Ventral Hernias
Conditions
Brief summary
Postoperative seroma formation is one of the most common complications after ventral hernia repair. Although some seromas may not have clinical impact, postoperative seroma formation often causes pain and discomfort and may even compromise wound healing. The use of postoperative abdominal binder is often recommended after ventral hernia repair to prevent seroma and diminish pain, but still with no scientific evidence. The primary aim of the present study is to investigate the effect of postoperative abdominal binders after laparoscopic ventral hernia repair on postoperative pain, discomfort and quality of life. Secondary, we register seroma formation. Method and material Randomized, controlled, multi-center, investigator-blinded study. A minimum of 56 patients (2X28 umbi/epi) are included, inclusion number is based on power calculations. Patients are randomized either to abdominal binder or no abdominal binder. The abdominal binder is worn from immediately after the operation and continuously for 7 days, night and day. Outcomes are based on patient self-reported registrations using Visual Analog Scales (VAS) and Carolina Comfort Scale (CCS), which is a validated, hernia-specific tool to estimate quality of life, pain and discomfort. Patients are followed-up for 30 days. For secondary outcome we use ultrasound to measure the volume of seroma formation. We use Mann-Witney, non-parametric statistics calculating the seroma formation and Friedmanns test for pain, discomfort and quality of life for the effect of time on inter- and intragroup differences during the study period. P \< 0.05 is considered significant.
Detailed description
Postoperative seroma formation is one of the most common complications after ventral hernia repair. Although some seromas may not have clinical impact postoperative seroma formation often causes pain and discomfort and may even compromise wound healing. Several interventional procedures have been investigated to reduce or avoid postoperative seroma formation such as removal of the hernia sac, VAC (vacuum-assisted closure) therapy, talcum application to the subcutaneous layer, suction etc., but results are conflicting and evidence is of poor quality. The use of postoperative abdominal binder is often recommended after ventral hernia repair to prevent seroma and diminish pain, but still with no scientific evidence. Randomized, controlled, multi-center, investigator-blinded study supplemented with blinded statistical analysis (see below). 56 patients (2 x 28, umbi/epi) Due to power calculations. An intention to treat analysis is done. Patients are randomized either to abdominal binder or no abdominal binder. The abdominal binder is worn from immediately after the operation and continuously for 7 days, night and day. The belts are standard elastic belts (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 before the operation by waist measurement according to the recommendation from the company. Patients are followed-up for 30 days with clinical follow-up at day 7 and 30.
Interventions
DEVICEETO garments
patients wearing abdominal binder for 7 days postoperatively
Sponsors
Copenhagen University Hospital at Herlev
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 umbilical and epigastric hernia repair with mesh reinforcement * Fascia defects 2-8 cm measured preoperatively by the surgeon at the out-patient clinic for umbi/epi * Elective, primary and recurrent laparoscopic trocar-site hernia * Patients between 18-80 years
Exclusion criteria
* Open ventral hernia repair * Expected low compliance (language problems, dementia and abuse etc.) * Fascia defects \>8 cm at the preoperative clinical examination. * Acute operation * Chronic pain syndrome * Decompensated liver cirrhosis (Child-Pugh B-C) * Patients with a stoma * If a secondary operation is performed during the hernia repair procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale of Pain Activity | 24 hours after hernia repair | Outcome is based on patient self-reported registrations using Visual Analog Scales (VAS) where 0 is no pain in activity and 100 is worst imaginable pain in activity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Seroma Formation | postoperative day 7 | Seroma formation measured on day 7 postoperatively with trans abdominal ultrasound scan (US). The method used in this study to estimate the volume of seroma is to measure the longitudinal section and cross section of the effusion and thereby calculating the volume. |
Countries
Denmark
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Abdominal Binder The abdominal binder is worn from immediately after the operation and continuously for 7 days, night and day. The belts are standard elastic belts (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 before the operation by waist measurement according to the recommendation from the company.
ETO garments: patients wearing abdominal binder for 7 days postoperatively | 28 |
| no Abdominal Binder no abdominal binder was warn | 28 |
| Total | 56 |
Baseline characteristics
| Characteristic | Abdominal Binder | no Abdominal Binder | Total |
|---|---|---|---|
| Age, Continuous | 51 years | 51 years | 51 years |
| Sex: Female, Male Female | 6 Participants | 6 Participants | 12 Participants |
| Sex: Female, Male Male | 22 Participants | 22 Participants | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 28 | 0 / 28 |
| serious Total, serious adverse events | 0 / 28 | 0 / 28 |
Outcome results
Primary
Visual Analog Scale of Pain Activity
Outcome is based on patient self-reported registrations using Visual Analog Scales (VAS) where 0 is no pain in activity and 100 is worst imaginable pain in activity.
Time frame: 24 hours after hernia repair
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Abdominal Binder | Visual Analog Scale of Pain Activity | 50 units on a scale |
| no Abdominal Binder | Visual Analog Scale of Pain Activity | 70 units on a scale |
Secondary
Seroma Formation
Seroma formation measured on day 7 postoperatively with trans abdominal ultrasound scan (US). The method used in this study to estimate the volume of seroma is to measure the longitudinal section and cross section of the effusion and thereby calculating the volume.
Time frame: postoperative day 7
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Abdominal Binder | Seroma Formation | 7 mL |
| no Abdominal Binder | Seroma Formation | 9 mL |