Burst Abdomen, Hernia, Pain, Quality of Life, Wound Infection
Conditions
Keywords
surgery, incisional hernia, woundinfection, burst abdomen, pain
Brief summary
The objective of the study is reduction of the incidence of the most frequent complication of abdominal surgery, incisional hernia. In this multi center double-blinded prospective randomized controlled trial, in which a new suture technique using small bites is compared with the traditionally applied large bites (mass closure) technique for midline incisions.
Interventions
PROCEDUREClosure of the abdominal wall after midline incisions
Closure of the midline incision after any abdominal operation. Suturing of the fascia of the abdominal wall with two different techniques
Sponsors
Sint Franciscus Gasthuis
Vlietland Ziekenhuis
Elisabeth-TweeSteden Ziekenhuis
Meander Medical Center
Kennemer Gasthuis
Rijnstate Hospital
Groene Hart Ziekenhuis
Havenziekenhuis
Red Cross Hospital Beverwijk
Erasmus Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Signed informed consent * All laparotomies with a midline incision * Age \> 18 years
Exclusion criteria
* Previous incisional hernia after midline incision * Previous surgery through a midline incision within 3 months * Pregnancy (in women)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incisional hernia occurrence within one year after operation clinical and/or radiographically detected | one year |
Secondary
| Measure | Time frame |
|---|---|
| postoperative complications; in particular wound infection (during admission), burst abdomen (during admission) and wound pain (measured with a visual analog scale (VAS) during the first 6 days after surgery). | one month |
Countries
Netherlands
Outcome results
None listed