Colorectal Cancer, Incisional Hernia After Midline Laparotomy
Conditions
Keywords
Laparotomy, Incisional hernia, Device assisted closure, Small-bites, Burst abdomen, Wound infection, Laparotomy closure
Brief 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.
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.
Interventions
DEVICEDevice 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.
BEHAVIORALManual laparotomy closure
Standard practice of laparotomy closure using standard needle driver and curved needle
Sponsors
Suturion AB
Lund University
Region Skåne Sweden
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Cohort study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incisional hernia at 1-year | 1-year | Incisional hernia detected by review of CT-scan or clinical examination or chart review revealing incisional hernia. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wound infection | 30 days | Wound infection detected by reviewing patient chart |
| Suture length to wound length ratio | At the surgical procedure date | Data collected by reviewing operative notes |
| Wound dehiscence | 30 days from surgical procedure | Wound dehiscence detected by review of patient chart. |
| Death due to abdominal wall related complication | 30 days | — |
Countries
Sweden
Outcome results
None listed