A One-year Follow-up of Incisional Hernia Formation Between Device Assisted and Manual Laparotomy Closure
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.
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Skåne County
-
Helsingborg, Skåne County, Sverige, 251 87
- Rekrytering
- Helsingborg Hospital
-
Kontakt:
- Gabriel Börner, MD, PhD
- Telefonnummer: +460704641910
- E-post: gabriel.borner@med.lu.se
-
Kontakt:
- Marcus Edelhamre, Associated professor
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Device assisted laparotomy closure
38 patients undergoing elective treatment for colorectal diseases and abdominal wall closure with a device for standardized 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.
Andra namn:
|
|
Övrig: Manual laparotomy closure
180 patients undergoing elective treatment for colorectal diseases and abdominal wall closure by manual laparotomy closure
|
Standard practice of laparotomy closure using standard needle driver and curved needle
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Incisional hernia at 1-year
Tidsram: 1-year
|
Incisional hernia detected by review of CT-scan or clinical examination or chart review revealing incisional hernia.
|
1-year
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Wound infection
Tidsram: 30 days
|
Wound infection detected by reviewing patient chart
|
30 days
|
|
Suture length to wound length ratio
Tidsram: At the surgical procedure date
|
Data collected by reviewing operative notes
|
At the surgical procedure date
|
|
Wound dehiscence
Tidsram: 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
Tidsram: 30 days
|
30 days
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Demographic data
Tidsram: 1 year
|
Demographic data retrieved from patients chart
|
1 year
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Postoperativa komplikationer
- Patologiska processer
- Neoplasmer efter plats
- Neoplasmer
- Patologiska tillstånd, anatomiska
- Tarmsjukdomar
- Infektioner
- Gastrointestinala neoplasmer
- Neoplasmer i matsmältningssystemet
- Matsmältningssystemets sjukdomar
- Gastrointestinala sjukdomar
- Intestinala neoplasmer
- Rektala sjukdomar
- Kolonsjukdomar
- Bråck
- Patologiska tillstånd, tecken och symtom
- Incisional bråck
- Kolorektala neoplasmer
- Sårinfektion
Andra studie-ID-nummer
- Dnr 2026-00853-01
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Tidsram för IPD-delning
Kriterier för IPD Sharing Access
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
- CSR
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