Open ventral hernia repair with a composite ventral patch - final results of a multicenter prospective study.
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ABSTRACT:
SUBMITTER: Berrevoet F
PROVIDER: S-EPMC6633695 | biostudies-literature | 2019 Jul
REPOSITORIES: biostudies-literature
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Open ventral hernia repair with a composite ventral patch - final results of a multicenter prospective study.
Berrevoet F F Doerhoff C C Muysoms F F Hopson S S Muzi M G MG Nienhuijs S S Kullman E E Tollens T T Schwartz M M Leblanc K K Velanovich V V Jørgensen L N LN
BMC surgery 20190716 1
<h4>Background</h4>This study assessed clinical outcomes, including safety and recurrence, from the two-year follow-up of patients who underwent open ventral primary hernia repair with the use of the Parietex™ Composite Ventral Patch (PCO-VP).<h4>Methods</h4>A prospective single-arm, multicenter study of 126 patients undergoing open ventral hernia repair for umbilical and epigastric hernias with the PCO-VP was performed.<h4>Results</h4>One hundred twenty-six subjects (110 with umbilical hernia a ...[more]
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Project description:PurposeThis study assessed the recurrence rate and other safety and efficacy parameters following ventral hernia repair with a polyester composite prosthesis (Parietex™ Composite Ventral Patch [PCO-VP]).Patients and methodsA single-arm, multicenter prospective study of 126 patients undergoing open ventral hernia repair with the PCO-VP was performed. Patient outcomes were assessed at discharge and at 10 days, 1, 6, 12, and 24 months postoperative.ResultsAll patients had hernioplasty for umbilical (n = 110, 87.3%) or epigastric hernia (n = 16, 12.7%). Mean hernia diameter was 1.8 ± 0.8 cm. Mean operative time was 36.2 ±15.6 minutes, with a mean mesh positioning time of 8.1 ± 3.4 minutes. Surgeons reported satisfaction with mesh ease of use in 95% of surgeries. The cumulative hernia recurrence rate at 1 year was 2.8% (3/106). Numeric Rating Scale (NRS) pain scores showed improvement from 2.1 ± 2.0 at preoperative baseline to 0.5 ± 0.7 at 1 month postoperative (P < 0.001), and this low pain level was maintained at 12 months postsurgery (P < 0.001). The mean global Carolina's Comfort Scale® (CCS) score improved postoperatively from 3.8 ± 6.2 at 1 month to 1.6 ± 3.5 at 6 months (P < 0.001). One patient was unsatisfied with the procedure.ConclusionThis 1-year interim analysis using PCO-VP for primary umbilical and epigastric defects shows promising results in terms of mesh ease of use, postoperative pain, and patient satisfaction. Recurrence rate is low, but, as laparoscopic evaluation shows a need for patch repositioning in some cases, an accurate surgical technique remains of utmost importance.
| S-EPMC5440003 | biostudies-literature
Project description:OBJECTIVE:To determine whether robotic ventral hernia repair is associated with fewer days in the hospital 90 days after surgery compared with laparoscopic repair. DESIGN:Pragmatic, blinded randomized controlled trial. SETTING:Multidisciplinary hernia clinics in Houston, USA. PARTICIPANTS:124 patients, deemed appropriate candidates for elective minimally invasive ventral hernia repair, consecutively presenting from April 2018 to February 2019. INTERVENTIONS:Robotic ventral hernia repair (n=65) versus laparoscopic ventral hernia repair (n=59). MAIN OUTCOME MEASURES:The primary outcome was number of days in hospital within 90 days after surgery. Secondary outcomes included emergency department visits, operating room time, wound complications, hernia recurrence, reoperation, abdominal wall quality of life, and costs from the healthcare system perspective. Outcomes were pre-specified before data collection began and analyzed as intention to treat. RESULTS:Patients from both groups were similar at baseline. Ninety day follow-up was completed in 123 (99%) patients. No evidence was seen of a difference in days in hospital between the two groups (median 0 v 0 days; relative rate 0.90, 95% confidence interval 0.37 to 2.19; P=0.82). For secondary outcomes, no differences were noted in emergency department visits, wound complications, hernia recurrence, or reoperation. However, robotic repair had longer operative duration (141 v 77 min; mean difference 62.89, 45.75 to 80.01; P?0.001) and increased healthcare costs ($15?865 (£12?746; €14?125) v $12?955; cost ratio 1.21, 1.07 to 1.38; adjusted absolute cost difference $2767, $910 to $4626; P=0.004). Among patients with robotic ventral hernia repair, two had an enterotomy compared none with laparoscopic repair. The median one month postoperative improvement in abdominal wall quality of life was 3 with robotic ventral hernia repair compared with 15 following laparoscopic repair. CONCLUSION:This study found no evidence of a difference in 90 day postoperative hospital days between robotic and laparoscopic ventral hernia repair. However, robotic repair increased operative duration and healthcare costs. TRIAL REGISTRATION:Clinicaltrials.gov NCT03490266.
| S-EPMC7359869 | biostudies-literature
Project description:BACKGROUND:For ventral hernia, endoscopic sublay repair (ESR) may overcome the disadvantages of open sublay and laparoscopic intraperitoneal onlay mesh repair. This retrospective study presents the preliminary multicenter results of ESR from China. The feasibility, safety, and effectiveness of ESR were evaluated; its surgical points and indications were summarized. METHODS:The study reviewed 156 ventral hernia patients planned to perform with ESR in ten hospitals between March 2016 and July 2019. Patient demographics, hernia characteristics, operative variables, and surgical results were recorded and analyzed. RESULTS:ESR was performed successfully in 153 patients, 135 with totally extraperitoneal sublay (TES) and 18 with transabdominal sublay (TAS). In 19 patients, TES was performed with the total visceral sac separation (TVS) technique, in which the space separation is carried out along the peritoneum, avoiding damage to the aponeurotic structure. Endoscopic transversus abdominis release (eTAR) was required in 17.0% of patients, and only 18.3% of patients required permanent mesh fixation. The median operative time was 135?min. Most patients had mild pain and resume eating soon after operation. No severe intraoperative complications occurred. Bleeding in the extraperitoneal space occurred in two patients and was stopped by nonsurgical treatment. Seroma and chronic pain were observed in 5.23 and 3.07% of patients. One recurrence occurred after TAS repair for an umbilical hernia. CONCLUSION:ESR is feasible, safe, and effective for treating ventral hernias when surgeons get the relevant surgical skills, such as the technique of "partition breaking," TVS, and eTAR. Small-to-medium ventral hernias are the major indications.
| S-EPMC7552516 | biostudies-literature
Project description:Background:The objective of the present study is to compare the outcomes open PVHR and robotic PVHR. Methods/Design:The present study will be a randomized single-blinded controlled trial with intention-to-treat analysis comparing robotic PVHR to open PVHR in adult patients undergoing elective PVHR with a defect ranging between 1-5 cm. Patient refusing to participate, not able to give informed consent, with history of intra-abdominal surgery contraindicating a robotic surgical approach will be excluded. The intervention will consist in laparoscopic robotically assisted trans-abdominal pre-peritoneal epigastric or umbilical PVHR with closure of fascial defect and non-adsorbable mesh reinforcement. The control will be open pre-peritoneal epigastric or umbilical hernia repair with closure of fascial defect and non-absorbable mesh reinforcement. The primary outcome will be the incidence of wound-related complication within 1 month. The secondary outcomes will be esthetic satisfaction, pain, pain-killers consumption, general complications, costs, operative time and early hernia recurrence. Discussion:Open PVHR is potentially associated to more wound-related complications, but has the advantages of cost-effectiveness, short operative time and totally extra-peritoneal repair. Laparoscopic PVHR has lower wound-related complications but implies placing the mesh in intra-peritoneal position, requires advanced laparoscopic skills, usually does not allow the closure of the defect, and can lead to excessive pain and pain-killers consumption. Robotic PVHR uses the same laparoscopic access as laparoscopic PVHR, but thanks to the extended range of motion given by the robotic system, allows defect closure, pre-peritoneal placement of the mesh and requires less technical skills.In the present randomized controlled trial, we expect to show that robotic PVHR leads to better wound-related outcomes than open PVHR. Trial registration:The present randomized controlled trial was registered into clinicaltrials.gov under registration number NCT04171921.
| S-EPMC7186553 | biostudies-literature
Project description:OBJECTIVE:The aim of the study was to evaluate biosynthetic absorbable mesh in single-staged contaminated (Centers for Disease Control class II and III) ventral hernia (CVH) repair over 24 months. BACKGROUND:CVH has an increased risk of postoperative infection. CVH repair with synthetic or biologic meshes has reported chronic biomaterial infections and high hernia recurrence rates. METHODS:Patients with a contaminated or clean-contaminated operative field and a hernia defect at least 9?cm had a biosynthetic mesh (open, sublay, retrorectus, or intraperitoneal) repair with fascial closure (n = 104). Endpoints included overall Kaplan-Meier estimates for hernia recurrence and postoperative wound infection rates at 24 months, and the EQ-5D and Short Form 12 Health Survey (SF-12). Analyses were conducted on the intent-to-treat population, and health outcome measures evaluated using paired t tests. RESULTS:Patients had a mean age of 58 years, body mass index of 28?kg/m, 77% had contaminated wounds, and 84% completed 24-months follow-up. Concomitant procedures included fistula takedown (n = 24) or removal of infected previously placed mesh (n = 29). Hernia recurrence rate was 17% (n = 16). At the time of CVH repair, intraperitoneal placement of the biosynthetic mesh significantly increased the risk of recurrences (P ? 0.04). Surgical site infections (19/104) led to higher risk of recurrence (P < 0.01). Mean 24-month EQ-5D (index and visual analogue) and SF-12 physical component and mental scores improved from baseline (P < 0.05). CONCLUSIONS:In this prospective longitudinal study, biosynthetic absorbable mesh showed efficacy in terms of long-term recurrence and quality of life for CVH repair patients and offers an alternative to biologic and permanent synthetic meshes in these complex situations.
| S-EPMC5181129 | biostudies-literature
Project description:BACKGROUND:The objective of this study was to evaluate the mechanical and histological properties of a fully absorbable poly-4-hydroxybutyrate/absorbable barrier composite mesh (Phasix™ ST) compared to partially absorbable (Ventralight™ ST), fully absorbable (Phasix™), and biologically derived (Strattice™) meshes in a porcine model of ventral hernia repair. METHODS:Bilateral abdominal surgical defects were created in twenty-four Yucatan pigs, repaired with intraperitoneal (Phasix™ ST, Ventralight™ ST) or retromuscular (Phasix™, Strattice™) mesh, and evaluated at 12 and 24 weeks (n = 6 mesh/group/time point). RESULTS:Prior to implantation, Strattice™ demonstrated significantly higher (p < 0.001) strength (636.6 ± 192.1 N) compared to Ventralight™ ST (324.3 ± 37.1 N), Phasix™ ST (206.9 ± 11.3 N), and Phasix™ (200.6 ± 25.2 N). At 12 and 24 weeks, mesh/repair strength was significantly greater than NAW (p < 0.01 in all cases), and no significant changes in strength were observed for any meshes between 12 and 24 weeks (p > 0.05). Phasix™ mesh/repair strength was significantly greater than Strattice™ (p < 0.001) at 12 and 24 weeks, and Ventralight™ ST mesh/repair strength was significantly greater than Phasix™ ST mesh (p < 0.05) at 24 weeks. At 12 and 24 weeks, Phasix™ ST and Ventralight™ ST were associated with mild inflammation and minimal-mild fibrosis/neovascularization, with no significant differences between groups. At both time points, Phasix™ was associated with minimal-mild inflammation/fibrosis and mild neovascularization. Strattice™ was associated with minimal inflammation/fibrosis, with minimal neovascularization at 12 weeks, which increased to mild by 24 weeks. Strattice™ exhibited significantly less neovascularization than Phasix™ at 12 weeks and significantly greater inflammation at 24 weeks due to remodeling. CONCLUSIONS:Phasix™ ST demonstrated mechanical and histological properties comparable to partially absorbable (Ventralight™ ST) and fully resorbable (Phasix™) meshes at 12 and 24 weeks in this model. Data also suggest that fully absorbable meshes with longer-term resorption profiles may provide improved mechanical and histological properties compared to biologically derived scaffolds.
| S-EPMC4992027 | biostudies-literature
Project description:BACKGROUND:Laparoscopic repair of ventral and incisional hernias has gained popularity since many studies have reported encouraging results in terms of outcomee and recurrence. Choice of mesh and fixation methods are considered crucial issues in preventing recurrences and complications. Lightweight meshes are considered the first choice due to their biomechanical properties and the ability to integrate into the abdominal wall. Titanium helicoidal tacks still represent the "gold standard" for mesh fixation, even if they have been suggested to be involved in the genesis of post-operative pain and complications. Recently, absorbable tacks have been introduced, under the hypothesis that there will be no need to maintain a permanent fixation device after mesh integration. Nevertheless, there is no evidence that absorbable tacks may guarantee the same results as titanium tacks in terms of strength of fixation and recurrence rates. The primary end point of the present trial is to test the hypothesis that absorbable tacks are non-inferior to titanium tacks in laparoscopic incisional and ventral hernia repair (LIVHR) by lightweight polypropylene mesh, in terms of recurrence rates at 3-year follow-up. Surgical complications, post-operative stay, comfort and pain are secondary end points to be assessed. METHODS/DESIGN:Two hundred and twenty patients with ventral hernia will be randomized into 2 groups: Group A (110) patients will be submitted to LIVHR by lightweight polypropylene mesh fixed by titanium tacks; Group B (110) patients will be submitted to LIVHR by lightweight polypropylene mesh fixed by absorbable tacks. DISCUSSION:A few retrospective studies have reported similar results when comparing absorbable versus non-absorbable tacks in terms of intraoperative and early post-operative outcomes. These studies have the pitfalls to be retrospective evaluation of small series of patients, and the reported results still need to be validated by larger series and prospective studies. The aim of the present trial is to investigate and test the non-inferiority of absorbable versus non-absorbable tacks in terms of hernia recurrence rates, in order to assess whether the use of absorbable tacks may achieve the same results as non-absorbable tacks in mid-term and long-term settings. TRIAL REGISTRATION NUMBER:NCT02076984: 5 June 2014 (ClinicalTrials.gov).
| S-EPMC4460685 | biostudies-literature
Project description:Primary ventral hernias and ventral incisional hernias have been a challenge for surgeons throughout the ages. In the current era, incisional hernias have increased in prevalence due to the very high number of laparotomies performed in the 20(th) century. Even though minimally invasive surgery and hernia repair have evolved rapidly, general surgeons have yet to develop the ideal, standardized method that adequately decreases common postoperative complications, such as wound failure, hernia recurrence and pain. The evolution of laparoscopy and ventral hernia repair will be reviewed, from the rectoscopy of the 4(th) century to the advent of laparoscopy, from suture repair to the evolution of mesh reinforcement. The nuances of minimally invasive ventral and incisional hernia repair will be summarized, from preoperative considerations to variations in intraoperative practice. New techniques have become increasingly popular, such as primary defect closure, retrorectus mesh placement, and concomitant component separation. The advent of robotics has made some of these repairs more feasible, but only time and well-designed clinical studies will tell if this will be a durable modality for ventral and incisional hernia repair.
| S-EPMC4663383 | biostudies-other
Project description:Effective postoperative analgesia is a key element in reducing postoperative morbidity, accelerating recovery and avoiding chronic postoperative pain. The aim of this study was to evaluate the effectiveness of ultrasound-guided Transversus Abdominis Plane (TAP) block, performed before surgical incision, in providing postoperative analgesia for patients undergoing open ventral hernia repair under general anaesthesia.Seventy elective patients scheduled for open ventral hernia repair surgery under general anaesthesia were divided randomly into two equal groups: Group I received bilateral TAP block performed before surgical incision (n = 35); Group II received systemic postoperative analgesia with parenteral opioid (morphine) alone (n = 35). Postoperatively pain scores at rest and with movement, total morphine consumption and opioid related side effects were recorded.Postoperative pain scores at rest and mobilization/cough were significantly higher in patients without TAP block (p < 0.05). Mean intraoperative fentanyl consumption was comparable between the two groups: 0.75 ± 0.31 mg in group I (TAP) and 0.86 ± 0.29 mg in group II (MO), p = 0.1299. Patients undergoing preincisional TAP block had reduced morphine requirements during the first 24 hours after surgery, compared to patients from group II, without TAP block (p = 0.0001). There was no difference in the incidence of opioid related side effects (nausea, vomiting) in the both groups during the first 24 postoperative hours.The use of preincisional ultrasound guided TAP block reduced the pain scores at rest and with movement/cough, opioid consumption and opioid-related side effects after ventral hernia repair when compared with opioid-only analgesia.
| S-EPMC5642852 | biostudies-other
Project description:Robotic ventral hernia repair (VHR) has seen rapid adoption, but with limited data assessing clinical outcome or cost. This systematic review compared robotic VHR with laparoscopic and open approaches. This systematic review was undertaken in accordance with PRISMA guidelines. PubMed, MEDLINE, Embase, and Cochrane databases were searched for articles with terms relating to 'robot-assisted', 'cost effectiveness', and 'ventral hernia' or 'incisional hernia' from 1 January 2010 to 10 November 2020. Intraoperative and postoperative outcomes, pain, recurrence, and cost data were extracted for narrative analysis. Of 25 studies that met the inclusion criteria, three were RCTs and 22 observational studies. Robotic VHR was associated with a longer duration of operation than open and laparoscopic repairs, but with fewer transfusions, shorter hospital stay, and lower complication rates than open repair. Robotic VHR was more expensive than laparoscopic repair, but not significantly different from open surgery in terms of cost. There were no significant differences in rates of intraoperative complication, conversion to open surgery, surgical-site infection, readmission, mortality, pain, or recurrence between the three approaches. Robotic VHR was associated with a longer duration of operation, fewer transfusions, a shorter hospital stay, and fewer complications compared with open surgery. Robotic VHR had higher costs and a longer operating time than laparoscopic repair. Randomized or matched data with standardized reporting, long-term outcomes, and cost-effectiveness analyses are still required to weigh the clinical benefits against the cost of robotic VHR.
| S-EPMC8599882 | biostudies-literature