Synthetics, Biologics Compared for Complex Hernia Repairs

Biologic mesh was associated with nearly double the rate of surgical site infections, wound dehiscence and readmissions compared with synthetic mesh in a small randomized controlled trial in patients undergoing complex open ventral hernia repair.

The results, which were presented at the American College of Surgeons 2020 Clinical Congress, come from a pilot study of 87 adults who were treated at a single institution and have been followed for at least one year after surgery. Study participants had a wide range of hernias; approximately two-thirds had a hernia of CDC wound class 2 to 4. The mean mesh area was 390 cm² in the biologic group and 383 cm² in the synthetic group, and component separation was carried out in 32% and 42%, respectively.

Fourteen patients (42.4%) in the biologic mesh group developed major complications, including mesh infection, recurrence and reoperation, compared with eight patients (21.6%) in the synthetic mesh group. Although the difference was not statistically significant (P=0.071), Bayesian analysis demonstrated a 95% probability of an increased risk for major complications with biologic mesh.

The analysis showed no differences in rates of seromas, hematomas or Clavien-Dindo complication grade between mesh groups.

Additional randomized controlled trials with longer follow-up are needed, said lead author Oscar A. Olavarria, MD, a surgery resident with McGovern Medical School at UT Health Science Center, in Houston. He noted that this study is underpowered and should be considered hypothesis generating. It is “a guide to surgeons, not the definitive answer,” he said.

Based on this trial’s results, “there is no clear advantage of biologic mesh over synthetic mesh during open ventral hernia repair when the mesh is placed in the retromuscular position,” Dr. Olavarria said.

Michael J. Rosen, MD, the director of Cleveland Clinic Center for Abdominal Core Health, who is leading another trial examining this question, said: “The results are compelling in that we should at least question the utility of biologic mesh as a whole.”

These findings are the first publicly available data from a randomized controlled trial comparing the two types of mesh in open complex ventral hernia repair. Several larger trials are underway, with at least one having completed accrual.

The UT Health trial used major complications as the primary outcome, grouping together mesh infection, reoperation and recurrence. Using major complications as a composite outcome measure increased the number of events for analysis and reduced the number of patients needed to detect a difference between the two groups, said Benjamin Poulose, MD, the chief of the Division of General and Gastrointestinal Surgery and co-director of the Center for Abdominal Core Health at the Ohio State University Wexner Medical Center, in Columbus. “Although having a composite measure in and of itself is not [a] problem, when it combines different outcomes it can be,” he said.

Patients were operated on between March 2017 and January 2019, and were not suitable candidates for a minimally invasive repair. They were randomized in a 1:1 ratio to a repair with biologic or synthetic mesh. Nearly half were ASA physical status class III to IV, and 34% in the biologic group and 23% in the synthetic group had diabetes, while 11% and 7% were smokers, respectively. About 40% of patients had a recurrent hernia.

Surgeons performed a posterior fascial closure, with posterior component separation if needed, and placed the mesh in retromuscular fashion with anterior fascial closure.

The repairs were performed by surgeons with high volumes of abdominal wall reconstruction, which may limit the generalizability of the findings, the authors said.

They plan to complete three- and five-year follow-up of patients to assess long-term outcomes.

It is possible that biologic mesh has a place in complex open ventral hernia repair, Dr. Olavarria noted. The study did not look at biologic mesh in bridged repairs or in placements other than retromuscular. Mesh in these settings should be studied in randomized controlled trials, he said.

The investigators used a porcine acellular dermal matrix mesh and a mid-density, macroporous polypropylene mesh.

The study will be published in an upcoming issue of Surgical Infections.

A Surgeon and His Art

“The Beach at the Breakers”: A Watercolor by Gerald Marks, MD

The Northeastern Society of Colon and Rectal Surgeons (NESCRS), an amalgam of three societies, as a group, discovered the special joy of including families with their scientific meeting. The creativity of Jim Guthrie, may his soul rest in peace, enabled us to meet in the off-season at the iconic Breakers Hotel in Palm Beach, FL, where we met for over a dozen years. Collectively, we learned the meaning of “gracious living” while we enjoyed what everyone agreed were scientifically superb presentations and discussions frequently heralding important new attitudes and procedures, often in conjunction with Dr. Steven Wexner and the Cleveland Clinic Florida, in Weston. A nightly reception and dinner set the stage for a meaningful social interaction that helped define the exceptional soul of the meeting. This painting is dedicated to the memory of those wonderful meetings and all their extraordinary participants.

This article is from the January 2021 print issue.