Incisional Hernia
Conditions
Brief summary
Postoperative seroma formation is one of the most common complications after ventral hernia repair with mesh. Although some seromas may not have clinical impact postoperative seroma formation often causes pain and discomfort and may even compromise wound healing. Abdominal binders (also called trusses, girdle, ostomy belt, longuette or abdominal belt) (AB) are commonly used in abdominal and plastic surgery to prevent seroma formation and diminish pain and discomfort after operation. The primary aim of the present study is to investigate the effect of postoperative abdominal binders after laparoscopic incisional hernia repair on postoperative pain, discomfort and quality of life. Secondary, we register seroma formation. A randomized, controlled, investigator-blinded study supplemented with blinded statistical analysis. We include 60 (2x30) incisional hernia repairs. Patients are randomized either to abdominal binder or no abdominal binder (controls). The abdominal binder is worn from immediately after the operation and continuously for 7 days and nights. All patients have a standardized operation with standardized intra- and postoperative medication regimen. Endpoints measurements are clinically detectable seroma formation scored with seroma classification system buý S. Morales-Conde, pain scored with self-registrations with VAS, and quality of life scored with EQ-5D, recurrence and other complications are also registered. Patients are followed until 90 days after the operation.
Interventions
DEVICEAbdominal binder
The abdominal binder is worn from immediately after the operation and continuously for 7 days and nights. The belts are standard abdominal binders (ostomy belts) from ETO garments© with standard height of 22 cm. and five different sizes in width (S, M, L, XL, XXL- depending on waist measure). A fitting will be done for all included patients before the operation by waist measurement according to the recommendation from the company (see below). When applied, the patients are advised to apply the belt in a lying position.
Sponsors
Hvidovre University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* elective, primary and recurrent laparoscopic and open incisional hernia repair hernia with mesh reinforcement * fascia defects 6-20 cm measured preoperatively by the surgeon at the out-patient clinic * patients between 18-80 years
Exclusion criteria
* expected low compliance (language problems, dementia and abuse etc.) * fascia defects \>20 cm measured at the preoperative clinical examination. * acute operation * decompensated liver cirrhosis (Child-Pugh 3-4) * patients with a stoma * if a secondary operation is performed during the hernia repair procedure. * if a patient withdraws his inclusion consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| seroma formation | 30 days postoperatively | clinically detectable seroma formation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| postoperative pain | pain during the postoperative days 1-3, 7, and 30. | Measured with self-registration VAS scales |
Other
| Measure | Time frame | Description |
|---|---|---|
| Quality of life | on day 30 and 90 postoperatively | measured with EQ-5D |
| postoperative complications, readmittance, and need for general practitioner visits | 30 days postoperatively | 30-day complications will be registered by patient interview and by cross-checking patient files and the Danish national patient registry |
| Cosmetic result | 3 months postoperatively | measured with verbal rating scale |
Countries
Denmark
Outcome results
None listed