The effect of an abdominal binder on postoperative outcome after open incisional hernia repair in sublay technique: a multicenter, randomized pilot trial (ABIHR-II)

Abstract

Abstract Introduction Although the evidence is minimal, an abdominal binder is commonly prescribed after open incisional hernia repair (IHR) to reduce pain. This study aimed to investigate this common postoperative treatment. Methods The ABIHR-II trial was a national prospective, randomized, multicenter non-AMG/MPG pilot study with two groups of patients (wearing an abdominal binder (AB) for 2 weeks during daytime vs. not wearing an AB following open IHR with the sublay technique). Patient enrollment took place from July 2020 to February 2022. The primary endpoint was pain at rest on the 14th postoperative day (POD) using the visual analog scale (VAS). The use of analgesics was not systematically recorded. Mixed-effects linear regression models were used. Results A total of 51 individuals were recruited (25 women, 26 men; mean age 61.4 years; mean body mass index 30.65 kg/m2). The per-protocol analysis included 40 cases (AB group, n = 21; No-AB group, n = 19). Neither group showed a significant difference in terms of pain at rest, limited mobility, general well-being, and seroma formation and rate. Patients among the AB group had a significantly lower rate of surgical site infection (SSI) on the 14th POD (AB group 4.8% (n = 1) vs. No-AB group 27.8% (n = 5), p = 0.004). Conclusion Wearing an AB did not have an impact on pain and seroma formation rate but it may reduce the rate of postoperative SSI within the first 14 days after surgery. Further trials are mandatory to confirm these findings.