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| Name | Class |
|---|---|
| Copenhagen University Hospital at Herlev | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| abdominal binder | Active Comparator | 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. |
|
| no abdominal binder | No Intervention | no abdominal binder |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ETO garments | Device | patients wearing abdominal binder for 7 days postoperatively |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 hours after hernia repair |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | postoperative day 7 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thue Bisgaard, MD | University Hospital HVidovre | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hvidovre Hospital | Hvidovre | CPH | 2650 | Denmark |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | no Abdominal Binder | no abdominal binder |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
patiens were median 51 years, gender M:F=22:6.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Median | Full Range | units on a scale | 24 hours after hernia repair |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mette W. Christoffersen | Hvidovre Hospital University of Copenhagen | 38625826 | mette.willaume@gmail.com |
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| ID | Term |
|---|---|
| D006555 | Hernia, Ventral |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D014340 | Trusses |
| ID | Term |
|---|---|
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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| BG001 | no Abdominal Binder | no abdominal binder was warn |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| no Abdominal Binder |
no abdominal binder |
|
|
| 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. | Posted | Median | Full Range | mL | postoperative day 7 |
|
|
|
| 0 |
| 28 |
| 0 |
| 28 |
| EG001 | no Abdominal Binder | no abdominal binder | 0 | 28 | 0 | 28 |
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