Incisional Hernia Clinical Trial
Official title:
The Effect of Postoperative Abdominal Binder to Reduce Seroma Formation and Improve Early Clinical Outcome After Incisional Hernia Repair.
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06016426 -
Mass Closure vs Layer by Layer Closure
|
N/A | |
Recruiting |
NCT05734222 -
Optimization of Surgical Treatment of Patients With Incisional Ventral Hernias
|
N/A | |
Enrolling by invitation |
NCT03105895 -
Prevention of Incisional Hernia With an Onlay Mesh Visible on MRI
|
N/A | |
Completed |
NCT02089958 -
Standardization of Laparoscopic Hernia Repair
|
N/A | |
Completed |
NCT01961687 -
A Prospective, Multi-Center Study of Phasix™ Mesh for Ventral or Incisional Hernia Repair.
|
N/A | |
Completed |
NCT00998907 -
PDS*Plus and Wound Infections After Laparotomy
|
N/A | |
Terminated |
NCT00498810 -
COMplete Versus PArtial Open inCisional Hernia Repair (COMPAC-TRIAL)
|
N/A | |
Completed |
NCT04961346 -
RCT Comparing Lightweight vs. Heavyweight Meshes in Incisional Hernia Repair
|
N/A | |
Terminated |
NCT03912662 -
ProGripTM Self-Gripping Polyester Mesh in Incisional Hernia Prevention
|
N/A | |
Recruiting |
NCT05620121 -
ACute Treatment of Incisional Ventral Hernia
|
||
Recruiting |
NCT03561727 -
Risk Factors for Development of Incisional Hernia in Transverse Incisions
|
N/A | |
Completed |
NCT03938688 -
Randomized Control Trial Comparing Transfascial Suture for Mesh Fixation to No Mesh Fixation
|
N/A | |
Not yet recruiting |
NCT05568238 -
Vacuum Assisted Wound Closure and Permanent On-lay Mesh-mediated Fascial Traction in Patients With Open Abdomen
|
N/A | |
Not yet recruiting |
NCT02896686 -
Efficacy of an Onlay Mesh for Prevention of Incisional Hernia After Loop Ileostomy Closure
|
Phase 4 | |
Recruiting |
NCT02277262 -
PROPHYlactic Implantation of BIOlogic Mesh in Peritonitis (PROPHYBIOM)
|
Phase 4 | |
Active, not recruiting |
NCT02328352 -
"BP as a New Device for Surgery and Solid Cancer and Hematopoietic System Tumors Treatment. Effects of BP Implantation"
|
Phase 1/Phase 2 | |
Suspended |
NCT01520168 -
Composix Kugel Mesh Recall Leaves Unresolved Problems of Patient Management
|
N/A | |
Completed |
NCT05579652 -
Change in Fascial Tension in Open Abdomens
|
||
Active, not recruiting |
NCT03390764 -
Hernia After Colorectal Cancer Surgery
|
N/A | |
Completed |
NCT02321059 -
Validation of the Goodstrength System for Assessment of Abdominal Wall Strength in Patients With Incisional Hernia
|
N/A |