This is an RSS newsfeed from BioMed Central It is intended to be used with an RSS reader. For more information about RSS newsfeeds from BioMed Central, visit http://www.biomedcentral.com/info/about/rss/ http://www.biomedcentral.com/bmcsurg/ The latest articles from BMC Surgery (ISSN 1471-2482) published by BioMed Central Background: With the availability of infliximab, nowadays recurrent Crohn's disease, defined as disease refractory to immunomodulatory agents that has been treated with steroids, is generally treated with infliximab. Infliximab is an effective but expensive treatment and once started it is unclear when therapy can be discontinued. Surgical resection has been the golden standard in recurrent Crohn's disease. Laparoscopic ileocolic resection proved to be safe and is characterized by a quick symptom reduction. The objective of this study is to compare infliximab treatment with laparoscopic ileocolic resection in patients with recurrent Crohn's disease of the distal ileum with respect to quality of life and costs. Methods/design: The study is designed as a multicenter randomized clinical trial including patients with Crohn's disease located in the terminal ileum that require infliximab treatment following recent consensus statements on inflammatory bowel disease treatment: moderate to severe disease activity in patients that fail to respond to steroid therapy or immunomodulatory therapy. Patients will be randomized to receive either infliximab or undergo a laparoscopic ileocolic resection. Primary outcomes are quality of life and costs. Secondary outcomes are hospital stay, early and late morbidity, sick leave and surgical recurrence. In order to detect an effect size of 0.5 on the Inflammatory Bowel Disease Questionnaire at a 5% two sided significance level with a power of 80%, a sample size of 65 patients per treatment group can be calculated. An economic evaluation will be performed by assessing the marginal direct medical, non-medical and time costs and the costs per Quality Adjusted Life Year (QALY) will be calculated. For both treatment strategies a cost-utility ratio will be calculated. Patients will be included from December 2007.DiscussionThe LIR!C-trial is a randomized multicenter trial that will provide evidence whether infliximab treatment or surgery is the best treatment for recurrent distal ileitis in Crohn's disease. Trial registration: Nederlands Trial Register NTR1150 http://www.biomedcentral.com/1471-2482/8/15 Emma J Eshuis, Willem A Bemelman, Ad A van Bodegraven, Mirjam AG Sprangers, Patrick MM Bossuyt, Aw MARC van Milligen de Wit, Rogier MPH Crolla, Djuna L Cahen, Liekele E Oostenbrug, Meindert N Sosef, Annet MCJ Voorburg, Paul HP Davids, C JANNEKE van der Woude, Johan Lange, Rosalie C Mallant, Maarten J Boom, Rob J Lieverse, Edwin S van der Zaag, Martin HMG Houben, Juda Vecht, Robert EGJM Pierik, Theo JM Van Ditzhuijsen, Hubert A Prins, Willem A Marsman, Henricus B Stockmann, Menno A Brink, Esther CJ Consten, Sjoerd DJ van der Werf, Andreas WKS Marinelli and Jeroen M Jansen BMC Surgery 2008, 8:15 2008-08-22 doi:10.1186/1471-2482-8-15 BMC Surgery 1471-2482 8 15 2008-08-22 Background: Waiting time and costs from referral to day case outpatient surgery are at an unacceptably high level. The waiting time in Norway averages 240 days for common surgical conditions. Furthermore, in North Norway the population is scattered throughout a large geographic area, making the cost of travel to a specialist examination before surgery considerable. Electronic standardised referrals and booking of day case outpatient surgery by GPs are possible through the National Health Network, which links all health care providers in an electronic network. New ways of using this network might reduce the waiting time and cost of outpatient day case surgery.Materials and MethodsIn a randomised controlled trial, selected patients (inguinal hernia, gallstone disease and pilonidal sinus) referred to the university hospital are either randomised to direct electronic referral and booking for outpatient surgery (one stop), or to the traditional patient pathway where all patients are seen at the outpatient clinic several weeks ahead of surgery.Consultants in gastrointestinal surgery designed standardised referral forms and guidelines. New software has been designed making it possible to implement referral forms, guidelines and patient information in the GP's electronic health record. For "one-stop" referral, GPs must provide mandatory information about the specific condition. Referrals were linked to a booking system, enabling the GPs to book the hospital, day and time for outpatient surgery. The primary endpoints are waiting time and costs. The sample size calculation was based on waiting time. A reduction in waiting time of 60 days (effect size), 25%, is significant, resulting in a sample size of 120 patients in total.DiscussionPoor communication between primary and secondary care often results in inefficiencies and unsatisfactory outcomes. We hypothesised that standardised referrals would improve the quality of information, making it feasible to use a one-stop approach for all patients undergoing surgery on an outpatient basis for inguinal hernia, pilonidal sinus and gallstones.In this study we wanted to investigate the waiting time and cost-effectiveness of direct electronic referral and booking of outpatient surgery compared to the traditional patient pathway, where the patient is seen at the outpatient clinic prior to surgery.Trial registrationThis trial has been registered at ClinicalTrials.gov. The trial registration number is: NCT00692497 http://www.biomedcentral.com/1471-2482/8/14 Knut Magne Augestad, Arthur Revhaug, Barthold Vonen, Roar Johnsen and Rolv-Ole Lindsetmo BMC Surgery 2008, 8:14 2008-08-11 doi:10.1186/1471-2482-8-14 BMC Surgery 1471-2482 8 14 2008-08-11 Background: Levator plate sagging (LPS), usually called descending perineum syndrome, is one of the main defects encountered in perineology. This defect is classically associated with colo-proctologic functional troubles (dyschesia and anal incontinence) but can also induce perineodynia, gynaecological and lower urinary tract symptoms. Methods: A retrospective case series of nine female patients (mean age: 44.3) underwent an isolated retro-anal levator plate myorrhaphy (RLPM) to treat symptomatic LPS confirmed by rectal examination and/or Perineocaliper(R). An anti-sagging test (support of the posterior perineum) must significantly improve the symptoms that were resistant to conservative treatment. The effect of the procedure on the symptoms of the 3 axes of the perineum (urological, colo-proctologic and gynecological) and on perineodynia was evaluated during a follow-up consultation more than 9 months after surgery. The effect of RLPM on the position of the anal margin and on the levator plate angle was studied using rectal examination, Perineocaliper (R) and retro-anal ultrasound. Results: Before surgery, anti-sagging tests were positive for dyschesia, urinary urgency and pain. After a mean follow-up of 16.1 months, RLPM resolved or improved 2/2 cases of stress urinary incontinence, 3/5 of urinary urgency, 3/4 of dysuria, 3/3 of anal incontinence, 7/8 of dyschesia, 3/4 of cystocele, 4/5 of rectocele, 5/8 of dyspareunia and 6/7 of perineodynia. Rectal examination showed a complete suppression of sagging in 4 patients and an improvement in the 5 others. The mean reduction of perineal descent was 1.08 cm (extremes: 0-1.5). Using retro-anal ultrasound of the levator plate, the mean reduction of sagging was 12.67 degrees (extremes: 1 - 21). Conclusions: Anti-sagging tests can be used before surgery to simulate the effect of RLPM. This surgical procedure seems to improve stress urinary incontinence, frequency, nocturia, urgency, dysuria, anal incontinence, dyschesia, dyspareunia, perineodynia, cystocele and rectocele. These results must be confirmed by a larger case series. http://www.biomedcentral.com/1471-2482/8/13 Jacques L Beco BMC Surgery 2008, 8:13 2008-07-30 doi:10.1186/1471-2482-8-13 BMC Surgery 1471-2482 8 13 2008-07-30 Background: Several randomized controlled trials have compared different suture materials and techniques for abdominal wall closure with respect to the incidence of incisional hernias after midline laparotomy and shown that it remains, irrespective of the methods used, considerably high, ranging from 9% to 20%. The development of improved suture materials which would reduce postoperative complications may help to lower its frequency.DesignThis is a historically controlled, single-arm, multi-centre, prospective trial to evaluate the safety of MonoMax® suture material for abdominal wall closure in 150 patients with primary elective midline incisions. INSECT patients who underwent abdominal closure using Monoplus® and PDS® will serve as historical control group. The incidences of wound infections and of burst abdomen are defined as composite primary endpoints. Secondary endpoints are the frequency of incisional hernias within one year after operation and safety. To ensure adequate comparability in surgical performance and recruitment, the 4 largest centres of the INSECT-Trial will participate. After hospital discharge, the investigators will examine the enrolled patients again at 30 days and at 12 ± 1 months after surgery. Conclusion: This historically controlled, single-arm, multi-centre, prospective ISSAAC trial aims to assess whether the use of an ultra-long-lasting absorbable monofilament suture material is safe and efficient.Trial registrationNCT005725079 http://www.biomedcentral.com/1471-2482/8/12 Lars Fischer, Petra Baumann, Johannes Hüsing, Christoph Seidlmayer, Markus Albertsmeier, Annette Franck, Steffen Luntz, Christoph M Seiler and Hanns-Peter Knaebel BMC Surgery 2008, 8:12 2008-07-21 doi:10.1186/1471-2482-8-12 BMC Surgery 1471-2482 8 12 2008-07-21 Background: Low transsphincteric fistulas less than 1/3 of the sphincter complex are easy to treat by fistulotomy with a high success rate. High transsphincteric fistulas remain a surgical challenge. Various surgical procedures are available, but recurrence rates of these techniques are disappointingly high. The mucosal flap advancement is considered the gold standard for the treatment of high perianal fistula of cryptoglandular origin by most colorectal surgeons. In the literature a recurrence rate between 0 and 63% is reported for the mucosal flap advancement. Recently Armstrong and colleagues reported on a new biologic anal fistula plug, a bioabsorbable xenograft made of lyophilized porcine intestinal submucosa. Their prospective series of 15 patients with high perianal fistula treated with the anal fistula plug showed promising results.The anal fistula plug trial is designed to compare the anal fistula plug with the mucosal flap advancement in the treatment of high perianal fistula in terms of success rate, continence, postoperative pain, and quality of life.Methods/designThe PLUG trial is a randomized controlled multicenter trial. Sixty patients with high perianal fistulas of cryptoglandular origin will be randomized to either the fistula plug or the mucosal advancement flap. Study parameters will be anorectal fistula closure-rate, continence, post-operative pain, and quality of life. Patients will be followed-up at two weeks, four weeks, and 16 weeks. At the final follow-up closure rate is determined by clinical examination by a surgeon blinded for the intervention.DiscussionBefore broadly implementing the anal fistula plug results of randomized trials using the plug should be awaited. This randomized controlled trial comparing the anal fistula plug and the mucosal advancement flap should provide evidence regarding the effectiveness of the anal fistula plug in the treatment of high perianal fistulas.Trial registrationISRCTN: 97376902 http://www.biomedcentral.com/1471-2482/8/11 Paul J van Koperen, Willem A Bemelman, Patrick MM Bossuyt, Michael F Gerhards, Quirijn AJ Eijsbouts, Willem F van Tets, Lucas WM Janssen, F Robert Dijkstra, Annette D van Dalsen and J Frederik M Slors BMC Surgery 2008, 8:11 2008-06-23 doi:10.1186/1471-2482-8-11 BMC Surgery 1471-2482 8 11 2008-06-23 Background: Postoperative deaths and neurological injury have resulted from hyponatraemia associated with the use of hypotonic saline solutions following surgery. We aimed to determine the rates and types of intravenous fluids being prescribed postoperatively for children in the UK. Methods: A questionnaire was sent to members of the British Association of Paediatric Surgeons (BAPS) and Association of Paediatric Anaesthetists of Great Britain and Ireland (APAGBI) based at UK paediatric centres. Respondents were asked to prescribe postoperative fluids for scenarios involving children of different ages. The study period was between May 2006 and November 2006. Results: The most frequently used solution was sodium chloride 0.45% with glucose 5% although one quarter of respondents still used sodium chloride 0.18% with glucose 4%. Isotonic fluids were used by 41% of anaesthetists and 9.8% of surgeons for the older child, but fewer for infants. Standard maintenance rates or greater were prescribed by over 80% of respondents. Conclusion: Most doctors said they would prescribe hypotonic fluids at volumes equal to or greater than traditional maintenance rates at the time of the survey. A survey to describe practice since publication of National Patient Safety Agency (NPSA) recommendations is required. http://www.biomedcentral.com/1471-2482/8/10 Polly Davies, Tim Hall, Tariq Ali and Kokila Lakhoo BMC Surgery 2008, 8:10 2008-06-09 doi:10.1186/1471-2482-8-10 BMC Surgery 1471-2482 8 10 2008-06-09 Background: With the increasing number of non palpable breast carcinomas, the need of a good and reliable localization method increases. Currently the wire guided localization (WGL) is the standard of care in most countries. Radio guided occult lesion localization (ROLL) is a new technique that may improve the oncological outcome, cost effectiveness, patient comfort and cosmetic outcome. However, the studies published hitherto are of poor quality providing less than convincing evidence to change the current standard of care.The aim of this study is to compare the ROLL technique with the standard of care (WGL) regarding the percentage of tumour free margins, cost effectiveness, patient comfort and cosmetic outcome.Methods/designThe ROLL trial is a multi center randomized clinical trial. Over a period of 2–3 years 316 patients will be randomized between the ROLL and the WGL technique. With this number, the expected 15% difference in tumour free margins can be detected with a power of 80%. Other endpoints include cosmetic outcome, cost effectiveness, patient (dis)comfort, degree of difficulty of the procedures and the success rate of the sentinel node procedure.The rationale, study design and planned analyses are described.Trial Registration(http://www.clinicaltrials.gov, study protocol number NCT00539474) http://www.biomedcentral.com/1471-2482/8/9 Stijn van Esser, Monique GG Hobbelink, Petra HM Peeters, Erik Buskens, Iris M van der Ploeg, Willem PTHM Mali, Inne H M Borel Rinkes and Richard van Hillegersberg BMC Surgery 2008, 8:9 2008-05-21 doi:10.1186/1471-2482-8-9 BMC Surgery 1471-2482 8 9 2008-05-21 Background: Standard methods for assessment of organ viability during surgery are typically limited to visual cues and tactile feedback in open surgery. However, during laparoscopic surgery, these processes are impaired. This is of particular relevance during laparoscopic renal donation, where the condition of the kidney must be optimized despite considerable manipulation. However, there is no in vivo methodology to monitor renal parenchymal oxygenation during laparoscopic surgery. Methods: We have developed a method for the real time, in vivo, whole organ assessment of tissue oxygenation during laparoscopic nephrectomy to convey meaningful biological data to the surgeon during laparoscopic surgery. We apply the 3-CCD (charge coupled device) camera to monitor qualitatively renal parenchymal oxygenation with potential real-time video capability. Results: We have validated this methodology in a porcine model across a range of hypoxic conditions, and have then applied the method during clinical laparoscopic donor nephrectomies during clinically relevant pneumoperitoneum. 3-CCD image enhancement produces mean region of interest (ROI) intensity values that can be directly correlated with blood oxygen saturation measurements (R2 > 0.96). The calculated mean ROI intensity values obtained at the beginning of the laparoscopic nephrectomy do not differ significantly from mean ROI intensity values calculated immediately before kidney removal (p > 0.05). Conclusion: Here, using the 3-CCD camera, we qualitatively monitor tissue oxygenation. This means of assessing intraoperative tissue oxygenation may be a useful method to avoid unintended ischemic injury during laparoscopic surgery. Preliminary results indicate that no significant changes in renal oxygenation occur as a result of pneumoperitoneum. http://www.biomedcentral.com/1471-2482/8/8 Nicole J Crane, Peter A Pinto, Douglas Hale, Frederick A Gage, Doug Tadaki, Allan D Kirk, Ira W Levin and Eric A Elster BMC Surgery 2008, 8:8 2008-04-17 doi:10.1186/1471-2482-8-8 BMC Surgery 1471-2482 8 8 2008-04-17 Background: Laparoscopic mesh-reinforcement of the hiatal region in the treatment of gastroesophageal reflux disease (GERD) and paraesophageal hernia (PEH) reduces the risk of recurrence. However, there are still controversies about the technique of mesh placement, shape, structure and material. We therefore compared tissue integration and scar formation after implantation of two different polypropylene-meshes in a rabbit model. Methods: A total of 20 female chinchilla rabbits were included in this study. Two different meshes (Polypropylene PP, Polyglecaprone 25 Composite PP-PG) were implanted on the abdominal diaphragm around the oesophagus. After 3 months the implanted meshes were excised en-bloc. Histological and morphological analyses were carried out accordingly proliferation rate, apoptosis and collagen type I/III ratio. Results: Regarding proliferation rate of oesophagus PP (9.31 ± 3.4%) and PP-PG (13.26 ± 2.54%) differ in a significant (p = 0.0097) way. In the diaphragm we found a significant (p = 0.00066) difference between PP (9.43 ± 1.45%) and PP-PG (18.73 ± 5.92%) respectively. Comparing oesophagus and diaphragm we could prove a significant difference within PP-PG-group (p = 0.0195). Within PP-group the difference reached no statistical significance (p = 0.88). We found analogous results regarding apoptosis.Furthermore, there is a significant (p = 0.00013) difference of collagen type I/III ratio in PP-PG (12.28 ± 0.8) compared to PP (8.44 ± 1,63) in case of oesophageal tissue. Concerning diaphragm we found a significant difference (p = 0.000099) between PP-PG (8.85 ± 0.81) and PP (6.32 ± 1.07) as well. Conclusion: The histologic and morphologic characteristics after prosthetic enforcement of the hiatus in this animal model show a more distinct tissue integration using PP-PG compared to PP. Additionally, different wound healing and remodelling capability influence tissue integration of the mesh in diaphragm and oesophagus. http://www.biomedcentral.com/1471-2482/8/7 Jens Otto, Daniel Kämmer, Petra Lynen Jansen, Michael Anurov, Svetlana Titkova, Alexander Öttinger, Raphael Rosch, Volker Schumpelick and Marc Jansen BMC Surgery 2008, 8:7 2008-04-12 doi:10.1186/1471-2482-8-7 BMC Surgery 1471-2482 8 7 2008-04-12 Background: Surgical hepatic resection remains the treatment of choice for patients with liver metastases from colorectal cancer despite the use of alternative therapeutic strategies. Although this procedure provides long-term survival in a significant number of patients, 50–75% of the patients develop intra- and/or extrahepatic recurrence. One possible reason for tumor recurrence may be intraoperative hematogenous tumor cell dissemination due to mechanical manipulation of the tumor during hepatic resection. Surgical technique may have an influence on hematogenous tumor cell spread. We hypothesize that hematogenous tumor cell dissemination may be reduced by using the anterior approach technique compared to conventional liver resection.Methods/DesignThis is a multi-centre prospective randomized controlled, superiority trial to compare two liver resection techniques of liver metastases from colorectal cancer. 150 patients will be included and randomized intraoperatively after surgical exploration just prior to resection. The primary objective is to compare the anterior approach with the conventional liver resection technique with regard to intraoperative haematogenous tumor cell dissemination. As secondary objectives we examine five year survival rates (OS and DFS), blood loss, duration of operation, requirement of blood transfusions, morbidity rate, prognostic relevance of tumor cell detection in blood and bone marrow and the comparison of tumor cell detection by different detection methods. Conclusion: This trial will answer the question whether there is an advantage for the anterior approach technique compared to the conventional resection group with regard to tumor cell dissemination. It will also add further information about prognostic differences, safety, advantages and disadvantages of each technique.Trial registrationCurrent controlled trials – ISRCTN45066244 http://www.biomedcentral.com/1471-2482/8/6 T Schmidt, M Koch, D Antolovic, C Reissfelder, FH Schmitz-Winnenthal, NN Rahbari, J Schmidt, CM Seiler, MW Büchler and J Weitz BMC Surgery 2008, 8:6 2008-03-05 doi:10.1186/1471-2482-8-6 BMC Surgery 1471-2482 8 6 2008-03-05