Prophylactic mesh placement to prevent parastomal hernia, early results of a prospective multicentre randomized trial.

PURPOSE: Parastomal hernia (PSH) is a common complication after colostomy formation. Recent studies indicate that mesh implantation during formation of a colostomy might prevent a PSH. To determine if placement of a retromuscular mesh at the colostomy site is a feasible, safe and effective procedure in preventing a parastomal hernia, we performed a multicentre randomized controlled trial in 11 large teaching hospitals and three university centres in The Netherlands. METHODS: Augmentation of the abdominal wall with a retromuscular light-weight polypropylene mesh (Parietene Light™, Covidien) around the trephine was compared with traditional colostomy formation. Patients undergoing elective open formation of a permanent end-colostomy were eligible. 150 patients were randomized between 2010 and 2012. Primary endpoint of the PREVENT trial is the incidence of parastomal hernia. Secondary endpoints are morbidity, pain, quality of life, mortality and cost-effectiveness. This article focussed on the early results of the PREVENT trial and, therefore, operation time, postoperative morbidity, pain, and quality of life were measured. RESULTS: Outcomes represent results after 3 months of follow-up. A total of 150 patients were randomized. Mean operation time of the mesh group (N = 72) was significantly longer than in the control group (N = 78) (182.6 vs. 156.8 min; P = 0.018). Four (2.7 %) peristomal infections occurred of which one (1.4 %) in the mesh group. No infection of the mesh occurred. Most of the other infections were infections of the perineal wound, equally distributed over both groups. No statistical differences were discovered in stoma or mesh-related complications, fistula or stricture formation, pain, or quality of life. CONCLUSIONS: During open and elective formation of an end-colostomy, primary placement of a retromuscular light-weight polypropylene mesh for prevention of a parastomal hernia is a safe and feasible procedure. The PREVENT trial is registered at: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2018 .

Update with level 1 studies of the European Hernia Society guidelines on the treatment of inguinal hernia in adult patients.

PURPOSE: In 2009, the European Hernia Society published the EHS Guidelines for the Treatment of Inguinal Hernia in Adult Patients. The Guidelines contain recommendations for the treatment of inguinal hernia from diagnosis till aftercare. The guidelines expired January 1, 2012. To keep them updated, a revision of the guidelines was planned including new level 1 evidence. METHODS: The original Oxford Centre for Evidence-Based Medicine ranking was used. All relevant level 1A and level 1B literature from May 2008 to June 2010 was searched (Medline and Cochrane) by the Working Group members. All chapters were attributed to the two responsible authors in the initial guidelines document. One new chapter on fixation techniques was added. The quality was assessed by the Working Group members during a 2-day meeting and the data were analysed, especially with respect to any change in the level and/or text of any of the conclusions or recommendations of the initial guidelines. In the end, all relevant references published until January 1, 2013 were included. The final text was approved by all Working Group members. RESULTS: For the following topics, the conclusions and/or recommendations have been changed: indications for treatment, treatment of inguinal hernia, day surgery, antibiotic prophylaxis, training, postoperative pain control and chronic pain. The addendum contains all current level 1 conclusions, Grade A recommendations and new Grade B recommendations based on new level 1 evidence (with the changes in bold). CONCLUSIONS: Despite the fact that the Working Group responsible for it tried to represent most kinds of surgeons treating inguinal hernias, such general guidelines inevitably must be fitted to the daily practice of every individual surgeon treating his/her patients. There is no doubt that the future of guideline implementation will strongly depend on the development of easy to use decision support algorithms tailored to the individual patient and on evaluating the effect of guideline implementation on surgical outcome. At the 35th International Congress of the EHS in Gdansk, Poland (May 12-15, 2013), it was decided that the EHS, IEHS and EAES will collaborate from now on with the final goal to publish new joint guidelines, most likely in 2015.

Systematic review and meta-analysis on heavy and lightweight polypropylene mesh in Lichtenstein inguinal hernioplasty.

BACKGROUND: Recurrence and pain are the two most important outcomes after inguinal hernia surgery. The concept of lightweight or partially absorbable macroporous meshes was developed under the assumption that the observed pain rate could be decreased without increasing the number of recurrences. Few randomized trials were published to analyze their clinical value, and some concern was raised because of an increased risk of recurrence. A systematic review and a meta-analysis of RCTs were carried out to determine whether the use of lightweight meshes influenced the pain and recurrence rate after Lichtenstein hernioplasty. METHODS: To assess the value of the lightweight mesh, an extensive literature search was performed. The random-effect meta-analysis model was used to correct for clinical diversity and methodological variations between studies. Recurrence rate, aspects of chronic pain and foreign body feeling at 6-60 months postoperatively were assessed. RESULTS: Eight prospective RCTs of good quality were identified. Analysis demonstrated no significant difference regarding recurrence (OR, 1.11; 95 % CI, 0.57-2.14; p = 0.77). No significant difference was observed concerning severe pain (OR, 0.99; 95 % CI, 0.48-2.02; p = 0.97). Description of any pain resulted in a significant improvement in the lightweight group (OR, 0.65; 95 % CI, 0.50-0.84; p = 0.001). The presence of foreign body feeling was favoring the lightweight group (OR, 0.62; 95 % CI, 0.41-0.94; p = 0.02). CONCLUSIONS: The use of lightweight mesh did not neither increase the recurrence rate nor reduce the incidence of severe pain. A significant reduction in foreign body feeling and overall pain rate in the postoperative period was recorded. Lightweight meshes could be considered as a material of choice in primary inguinal hernioplasty.

Systematic review of the effect of external beam radiation therapy to the breast on axillary recurrence after negative sentinel lymph node biopsy.

BACKGROUND: Axillary recurrence after negative sentinel lymph node biopsy (SLNB) in patients with invasive breast carcinoma remains a concern. Previous investigations to identify prognostic factors for axillary recurrence identified that a disproportionate number of patients with an axillary recurrence after negative SLNB were not treated with external beam radiation therapy (EBRT) of the breast as part of initial treatment. This finding prompted a systematic review to test the hypothesis that EBRT to the breast reduces the risk of axillary recurrence after negative SLNB. METHODS: A literature search was performed in PubMed, the Cochrane Library and the Spanish-language database LILACS to identify articles publishing data regarding follow-up of sentinel lymph node (SLN)-negative patients. Reports and articles lacking information on the initial treatment were excluded. RESULTS: Forty-five articles were accepted for review. A total of 23,357 SLN-negative patients were identified with median follow-up ranging from 15 to 102 months. Some 18,878 patients were treated with EBRT to the breast as part of their initial treatment. One hundred and twenty-seven patients with an axillary recurrence were identified, of whom 73 had EBRT as part of their initial treatment. Meta-analysis showed that EBRT was associated with a lower rate of axillary recurrence (P < 0·001), but this finding was subject to heterogeneity. CONCLUSION: This review and meta-analysis showed that EBRT is associated with a significantly lower axillary recurrence rate after negative SLNB.

Inguinal hernia surgery in The Netherlands: are patients treated according to the guidelines?

PURPOSE: In 2003, a dedicated Dutch committee developed evidence-based guidelines for the treatment of inguinal hernia (IH) in children and adults. The aim of this study was to describe trends in hernia care before and after the publication of the guidelines on IH surgery in The Netherlands. METHODS: Originally, a retrospective baseline analysis of IH surgery in 90 Dutch hospitals was performed among patients treated for IH in 2001. The results of this baseline analysis were compared with a recently performed second analysis of patients treated for IH in 2005. RESULTS: In children <4 years of age, the study showed a significant decrease of contralateral explorations. In adults, the study showed that significantly more patients were treated with a mesh-based repair in 2005 (95.9 vs. 78.8%, P < 0.01). Moreover, there was an increase of patients with bilateral hernia treated with an endoscopic technique (41.5 vs. 22.3%, P < 0.01) and more patients were treated in day surgery (53.5 vs. 38.6%, P < 0.01). Lastly, a decline in operations performed for recurrent IH in adults was observed (10.9 vs. 13.3%, P < 0.01). CONCLUSION: This study showed that most patients with IH in The Netherlands were treated according to the main recommendations of the Dutch evidence-based guidelines.

European Hernia Society guidelines on the treatment of inguinal hernia in adult patients.

The European Hernia Society (EHS) is proud to present the EHS Guidelines for the Treatment of Inguinal Hernia in Adult Patients. The Guidelines contain recommendations for the treatment of inguinal hernia from diagnosis till aftercare. They have been developed by a Working Group consisting of expert surgeons with representatives of 14 country members of the EHS. They are evidence-based and, when necessary, a consensus was reached among all members. The Guidelines have been reviewed by a Steering Committee. Before finalisation, feedback from different national hernia societies was obtained. The Appraisal of Guidelines for REsearch and Evaluation (AGREE) instrument was used by the Cochrane Association to validate the Guidelines. The Guidelines can be used to adjust local protocols, for training purposes and quality control. They will be revised in 2012 in order to keep them updated. In between revisions, it is the intention of the Working Group to provide every year, during the EHS annual congress, a short update of new high-level evidence (randomised controlled trials [RCTs] and meta-analyses). Developing guidelines leads to questions that remain to be answered by specific research. Therefore, we provide recommendations for further research that can be performed to raise the level of evidence concerning certain aspects of inguinal hernia treatment. In addition, a short summary, specifically for the general practitioner, is given. In order to increase the practical use of the Guidelines by consultants and residents, more details on the most important surgical techniques, local infiltration anaesthesia and a patient information sheet is provided. The most important challenge now will be the implementation of the Guidelines in daily surgical practice. This remains an important task for the EHS. The establishment of an EHS school for teaching inguinal hernia repair surgical techniques, including tips and tricks from experts to overcome the learning curve (especially in endoscopic repair), will be the next step. Working together on this project was a great learning experience, and it was worthwhile and fun. Cultural differences between members were easily overcome by educating each other, respecting different views and always coming back to the principles of evidence-based medicine. The members of the Working Group would like to thank the EHS board for their support and especially Ethicon for sponsoring the many meetings that were needed to finalise such an ambitious project.

Do guidelines influence results in inguinal hernia treatment? A descriptive study of 2,535 hernia repairs in one teaching hospital from 1994 to 2004.

BACKGROUND: The Onze Lieve Vrouwe Gasthuis (OLVG) hospital is a large district teaching hospital with a residency programme for general surgery. Since 1998, inguinal hernia (IH) repairs in this hospital were performed according to the preliminary "evidence-based guidelines" concerning IH repair. The aim of this study was to analyse whether the use of the guidelines improves the quality of IH repair measured by a reduction of the operated recurrences, especially from the patients who underwent the previous repair in this hospital. METHODS: A retrospective study was performed which included all male adults (>18 years of age) undergoing IH surgery in the OLVG hospital for a primary or recurrent inguinal hernia from 1994 until 2004. RESULTS: The use of mesh for primary hernia increased significantly from 0.6% in 1994 to 100% in 2004 (P < 0.001). The number of operations performed for recurrent IH fluctuated between 7% and almost 18%. However, the tendency towards a decrease in recurrence is clearly demonstrated by comparing the average recurrence rates of two time periods, namely, 1994-1998 (15.8%) and 2002-2004 (10.6%), proving a significant decrease (P < 0.002). The decreasing portion of recurrences previously operated in the study hospital from 64.3% (1994) to 14.3% (2004) was striking (P < 0.001). The prior operation performed before the recurrence was mesh-based in an average of 42/273 (15.4%) patients and increased each year. CONCLUSIONS: Between 1994 and 2004, a significant increase in the use of mesh-based techniques for the treatment of IH, influenced by the Dutch evidence-based guidelines, probably resulted in a significant decrease in the number of operations performed for recurrent IH.

A Rare Cause of Acute Upper Gastrointestinal Hemorrhage.

Acute upper gastrointestinal tract hemorrhage represents a frequent morbidity which can be localized and treated endoscopically. When endoscopic treatment alone is failing, radiological or surgical treatment may be warranted. A case history will be presented regarding a rare cause of intestinal hemorrhage with an extraordinary course of illness.

[Neuralgic pain, a significant complication after a Lichtenstein procedure for inguinal hernia repair]. / Neuralgische pijn, een niet te onderschatten complicatie van een liesbreukoperatie volgens de methode van Lichtenstein.

Two male patients, aged 37 and 56, suffered from neuralgic pain after a Lichtenstein procedure for inguinal hernia repair using prosthetic reinforcement. Since mesh-based repair techniques have decreased the recurrence rate, postoperative inguinal pain has become a major complication of these operations. Three months after surgery, 20% of the patients experience some pain. In 12% of the patients this pain limits daily activities and 1-3% of the patients are invalidated by neuralgic pain. Preventing damage to sensory nerves during the operation is one way of preventing neuralgic pain. Damaged sensory nerves should be excised. Neuralgic pain after the operation may be alleviated by tricyclic antidepressants, opioids or antiepileptic drugs. In selected patients with neuralgic pain neurectomy is indicated. In one of the patients presented the neuralgic pain disappeared after neurectomy of the ilioinguinal nerve. Triple neurectomy in the other patient, however, was unsuccessful.

Systematic review and meta-analysis of the effectiveness of antibiotic prophylaxis in prevention of wound infection after mesh repair of abdominal wall hernia.

BACKGROUND: The aim was to determine whether systemic antibiotic prophylaxis prevented wound infection after repair of abdominal wall hernia with mesh. METHODS: This was a systematic review of the available literature identified from multiple databases using the terms 'hernia' and 'antibiotic prophylaxis'. Randomized placebo-controlled trials of antibiotic prophylaxis in abdominal wall mesh hernia repair with explicitly defined wound infection criteria and a minimum follow-up of 1 month were included. After independent quality assessment and data extraction, data were pooled for meta-analysis using a random-effects model. RESULTS: The search process identified eight relevant trials. Two papers on umbilical, incisional or laparoscopic hernias, and six concerning inguinal and femoral (groin) hernias were suitable for meta-analysis. The incidence of infection after groin hernia repair was 38 (3.0 per cent) of 1277 in the placebo group and 18 (1.5 per cent) of 1230 in the antibiotic group. Antibiotic prophylaxis did not significantly reduce the incidence of infection: odds ratio 0.54 (95 per cent confidence interval 0.24 to 1.21); number needed to treat was 74. The number of deep infections was six (0.6 per cent) in the placebo group and three (0.3 per cent) in the antibiotic prophylaxis group: odds ratio 0.50 (95 per cent c.i. 0.12 to 2.09). CONCLUSION: Antibiotic prophylaxis did not prevent the occurrence of wound infection after groin hernia surgery. More trials are needed for complete evidence in other areas of abdominal wall hernia.

Hernia surgery changes in the Amsterdam region 1994-2001: decrease in operations for recurrent hernia.

Inguinal hernia (IH) surgery has changed substantially in the past decade. Conventional (nonmesh) techniques have largely given way to prostheses. This study's aim was to analyse whether changes in technique used for IH repair influenced the operation rate for recurrence. A retrospective study was performed on all adult males who had undergone IH surgery in the Amsterdam region during the calendar years of 1994, 1996, 1999, and 2001. Data were obtained for 3,649 subjects and included patient demographics, hernia type, and surgical technique. We observed a decrease in the use of conventional techniques and a significant increase (P<0.05) in the use of prosthetic materials. The number of operations performed for recurrent hernia decreased from 19.5% (216/1,108) in 1994, to 16.8% 197/1,170) in 1996, to 14.0% (152/1,088) in 1999, and to 14.1% (40/283) in 2001. When comparing 1999 and 2001 with 1994, there was a significant decrease in operations performed for recurrent hernia (P=0.005). There was also a significant increase in supervision of the surgical resident by a surgeon.