Hvidovre Hospital
Hvidovre, CPH, 2650, Denmark
NCT Number: NCT01673568
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.
Looking for future studies?
Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Hvidovre, CPH, 2650, Denmark
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
patients wearing abdominal binder for 7 days postoperatively
Other names: longuette, ostomy belt, trusses, girdle
Time frame: 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.
Time frame: 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.
Hvidovre University Hospital
Other
Postoperative Abdominal Binder in Reducing Seroma Formation and Pain After Ventral (Umbi/Epi) Hernia Repair.
Acronym: ABD- BINDER
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT01962480
Hernia, Hernia, Abdominal
Hvidovre, Denmark
View Trial DetailsNCT01784822
Hernia, Hernia, Abdominal
Durham, North Carolina, United States
View Trial DetailsNCT01183325
Congenital, Hereditary, and Neonatal Diseases and Abnormalities, Hernia
Bonheiden, Belgium
View Trial DetailsNCT07451483
Abdominal Neoplasms, Adenocarcinoma
Anderlecht, Brussels Capital, Belgium
View Trial Details