Injury of Abdominal Wall
Conditions
Keywords
Laparotomy, short stitch, long stitch, MonoMax
Brief summary
The major long term complication of abdominal wall closure after a median laparotomy is the development of an incisional hernia. Several suture technique and suture material have been used but the incidence of this complication still lies between 9 -20%. Synthetic suture material which have become available over the last decades have the advantage that they are degraded by the body system and fully absorbed within 70-180 days; however they loss 50% of their initial strength already after 14-30 days and may not be the optimal suture material for abdominal wall closure. A new suture material (Monomax®) was developed with an extra-long absorption profile, high elasticity and with a superior initial strength. Therefore, the ESTOIH-Study was designed to investigate the influence of the stitch length on the occurrence of incisional hernia using the extra-long term absorbable, elastic, monofilament suture (Monomax®).
Interventions
AWC with the long stitch technique using MonoMax USP 1, 150 cm loop, HR48 mm
Short stitch suture technique using MonoMax USP 2/0, 150 cm, HR26 mm
Sponsors
Study design
Eligibility
Inclusion criteria
* Age ≥18 years * Patients undergoing an elective, primary median laparotomy with an incision length of ≥ 15 cm * Expected survival time longer than 1 year * ASA I-III * Written informed consent
Exclusion criteria
* Emergency surgery * Patient undergoing surgery due to a pancreas carcinoma * Patients who will be operated due to an abdominal aortic aneurysm * Peritonitis * Coagulopathy * Current immunosuppressive therapy (more than 40 mg of a corticoid per day or azathioprin) * Chemotherapy within the last 2 weeks before operation * Radiotherapy of the abdomen within the last 6 weeks before operation * Pregnant women (pregnancy test has to be performed) * Severe neurologic and psychiatric disease * Lack of compliance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incisional hernia rate | 1 year postoperatively | Incisional hernia rate 1 year postoperatively (assessment by ultrasound). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reoperation due to burst abdomen | participants will be followed for the duration of hospital stay, an expected average of 10 days | Burst abdomen is defined as a clinically evident rupture of the laparotomy wound |
| Frequency of wound infections | participants will be followed for the duration of hospital stay, an expected average of 10 days and 30 days postop | Wound infections are classified according to the US centres for disease control and prevention (CDC) as either deep or superficial. |
| Wound healing complications | until 30 days postoperatively | Wound healing complications: Seroma, hematoma, necrosis, fistula |
| Long Term Incisional hernia rate | 3 and 5 years postoperatively | assessment by ultrasound |
| Frequency of burst abdomen | participants will be followed for the duration of hospital stay, an expected average of 10 days | Burst abdomen is defined as a clinically evident rupture of the laparotomy wound |
| Long Term Wound healing complications | until 1 year postoperatively | Wound healing complications: Seroma, hematoma, necrosis, fistula |
| Costs | until 5 years postop | Costs including material cost, cost per operation minute, cost per hospital stay, cost saving per incisional hernia. |
| Length of postoperative hospital stay | participants will be followed for the duration of hospital stay, an expected average of 10 days | Number of days the patient has to stay in hospital after the intervention |
| Course of Health status with EQ-5D Score | preop, 30 days postop, 1 year, 3 years, 5 years postop | The EQ-5D-5L essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. Each answer results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions are combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement. |
| Long term Wound infections | 1 year postoperatively | Wound infections are classified according to the US centres for disease control and prevention (CDC) as either deep or superficial. |
Countries
Austria, Germany