Incisional Hernia After Midline LaparotomyNCT07766044
A One-year Follow-up of Incisional Hernia Formation Between Device Assisted and Manual Laparotomy Closure
A study testing Device assisted laparotomy closure and Manual laparotomy closure in people with Incisional Hernia After Midline Laparotomy and Colorectal Cancer, run by Suturion AB at 1 site in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Incisional Hernia After Midline Laparotomy, Colorectal Cancer
- What is being tested?
- Device assisted laparotomy closure and Manual laparotomy closure
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 218 participants
- Where
- 1 siteSweden
- Study dates
- 18 Jul 2026to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >18 years of age
- Patients selected for elective surgical procedure through a midline incision due to colorectal disease
Who cannot join
- Previous surgery including the midline
- Previous hernia including the midline
- Collagen disease
- Disseminated disease at the time of surgery
- Life expectancy less than 1 year.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Helsingborg hospital
Helsingborg, Skåne County, 251 87
Gabriel Börner, MD, PhD, +460704641910, gabriel.borner@med.lu.se
Marcus Edelhamre, Associated professor
About this study
Official title: A One-year Follow-up Comparison of Incisional Hernia Formation Between Device Assisted and Manual Closure in Patients Undergoing Elective Laparotomy for Colorectal Diseases
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.
Read the detailed description
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.
- Being tested
- Device assisted laparotomy closure, Manual laparotomy closure
- Keywords
- Laparotomy, Incisional hernia, Device assisted closure, Small-bites, Burst abdomen, Wound infection, Laparotomy closure
- Medical subject headings
- Colorectal Neoplasms, Incisional Hernia, Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device assisted laparotomy closureDevice
Also called SutureTOOL
SutureTOOL is a single patient device for standardized laparotomy closure. The devices use a 2/0 polydioxanone suture and secures a small-bites closure.
Manual laparotomy closureBehavioural
Standard practice of laparotomy closure using standard needle driver and curved needle
| Study group | Role | What they receive |
|---|---|---|
| Device assisted laparotomy closure | Active comparator | 38 patients undergoing elective treatment for colorectal diseases and abdominal wall closure with a device for standardized laparotomy closure Receives: Device: Device assisted laparotomy closure |
| Manual laparotomy closure | Other | 180 patients undergoing elective treatment for colorectal diseases and abdominal wall closure by manual laparotomy closure Receives: Behavioral: Manual laparotomy closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incisional hernia at 1-year
Incisional hernia detected by review of CT-scan or clinical examination or chart review revealing incisional hernia.
Measured: 1-year
Secondary outcomes (4)
Wound infection
Wound infection detected by reviewing patient chart
Measured: 30 days
Suture length to wound length ratio
Data collected by reviewing operative notes
Measured: At the surgical procedure date
Wound dehiscence
Wound dehiscence detected by review of patient chart.
Measured: 30 days from surgical procedure
Death due to abdominal wall related complication
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study start18 Jul 2026
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incisional Hernia After Midline LaparotomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Cohort study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 218 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suturion AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Lund University, Region Skåne Sweden
- Responsible party
- Principal investigator, Gabriel Börner, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07766044
- Sponsor's protocol ID
- Dnr 2026-00853-01
- Status last verified
- Aug 2026
- First submitted
- 10 Aug 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized data can be shared upon request
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A One-year Follow-up Comparison of Incisional Hernia Formation Between Device Assisted and Manual Closure in Patients Undergoing Elective Laparotomy for Colorectal Diseases
- ClinicalTrials.gov ID
- NCT07766044
- Acronym / sponsor ID
- Dnr 2026-00853-01
- Keywords
- Laparotomy, Incisional hernia, Device assisted closure, Small-bites, Burst abdomen, Wound infection, Laparotomy closure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 218 participants (estimated)
- Lead sponsor
- Suturion ABIndustry (pharma, biotech, devices)
- Collaborators
- Lund University, Region Skåne Sweden
- Study start
- 18 Jul 2026 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 14 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Cohort study
| Arm | Type | Receives |
|---|---|---|
| Device assisted laparotomy closure | Active comparator | Device: Device assisted laparotomy closure38 patients undergoing elective treatment for colorectal diseases and abdominal wall closure with a device for standardized laparotomy closure |
| Manual laparotomy closure | Other | Behavioral: Manual laparotomy closure180 patients undergoing elective treatment for colorectal diseases and abdominal wall closure by manual laparotomy closure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- >18 years of age
- Patients selected for elective surgical procedure through a midline incision due to colorectal disease
Key exclusion criteria (5 listed)
- Previous surgery including the midline
- Previous hernia including the midline
- Collagen disease
- Disseminated disease at the time of surgery
- Life expectancy less than 1 year.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Device assisted laparotomy closureAlso: SutureTOOLSutureTOOL is a single patient device for standardized laparotomy closure. The devices use a 2/0 polydioxanone suture and secures a small-bites closure. | Device | Device assisted laparotomy closure |
| Manual laparotomy closureStandard practice of laparotomy closure using standard needle driver and curved needle | Behavioural | Manual laparotomy closure |
Primary outcome
Incisional hernia at 1-year
Time frame: 1-year
Incisional hernia detected by review of CT-scan or clinical examination or chart review revealing incisional hernia.
4 secondary outcomes
Wound infection
Time frame: 30 days
Suture length to wound length ratio
Time frame: At the surgical procedure date
Wound dehiscence
Time frame: 30 days from surgical procedure
Death due to abdominal wall related complication
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: Yes. Anonymized data can be shared upon request
Related trials for Incisional Hernia After Midline Laparotomy
Not yet recruiting
Prophylactic Mesh Reinforcement Versus Primary Closure After Emergency Midline Laparotomy (PREEMPT)
Incisional Hernia After Midline Laparotomy, Emergency Abdominal Surgery
Active, not recruiting
Clinical Trial on the Use of Stratafix Symmetric vs. Resorbable Monofilament for Closure of Large Median Laparotomy in Oncological Patients
Incisional Hernia After Midline Laparotomy
Recruiting
NoPro - Norwegian Hernia Prophylaxis Study
Incisional Hernia After Midline Laparotomy, Quality of Life (QOL)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Device assisted laparotomy closure and Manual laparotomy closure in people with Incisional Hernia After Midline Laparotomy and Colorectal Cancer, run by Suturion AB at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incisional hernia at 1-year (time frame: 1-year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.