An interventional study of Device assisted laparotomy closure and Manual laparotomy closure in Incisional Hernia After Midline Laparotomy and Colorectal Cancer, sponsored by Suturion AB. Recruiting at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-02.
Sponsored by Suturion AB · Not applicable, Interventional, and Prevention
The study compares one-year incisional hernia formation between two cohorts of patients that underwent open surgery for colorectal diseases. The patients had the abdominal wall closure performed with either a device for standardized closure or manual closure.
The devices aims to secure the closure technique that is advocated by guidelines and could potentially reduce abdominal wall complications. Upholding closure quality can be cumbersome and time consuming and hence inferior closure can sometimes be associated with manual closure.
Follow-up will include short term complications like wound infection and burst abdomen and one-year follow-up include a review of patients chart and CTscans performed as part of standard clinical practice.
This is a single center retrospective study, comparing short and long term abdominal wall related complications among a cohort of 38 patients that underwent abdominal wall closure with a device for standardized laparotomy closure, and a cohort of 180 patients that underwent closure with manual technique during 2020 to 2023.
Included patients were selected for open surgery for colorectal disease according to institutions standard practice. Patients will be identified from a previous study on the device for standardized laparotomy closure and the controls will be identified through the operation administrative system.
Data on short term complications will be retrieved from the patients chart and incisional hernia will be identified by reviewing the CTscans performed as a part of the standard clinical pathway. Reviewing will be performed according to the EHS classification for incisional hernia by two radiologists blinded for the closure technique.
External statistic analysis will be perfromed. Data will be disseminated as a scientific publication.
6,541 studies on the registry are indexed under Colorectal Neoplasms; 1,667 are open to participants now.
This study's planned enrollment of 218 is above the median of 76 across 4,800 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Suturion AB is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
38 patients undergoing elective treatment for colorectal diseases and abdominal wall closure with a device for standardized laparotomy closure
Device: Device assisted laparotomy closure
180 patients undergoing elective treatment for colorectal diseases and abdominal wall closure by manual laparotomy closure
Behavioral: Manual laparotomy closure
SutureTOOL is a single patient device for standardized laparotomy closure. The devices use a 2/0 polydioxanone suture and secures a small-bites closure.
Also known as: SutureTOOL
Standard practice of laparotomy closure using standard needle driver and curved needle
Incisional hernia at 1-year
Incisional hernia detected by review of CT-scan or clinical examination or chart review revealing incisional hernia.
Time frame: 1-year
Wound infection
Wound infection detected by reviewing patient chart
Time frame: 30 days
Suture length to wound length ratio
Data collected by reviewing operative notes
Time frame: At the surgical procedure date
Wound dehiscence
Wound dehiscence detected by review of patient chart.
Time frame: 30 days from surgical procedure
Death due to abdominal wall related complication
Time frame: 30 days
Demographic data
Demographic data retrieved from patients chart
Time frame: 1 year
Plan to share: Yes — Anonymized data can be shared upon request
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: After publication
Access criteria: upon request
Started Jul 2026 (actual). Primary completion is estimated for Oct 2026, 3 months after the start.
Of 57 industry-sponsored interventional studies with no phase under Colorectal Neoplasms, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 35. This study's planned 3 months is below that.
Counting every sponsor, half of 955 studies reached it within 32 months; a quarter within 14 and three quarters within 60.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Suturion AB