A One-year Follow-up of Incisional Hernia Formation Between Device Assisted and Manual Laparotomy Closure

August 28, 2026 updated by: Gabriel Börner, Suturion AB

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

218

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Skåne County
      • Helsingborg, Skåne County, Sweden, 251 87
        • Recruiting
        • Helsingborg Hospital
        • Contact:
        • Contact:
          • Marcus Edelhamre, Associated professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • >18 years of age
  • Patients selected for elective surgical procedure through a midline incision due to colorectal disease

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Device assisted laparotomy closure
38 patients undergoing elective treatment for colorectal diseases and abdominal wall closure with a device for standardized laparotomy closure
Device: Device assisted 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.
Other Names:
  • SutureTOOL
Other: Manual laparotomy closure
180 patients undergoing elective treatment for colorectal diseases and abdominal wall closure by manual laparotomy closure
Behavioral: Manual laparotomy closure
Standard practice of laparotomy closure using standard needle driver and curved needle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1-year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wound infection
Time Frame: 30 days
Wound infection detected by reviewing patient chart
30 days
Suture length to wound length ratio
Time Frame: At the surgical procedure date
Data collected by reviewing operative notes
At the surgical procedure date
Wound dehiscence
Time Frame: 30 days from surgical procedure
Wound dehiscence detected by review of patient chart.
30 days from surgical procedure
Death due to abdominal wall related complication
Time Frame: 30 days
30 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demographic data
Time Frame: 1 year
Demographic data retrieved from patients chart
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Suturion AB

Collaborators

Lund University
Region Skåne Sweden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 18, 2026

Primary Completion (Estimated)

October 30, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

August 10, 2026

First Submitted That Met QC Criteria

August 10, 2026

First Posted (Actual)

August 14, 2026

Study Record Updates

Last Update Posted (Actual)

September 2, 2026

Last Update Submitted That Met QC Criteria

August 28, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dnr 2026-00853-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized data can be shared upon request

IPD Sharing Time Frame

After publication

IPD Sharing Access Criteria

upon request

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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