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

Sponsor
Suturion AB
Study ID
NCT07766044
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • Manual laparotomy closure — BEHAVIORAL
    Standard practice of laparotomy closure using standard needle driver and curved needle

Study Details

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.

Key Dates

First listed
Aug 14, 2026
Start date
Jul 18, 2026
Status verified
Aug 2026
Primary completion
Oct 30, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
218 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • 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
  • Other: Manual laparotomy closure
    180 patients undergoing elective treatment for colorectal diseases and abdominal wall closure by manual laparotomy closure

Primary Outcome Measure

Incisional hernia at 1-year [ Time Frame: 1-year ]

Find similar trials

Nationwide
Colorectal cancer trialsOncology trialsGI oncology trials

Related Studies