Prevention of incisional hernia with prophylactic onlay and sublay mesh reinforcement vs. primary suture only in midline laparotomies (PRIMA): long-term outcomes of a multicentre, double-blind, randomised controlled trial.

Background: Incisional hernia occurs approximately in 40% of high-risk patients after midline laparotomy. Prophylactic mesh placement has shown promising results, but long-term outcomes are needed. The present study aimed to assess the long-term incisional hernia rates of the previously conducted PRIMA trial with radiological follow-up. Methods: In the PRIMA trial, patients with increased risk of incisional hernia formation (AAA or BMI ≥27 kg/m2) were randomised in a 1:2:2 ratio to primary suture, onlay mesh or sublay mesh closure in three different countries in eleven institutions. Incisional hernia during follow-up was diagnosed by any of: CT, ultrasound and physical examination, or during surgery. Assessors and patients were blinded until 2-year follow-up. Time-to-event analysis according to intention-to-treat principle was performed with the Kaplan-Meier method and Cox proportional hazard models. Trial registration: NCT00761475 (ClinicalTrials.gov). Findings: Between 2009 and 2012, 480 patients were randomized: 107 primary suture, 188 onlay mesh and 185 sublay mesh. Five-year incisional hernia rates were 53.4% (95% CI: 40.4-64.8), 24.7% (95% CI: 12.7-38.8), 29.8% (95% CI: 17.9-42.6), respectively. Compared to primary suture, onlay mesh (HR: 0.390, 95% CI: 0.248-0.614, p < 0.001) and sublay mesh (HR: 0.485, 95% CI: 0.309-0.761, p = 0.002) were associated with a significantly lower risk of incisional hernia development. Interpretation: Prophylactic mesh placement remained effective in reducing incisional hernia occurrence after midline laparotomy in high-risk patients during long-term follow-up. Hernia rates in the primary suture group were higher than previously anticipated. Funding: B. Braun.

Laparoscopic transabdominal preperitoneal (TAPP) groin hernia repair using n-butyl-2-cyanoacrylate (LiquiBandFIX8) for mesh fixation and peritoneal closure: case report about extraperitoneal hematoma.

Introduction: A symptomatic inguinal hernia is a prevalent condition that typically requires surgical intervention. Various surgical approaches have been established for hernia repair, including several techniques for peritoneal closure and mesh fixation in laparoscopic surgery. N-butyl-2-cyanoacrylate, such as LiquiBandFIX8, offers a time-saving alternative to invasive methods for both mesh fixation and peritoneal closure. While n-butyl-2-cyanoacrylate is employed in various closure procedures, LiquiBandFIX8 is specifically designed for mesh fixation in inguinal hernia repair. Case presentation: We present a case of a 68-year old man undergoing transabdominal preperitoneal inguinal hernia repair under full heparinization. LiquiBandFIX8 was employed for mesh fixation and peritoneal closure. Upon conducting a revision laparoscopy due to a significant postoperative hematoma, we found that the mesh and peritoneum remained undamaged and fully sealed, indicating an effective fixing technique. Both the initial repair and the subsequent revision surgery were documented and the videos were subsequently analyzed. Conclusion: LiquiBandFIX8 provides a reliable adhesive strength and appropriate application for peritoneal closure and mesh fixation. When encountering extraperitoneal fluid collection, there is no anticipation of intraabdominal complications.

Updated guideline for closure of abdominal wall incisions from the European and American Hernia Societies.

BACKGROUND: Incisional hernia is a frequent complication of abdominal wall incision. Surgical technique is an important risk factor for the development of incisional hernia. The aim of these updated guidelines was to provide recommendations to decrease the incidence of incisional hernia. METHODS: A systematic literature search of MEDLINE, Embase, and Cochrane CENTRAL was performed on 22 January 2022. The Scottish Intercollegiate Guidelines Network instrument was used to evaluate systematic reviews and meta-analyses, RCTs, and cohort studies. The GRADE approach (Grading of Recommendations, Assessment, Development and Evaluation) was used to appraise the certainty of the evidence. The guidelines group consisted of surgical specialists, a biomedical information specialist, certified guideline methodologist, and patient representative. RESULTS: Thirty-nine papers were included covering seven key questions, and weak recommendations were made for all of these. Laparoscopic surgery and non-midline incisions are suggested to be preferred when safe and feasible. In laparoscopic surgery, suturing the fascial defect of trocar sites of 10 mm and larger is advised, especially after single-incision laparoscopic surgery and at the umbilicus. For closure of an elective midline laparotomy, a continuous small-bites suturing technique with a slowly absorbable suture is suggested. Prophylactic mesh augmentation after elective midline laparotomy can be considered to reduce the risk of incisional hernia; a permanent synthetic mesh in either the onlay or retromuscular position is advised. CONCLUSION: These updated guidelines may help surgeons in selecting the optimal approach and location of abdominal wall incisions.

An incisional hernia results from a weakness of the abdominal wall muscles that allows fat from the inside or organs to bulge out. These hernias are quite common after abdominal surgery at the site of a previous incision. There is research that discusses different ways to close an incision and this may relate to the chance of hernia formation. The aim of this study was to review the latest research and to provide a guide for surgeons on how best to close incisions to decrease hernia rates. When possible, surgery through small incisions may decrease the risk of hernia formation. If small incisions are used, it may be better if they are placed away from areas that are already weak (such as the belly button). If the incision is larger than 1 cm, it should be closed with a deep muscle-fascia suture in addition to skin sutures. If there is a large incision in the middle of the abdomen, the muscle should be sutured using small stitches that are close together and a slowly absorbable suture should be used. For patients who are at higher risk of developing hernias, when closing the incision, the muscle layer can be strengthened by using a piece of (synthetic) mesh. There is no good research available on recovery after surgery and no clear guides on activity level or whether a binder will help prevent hernia formation.

Embryology of the Abdominal Wall and Associated Malformations-A Review.

In humans, the incidence of congenital defects of the intraembryonic celom and its associated structures has increased over recent decades. Surgical treatment of abdominal and diaphragmatic malformations resulting in congenital hernia requires deep knowledge of ventral body closure and the separation of the primary body cavities during embryogenesis. The correct development of both structures requires the coordinated and fine-tuned synergy of different anlagen, including a set of molecules governing those processes. They have mainly been investigated in a range of vertebrate species (e.g., mouse, birds, and fish), but studies of embryogenesis in humans are rather rare because samples are seldom available. Therefore, we have to deal with a large body of conflicting data concerning the formation of the abdominal wall and the etiology of diaphragmatic defects. This review summarizes the current state of knowledge and focuses on the histological and molecular events leading to the establishment of the abdominal and thoracic cavities in several vertebrate species. In chronological order, we start with the onset of gastrulation, continue with the establishment of the three-dimensional body shape, and end with the partition of body cavities. We also discuss well-known human etiologies.

Effects of the short stitch technique for midline abdominal closure on incisional hernia (ESTOIH): randomized clinical trial.

BACKGROUND: Incisional hernia remains a frequent problem after midline laparotomy. This study compared a short stitch to standard loop closure using an ultra-long-term absorbent elastic suture material. METHODS: A prospective, multicentre, parallel-group, double-blind, randomized, controlled superiority trial was designed for the elective setting. Adult patients were randomly assigned by computer-generated sequence to fascial closure using a short stitch (5 to 8 mm every 5 mm, USP 2-0, single thread HR 26 mm needle) or long stitch technique (10 mm every 10 mm, USP 1, double loop, HR 48 mm needle) with a poly-4-hydroxybutyrate-based suture material (Monomax®). Incisional hernia assessed by ultrasound 1 year after surgery was the primary outcome. RESULTS: The trial randomized 425 patients to short (n = 215) or long stitch technique (n = 210) of whom 414 (97.4 per cent) completed 1 year of follow-up. In the short stitch group, the fascia was closed with more stitches (46 (12 s.d.) versus 25 (7 s.d.); P < 0.001) and higher suture-to-wound length ratio (5.3 (2.2 s.d.) versus 4.0 (1.3 s.d.); P < 0.001). At 1 year, seven of 210 (3.3 per cent) patients in the short and 13 of 204 (6.4 per cent) patients in the long stitch group developed incisional hernia (odds ratio 1.97, 95 per cent confidence interval 0.77 to 5.05; P = 0.173). CONCLUSION: The 1-year incisional hernia development was relatively low with clinical but not statistical difference between short and long stitches. Registration number: NCT01965249 (http://www.clinicaltrials.gov).

The Best Closure Technique Without Mesh in Elective Midline Laparotomy Closure.

Introduction: The risk of developing an incisional hernia after primary elective median laparotomy is reported in the literature as being between 5 and 20 percent. The basic of an optimal outcome after midline incision is the appropriate closure technique with or without a prophylactic mesh. The objective of this paper is to critically examine the various closure techniques and, in particular, to present a detailed comparison of the long stitch and short stitch techniques. Method: Based on the available literature, the characteristics of the different closure techniques are described in detail, advantages and disadvantages are compared, and the current status of a practicable recommendation is discussed. Special attention is paid to the criteria of the short stitch technique, such as the suture to incision length ratio, number of stitches and distances, as well as suture material. Results: For elective midline closures, the use of a continuous closure using a slowly absorbable suture material in the small-bites technique with suture to wound ratio of at least 5:1 result in significantly lower risk of complications such as bursting abdomen and less incisional hernia rates compared to the large-bites technique. Conclusion: Based on the present evidence in midline closure after elective laparotomy the small bites technique can be recommended to significantly reduce the rate of incisional hernia.

Forensic Implications of Anatomical Education and Surgical Training With Cadavers.

Anatomical education and surgical training with cadavers are usually considered an appropriate method of teaching, above all for all surgeons at various levels. Indeed, in such a way they put into practice and exercise a procedure before performing it live, reducing the learning curve in a safe environment and the risks for the patients. Really, up to now it is not clear if the nonuse of the cadavers for anatomical education and surgical training can have also forensic implications. A substantial literature research was used for this review, based on PubMed and Web of Science database. From this review, it is clear that the cadaveric training could be considered mandatory, both for surgeons and for medical students, leading to a series of questions with forensic implications. Indeed, there are many evidences that a cadaver lab can improve the learning curve of a surgeon, above all in the first part of the curve, in which frequent and severe complications are possible. Consequently, a medical responsibility for residents and surgeons which perform a procedure without adequate training could be advised, but also for hospital, that has to guarantee a sufficient training for its surgeons and other specialists through cadaver labs. Surely, this type of training could help to improve the practical skills of surgeons working in small hospitals, where some procedures are rare. Cadaver studies can permit a better evaluation of safety and efficacy of new surgical devices by surgeons, avoiding using patients as ≪guinea pigs≫. Indeed, a legal responsibility for a surgeon and other specialists could exist in the use of a new device without an apparent regulatory oversight. For a good medical practice, the surgeons should communicate to the patient the unsure procedural risks, making sure the patients' full understanding about the novelty of the procedure and that they have used this technique on few, if any, patients before. Cadaver training could represent a shortcut in the standard training process, increasing both the surgeon learning curve and patient confidence. Forensic clinical anatomy can supervise and support all these aspects of the formation and of the use of cadaver training.

Outcomes of a new slowly resorbable biosynthetic mesh (Phasix™) in potentially contaminated incisional hernias: A prospective, multi-center, single-arm trial.

BACKGROUND: Resorbable biomaterials have been developed to reduce the amount of foreign material remaining in the body after hernia repair over the long-term. However, on the short-term, these resorbable materials should render acceptable results with regard to complications, infections, and reoperations to be considered for repair. Additionally, the rate of resorption should not be any faster than collagen deposition and maturation; leading to early hernia recurrence. Therefore, the objective of this study was to collect data on the short-term performance of a new resorbable biosynthetic mesh (Phasix™) in patients requiring Ventral Hernia Working Group (VHWG) Grade 3 midline incisional hernia repair. MATERIALS AND METHODS: A prospective, multi-center, single-arm trial was conducted at surgical departments in 15 hospitals across Europe. Patients aged ≥18, scheduled to undergo elective Ventral Hernia Working Group Grade 3 hernia repair of a hernia larger than 10 cm2 were included. Hernia repair was performed with Phasix™ Mesh in sublay position when achievable. The primary outcome was the rate of surgical site occurrence (SSO), including infections, that required intervention until 3 months after repair. RESULTS: In total, 84 patients were treated with Phasix™ Mesh. Twenty-two patients (26.2%) developed 32 surgical site occurrences. These included 11 surgical site infections, 9 wound dehiscences, 7 seromas, 2 hematomas, 2 skin necroses, and 1 fistula. No significant differences in surgical site occurrence development were found between groups repaired with or without component separation technique, and between clean-contaminated or contaminated wound sites. At three months, there were no hernia recurrences. CONCLUSION: Phasix™ Mesh demonstrated acceptable postoperative surgical site occurrence rates in patients with a Ventral Hernia Working Group Grade 3 hernia. Longer follow-up is needed to evaluate the recurrence rate and the effects on quality of life. This study is ongoing through 24 months of follow-up.

Delayed Closure of Open Abdomen in Septic Patients Treated With Negative Pressure Vacuum Therapy and Dynamic Sutures: A 10-Years Follow-Up on Long-Term Complications.

Introduction: Patients with open abdomen after surgical interventions associated with the complication of secondary peritonitis are successfully treated with negative pressure wound therapy. The use of dynamic fascial sutures reduces fascial lateralization and increases successful delayed fascial closure after open abdomen treatment. Methods: In 2017 we published the follow-up results of 38 survivors out of 87 open abdomen patients treated with negative pressure wound therapy and dynamic fascial sutures between 2007 and 2012. In our current study we present the 10-years follow-up results regarding long-term complications with the focus on incisional hernias and pain. Since 2017 seven more patients have died, hence 31 patients were included in the current study. The patients were asked to answer questions about specific long-term complications of OA treatment including pain, the presence of incisional hernias and subsequent surgical interventions. Demographic data and data regarding fascial closure after open abdomen treatment were collected. All results were analyzed quantitatively. The follow-up period was 8-13 years. Results: The median age was 69 (30-90) years, and 15 (48.4%) were females. Twenty-four patients (77.4%) responded to the questionnaire: Three patients (12.5%) suffered from pain in the original operating field, all three at rest but not during exercise. None of the patients required analgesic treatment. Eleven patients (45.8%) were found to have incisional hernias. Five out of 11 hernias (45.5%) were treated by surgery and did not declare any pain in the operating field. Among the patients with incisional hernias lower MPI (Mannheimer Peritonitis Index) at the time of primary surgery but more reoperations and treatment days were found. The technique of fascial closure was heterogenic and no differences in the occurrence of incisional hernia could be detected. Conclusion: The incidence of incisional hernias after open abdomen treatment is still high, but are associated with little pain in the original operating field. Further studies are required to investigate methods for fascial closure techniques after OA treatment.

Small and Laterally Placed Incisional Hernias Can be Safely Managed with an Onlay Repair.

INTRODUCTION: In meta-analyses and systematic reviews, clear advantages have been identified for the sublay versus onlay technique for treatment of incisional hernias. Nonetheless, an expert panel has noted that the onlay mesh location may be useful in certain settings. MATERIALS AND METHODS: First, unadjusted analysis of data from the Herniamed Registry was performed to compare 6797 sublay operations with 1024 onlay operations for repair of incisional hernias. Then, using propensity score matching to account for the influence of variables age, gender, ASA score, BMI, risk factors, preoperative pain, defect size, and defect localization, 1016 pairs were formed and compared with each other. RESULTS: Unadjusted analysis revealed that the onlay operation was used significantly more often for small defects, lateral defect localization, and in women. After comparing the propensity score-matched pairs, no significant difference was found between the sublay and onlay technique in the outcome criteria intra- and postoperative complications, general complications, complication-related reoperations, pain at rest, pain on exertion, chronic pain requiring treatment, and recurrence on 1-year follow-up. But that was true only for this carefully selected patient collective. CONCLUSION: In a selected patient collective with small and lateral incisional hernias and with a large proportion of women, outcomes obtained for the onlay and sublay techniques do not differ significantly.

Influencing Factors on the Outcome in Female Groin Hernia Repair: A Registry-based Multivariable Analysis of 15,601 Patients.

OBJECTIVE: Based on an analysis of data from the Herniamed Registry, this study aims to identify all factors influencing the outcome in female groin hernia repair. BACKGROUND: In a systematic review and meta-analysis of observational studies, female sex was found to be a significant risk factor for recurrence. In the guidelines, the totally extraperitoneal patch plasty (TEP) and transabdominal preperitoneal patch plasty (TAPP) laparo-endoscopic techniques are recommended for female groin hernia repair. However, even when complying with the guidelines, a less favorable outcome must be expected than in men. To date, there is no study in the literature for analysis of all factors influencing the outcome in female groin hernia repair. METHODS: In all, 15,601 female patients from the Herniamed Registry who had undergone primary unilateral groin hernia repair with the Lichtenstein, Shouldice, TEP or TAPP technique, and for whom 1-year follow-up was available, were selected between September 1, 2009 and July 1, 2017. Using multivariable analyses, influencing factors on the various outcome parameters were identified. RESULTS: In the multivariable analysis, a significantly higher risk of postoperative complications, complication-related reoperations, recurrences, and pain on exertion was found only for the Lichtenstein technique. No negative influence on the outcome was identified for the TEP, TAPP, or Shouldice techniques. Relevant risk factors for occurrence of perioperative complications, recurrences, and chronic pain were preoperative pain, existing risk factors, larger defects, a higher body mass index (BMI), higher American Society of Anesthesiologists (ASA) classification and postoperative complications. Higher age had a negative association with postoperative complications and positive association with pain rates. CONCLUSIONS: Female groin hernia repair should be performed with the TEP or TAPP laparo-endoscopic technique, or, alternatively, with the Shouldice technique, if there is no evidence of a femoral hernia. By contrast, the Lichtenstein technique has disadvantages in terms of postoperative complications, recurrences, and pain on exertion. Important risk factors for an unfavorable outcome are preoperative pain, existing risk factors, higher ASA classification, higher BMI, and postoperative complications. A higher age and larger defects have an unfavorable impact on postoperative complications and a more favorable impact on chronic pain.

Classification of Rectus Diastasis-A Proposal by the German Hernia Society (DHG) and the International Endohernia Society (IEHS).

Introduction: Recently, the promising results of new procedures for the treatment of rectus diastasis with concomitant hernias using extraperitoneal mesh placement and anatomical restoration of the linea alba were published. To date, there is no recognized classification of rectus diastasis (RD) with concomitant hernias. This is urgently needed for comparative assessment of new surgical techniques. A working group of the German Hernia Society (DHG) and the International Endohernia Society (IEHS) set itself the task of devising such a classification. Materials and Methods: A systematic search of the available literature was performed up to October 2018 using Medline, PubMed, Scopus, Embase, Springer Link, and the Cochrane Library. A meeting of the working group was held in May 2018 in Hamburg. For the present analysis 30 publications were identified as relevant. Results: In addition to the usual patient- and technique-related influencing factors on the outcome of hernia surgery, a typical means of rectus diastasis classification and diagnosis should be devised. Here the length of the rectus diastasis should be classified in terms of the respective subxiphoidal, epigastric, umbilical, infraumbilical, and suprapubic sectors affected as well as by the width in centimeters, whereby W1 < 3 cm, W2 = 3- ≤ 5 cm, and W3 > 5 cm. Furthermore, gender, the concomitant hernias, previous abdominal surgery, number of pregnancies and multiple births, spontaneous birth or caesarian section, skin condition, diagnostic procedures and preoperative pain rate and localization of pain should be recorded. Conclusion: Such a unique classification is needed for assessment of the treatment results in patients with RD.

Abdominal Wall Closure in Elective Midline Laparotomy: The Current Recommendations.

INTRODUCTION: The risk of developing an incisional hernia after primary elective median laparotomy is reported in the literature as being between 5 and 20 percent. The goal of this systematic review was to evaluate different closure techniques for midline laparotomies and the use of additional prophylactic mesh augmentation for midline closure in high risk patients. METHOD: A systematic literature search was performed until September 2017. The quality of the RCTs was evaluated and analysed. The data are reported in accordance with the Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. RESULTS: In the systematic review for closure techniques a total of 23 RCTs and 9 RCTs for the use of prophylactic mesh were included. In elective midline closure the use of a slowly absorbable suture material for continuous closure using the small bites technique results in significantly less incisional hernias than a large bites technique (OR 0.41; 95% CI 0.19, 0.86). The use of prophylactic mesh versus the suture closure of the midline achieved a significant reduction of the incisional hernia rate [OR 0.14 (95% CI 0.07-0.27)]. CONCLUSIONS: Based on the currently evidence in midline closure after elective laparotomy in the small bites technique can be recommended to reduce significantly the rate of incisional hernia. The additional use of a prophylactic mesh in high risk patients can significantly reduce the occurrence of incisional hernia.