Effects of Umbilical Preparation Before Trans-umbilical Laparo-endoscopic Single-site Surgery on Umbilical Wounds Healing: a Randomized Controlled Trial

Objective: The umbilicus is the only anatomic entrance and incision site for trans-umbilical laparoendoscopic single-site surgery (TU-LESS). Data on incisional surgical site infections (ISSI) and incision healing in TU-LESS are lacking. Therefore, we aimed to observe umbilical incision healing and possible hernia after TU-LESS and explore the efficacy of preoperative umbilicus preparation on ISSI. Subjects and Methods: Consecutive patients aged 18 to 65 years, who were scheduled to undergo TU-LESS at a teaching hospital between March 2020 and November 2021, were enrolled in this prospective study. All patients were randomized to the study group with preoperative umbilicus preparation 30 minutes before patients were sent to the operating room and to the control group without preparation. The umbilical dimple was disinfected twice using povidone-iodine in both groups before the skin incision. The primary outcome was ISSI within 30 days of surgery. Umbilical hernia at 3 months after surgery and perioperative data such as operation time, complications, and incision healing were recorded and compared. Results: A total of 400 patients were recruited for this study. TU-LESS was performed in all patients without major complications. ISSI occurred in 5 patients in the study group (2.5%) and 3 patients in the control group (1.5%), with no significant differences between both groups ( P =0.479). No umbilical hernia occurred in any patient during the 3 months follow-up. Six patients in the study group (3.1%) and 1 in the control group (0.5%) experienced excessive scarring, a relatively high incidence in the study group, though the difference was not statistically significant ( P =0.067). Conclusions: TU-LESS-related umbilical hernias are rare with existing suturing methods. Umbilicus preparation before TU-LESS could not decrease ISSI; however, it increased the nursing workload, which should be avoided.