Pain, Quality of Life, Recurrence
Conditions
Keywords
Ventral hernia, Laparoscopy, Robot-assisted, pain
Brief summary
Laparoscopic ventral hernia repair (LVHR) may be associated with chronic pain, seroma formation, bulging and failure to restore abdominal wall function. These outcomes are risk factors for hernia recurrence and poor quality of life (QoL). Our study evaluates whether robotic-assisted ventral hernia repair (rVHR) diminish these complications compared to LVHR with primary closure of the defect (hybrid).
Detailed description
Thirty patients undergoing incisional ventral hernia operation with fascial defect size from 3 to 6 cm will be recruited. Fifteen patients undergo rVHR and fifteen undergo hybrid operation.The main outcome measure is postoperative pain, evaluated with visual analogue scale (VAS: 0-10) preoperatively, at 1-week, at 1-month and at 1-year. Hernia recurrence will be evaluated with ultrasound examination at 1-year and QoL using the generic SF-36 short form questionnaire preoperatively, at 1-month and at 1-year.
Interventions
Sponsors
Kuopio University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* ventral hernia size 3-6 cm
Exclusion criteria
* previous ventral hernia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Robotic-assisted ventral hernia repair vs hybrid. Change in pain | 1-year | VAS scale from 0 to 10. Zero in VAS is no pain and number ten is the highest possible pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Robotic-assisted ventral hernia repair vs hybrid. Change in the social functioning status. | 1-year | SF-36. Scale from 0 to 100. For all scales, higher scores (100) represent better function or outcome |
Countries
Finland
Contacts
Primary ContactPirjo Käkelä, PhD
Backup ContactKirsi Mustonen, MD
Outcome results
None listed