Dataset Information

Titanium versus absorbable tacks comparative study (TACS): a multicenter, non-inferiority prospective evaluation during laparoscopic repair of ventral and incisional hernia: study protocol for randomized controlled trial.

ABSTRACT: 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).

SUBMITTER: Silecchia G

PROVIDER: S-EPMC4460685 | biostudies-literature | 2015 Jun

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:ObjectiveTo determine whether robotic ventral hernia repair is associated with fewer days in the hospital 90 days after surgery compared with laparoscopic repair.DesignPragmatic, blinded randomized controlled trial.SettingMultidisciplinary hernia clinics in Houston, USA.Participants124 patients, deemed appropriate candidates for elective minimally invasive ventral hernia repair, consecutively presenting from April 2018 to February 2019.InterventionsRobotic ventral hernia repair (n=65) versus laparoscopic ventral hernia repair (n=59).Main outcome measuresThe 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.ResultsPatients 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.ConclusionThis 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 registrationClinicaltrials.gov NCT03490266.

Project description:BackgroundThis prospective, multicenter, single-arm, open-label study evaluated P4HB-ST mesh in laparoscopic ventral or incisional hernia repair (LVIHR) in patients with Class I (clean) wounds at high risk for Surgical Site Occurrence (SSO).MethodsPrimary endpoint was SSO requiring intervention <45 days. Secondary endpoints included: surgical procedure time, length of stay, SSO >45 days, hernia recurrence, device-related adverse events, reoperation, and Quality of Life at 1, 3, 6, 12, 18, and 24-months.Results120 patients (52.5% male), mean age of 55.0 ± 14.9 years, and BMI of 33.2 ± 4.5 kg/m2 received P4HB-ST mesh. Patient-reported comorbid conditions included: obesity (86.7%), active smoker (45.0%), COPD (5.0%), diabetes (16.7%), immunosuppression (2.5%), coronary artery disease (7.5%), chronic corticosteroid use (2.5%), hypoalbuminemia (0.8%), advanced age (10.0%), and renal insufficiency (0.8%). Hernia types were primary ventral (44.2%), primary incisional (37.5%), recurrent ventral (5.8%), and recurrent incisional (12.5%). Patients underwent LVIHR in laparoscopic (55.8%) or robotic-assisted cases (44.2%), mean defect size 15.7 ± 28.3 cm2, mean procedure time 85.9 ± 43.0 min, and mean length of stay 1.0 ± 1.4 days. There were no SSOs requiring intervention beyond 45 days, n = 38 (31.7%) recurrences, n = 22 (18.3%) reoperations, and n = 2 (1.7%) device-related adverse events (excluding recurrence).ConclusionP4HB-ST mesh demonstrated low rates of SSO and device-related complications, with improved quality of life scores, and reoperation rate comparable to other published studies. Recurrence rate was higher than expected at 31.7%. However, when analyzed by hernia defect size, recurrence was disproportionately high in defects ≥7.1 cm2 (43.3%) compared to defects <7.1 cm2 (18.6%). Thus, in LVIHR, P4HB-ST may be better suited for small defects. Caution is warranted when utilizing P4HB-ST in laparoscopic IPOM repair of larger defects until additional studies can further investigate outcomes.

Project description:Importance:Ventral and incisional hernia repair (VIHR) is an extremely common operation, after which complications are also fairly common. A number of preoperative risk factors are known to contribute to increased complications after surgical repair; however, the individual relative association of these risk factors with adverse outcomes and increased spending is unclear. Quantifying the association of individual risk factors may help surgeons implement targeted surgical optimization, improve outcomes, and reduce spending. Objective:To identify the attributable association of modifiable risk factors for adverse outcomes after VIHR on outcomes and episode-of-care payments. Design, Setting, and Participants:This cross-sectional study was performed using a population-based sample of adult patients and episode spending data from January 1, 2012, to December 31, 2018, from a statewide multipayer registry. A multilevel mixed-effects logistic regression model was used to examine the contribution of patient-specific risk factors to adverse outcomes. Attributable risk and population attributable risk fraction were calculated to estimate the additional spending attributable to individual risk factors. Data were analyzed from April 2018 to September 2018. Main Outcomes and Measures:Any complications, serious complication, discharge not to home, 30-day emergency department utilization, and 30-day readmission. Episode-of-care spending was calculated for these outcomes. Results:This study included 22 664 patients (median [interquartile range] age, 55 [44-64] years; 10 496 [46.3%] women) undergoing VIHR with identified significant preoperative risk factors. Fourth-quartile body mass index (BMI), calculated as weight in kilograms divided by height in meters squared and defined as a mean (SD) BMI of 43 (6), was associated with increased risk of any complication (odds ratio [OR], 1.64; 95% CI, 1.30-2.06; P < .001) and serious complication (OR, 1.67; 95% CI, 1.22-2.31; P = .002). Insulin-dependent diabetes was associated with increased risk of any complication (OR, 1.34; 95% CI, 1.03-1.73; P = .03), serious complication (OR, 1.51; 95% CI, 1.08-2.12; P = .02), discharge not to home (OR, 1.49; 95% CI, 1.12-1.98; P = .005), and 30-day readmission (OR, 1.68; 95% CI, 1.32-2.14; P < .001). Median (interquartile range) additional episode spending for any complication was $9934 ($9224-$11 851), of which $1304 ($1208-$1552) was attributable to fourth-quartile BMI. Median (interquartile range) additional episode spending for a serious complication was $26 648 ($20 632-$33 166), of which $3638 ($2827-$4544) was attributable to fourth-quartile BMI, $650 ($495-$796) was attributable to insulin-dependent diabetes, and $567 ($433-$696) was attributable to unhealthy alcohol use. Conclusions and Relevance:In this cross-sectional study, modifiable risk factors, such as obesity, insulin-dependent diabetes, and unhealthy alcohol use, were associated with adverse outcomes after VIHR. These factors were significantly associated with increased health care spending; therefore, preoperative optimization may improve outcomes and decrease episode-of-care costs.

Dataset Information

Titanium versus absorbable tacks comparative study (TACS): a multicenter, non-inferiority prospective evaluation during laparoscopic repair of ventral and incisional hernia: study protocol for randomized controlled trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets