A feasibility and safety trial investigating a device for swift and standardized median laparotomy closure
Börner, Gabriel LU ; Toft, Lena ; Rogmark, Peder LU
and Edelhamre, Marcus
LU
(2025)
In Hernia
29(1).
- Abstract
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... (More)
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.
(Less)
- author
- Börner, Gabriel
LU
; Toft, Lena
; Rogmark, Peder
LU
and Edelhamre, Marcus
LU
- organization
- publishing date
- 2025-12
- type
- Contribution to journal
- publication status
- published
- subject
- keywords
- Abdominal wall closure, Incisional hernia prevention, Innovation, Laparotomy, Suturing technique
- in
- Hernia
- volume
- 29
- issue
- 1
- article number
- 196
- publisher
- Springer
- external identifiers
-
- scopus:105007216597
- pmid:40459612
- ISSN
- 1265-4906
- DOI
- 10.1007/s10029-025-03378-9
- language
- English
- LU publication?
- yes
- id
- 16ebb39c-a5e2-485b-a381-1b2fc63cbde5
- date added to LUP
- 2025-07-14 11:23:26
- date last changed
- 2025-07-15 03:00:11
@article{16ebb39c-a5e2-485b-a381-1b2fc63cbde5,
abstract = {{<p>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.</p>}},
author = {{Börner, Gabriel and Toft, Lena and Rogmark, Peder and Edelhamre, Marcus}},
issn = {{1265-4906}},
keywords = {{Abdominal wall closure; Incisional hernia prevention; Innovation; Laparotomy; Suturing technique}},
language = {{eng}},
number = {{1}},
publisher = {{Springer}},
series = {{Hernia}},
title = {{A feasibility and safety trial investigating a device for swift and standardized median laparotomy closure}},
url = {{http://dx.doi.org/10.1007/s10029-025-03378-9}},
doi = {{10.1007/s10029-025-03378-9}},
volume = {{29}},
year = {{2025}},
}