A randomized controlled trial comparing large versus small stitch incision closure in gynaecological malignancies (CLaSSIC Study)
The study aimed to compare Small Stitch Closure (SSC) and Large Stitch Closure (LSC) techniques for reducing incisional ventral hernia (IVH) and surgical site infection (SSI) rates in gynaecological malignancies. We conducted a single-blind, randomised controlled trial at our gynaecological oncology department. Patients aged ≥18 years scheduled for elective oncological surgery with midline laparotomy were randomly assigned to receive small stitches of 5 mm every 5 mm or large stitches of 1 cm every 1 cm. Between March 1, 2022, and August 13, 2023, 218 patients were randomly assigned to either the LSC group (n = 110) or the SSC group (n = 108). Follow-up ended on August 20, 2024, with 213 patients completing it. After one year, the SSC group had significantly lower rates of IVH at 3.7 % compared to 12.1 % for the LSC group (p = 0.02); this difference remained significant in multivariate analysis (p = 0.04, OR: 5.78). SSI rates were similar, with the LSC group at 2.8 % and the SSC group at 3.5 % (p = 0.11). In the multivariate analysis, preoperative chemotherapy was significantly associated with IVH (p = 0.04, OR: 3.83), while a postoperative hospital stay of 72 h or more increased the risk of SSI (p = 0.02, OR: 11.51). LSC was associated with a significantly higher rate of IVH compared to SSC, while SSI rates were similar between both groups. Preoperative chemotherapy was a key factor influencing IVH, and a longer postoperative hospital stay led to increased SSI rates.
