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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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

Study 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.

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.

Eligibility

Primary outcome measure(s)

• Incisional hernia at 1-year — 1-year
  Incisional hernia detected by review of CT-scan or clinical examination or chart review revealing incisional hernia.

Trial sites (1)

Other trials for the same condition