A feasibility and safety trial investigating a device for swift and standardized median laparotomy closure

This is the authors' abstract. We don't add key points for this paper.

PURPOSE: Abdominal wall complications can be reduced by adhering to guidelines for midline laparotomy closure. However, implementation of guidelines can be challenging. To address this issue, a laparotomy closure device for swift and standardized abdominal closure was developed. The study evaluated the quality of the suture, safety, and speed of the device in a clinical setting. METHODS: A prospective, one-armed investigation was carried out. Five surgeons participated in the study. The introduction to the device involved reading the user instructions and unsupervised dry lab training. Thirty-eight patients with colorectal disease, selected for laparotomy, were recruited. The primary endpoint was the proportion of patients that received a fascial closure with a suture-length to wound-length (SL/WL) ratio ≥ 4. Secondary endpoints included suturing time, glove puncture rate, wound infection (SSI), burst abdomen, and other adverse events. Follow-up included physical examination during hospital stay and postoperative visit and chart review six weeks postoperatively. RESULTS: All patients achieved the primary endpoint SL/WL ratio ≥ 4. The mean suturing time was 10.5 min, while the mean net closure time (NCT) was 7.4 min. The shortest NCT recorded was 2.2 min. Net mean closure speed was 27 s/cm. There were no glove punctures. One case of SSI was reported, and no burst abdomen was detected. The learning curve stabilized after the third fascial closure. CONCLUSION: The SutureTOOL is a promising device for clinical application. It is perceived as safe, user-friendly, and fast, yielding a standardized laparotomy closure with a brief learning curve. The next steps involve a multi-center randomized trial to evaluate the potential impact of SutureTOOL on short- and long-term complications related to abdominal wall closure.