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Could lymphatic mapping and sentinel node biopsy provide oncological providence for local resectional techniques for colon cancer? A review of the literature.
Ronan A Cahill, Joel Leroy and Jacques Marescaux Wed, 24 Sep 2008 00:00:00 -0000
Background: Endoscopic resectional techniques for colon cancer are undermined by their inability to determine lymph node status. This limits their application to only those lesions at the most minimal risk of lymphatic dissemination whereas their technical capacity could allow intraluminal or even transluminal address of larger lesions. Sentinel node biopsy may theoretically address this breach although the variability of its reported results for this disease is worrisome. Methods: Medline, EMBASE and Cochrane databases were interrogated back to 1999 to identify all publications concerning lymphatic mapping for colon cancer with reference cross-checking for completeness. All reports were examined from the perspective of in vivo technique accuracy selectively in early stage disease (i.e. lesions potentially within the technical capacity of endoscopic resection). Results: Fifty-two studies detailing the experiences of 3390 patients were identified. Considerable variation in patient characteristics as well as in surgical and histological quality assurances were however evident among the studies identified. In addition, considerable contamination of the studies by inclusion of rectal cancer without subgroup separation was frequent. Indeed such is the heterogeneity of the publications to date, formal meta-analysis to pool patient cohorts in order to definitively ascertain technique accuracy in those with T1 and/or T2 cancer is not possible. Although lymphatic mapping in early stage neoplasia alone has rarely been specifically studied, those studies that included examination of false negative rates identified high T3/4 patient proportions and larger tumor size as being important confounders. Under selected circumstances however the technique seems to perform sufficiently reliably to allow it prompt consideration of its use to tailor operative extent. Conclusion: The specific question of whether sentinel node biopsy can augment the oncological propriety for endoscopic resective techniques (including Natural Orifice Transluminal Endoscopic Surgery [NOTES]) cannot be definitively answered at present. Study heterogeneity may account for the variability evident in the results from different centers. Enhanced capacity (perhaps to the level necessary to consider selective avoidance of en bloc mesenteric resection) by its confinement to only early stage disease is plausible although not proven. Specific study of the technique in early stage tumors is clearly essential before proffering this approach.
Robotic Assisted Laparoscopic Partial Nephrectomy for Suspected Renal Cell Carcinoma: Retrospective Review of Surgical Outcomes of 35 Cases
Sam B Bhayani and Nitin Das Wed, 24 Sep 2008 00:00:00 -0000
Background: A standard of care for the treatment of small renal masses is partial nephrectomy. The open and laparoscopic approaches have been well described in the literature. Robotic assistance may augment partial nephrectomy by aiding in dissection and renal reconstruction. In this communication we describe the surgical outcomes of 35 patients undergoing robotic partial nephrectomy. Methods: Patient records and databases were reviewed for 35 consecutive patients undergoing RPN. Clinical, pathological, and radiographic data were obtained. The data was deidentified. Results: Thirty five patients successfully underwent RPN. An additional 2 patients were converted to other nephron sparing procedures. Mean tumor size was 2.8 cm, and mean OR time was 142 minutes. Mean warm ischemia time was 20 minutes. All margins were negative. There were 4 complications, and no patients required reoperation. Conclusions: Robotic partial nephrectomy can produce excellent initial results. Further studies should be performed to compare the outcomes to laparoscopic and open operations.
Laparoscopic ileocolic resection versus infliximab treatment of distal ileitis in Crohn's disease: a randomized multicenter trial (LIR!C-trial)
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 Fri, 22 Aug 2008 00:00:00 -0000
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/designThe 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 registrationNederlands Trial Register NTR1150
The One-stop trial: Does electronic referral and booking by the general practitioner (GPs) to outpatient day case surgery reduce waiting time and costs? A randomized controlled trial protocol
Knut Magne Augestad, Arthur Revhaug, Barthold Vonen, Roar Johnsen and Rolv-Ole Lindsetmo Mon, 11 Aug 2008 00:00:00 -0000
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
Interest of retro-anal levator plate myorrhaphy in selected cases of descending perineum syndrome with positive anti-sagging test
Jacques Beco Wed, 30 Jul 2008 00:00:00 -0000
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®. 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® 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). Conclusion: 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.
A historically controlled, single-arm, multi-centre, prospective trial to evaluate the safety and efficacy of MonoMax® suture material for abdominal wall closure after primary midline laparotomy. ISSAAC-Trial [NCT005725079]
Lars Fischer, Petra Baumann, Johannes Hüsing, Christoph Seidlmayer, Markus Albertsmeier, Annette Franck, Steffen Luntz, Christoph M Seiler and Hanns-Peter Knaebel Mon, 21 Jul 2008 00:00:00 -0000
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
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Could lymphatic mapping and sentinel node biopsy provide oncological providence for local resectional techniques for colon cancer? A review of the literature.
Ronan A Cahill, Joel Leroy and Jacques Marescaux Wed, 24 Sep 2008 00:00:00 -0000
Background: Endoscopic resectional techniques for colon cancer are undermined by their inability to determine lymph node status. This limits their application to only those lesions at the most minimal risk of lymphatic dissemination whereas their technical capacity could allow intraluminal or even transluminal address of larger lesions. Sentinel node biopsy may theoretically address this breach although the variability of its reported results for this disease is worrisome. Methods: Medline, EMBASE and Cochrane databases were interrogated back to 1999 to identify all publications concerning lymphatic mapping for colon cancer with reference cross-checking for completeness. All reports were examined from the perspective of in vivo technique accuracy selectively in early stage disease (i.e. lesions potentially within the technical capacity of endoscopic resection). Results: Fifty-two studies detailing the experiences of 3390 patients were identified. Considerable variation in patient characteristics as well as in surgical and histological quality assurances were however evident among the studies identified. In addition, considerable contamination of the studies by inclusion of rectal cancer without subgroup separation was frequent. Indeed such is the heterogeneity of the publications to date, formal meta-analysis to pool patient cohorts in order to definitively ascertain technique accuracy in those with T1 and/or T2 cancer is not possible. Although lymphatic mapping in early stage neoplasia alone has rarely been specifically studied, those studies that included examination of false negative rates identified high T3/4 patient proportions and larger tumor size as being important confounders. Under selected circumstances however the technique seems to perform sufficiently reliably to allow it prompt consideration of its use to tailor operative extent. Conclusion: The specific question of whether sentinel node biopsy can augment the oncological propriety for endoscopic resective techniques (including Natural Orifice Transluminal Endoscopic Surgery [NOTES]) cannot be definitively answered at present. Study heterogeneity may account for the variability evident in the results from different centers. Enhanced capacity (perhaps to the level necessary to consider selective avoidance of en bloc mesenteric resection) by its confinement to only early stage disease is plausible although not proven. Specific study of the technique in early stage tumors is clearly essential before proffering this approach.
Robotic Assisted Laparoscopic Partial Nephrectomy for Suspected Renal Cell Carcinoma: Retrospective Review of Surgical Outcomes of 35 Cases
Sam B Bhayani and Nitin Das Wed, 24 Sep 2008 00:00:00 -0000
Background: A standard of care for the treatment of small renal masses is partial nephrectomy. The open and laparoscopic approaches have been well described in the literature. Robotic assistance may augment partial nephrectomy by aiding in dissection and renal reconstruction. In this communication we describe the surgical outcomes of 35 patients undergoing robotic partial nephrectomy. Methods: Patient records and databases were reviewed for 35 consecutive patients undergoing RPN. Clinical, pathological, and radiographic data were obtained. The data was deidentified. Results: Thirty five patients successfully underwent RPN. An additional 2 patients were converted to other nephron sparing procedures. Mean tumor size was 2.8 cm, and mean OR time was 142 minutes. Mean warm ischemia time was 20 minutes. All margins were negative. There were 4 complications, and no patients required reoperation. Conclusions: Robotic partial nephrectomy can produce excellent initial results. Further studies should be performed to compare the outcomes to laparoscopic and open operations.
Laparoscopic ileocolic resection versus infliximab treatment of distal ileitis in Crohn's disease: a randomized multicenter trial (LIR!C-trial)
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 Fri, 22 Aug 2008 00:00:00 -0000
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/designThe 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 registrationNederlands Trial Register NTR1150
The One-stop trial: Does electronic referral and booking by the general practitioner (GPs) to outpatient day case surgery reduce waiting time and costs? A randomized controlled trial protocol
Knut Magne Augestad, Arthur Revhaug, Barthold Vonen, Roar Johnsen and Rolv-Ole Lindsetmo Mon, 11 Aug 2008 00:00:00 -0000
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
Interest of retro-anal levator plate myorrhaphy in selected cases of descending perineum syndrome with positive anti-sagging test
Jacques Beco Wed, 30 Jul 2008 00:00:00 -0000
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®. 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® 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). Conclusion: 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.
A historically controlled, single-arm, multi-centre, prospective trial to evaluate the safety and efficacy of MonoMax® suture material for abdominal wall closure after primary midline laparotomy. ISSAAC-Trial [NCT005725079]
Lars Fischer, Petra Baumann, Johannes Hüsing, Christoph Seidlmayer, Markus Albertsmeier, Annette Franck, Steffen Luntz, Christoph M Seiler and Hanns-Peter Knaebel Mon, 21 Jul 2008 00:00:00 -0000
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
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