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NCT Number: NCT07766044

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

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.

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Key information

Conditions

Incisional Hernia After Midline Laparotomy Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Hernia Incisional Hernia Infections Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Complications Rectal Diseases Wound Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helsingborg hospital

Helsingborg, Skåne County, 251 87, Sweden

Location status: Recruiting

Location contact

Gabriel Börner, MD, PhD

CONTACT

[email protected]

+460704641910

Marcus Edelhamre, Associated professor

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Device assisted laparotomy closure

Device

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

Manual laparotomy closure

Behavioral

Standard practice of laparotomy closure using standard needle driver and curved needle

Primary outcomes

  1. 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.

Secondary outcomes

  1. Wound infection

    Time frame: 30 days

    Wound infection detected by reviewing patient chart

  2. Suture length to wound length ratio

    Time frame: At the surgical procedure date

    Data collected by reviewing operative notes

  3. Wound dehiscence

    Time frame: 30 days from surgical procedure

    Wound dehiscence detected by review of patient chart.

  4. Death due to abdominal wall related complication

    Time frame: 30 days

Other outcomes

  1. Demographic data

    Time frame: 1 year

    Demographic data retrieved from patients chart

Sponsors and collaborators

Lead sponsor

Suturion AB

Industry

Collaborators

  • Lund University
  • Region Skåne Sweden

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 14, 2026
Registry last updated
Aug 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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