Dataset Information

Prospective, multicenter study of P4HB (Phasix™) mesh for hernia repair in cohort at risk for complications: 3-Year follow-up.

ABSTRACT:

Background

This study represents a prospective, multicenter, open-label study to assess the safety, performance, and outcomes of poly-4-hydroxybutyrate (P4HB, Phasix™) mesh for primary ventral, primary incisional, or multiply-recurrent hernia in subjects at risk for complications. This study reports 3-year clinical outcomes.

Materials and methods

P4HB mesh was implanted in 121 patients via retrorectus or onlay technique. Physical exam and/or quality of life surveys were completed at 1, 3, 6,12, 18, 24, and 36 months, with 5-year (60-month) follow-up ongoing.

Results

A total of n = 121 patients were implanted with P4HB mesh (n = 75 (62%) female) with a mean age of 54.7 ± 12.0 years and mean BMI of 32.2 ± 4.5 kg/m² (±standard deviation). Comorbidities included: obesity (78.5%), active smokers (23.1%), COPD (28.1%), diabetes mellitus (33.1%), immunosuppression (8.3%), coronary artery disease (21.5%), chronic corticosteroid use (5.0%), hypo-albuminemia (2.5%), advanced age (5.0%), and renal insufficiency (0.8%). Hernias were repaired via retrorectus (n = 45, 37.2% with myofascial release (MR) or n = 43, 35.5% without MR), onlay (n = 8, 6.6% with MR or n = 24, 19.8% without MR), or not reported (n = 1, 0.8%). 82 patients (67.8%) completed 36-month follow-up. 17 patients (17.9% ± 0.4%) experienced hernia recurrence at 3 years, with n = 9 in the retrorectus group and n = 8 in the onlay group. SSI (n = 11) occurred in 9.3% ± 0.03% of patients.

Conclusions

Long-term outcomes following ventral hernia repair with P4HB mesh demonstrate low recurrence rates at 3-year (36-month) postoperative time frame with no patients developing late mesh complications or requiring mesh removal. 5-year (60-month) follow-up is ongoing.

SUBMITTER: Roth JS

PROVIDER: S-EPMC7750179 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature

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Publications

Prospective, multicenter study of P4HB (Phasix™) mesh for hernia repair in cohort at risk for complications: 3-Year follow-up.

Roth John Scott JS Anthone Gary J GJ Selzer Don J DJ Poulose Benjamin K BK Pierce Richard A RA Bittner James G JG Hope William W WW Dunn Raymond M RM Martindale Robert G RG Goldblatt Matthew I MI Earle David B DB Romanelli John R JR Mancini Gregory J GJ Greenberg Jacob A JA Linn John G JG Parra-Davila Eduardo E Sandler Bryan J BJ Deeken Corey R CR Verbarg Jasenka J Salluzzo Jennifer L JL Voeller Guy R GR

Annals of medicine and surgery (2012) 20201215

<h4>Background</h4>This study represents a prospective, multicenter, open-label study to assess the safety, performance, and outcomes of poly-4-hydroxybutyrate (P4HB, Phasix™) mesh for primary ventral, primary incisional, or multiply-recurrent hernia in subjects at risk for complications. This study reports 3-year clinical outcomes.<h4>Materials and methods</h4>P4HB mesh was implanted in 121 patients via retrorectus or onlay technique. Physical exam and/or quality of life surveys were completed ...[more]

PMID: 33363718

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Project description:Background Typically, in-person follow-up in clinic is utilized after outpatient inguinal hernia repair. Studies have shown that phone follow-up may be successfully used for the detection of postoperative hernia recurrences. However, no studies have evaluated the detection rates of other postoperative complications, such as emergency department visits and readmissions, with the utilization of phone follow-up after inguinal hernia repair. The objective of our study was to investigate the safety of a phone follow-up care pathway following elective, outpatient inguinal hernia repair. Methods In this retrospective cohort study, adult patients who underwent elective, outpatient inguinal hernia repair between 2013 and 2019 at a large academic health system in the Midwest United States were identified from the electronic health record. Patients were categorized by type of postoperative follow-up: in-person or phone follow-up. Baseline demographics, operative, and postoperative data were compared between follow-up groups. Multivariable logistic regression was performed to investigate predictors of having any related emergency department (ED) visit/readmission/reoperation within 90 days. Results We included 2009 patients who underwent elective inguinal hernia repair during the study period. 321 patients had in-person follow-up only, while 1,688 patients had phone follow-up. There was a higher rate of laparoscopic repair in the phone follow-up group (85.4% vs. 53.0% for in-person follow-up). There were no differences in rates of related 90-day ED visits, readmissions, and reoperations between the phone and in-person follow-up groups. On multivariable logistic regression, receipt of phone follow-up was not a predictor of having 90-day ED visits, readmissions, or reoperations (OR 1.30, 95% CI [0.83, 2.05]). Conclusions Patients who underwent phone follow-up had similarly low rates of adverse outcomes to those with in-person follow-up. Phone follow-up protocols may be implemented as an alternative for patients and provide a means to decrease healthcare utilization following inguinal hernia repair. Electronic supplementary material The online version of this article (10.1007/s00464-020-08005-5) contains supplementary material, which is available to authorized users.

Project description:BACKGROUND:Minimally invasive incisional hernia repair has been established as a safe and efficient surgical option in most centres worldwide. Laparoscopic technique includes the placement of an intraperitoneal onlay mesh with fixation achieved using spiral tacks or sutures. An additional step is the closure of the fascial defect depending upon its size. Key outcomes in the evaluation of ventral abdominal hernia surgery include postoperative pain, the presence of infection, seroma formation and hernia recurrence. TACKoMESH is a randomised controlled trial that will provide important information on the laparoscopic repair of an incisional hernia; 1) with fascial closure, 2) with an IPOM mesh and 3) comparing the use of an articulating mesh-fixation device that deploys absorbable tacks with a straight-arm mesh-fixation device that deploys non-absorbable tacks. METHODS:A prospective, single-centre, double-blinded randomised trial, TACKoMESH, will establish whether the use of absorbable compared to non-absorbable tacks in adult patients undergoing elective incisional hernia repair produces a lower rate of pain both immediately and long-term. Eligible and consenting patients will be randomized to surgery with one of two tack-fixation devices and followed up for a minimum one year. Secondary outcomes to be explored include wound infection, seroma formation, hernia recurrence, length of postoperative hospital stay, reoperation rate, operation time, health related quality of life and time to return to normal daily activity. DISCUSSION:With ongoing debate around the best management of incisional hernia, continued trials that will add substance are both necessary and important. Laparoscopic techniques have become established in reducing hospital stay and rates of infection and report improvement in some patient centered outcomes whilst achieving similarly low rates of recurrence as open surgical techniques. The laparoscopic method with tack fixation has developed a reputation for its tendency to cause post-operative pain. Novel additions to technique, such as intraoperative-sutured closure of a fascial defect, and developments in surgical technology, such as the evolution of composite mesh design and mesh-fixation devices, have brought about new considerations for patient and surgeon. This study will evaluate the efficacy of several new technical considerations in the setting of elective laparoscopic incisional hernia repair. TRIAL REGISTRATION:Name of registry - ClinicalTrials.gov Registration number: NCT03434301 . Retrospectively registered on 15th February 2018.

Dataset Information

Prospective, multicenter study of P4HB (Phasix™) mesh for hernia repair in cohort at risk for complications: 3-Year follow-up.

Background

Materials and methods

Results

Conclusions

Publications

Prospective, multicenter study of P4HB (Phasix™) mesh for hernia repair in cohort at risk for complications: 3-Year follow-up.

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