient and only a very limited number of clinical recommendations could be made. In conclusion, the existing Cochrane reviews in the field of hand surgery show both an increasing interest in establishing systematically summarised knowledge and an enormous demand for good-quality randomised controlled trials.

Laparoscopic splenectomy: the clinical practice guidelines of the European Association for Endoscopic Surgery (EAES).

BACKGROUND: Although laparoscopic splenectomy (LS) has become the standard approach for most splenectomy cases, some areas still remain controversial. To date, the indications that preclude laparoscopic splenectomy are not clearly defined. In view of this, the European Association for Endoscopic Surgery (EAES) has developed clinical practice guidelines for LS. METHODS: An international expert panel was invited to appraise the current literature and to develop evidence-based recommendations. A consensus development conference using a nominal group process convened in May 2007. Its recommendations were presented at the annual EAES congress in Athens, Greece, on 5 July 2007 for discussion and further input. After a further Delphi process between the experts, the final recommendations were agreed upon. RESULTS: Laparoscopic splenectomy is indicated for most benign and malignant hematologic diseases independently of the patient's age and body weight. Preoperative investigation is recommended for obtaining information on spleen size and volume as well as the presence of accessory splenic tissue. Preoperative vaccination against meningococcal, pneumococcal, and Haemophilus influenzae type B infections is recommended in elective cases. Perioperative anticoagulant prophylaxis with subcutaneous heparin should be administered to all patients and prolonged anticoagulant prophylaxis to high-risk patients. The choice of approach (supine [anterior], semilateral or lateral) is left to the surgeon's preference and concomitant conditions. In cases of massive splenomegaly, the hand-assisted technique should be considered to avoid conversion to open surgery and to reduce complication rates. The expert panel still considered portal hypertension and major medical comorbidities as contraindications to LS. CONCLUSION: Despite a lack of level 1 evidence, LS is a safe and advantageous procedure in experienced hands that has displaced open surgery for almost all indications. To support the clinical evidence, further randomized controlled trials on different issues are mandatory.

Differential immunoresponses following experimental traumatic brain injury, bone fracture and "two-hit"-combined neurotrauma.

OBJECTIVE AND DESIGN: Cytokine-mediated immunoresponses are consequences of isolated traumatic brain injury (TBI) and muskuloskeletal trauma but little is known when both impacts occur simulanteously in combined neurotrauma (CNT), i. e. TBI + muskuloskeletal trauma (bone fracture). MATERIALS AND METHODS: A "two-hit"-experimental model of CNT (TBI + tibia fracture) was used to investigate circulating cytokine interleukin-1-beta, -6, -10 and sTNF-R1 concentrations following peripheral bone fracture only, TBI only and CNT. Blood samples were drawn at 30 min, 6 h, 24 h, 48 h, and 7 days following trauma and circulating cytokine concentrations were determined via immunoassay. RESULTS: Circulating cytokines were increased after trauma (p <0.001 vs. controls), but peaked at different time points. sTNF R1 peaked first at 30 min, followed by IL-6 at 6 h after trauma. IL-10 levels were highest at 24 h, and those for IL-1beta at 48 h after trauma. Circulating IL-6 and IL-10 levels were highest in CNT at 8/10 time points studied (p <0.001). CONCLUSION: Circulating cytokine IL-1-beta, -6, -10 and sTNF-R1 concentrations are increased after trauma (TBI, fracture and CNT) but peak at different time points. Pronounced IL-6 and IL-10 responses after CNT may contribute to the increased susceptibility for complications in CNT versus monotrauma.

Impact of laparoscopic adjustable gastric banding on obesity co-morbidities in the medium- and long-term.

BACKGROUND: The authors evaluated the impact of laparoscopic adjustable gastric banding (LAGB) on obesity-associated diseases in a series at 3 to 8 years postoperatively, namely diabetes, pulmonary disease, hypertension and knee joint pain. METHODS: 145 morbidly obese patients underwent LAGB with mean age 38 years and preoperative BMI 48.5 kg/m2 (range 34-77). Changes in BMI and excess BMI loss (EBL) were evaluated. RESULTS: 138 of the 145 patients (95%) were available for full follow-up. At last follow-up, BMI had dropped to 34.0 +/- 6.4 SD kg/m2, and mean EBL was 61.9 +/- 26.1%. Prevalence of obesity-associated disease was significantly reduced: diabetes decreased from 10% to 4%, treatment-requiring pulmonary disease from 15% to 5%, hypertension from 43% to 27%, and knee pain from 47% to 38%. CONCLUSION: Following gastric banding, >75% of patients suffering from obesity-related disease had significant decrease or resolution of their co-morbidities.