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

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.